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John W. Dean III's Files
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DOCUMENT WITHDRAWAL RECORD (NIXON PROJECT)
DOCUMENT
DOCUMENT
SUBJECT/TITLE OR CORRESPONDENTS
DATE
RESTRICTION
NUMBER
TYPE
1
meno
Memo from William E. Ryan, Chief,
Narcotic and Dangerous Drug Section to
Feb, 1970
P
John Dear concerning case pending
against Edward J. Doherty, 2 copies, Hpp
attached to correspondence between
Sidney Greenberger and John Deen
2
memo
Michael R. Sonnen reich to John Dean
commenting on proposed drug legislation,
May 21, 1969
B (c)
2 copies, 2 PP.
FILE GROUP TITLE
BOX NUMBER
WHSF - Staff Member and Office Files- John Dean
2437
FOLDER TITLE
[Mministation Drug Bill
RESTRICTION CODES
A. Release would violate a Federal statute.
E. Release would disclose trade secrets or confidential commercial or finan-
B. National security classified information.
cial information.
C. Pending or approved claim that release would violate an individual's
F. Release would disclose investigatory information compiled for law
rights.
enforcement purposes.
D. Release would constitute a clearly unwarranted invasion of privacy or a
G. Withdrawn and return private and personal material.
libel of a living person.
H. Withdrawn and returned non-historical material.
GENERAL SERVICES ADMINISTRATION
GSA FORM 7279 (10-79)
Reproduced at the Richard Nixon Presidential Library
NO-KNOCK AND NONSENSE, AN ALLEGED
CONSTITUTIONAL PROBLEM
MICHAEL R. SONNENREICH
STANLEY EBNER
Reprinted from
ST. JOHN'S LAW REVIEW
Volume 44, No. 4, April 1970
Copyright, © 1970, by St. John's Law Review Association
Brooklyn, New York
Reproduced at the Richard Nixon Presidential Library
NO-KNOCK AND NONSENSE, AN ALLEGED
CONSTITUTIONAL PROBLEM+
MICHAEL R. SONNENREICH*
STANLEY EBNER**
On July 16, 1969, the Nixon Administration sent to the Congress
a major revision of the existing federal narcotic and dangerous drug
laws entitled the Controlled Dangerous Substances Act.¹ Hearings
have been held in the Senate and much debate has ensued. In addition
to discussions concerning penalties, industry regulation and research,
one item has attracted a great deal of attention, indeed, far more than
anyone involved with the proposal originally thought. From the first,
"no-knock" was the lead for newspaper articles concerning the bill.²
It became immediately apparent that there existed a great deal of
misinformation about this no-knock authority and its impact upon the
average citizen. Visions of kicked-in doors, sinister police invading resi-
dences in the dark of night, and other manifestations of the "police
state" sprang to mind. In addition to this popular misconception, the
only formal disagreement to come out of the Senate Judiciary Com-
mittee, which reported favorably on the Controlled Dangerous Sub-
stances Act, concerned no-knock and questioned its constitutionality.
Indeed, this controversy eventually led to a revision of the original
no-knock provision before the proposed Act was passed by the Senate.
The House has not yet acted on the bill.
This article has been written to place the issue in proper perspec-
tive. The historical origins of no-knock in the common law will be
traced, and the relevant state statutes and decisions will be analyzed.
The federal posture, legislation and case law, will also be examined.
Finally, the article will refocus upon the proposed Controlled Dan-
gerous Substances Act and its no-knock provision, section 702(b). It is
the opinion of the authors that this section is, in fact, a realistic com-
promise between those who favor the common-law exception in its
+ The views expressed herein are those of the authors and do not necessarily repre-
sent the views of the Bureau of Narcotics and Dangerous Drugs specifically, nor of the
Department of Justice generally. The authors wish to acknowledge the invaluable as-
sistance of Roy E. Kinsey and Robert G. Pinco.
*
Deputy Chief Counsel, Bureau of Narcotics and Dangerous Drugs, United States
Department of Justice. B.A., University of Wisconsin, 1960; LL.B., Harvard University,
1963.
Legislative Attorney, Office of the Deputy Attorney General, United States De-
partment of Justice. B.A., Yale University, 1955; LL.B., Yale University, 1958.
1 S.3246, 91st Cong. 2d Sess. (1970).
2 See, e.g., Stokes, Nixon's Drug Bill, THE NATION, Sept. 22, 1969, at 271.
626
Reproduced at the Richard Nixon Presidential Library
NO-KNOCK AND NONSENSE
627
totality and those who insist that such authority is an unconstitutional
invasion of privacy.
I. HISTORICAL DEVELOPMENT OF "THE KNOCK"
COMMON LAW
England
A man's home, mortgaged though it may be, has long been consid-
ered under Anglo-American tradition to be his castle. Indeed, this
principle is embodied in the fourth amendment to the United States
Constitution, which prohibits "unreasonable searches and seizures."
Yet, long before the framers of that document set quill to ink, the
English judiciary had consistently been compelled to consider the issue
of the King's right of entry into private dwellings. The difficulties
inherently involved in this question can be illustrated by the fact that
the ancient principle which proclaims that "Every man's house is his
castle" is matched in age by the maxim that "The King's keys unlock
all doors."⁴ Actually, these principles relate to different processes, the
former applying to civil actions, and the latter to those of a criminal
nature. Thus, the fifteenth century statement of the rule indicated that
invasion of the home was justified in cases involving a felony; the ap-
prehension of the felon was in the interest of both the common weal
and the King. On the other hand, in cases involving debt or trespass,
the interest of a private party would not justify the invasion of a dwell-
ing to apprehend the wrongdoer.⁵
The most familiar statement of the common-law rule is contained
in Semayne's Case⁶:
In all cases when the King is [a] party, the sheriff (if the doors be
not open) may break the party's house, either to arrest him, or to
do other execution of the [King's] process, if otherwise he cannot
enter. But before he breaks it, he ought to signify the cause of his
coming, and to make request to open [the] doors
7
Since the opinion was actually concerned with a writ issued in a civil
3 The right of the people to be secure in their persons, houses, papers, and
effects, against unreasonable searches and seizures, shall not be violated, and no
Warrants shall issue, but upon probable cause, supported by Oath or affirmation,
and particularly describing the place to be searched, and the persons or things
to be seized.
U.S. CONST. amend. IV.
4 See BROOM'S LEGAL MAXIMS 281, 432 (10th ed. 1929).
5 Y. B. Pasch., 13 Edw. 4, f.9a (1455).
6 77 Eng. Rep. 194 (Ex. 1603). The use of the word "ought" in the last sentence of
the dictum should be noted as it relates to a central issue within the framework of this
article.
7 Id. at 195.
Reproduced at the Richard Nixon Presidential Library
628
ST. JOHN'S LAW REVIEW
[VOL. 44:626
case, it was only by way of dicta that "the knock," or announcement of
purpose, was enunciated as a specific obligation in connection with
authorized entry into private dwellings.
During this period in English history, authorities differed as to the
circumstances under which a breaking of doors would be permissible.
For example, Coke expressed the view in his Fourth Institutes that a
warrant to break open a house in search for a felon, issued upon suspi-
cion, contravened both the Magna Carta and existing case law.⁸ How-
ever, the indictment of the suspected party would empower the sheriff,
by virtue of the warrant, to forcibly enter the house.⁹ On the other
hand, Hale apparently believed that, even in the absence of a warrant,
a constable possessed sufficient power to break open a door whenever a
felony had actually been committed. In addition, he indicated that
when a suspected felon took flight and entered a house, a warrantless
constable could break in if "the door will not be opened upon demand
of the constable and notification of his business."
While the debate continued and the common-law standards
evolved,¹¹ it is apparent that houses were in fact being entered on a
sufficiently indiscriminate basis to contribute to a general feeling of un-
certainty and discontent. 12 Yet, it is clear that during this period, discus-
sion of the governmental right to break and enter private dwellings
centered not upon the necessity of prior warning or announcement of
purpose, but rather, upon the justification for the breaking or, in other
words, the "reasonableness" of the forced entry. Judges and legal schol-
ars of that era were concerned with such relevant questions as: Was
there a warrant? Was there hot pursuit? Was the commission of a felony
observed? Was there an immediate threat of violence or danger to the
law enforcement official? And finally, was there a previous notice of
authority and purpose?¹³
Within the context of the above circumstances, the phraseology
used in Semayne's Case becomes more significant as an expression of
seventeenth century legal philosophy in England. The sheriff "ought"
to signify why he is about to execute the King's process before he
breaks and enters. But the broadest examination of English law and
8 E. COKE, THE FOURTH PART OF THE INSTITUTES OF THE LAWS OF ENGLAND: CONCERN-
ING JURISDICTIONS OF COURT 177 (6th ed. 1681).
9 Id.
10 2 M. HALE, PLEAS OF THE CROWN 90-92 (1st Am. ed. 1847).
11 See W. HOLDSWORTH, HISTORY OF ENGLISH LAW 598 (3d ed. 1934).
12 Similarly, it was the subsequent employment of the so-called "writs of assistance"
during the colonial era which pointed to a parting of the ways between England and her
colonies.
13 See Accarino V. United States, 179 F.2d 456, 460-62 (D.C. Cir. 1949).
Reproduced at the Richard Nixon Presidential Library
1970]
NO-KNOCK AND NONSENSE
629
precedent discloses no evidence that such a suggestion was ever, in fact,
a requirement which would render the subsequent entry legal. For too
long this case has been read out of context; to ignore the precatory
wording is to further confuse the problem.
United States
In the United States, the common-law rule of Semayne's Case
was generally followed in early decisions. Thus, in Oystead U. Shed,14
the Massachusetts Supreme Judicial Court emphasized the right of a
citizen to be free from forcible entry into his home for civil arrest pur-
poses, although there is some question as to whether this pronounce-
ment was necessary to the decision. It was recognized, however, that
force could be utilized when the entry was effected to seize specific
goods (as under writs of attachment). 15 Similarly, it was recognized as
early as 1822 that, if notice was in fact a general requirement, under
certain circumstances that requirement would be rendered unneces-
sary. One such instance was clearly enunciated by a Connecticut court
in Read U. Case,¹⁶ which held that imminent danger to life eliminated
the need to provide notice. Indeed, a later Kentucky case, Hawkins U.
Commonwealth,17 attempted to extend this rule, indicating that no
notice whatsoever was required in criminal cases, since the "offender"
would then be presented with an opportunity to avoid the process of
the law. The continuing uncertainty regarding the notice or announce-
ment aspect in criminal cases was exemplified in Commonwealth U.
Reynolds,18 which attempted to summarize the existing law by stating
that an officer could always break and enter after announcement of
purpose and refusal, but that some courts had refused to impose such
an obligation upon law enforcement authorities where the crime con-
stituted a misdemeanor.
STATUTES
At the turn of the century, the states began to enact statutes specifi-
cally dealing with the authority of an officer to break and enter in order
to make an arrest. 19 Although initially the vast majority of these
statutes expressly required some form of notice prior to forcible entry,2⁰
14 13 Mass. 520 (1816).
15 Keith V. Johnson, 31 Ky. 604 (1833).
16 4 Conn. 166 (1822).
17 53 Ky. 395 (1854).
18 120 Mass. 190 (1876).
19 See notes 21-80 and accompanying text infra for a treatment of various state stat-
utes dealing with the authority to execute search or arrest warrants via forced entry.
20 See Blakey, The Rule of Announcement and Unlawful Entry: Miller U. United
States and Ker v. California, 112 U. PA. L. REV. 499, 508 (1964).
Reproduced at the Richard Nixon Presidential Library
630
ST. JOHN'S LAW REVIEW
[VOL. 44:626
a more recent trend has been toward the elimination of the notice
requirement under specified conditions.
California
California has developed a fairly stringent approach to noncom-
pliance with the "knock and notice" provisions of its penal code. The
California statute closely resembles its federal counterpart, section 3109
of the Criminal Code,²¹ but the decisions of the California judiciary
have developed a far more substantial basis for it than the federal courts.
In addition, the large number of California decisions has placed that
state in a position of leadership with respect to the numerous other
states which have identical or very similar statutes. 22 Thus, it is appro-
priate that our discussion of the relevant statutes should begin with an
examination of the California experience.
Section 844 of the California Penal Code provides:
To make an arrest, a private person, if the offense be a felony, and
in all cases a peace officer, may break open the door or window of
the house in which the person to be arrested is, or in which they
have reasonable grounds for believing him to be, after having
demanded admittance and explained the purpose for which admit-
tance is desired. 23
On its face, the statute is merely a codification of the common law and,
as such, the very fact that the common-law exceptions were omitted
would seem to preclude any form of no-knock arrest or search. Never-
theless, in 1956, compliance with the statute was interpreted by the
California Supreme Court in People U. Maddox²⁴ to be excused under
the common-law exceptions to the rule of announcement. 25 Thus, an-
nouncement before arrest was excused if the facts known to the officer
21 The officer may break open any outer or inner door or window of a house, or
any part of a house, or anything therein, to execute a search warrant, if after
notice of his authority and purpose, he is refused admittance or when necessary
to liberate himself or a person aiding him in the execution of the warrant.
18 U.S.C. § 3109 (1964).
22 See notes 44-80 and accompanying text infra.
23 CALIF. PENAL CODE § 844 (West Supp. 1968).
24 46 Cal. 2d 301, 294 P.2d 6, cert. denied, 352 U.S. 858 (1956). In Maddox, the police
had defendant's premises under surveillance for approximately a month and had wit-
nessed known narcotics addicts frequenting the place. In fact, on the day of the arrest
and immediately prior thereto, the police arrested two addicts who stated that they had
just left the premises. When the police knocked on defendant's door, they were told to
"wait a minute," and then they heard the sound of retreating footsteps. They then broke
the door and entered the house. See also People v. Martin, 45 Cal. 2d 755, 290 P.2d 855
(1955).
25 See 6 C.J.S. Arrest § 14 n.21 (1955).
Reproduced at the Richard Nixon Presidential Library
1970]
NO-KNOCK AND NONSENSE
631
before his entry were sufficient to support his good faith that com-
pliance would have increased his peril or frustrated the arrest. 26 Addi-
tionally, in Maddox, as well as in a series of similar cases which fol-
lowed, destruction of evidence was recognized as another ground for
noncompliance with section 844 or its warrant counterpart, section
1531.27 The destruction exception was traditionally limited to narcotics
and bookmaking paraphernalia, since it was based on the assumption
that, by the very nature of these items, they were easily disposable. The
California courts extended this standard in narcotic cases (which com-
prised the bulk of the cases in this area) by not requiring any showing
whatever of particular exigency, as would generally be required to
excuse compliance with the knock or notice provisions of its statutes.
During the decade following Maddox, the California courts failed
to grant suppression motions on unlawful entry pleas. 28 Finally, in
1967, in an abrupt reversal, the California Supreme Court in People
U. Gastelo²⁹ declared:
we have excused compliance with the statute in accordance with
established common law exceptions to the notice and demand re-
quirements on the basis of the specific facts involved. No such basis
exists for nullifying the statute in all narcotics cases, and, by
logical extension, in all other cases involving easily disposable
evidence.³⁰
Thus, the Court clearly foreclosed noncompliance with the statutory
requirements of knock and notice when such noncompliance was based
solely on the police officer's "general experience relative to the dis-
posability and the kind of evidence sought and the propensity of
offenders to effect disposal. "31
"Just as the police must have sufficiently particular reason to enter
26 Read V. Case, 4 Conn. 166, 170 (1822).
27 The officer may break open any outer door or inner door or window of a
house, or any part of a house, or anything therein, to execute the warrant, if, after
notice of his authority and purpose, he is refused admittance.
CALIF. PENAL CODE § 1531 (West 1956). See cases collected in People V. DeSantiago, 71
A.C. 18, 453 P.2d 353, 76 Cal. Rptr. 809 (1969).
28 See Blakey, supra note 20, at 532 n.245.
29 67 Cal. 2d 586, 432 P.2d 706, 63 Cal. Rptr. 10 (1967). In Gastelo, the police, on
the basis of a reliable informant's report that he had purchased narcotics from defendant
at the apartment of defendant's girlfriend, obtained a warrant for the search of said
apartment. Early one morning four officers went to the apartment, and without knocking,
announcing their purpose or demanding admittance, they forced entry. The police served
the warrant, searched the apartment and found a small packet of heroin. Defendant was
arrested and later confessed to possession of the heroin. On appeal from his conviction,
defendant contended that the trial court had committed prejudicial error in admitting
the heroin into evidence over his objection that it was illegally seized.
30 Id. at 588, 432 P.2d at 708, 63 Cal. Rptr. at 12.
31 People V. DeSantiago, 71 A.C. 18, 24, 453 P.2d 353, 359, 76 Cal. Rptr. 809, 815 (1969).
Reproduced at the Richard Nixon Presidential Library
632
ST. JOHN'S LAW REVIEW
[VOL. 44:626
at all, so must they have some particular reason to enter in the manner
chosen."³ The Court further stated that the particular reason for the
mode of entry had to be based upon specific facts which would lead a
police officer to reasonably conclude that the occupants of the place to
be searched had resolved to effect disposal in the event of police intru-
sion.³³
A month and a half later, in Meyer U. United States,³⁴ the United
States Court of Appeals for the Ninth Circuit, citing the Gastelo case,
granted a motion to suppress evidence seized in a raid on a "bookie
operation where officers had no reason for omitting a prior announce-
ment of their identity and purpose except general knowledge that de-
struction of evidence [betting slips] was likely in this type of offense."
The court, quoting from Gastelo, stated:
Under the Fourth Amendment, a specific showing must always be
made to justify any kind of police action attempting to disturb
the security of people in their homes. Unannounced forcible entry
is in itself a serious disturbance of that security and cannot be
justified on a blanket basis. Otherwise the constitutional test of
reasonableness would turn only on practical expediency, and the
amendment's primary safeguard - the requirement of particular-
ity - would be lost. 36
It at once became apparent that Gastelo (on the state level) and
Meyer (on the federal level) were redefining the constitutional and
practical limits of the knock and announce rule in a relatively exacting
manner. Then, in People U. Carillo,³⁷ the California Court retreated
slightly from the strict position it had assumed in Gastelo, by permit-
ting noncompliance when, immediately prior to entry, the arresting
officers were able to detect activity from within the residence which
might lead them to reasonably conclude that the occupants within were
then engaged in the destruction of the evidence sought.
In People U. Rosales,³⁸ and again in Greven U. Superior Court,³⁹
the Court attempted to clearly delineate the parameters of excusable
noncompliance with the knock and notice requirements of sections 844
and 1531. Defining the constitutional basis of the announcement re-
32 67 Cal. 2d 586, 588, 432 P.2d 706, 708, 63 Cal. Rptr. 10, 12 (1967).
33 Cf. People V. Barnett, 156 Cal. App. 2d 803, 320 P.2d 128 (1958).
34 386 F.2d 715 (9th Cir. 1967).
35 Id. at 718.
36 Id.
37 64 Cal. 2d 387, 412 P.2d 377, 50 Cal. Rptr. 185 (1968), citing Ker v. California, 374
U.S. 23, 46 (1963) (dissenting opinion of Mr. Justice Brennan).
38 68 Cal. 2d 299, 437 P.2d 489, 66 Cal. Rptr. 1 (1968).
39 71 A.C. 303, 455 P.2d 432, 78 Cal. Rptr. 504 (1969).
Reproduced at the Richard Nixon Presidential Library
1970]
NO-KNOCK AND NONSENSE
633
quirement, the Rosales Court stated "that [this] requirement is
the
essence
which safeguard[s] individual liberty."40 The Court also
emphasized that such rules reflect a concern not only for the rights of
persons suspected of crimes but also for the security of innocent persons
who may be on the premises. Similarly, the Greven Court noted that
"the reverence of the laws for the individual's right of privacy in his
house [is paramount],"⁴¹ and then expounded upon the public policy
argument of discouraging, whenever possible, creation of situations
conducive to violence.⁴² It went on to state that substantial compliance
with the knock and notice rule required at least an identifying an-
nouncement by officers, even if the exigencies of the situation would
have prevented a statement of purpose. This, the Court stated, was as
far as the case would stretch the term "substantial compliance" for
excusing law enforcement authorities from the mandates of sections 844
and 1531 of the penal code.
Thus, the California courts have placed the fourth amendment in
a fairly prominent position, restricting to a great degree the latitude
of discretion previously accorded law enforcement authorities. But
the restrictions have been fairly realistic, leaving the court, rather
than a formalistic rule, the arbiter of new situations arising out of
searches and arrests. This approach, as will be seen, is far more flexible
than the District of Columbia's approach which rejects most judicial
exceptions to its knock and notice statute. 43
Florida
Florida has a statute similar to California, but has adopted a much
stricter approach to its interpretation. 44 For example, in Benefield U.
40 68 Cal. 2d at 304, 437 P.2d at 492, 66 Cal. Rptr. at 4, quoting Ker v. California,
374 U.S. 23, 49 (1963) (dissenting opinion of Mr. Justice Brennan). The Court also quoted
from Miller v. United States, 357 U.S. 301 (1958), but did not apply the virtually certain
test. Rather, the Court required a reasonable good faith belief as to the exceptions to
the announcement requirement provided such belief was accompanied by more than
general knowledge as to the comparative ease of disposing of narcotics. For a discussion
of Miller, see notes 85-96 and accompanying text infra. Rosales held that the failure of
the enforcement authorities to explain their purpose and demand entrance vitiated the
arrest. The police, acting on information that defendant was selling narcotics, had ob-
served him from the window and surrounded the house prior to forcing entry. Under these
facts, noncompliance with section 844 could not be excused since there was "no suspicious
activity," and "no evidence that would justify a belief that such compliance would have
increased the officer's peril, frustrated the arrest, or resulted in the destruction of the
evidence."
41 71 A.C. at 306, 455 P.2d at 435, 78 Cal. Rptr. at 507, quoting Miller V. United
States, 357 U.S. 301, 313 (1958).
42 Id. at 307, 455 P.2d at 436, 78 Cal. Rptr. at 508.
43 See Miller V. United States, 357 U.S. 301, 309 (1958); Hair v. United States, 289
F.2d 894 (D.C. Cir. 1961).
44 FLA. STAT. ANN. § 901.19 (1965).
Reproduced at the Richard Nixon Presidential Library
634
ST. JOHN'S LAW REVIEW
[VOL. 44:626
State,⁴⁵ the Supreme Court of Florida noted that its statute, a mere
codification of the common law, was not burdened by the exceptions
to the knock and announce rule which had been engrafted by the Cali-
fornia courts onto their statute. 46 Nonetheless, the Court then devised
four exceptions to the Florida rule:
1. where the person within already knows the officer's au-
thority and purpose;
2. where the officers are justified in the belief that the persons
within are in imminent peril of bodily harm;
3. if the officer's peril would have been increased had he de-
manded entrance and stated the purpose or,
4. where those within made aware of the presence of someone
outside are then engaged in activities which justify the officers in
the belief that an escape or destruction of evidence is being at-
tempted.⁴⁷
The following year, in Koptyra U. State,⁴⁸ the Florida District Court of
Appeals was confronted with a no-notice entry situation in which no
force was involved. An undercover agent, after attending a "pot party"
for a short time, left and returned shortly thereafter with additional
officers to arrest those present at the party. The agent, who was ad-
mitted to the house upon knocking, merely permitted his colleagues to
follow him through the door. In concert, they then proceeded to arrest
the occupants and to search the entire area immediately adjacent
thereto. 49 The court affirmed the conviction, but sidestepped the con-
stitutional issue by distinguishing Benefield on the ground that the case
at bar did not involve a breaking. This interpretation, of course, was
rendered inapplicable.
Thus, it appears that the present state of the exceptions in Florida,
i.e., those stated in Benefield, represent a stricter interpretation of the
common-law exceptions to knock and notice than California has
adopted.
45 160 So. 2d 706 (Fla. 1964). The facts in Benefield closely parallel Miller V. United
States, 357 U.S. 301 (1958). For a discussion of Miller, see notes 85-96 and accom-
panying text infra. The Benefield court rejected the State's reliance upon Ker as justifica-
tion for noncompliance with the statute.
46 Id. at 710.
47 Id. In Benefield, the police gained access to defendant's home by opening an un-
locked door. Immediately prior to the entry, one Hollander had informed the officers
that he had deposited money with defendant as a "payoff" to secure a liquor license.
Under these facts, the unannounced entry was regarded as violative of the Florida
statute.
48 172 So. 2d 628 (Fla. D. Ct. 1965).
49 Under Chimel V. California, 395 U.S. 752 (1969), such a search incidental to an
arrest would no longer be permitted. See notes 123-124 and accompanying text infra.
Reproduced at the Richard Nixon Presidential Library
1970]
NO-KNOCK AND NONSENSE
635
Utah
Utah, Idaho, Iowa and South Dakota,⁵⁰ like Florida and many
other states which have adopted statutes resembling the knock and
notice provisions of the California Penal Code, have used California's
decisions as a basis for interpreting their own statutes. For example,
in 1967, Utah amended its search warrant provision to read:
Officer may break door or window to execute warrant - Au-
thority. The officer may break open any outer or inner door or
window of a house, or any part of a house or anything therein, to
execute the warrant:
(1) If, after notice of his authority and purpose, he is refused
admittance; or
(2) Without notice of his authority and purpose, if the judge,
justice or magistrate issuing the warrant has inserted a direction
therein that the officer executing it shall not be required to give
such notice. The judge, justice or magistrate may so direct only
upon proof under oath, to his satisfaction that the property sought
is a narcotic, illegal drug, or other similar substance which may be
easily and quickly destroyed or disposed of, or that danger to the
life or limb of the officer or any other may result, if such notice
were to be given. 51
Clearly, this provision merely codified California case law as it existed
immediately prior to the Gastelo,⁵² Rosales, 53 and Greven⁵⁴ cases. Al-
though the Utah Supreme Court has not yet interpreted the statute, it
has, in essence (at least on its face), rejected the fourth amendment
based argument. Instead, it has adopted an expanded common-law ap-
proach, requiring a mere affirmation by the arresting officer that the
object sought was of an easily disposable nature without any require-
ment as to the exigencies of the situation. Yet, the Utah Supreme Court
has been at least somewhat cognizant of the constitutional ramifications
of the no-knock provision. In State U. Louden,⁵⁵ the Court, addressing
itself to a slightly different situation, noted that, while constitutional
safeguards were not to be ignored, nevertheless they were to be weighed
against the "practical exigencies of police work. "56 This case seems to
50 UTAH CODE ANN. § 77-13-12 (1953); IDAHO CODE ANN. §§ 19-611, 19-4409 (1948);
IOWA CODE ANN. § 751.9 (1950); S.D. CODE §§ 23-22-18, 23-15-14 (1967).
51 UTAH CODE ANN. § 77-54-9 (1953).
52 67 Cal. 2d 586, 432 P.2d 706, 63 Cal. Rptr. 10 (1967).
53 68 Cal. 2d 299, 437 P.2d 489, 66 Cal. Rptr. 1 (1968).
54 71 A.C. 303, 455 P.2d 432, 78 Cal. Rptr. 504 (1969).
55 15 Utah 2d 64, 387 P.2d 240 (1963).
56 Id. at 67, 387 P.2d at 243. The Court discussed in detail the constitutional safe-
guards espoused by the United States Supreme Court in Ker v. California, 374 U.S. 23
(1963). For a discussion of this case, see notes 100-07 and accompanying text infra.
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have been the extent of Utah's consideration of no-knock, and repre-
sents, at best, an evasion of the constitutional issue - at least for the
time being.
Washington
Washington, which also has a statute similar to California's section
844, has interpreted noncompliance with the knock and announce rule
in a slightly different manner than California. Addressing itself to the
constitutional issue in State U. Young,5⁷ the Supreme Court of Washing-
ton held that, "when officers come armed with a search warrant,
forcible entry without announcement of identity and purpose may be
justified when exigent and necessitous circumstances exist."⁵⁸ Since
such circumstances may be deemed to exist when, "narcotics or other
property subject to immediate destruction" are involved,⁵⁹ the Wash-
ington Court adopted a position which is roughly analogous to the
post-Maddox attitude of the California courts. 60
New York, Nebraska, South Carolina and North Dakota
Several states have adopted a slightly different approach to the no-
knock exceptions to the rule requiring notice of identity and purpose
by the arresting officer. Nebraska, New York, North Dakota and South
Carolina⁶¹ have included the requirement of judicial approval for a
no-knock direction to any arrest or search warrant. Illustrative is sec-
tion 799 of the New York Code of Criminal Procedure which specifies:
The officer may break open an outer or inner door or window
of a building, or any part of the building, or anything therein, to
execute the warrant, (a) if, after notice of his authority and pur-
pose, he be refused admittance, or (b) without notice of his au-
thority and purpose, if the judge, justice or magistrate issuing the
warrant has inserted a direction therein that the officer executing
it shall not be required to give such notice. The judge, justice or
magistrate may so direct only upon proof under oath, to his satis-
faction, that the property sought may be easily and quickly de-
stroyed or disposed of, or that danger to the life or limb of the
officer or another may result, if such notice were to be given. 62
57 76 Wash. 2d 212, 455 P.2d 595 (1969).
58 Id. at 214, 455 P.2d at 598. The Court cited both Ker v. California, 374 U.S. 23
(1963) and Miller V. United States, 357 U.S. 301 (1958). Id. at 213-14, 455 P.2d at 597.
59 The Washington Supreme Court specifically noted that its new rule was similar
to the Maddox case. Id. at 214, 455 P.2d at 598.
60 Id.
61 NEB. REV. STAT. § 29411 (1965); N.Y. CODE CRIM. PROC. §§ 175, 178, 799 (McKinney
1964); N.D. CODE § 29-29.1-01 (1967); S.C. CODE §§ 17-257, 53-198 (1962).
62 N.Y. CODE CRIM. PROC. § 799 (McKinney 1964).
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There is presently a controversy as to whether the addition of this
clause requiring judicial approval will satisfy the fourth amendment
reasonableness requirement set out by the United States Supreme
Court in Ker U. California.⁶³ One point of view can be found in People
U. DeLago.⁶⁴ There, the New York Court of Appeals permitted police
officers armed with a search warrant to make an unannounced entry at
the apartment of the defendant where
it was represented to the court by affidavit that gambling materials
were likely to be found at this location and in issuing the warrant,
the court could take judicial notice that contraband of that nature
is easily secreted or destroyed if persons unlawfully in possession
thereof are notified in advance that the premises are about to be
searched. 65
Citing and discussing Ker and Maddox, the Court found that the police
tactics were inoffensive to constitutional standards, and that section
799, which authorizes the inclusion of the no-knock provision in the
search warrant after judicial approval, was also in compliance with
the mandates of the fourth amendment. The Court made this finding
notwithstanding the fact that
there [was] nothing in the affidavit to show specifically how or
where these gambling materials would be likely to be destroyed or
removed, [because] the likelihood they would be was an inference
of fact which the Judge signing the warrant might draw.⁶⁶
Thus DeLago indicates that the New York courts recognize that
there is a question of constitutional dimension, but that exigent cir-
cumstances, which do not have to be supported by specific facts, remove
the forcible entry from constitutional condemnation. It is also worth
noting that the lower New York courts have held that an unannounced
entry could be made without a warrant if there existed probable cause
to arrest and exigent circumstances justified noncompliance with the
statute.
67
63 374 U.S. 23 (1963). For a discussion of this case, see notes 100-07 and accom-
panying text infra.
64 16 N.Y.2d 289, 213 N.E.2d 659, 266 N.Y.S.2d 353 (1965), cert. denied, 383 U.S. 963
(1966).
65 Id. at 292, 213 N.E.2d at 661, 266 N.Y.S.2d at 356.
66 Id.
67 People V. McIlwain, 28 App. Div. 2d 711, 281 N.Y.S.2d 218 (2d Dep't 1967); People
v. Montanaro, 24 Misc. 2d 624, 229 N.Y.S.2d 677 (Kings County Ct. 1962); People v.
Cocchiara, 31 Misc. 2d 495, 221 N.Y.S.2d 856 (Ct. Gen. Sess. N.Y. County 1961).
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District of Columbia
Basically, three statutes concern search warrant entries in the
District of Columbia, and all three have very similar language;68 two
are local statutes applicable only to the District,⁶⁹ while the third,
section 3109 of the Criminal Code,⁷⁰ is of general application. For
many years the latter has been held applicable to the District of
Columbia, and the case law for any of the three has been considered
almost interchangeable.⁷¹ Each of the statutes bears a marked resem-
blance to the California statute, yet they have been interpreted in an
entirely different manner by the Supreme Court and the lower fed-
eral courts in the District. While the California courts have engrafted
a series of exceptions onto their statute, decisions in the District of
Columbia relating to section 3109 have continued to interpret any
possible exceptions to the "knock and wait" rule in a highly restrictive
manner.
One of the major cases in the District of Columbia was Accarino
U. United States,⁷² which involved a warrantless arrest and search, and
a subsequent gambling conviction. The Court of Appeals for the Dis-
trict of Columbia Circuit discussed at length the common-law back-
ground of the rule requiring notice and announcement of purpose. 73
Emphasizing "a man's right of privacy in his home," the Accarino
court rejected the Government's repeated attempts to excuse its failure
to obtain a warrant for the forcible arrest and search. (Accarino was
subsequently utilized by the District of Columbia courts as a basis for
their interpretation of the District of Columbia and federal warrant
statutes.)
In 1958 the landmark case of Miller U. United States⁷⁴ was handed
down by the Supreme Court. It would serve no purpose to discuss
Miller extensively at this point, since the case will be treated in con-
siderable depth in a subsequent section.' 75 Suffice it to say that Mr.
68 The officer may break open any outer or inner door or window of a house, or
any part of a house, or anything therein, to execute a search warrant, if, after
notice of his authority and purpose, he is refused admittance or when necessary
to liberate himself or a person aiding him in the execution of the warrant.
18 U.S.C. § 3109 (1964).
69 D.C. CODE ANN. § 25-129(g) (1967) (liquor); D.C. CODE ANN. § 33-414(g) (1967)
(narcotics).
70 18 U.S.C. § 3109 (1964).
71 See, e.g., United States v. Miller, 357 U.S. 301, 306 (1958); See Blakey, supra note
20, at 513 for a more complete explanation of the application of section 3109 to the
District of Columbia.
72 179 F.2d 456 (D.C. Cir. 1949).
73 Id. at 460; see Blakey, supra note 20, at 510-14.
74 357 U.S. 301 (1958).
75 See notes 85-96 and accompanying text infra. See generally Blakey, supra note 20,
at 516-31.
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Justice Brennan, who delivered the opinion for the Supreme Court,
evaded the issue of whether section 3109, as a codification of the
common law, implicitly encompassed exceptions adopted in such states
as California with the statement "whether the unqualified require-
ments of the rule admit an exception justifying noncompliance in exi-
gent circumstances is not a question we are called upon to decide in
this case. "76 However, other decisions by the District of Columbia Cir-
cuit interpreted possible exceptions to section 3109 in a fairly strict
manner, requiring almost total compliance with the statute's mandates.
For example, in Masiello U. United States,⁷⁷ there was a conflict in the
testimony as to whether or not the police, who had announced only
their presence before entering the premises, had notified the defendant
that they had a search warrant. The court remanded the case to deter-
mine if the police had in fact totally complied with the statute's knock
and notification requirements. Similarly, in Keiningham U. United
States⁷⁸ and Hair U. United States,⁷⁹ the court stated that the Miller
rule requires police officers "who seek to invade the privacy of an indi-
vidual's home to announce their authority and their purpose in de-
manding entrance before 'barging in.' ''80 These decisions indicate a
judicial reluctance to permit any expansion of no-knock in the District
of Columbia.
II. ANNOUNCEMENT AND THE CONSTITUTION
The fourth amendment to the United States Constitution de-
nounces only "unreasonable" searches and seizures. This is a word
which, quite naturally, has confounded legal scholars for hundreds of
years. Yet, the fourth amendment was approved only after the inclusion
of the language banning "unreasonable seizures and searches.' Un-
doubtedly, individual reaction against the so-called "general warrants"
or "writs of assistance" was primarily responsible for its inclusion.
However, as was previously indicated, neither this attitude nor the
76 357 U.S. at 309.
77 304 F.2d 399 (D.C. Cir. 1962).
78 287 F.2d 126 (D.C. Cir. 1960).
79 289 F.2d 894 (D.C. Cir. 1961).
80 Id. at 896. It is worth noting that the Hair court excluded evidence of gambling
paraphernalia; several state courts have held such material to be "easily disposable"
contraband which would permit noncompliance with their knock and notice statutes.
The Hair decision was merely a reaffirmation of a similar holding in an earlier case. See
Woods v. United States, 240 F.2d 37 (D.C. Cir. 1956).
81 See B. MITCHELL & L. MITCHELL, A BIOGRAPHY OF THE CONSTITUTION OF THE UNITED
STATES 199 (1964).
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standard was novel. The common law was fairly well settled against
unreasonable searches in general, although no rules of reason had been
clearly defined. Use of the term "unreasonable" was, of course, practical
and, at the same time, the most farsighted way of satisfying current
feeling in 1789, while providing flexibility for the future. Nevertheless,
the term must have had some definite connotations to the founding
fathers and their contemporaries during the consideration and ap-
proval of the Bill of Rights. The growth of the law in this area would
tend to obscure this fact, although modern courts often pay lip service
(and sometimes more) to common-law trends and traditions. 82 It might
be well to bear in mind the words of Mr. Chief Justice Taft on this
subject:
The Fourth Amendment is to be construed in the light of what was
deemed an unreasonable search and seizure when it was adopted,
and in a manner which will conserve public interests as well as
the interests and rights of individual citizens.⁸³
The language of the fourth amendment suggests that the search
and seizure itself was of primary concern to the drafters. The protec-
tion of the amendment extends to "persons, houses, papers, and
effects," each of which can involve different factual circumstances.
Whether an announcement of purpose is required for any or all of
these protected entities is beyond the scope of the present discussion,
for the Supreme Court in recent years has evidently concluded that a
statement of identity and purpose is a basic prerequisite to entry into
a home without the occupant's acquiescence - a prerequisite that has
constitutional dimensions. 84 However, the road to this conclusion is
sinuous at best, being paved with inconsistencies as well as exceptions.
Furthermore, the end of the road is not necessarily in sight.
In deciding the case of Miller U. United States,⁸⁵ Mr. Justice
Brennan and his colleagues were, in effect, confronting the rule of an-
82 See, e.g., Miller v. United States, 357 U.S. 301 (1958); Accarino v. United States, 179
F.2d 456 (D.C. Cir. 1949).
83 Carroll V. United States, 267 U.S. 132, 149 (1924).
84 Ker v. California, 374 U.S. 23 (1963).
85 357 U.S. 301 (1958). In Miller the officers involved had neither a search nor an
arrest warrant. After arriving at the apartment in question, one of the officers knocked
on the door, and in response to an inquiry as to who was there, replied in a low voice,
"police." The defendant opened the door slightly, leaving the safety chain intact. Upon
seeing the officer, he immediately started to close it. However, one officer grabbed the
door and was able to force entry by breaking the chain. Miller and his girlfriend were
arrested, and a search of the apartment uncovered marked informant money. The de-
fendants' pretrial motion to suppress the evidence as illegally seized was denied, and
when the trial judge subsequently refused to consider the question of suppression, the
defendants were found guilty of violating the District of Columbia's narcotics laws. This
conviction had been affirmed on appeal and the Supreme Court granted certiorari.
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nouncement for the first time. In rendering its decision, the Supreme
Court quite naturally turned to Accarino, which was considered some-
thing of a landmark at the time due to its extensive discussion of the
common-law rule on forcible entry. Accarino, like Miller, involved a
case arising in the District of Columbia, but there are several factors
which make Mr. Justice Brennan's deference to "the rule of Accarino"
somewhat unfortunate. To begin with, Accarino was based, to a great
extent, upon the absence of an arrest warrant. Judge Prettyman had
concluded:
Unless the necessities of the moment require that the officer break
down a door, he cannot do so without a warrant; and if in reason-
able contemplation there is opportunity to get a warrant, or the
arrest could as well be made by some other method, the outer door
to a dwelling cannot be broken to make an arrest without a war-
rant.⁸⁶
It was primarily on this basis that the Accarino court had determined
that the evidence, which was seized following the forced entry and
subsequent arrest of the defendant by law enforcement officers, should
have been excluded. Unfortunately, however, Judge Prettyman chose
to add the following comment:
Upon one topic there appears to be no dispute in the authorities.
Before an officer can break open a door to a home, he must make
known the cause of his demand for entry.87
If indeed there had been no dispute prior to Accarino, it was because
the issue had never been squarely presented in a modern criminal case.
Furthermore, as previously mentioned, the common law was by no
means fixed on this point (except in the general agreement that there
were reasonable exceptions to any announcement rule which might
exist).
Miller, like Accarino, was decided on non-constitutional grounds.
Language to the contrary notwithstanding, a close reading reveals that
Miller stands as a determination of District of Columbia law, the
fourth amendment being only indirectly involved. As in Accarino, the
officers who arrested Miller after the forced entry had no warrant.
Both cases speak in terms of a common-law right of privacy in the
home. 88 Similarly, both cite Semayne's Case⁸⁹ as well, but while Ac-
carino recognized that this venerable decision concerned a writ issued
86 179 F.2d at 464.
87 Id. at 465.
88 357 U.S. at 313; 179 F.2d at 464.
89 77 Eng. Rep. 194 (Ex. 1603).
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in a civil case, 90 Miller recited the oft-quoted pronouncement as if it
related to breaking in order to arrest for a felony.91 Such a misconcep-
tion with regard to Semayne's Case, and to the entire body of Anglo-
American law on this subject, is regrettably not uncommon. More
serious is the fact that Mr. Justice Brennan failed to reach any con-
clusions with respect to common-law exceptions (such as the immediate
threat of violence). Additionally, the rationale underlying the notice
rule, i.e., that a knock of notice was, in most cases, the better way to
avoid violence which might breach the King's peace, was completely
ignored. The concept of privacy, as relied upon by Miller,⁹² is a some-
what later and more amorphous development. Prior to the adoption
of the Constitution, the statement that "the King's keys unlock all
doors"93 was probably closer to the truth.
Although Miller may be based upon "the rule of Accarino" or
District of Columbia law, its implications are broader because of the
majority's insistence on relating its holding to section 3109 of the
Criminal Code.⁹⁴ In Mr. Justice Brennan's view, this section reflected
a congressional desire to codify the traditional rules of forced entry.95
He construed it as a restatement of Semayne's Case, and therefore
applicable, in effect, to all forcible entries, although by its language
section 3109 is limited to the execution of search warrants. The am-
biguity thus developed is evidenced by the decisions which followed
Miller.
96
In Wong Sun U. United States,⁹⁷ the Supreme Court's next major
opportunity to consider its holding in Miller, Mr. Justice Brennan
again articulated for the majority. Here, agents had forcibly entered a
dwelling without a prior notice of authority and purpose, although one
of the agents apparently identified himself to the defendant before
forcing open the door to effectuate the arrest. 98 Mr. Justice Brennan re-
peated the "virtual certainty" test he formulated in Miller, but could
find no facts justifying the conclusion that the officers were virtually
90 179 F.2d at 460. See note 7 and accompanying text supra.
91 357 U.S. at 308.
92 Id. at 307.
93 BROOM'S LEGAL MAXIMS, supra note 4, at 432.
94 18 U.S.C. § 3109 (1964).
95 357 U.S. at 313.
96 See, e.g., United States V. Barrow, 212 F. Supp. 837 (E.D. Pa. 1962), where Judge
Lord relied upon Miller as interpreting section 3109 to apply to the broad range of search
and seizure situations. As he put it, "[p]lainly stated, the Court had to decide not the
application of a local rule as such, but whether or not the criteria of section 3109 has
been met
Id. at 845.
97 371 U.S. 471 (1963).
98 Id. at 474.
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certain that the defendant already knew their purpose. However, the
door to other exceptions recognized at common law was opened some-
what wider in Wong Sun, when Mr. Justice Brennan specifically men-
tioned the exceptions of "the imminent destruction of vital evidence,
or the need to rescue a victim in peril"⁹⁹ while reiterating the fact that
the Government claimed no such circumstances in the case.
Up to this point, "the knock" itself had not yet assumed constitu-
tional proportions; prior holdings were based on common law, state
law, section 3109, and various combinations of these authorities. Con-
sequently, the stage was not particularly well set for Ker U. Cali-
fornia. 100 Mr. Justice Clark, who had dissented in both Miller and
Wong Sun, wrote for the Ker majority. Mr. Justice Brennan, on the
other hand, authored the dissent, which expressed the views of the
Chief Justice and two other Justices as well. 101 Although the decision
was extremely close, there was virtual unanimity on one point: the
rule of announcement is a constitutional requirement implicit in the
fourth amendment proscription against unreasonable searches and
seizures. But, while the minority felt that the circumstances in Ker
did not satisfy any exceptions to the "knock" requirement which they
were willing to recognize, the majority was of the view that
in the particular circumstances of this case the officers' method of
entry, sanctioned by the law of California, was not unreasonable
under the standards of the Fourth Amendment as applied to the
States through the Fourteenth Amendment. 102
George and Diane Ker were undoubtedly surprised when law
enforcement officers quietly utilized a pass key to enter their apartment.
In fact, they neglected to conceal a two pound brick of marihuana which
was resting ostentatiously in their kitchen. More marihuana was subse-
quently discovered in both the kitchen and bedroom after the Kers
were arrested. There was no warrant obtained, nor was there any an-
nouncement of identity and purpose, prior to the officers' surreptitious
entry. The omission of notice was ostensibly to prevent the destruction
of evidence, 103 and was sanctioned by a judicial exception to the Cali-
fornia statute which ordinarily required announcement. 104
Although no force was used to effect the entry in Ker, the majority
99 Id. at 484.
100 374 U.S. 23 (1963).
101 Id. at 46.
102 Id. at 40-41.
103 Id. at 28.
104 See, e.g., People v. Maddox, 46 Cal. 2d 301, 294 P.2d 6, cert. denied, 352 U.S. 858
(1956) discussed at note 24 and accompanying text supra.
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recognized that the use of a pass key under these circumstances was the
legal equivalent of a breaking. However, the Court refused to consider
the question of entry by ruse or trickery,¹⁰⁵ thereby fostering future
uncertainty on this issue. Additionally, despite the fact that this area
is pervaded with unresolved questions, the Court chose to overlook
the opportunity to clarify the relevant standards. In relying upon "the
particular circumstances of this case, Mr. Justice Clark evidently
recognized a "destruction of evidence" exception, but refused to discuss
other "exigent circumstances" - although Mr. Justice Brennan listed
his three somewhat restrictive exceptions. 107 Similarly, the majority
opinion did not clarify whether the same result would obtain in this
case if federal rather than state officers had been involved, or if a
search or arrest warrant had been issued. But one thing must be said
for Ker: although the rules for its application were left uncertain, with
Mr. Justice Clark and Mr. Justice Brennan polarized, an exception to
the announcement rule was incorporated into the fourth amendment
for situations where there is a reasonable possibility that evidence
might otherwise be destroyed.
At least one jurisdiction felt that the destruction exception set
forth in Ker should be clarified to a much greater degree. In Meyer U.
United States, 108 the Court of Appeals for the Ninth Circuit was faced
with a situation in which the police had, by their own admission, failed
to comply with the state statute. The omission of the required knock
and notice was based solely upon the general knowledge of the arrest-
ing officers regarding the disposability of paraphernalia used in book-
making operations. The Government conceded that a violation of the
knock and announce provisions of the statute would render the arrest
and subsequent search invalid and the evidence obtained inadmissible.
It argued, however, that because of the general nature of bookmaking
paraphernalia, the Ker destruction exception excused noncompliance
with the statute. The Ninth Circuit, in a per curiam decision, flatly
rejected this position. Citing the Gastelo case¹⁰⁹ as controlling, the
105 See Jones V. United States, 304 F.2d 381 (D.C. Cir. 1962), cert. denied, 371 U.S.
851 (1963); Leahy V. United States, 272 F.2d 487 (9th Cir. 1959), cert. granted, 363 U.S. 810
(1960), appeal dismissed per stipulation, 364 U.S. 945 (1961).
106 374 U.S. at 40-41.
107 (1) where the persons within already know of the officers' authority and pur-
pose, or (2) where the officers are justified in the belief that persons within are
in imminent peril of bodily harm, or (3) where those within, made aware of the
presence of someone outside (because, for example, there has been a knock at the
door), are then engaged in activity which justifies the officers in the belief that an
escape or the destruction of evidence is being attempted.
Id. at 47 (dissenting opinion).
108 386 F.2d 715 (9th Cir. 1967).
109 67 Cal. 2d 586, 432 P.2d 706, 63 Cal. Rptr. 10 (1967).
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court stated that neither it nor the Supreme Court had ever held that
mere disposability of the evidence sought would render a no-knock,
forcible entry constitutionally reasonable. The court noted that the
Supreme Court in Ker had divided four-to-four on the question of
whether the evidence offered to excuse compliance with the notice and
demand requirements was in fact constitutionally sufficient. It con-
strued Ker as excusing compliance with the statute, in accordance with
the established common-law exceptions, only on the basis of the
specific facts presented in that case; "[o]therwise, the constitutional test
of reasonableness would turn only on practical expediency and the
[fourth] amendment's primary safeguard - the requirement of par-
ticularity - would be lost. "110
Meyer thus attempted to clarify the destruction exception set forth
in Ker. Clearly, in the Ninth Circuit's view, that case stood for the
proposition that no-knock is permissible in the destruction of evidence
situation. However, it is equally clear that the Meyer court would
require a more stringent form of judicial review based upon the par-
ticularity of the facts in the case at hand.
In reliance upon Ker, 111 some states have codified the destruction
of evidence exception, and have authorized the issuance of no-knock
warrants; 112 predictably, state courts appear to be upholding such legis-
lation. 113 Sabbath U. United States, 114 the most recent Supreme Court
decision in this area, indicates that these courts are on relatively safe
ground. Although the decision in Sabbath turned upon an application
of section 3109, rather than the fourth amendment, Mr. Justice Mar-
shall's opinion helped to purify a few of Ker's muddy waters. It verified
that all entries into dwellings by federal officers are to be tested in
terms of section 3109; any unannounced entry constitutes a "breaking,"
regardless of actual force employed. This should not be surprising,
especially in view of Ker. However, entry by ruse was once again set
110 386 F.2d at 718.
111 The Supreme Court has refused thus far to reconsider its position in Ker. See
La Peluso v. California, 239 Cal. App. 2d 715, 49 Cal. Rptr. 85, cert. denied, 385 U.S. 829
(1966).
112 See, e.g., NEB. REV. STAT. § 29-411 (1964); N.Y. CODE CRIM. PROC. § 799 (McKinney
Supp. 1964); UTAH CODE ANN. § 77-54-9 (1967).
113 See, e.g., People v. DeLago, 16 N.Y.2d 289, 213 N.E.2d 659, 266 N.Y.S.2d 353
(1965), cert. denied, 383 U.S. 963 (1966). For a discussion of this, see notes 64-67 and
accompanying text supra.
114 391 U.S. 585 (1968). In Sabbath, customs agents had apprehended one Jones
crossing the border from Mexico to California with cocaine allegedly given him by the
defendant. The cocaine was also to be delivered to the defendant and the officers ar-
ranged for Jones to make the delivery. They waited five or ten minutes outside the
defendant's apartment after Jones had entered to make delivery. Then the agents, with-
out a warrant, knocked, waited a few seconds, and then opened the unlocked door.
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apart, which in itself provides some clarification. 115 Most importantly,
the Court reinforced the concept of implicit exceptions to the constitu-
tional rule of announcement. It did so in a somewhat curious way,
however, utilizing a footnote which speaks in terms of "[e]xceptions to
any possible constitutional rule. "116 And in referring to the "recog-
nized" exceptions, the note cites Mr. Justice Brennan's dissent in Ker
without reference to the majority opinion in that case. One can only
conclude that this reference was due to Mr. Justice Brennan's neat
exposition of what he viewed to be the exceptions - something Mr.
Justice Clark and the majority failed to do. In other words, the citation
should not be construed as favoring the minority view of the destruc-
tion of evidence exception over the majority view, thereby impliedly
circumscribing, if not overruling, the holding in Ker. However, one
cannot help but wish, once again, for greater certainty.
Where, then, are we at this point? For one thing, we seem to have
a federal statute¹¹ which is duplicative of both the common law and
the Constitution. In the alternative, it appears that entries by state
officers will be judged by state law and reviewed by fourth amendment
standards in appropriate cases. On the other hand, entries by federal
officers will be scrutinized in terms of section 3109, which codifies the
common law. Both section 3109 and the fourth amendment contem-
plate exceptions in exigent circumstances, but whether section 3109 is
more stringent in application cannot yet be determined. Certainly, there
is a constitutionally recognized exception to the announcement rule,
and a properly drafted amendment to section 3109 reflecting the excep-
tion for potential destruction of evidence should pass constitutional
muster. Other exceptions might survive judicial scrutiny as well. 118
One thing is certain: the constant growth in drug traffic is resulting in
increased pressure from law enforcement agencies which will, in turn,
encourage a corresponding growth in the law - or, if not growth, at
the very least a clarification or refinement of existing standards.
Proponents of a strict announcement requirement have created a
constitutional certainty from a common-law uncertainty. A structure
resting upon such dubious foundation cannot long avoid some shifting.
Undoubtedly, our founding fathers themselves would have disagreed if
115 Id. at 590 n.7, which indicates that the Court is not willing to go out of its
way to undermine the established view of entry by ruse as being outside the scope of
"breaking." Raised as a constitutional issue, the result might be different.
116 Id. at 591 n.8.
117 18 U.S.C. § 3109 (1964).
118 E.g., to avoid loss of life or when there is virtual certainty that the officers' pur-
pose is known.
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NO-KNOCK AND NONSENSE
647
asked specifically in 1789 whether they considered unannounced entries
into dwellings "unreasonable." In fact, the exclusionary rule itself was
not clearly formulated until almost one hundred years had elapsed. 119
Nor could they have foreseen the growth in organized crime and the
impact of present day gambling and drug traffic. To elevate the an-
nouncement rule to a constitutional requirement in 1963 was prob-
ably historically unsound. To premise it upon a vague right of privacy,
rather than on the avoidance of potential violence was a further de-
parture from precedent. Still, the rule exists and, as long as the right to
individual privacy is, in fact, balanced with the public interest in sup-
pressing illegal gambling and drug peddling, who will complain?
It is difficult to see, however, what actual protection is given to any
right of privacy by the announcement rule. Once identity and purpose
are stated, entry must always be permitted; if permission is denied, or
even delayed for an inordinate amount of time, entry may be forced,
provided the officer has a valid purpose in gaining admission. Since no
discretion is vested in the occupant, in what manner does notice protect
his privacy? If he has something to hide, perhaps the knock will provide
him with more time to conceal or destroy it. If he plans to resist or flee,
he will be alerted. On the other hand, if he plans none of these and is
otherwise lawfully engaged, how will the knock benefit him? If the
door is locked, he may be able to avoid a broken door by responding to
the demand for entry. If he is engaged in very private activities, per-
haps of a carnal nature, or is otherwise indisposed, he may have time to
avoid embarrassment - but not interruption. Or if he is asleep, he
will be spared the possible shock of awakening to the sight of a stranger
in his home (entry by stealth), or of awakening to the sound of a break-
ing door.
Thus balanced, the protections to privacy seem to be somewhat
tenuous when compared to the potential for public harm. This is
particularly true with respect to potential destruction of evidence,
especially when one considers that the probable cause requirement
would have to be met in any event. And where a statute provides for
the issuance of no-knock warrants, the judicial review factor must be
added to the scales. In jurisdictions where such warrants are available,
courts should of course look with a jaundiced eye upon officers who
fail to obtain warrants without good cause. This is not to say that
privacy should not be protected - constitutionally, if necessary. Many,
if not most, searches would be "unreasonable" under the fourth amend-
ment if preceded by an unannounced entry. But there is an extreme
119 Boyd v. United States, 116 U.S. 616 (1886).
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need for reasonable exceptions to be identified and clarified. Exclu-
sionary rules will not deter if they are not understood by the policeman
on the beat. 120
Perhaps our view of privacy should be reconsidered. Would it not
be inconsistent to permit electronic eavesdropping under the fourth
amendment with appropriate judicial supervision, 121 while denying no-
knock entry under limited circumstances with similar supervision?
Which is the greater invasion of privacy? It bears repeating that, if we
are to continue to judge the announcement rule and its exceptions by
fourth amendment standards, the somewhat vague and recent concept
of privacy should not be given undue priority over traditional and
more comprehensible concepts of reasonableness. Language from Mr.
Justice Frankfurter's opinion in United States U. Rabinowitz, 122 which
was cited with approval by Mr. Justice Stewart in a more recent opinion
overruling Rabinowitz,¹²³ helps to place the matter in perspective:
To say that the search must be reasonable is to require some
criteria of reason. It is no guide at all either for a jury or for dis-
trict judges or the police to say that an "unreasonable search" is
forbidden - that the search must be reasonable. What is the test
of reason which makes a search reasonable? The test is the reason
underlying and expressed by the Fourth Amendment: the history
and the experience which it embodies and the safeguards afforded
by it against the evils to which it was a response. 124
III. NEW APPROACHES TO No-KNOCK
The proposed Controlled Dangerous Substances Act contains a
no-knock warrant provision similar to many of those mentioned earlier
in this article. 125 Subsection (b) authorizes unannounced entries in cir-
120 See Blakey, supra note 20, at 533.
121 See Berger v. New York, 388 U.S. 41 (1967).
122 339 U.S. 56, 68 (1950) (dissenting opinion).
123 Chimel V. California, 395 U.S. 752, 760 (1969). In Chimel, police officers, after
serving the defendant with an arrest warrant at his home, proceeded to search the entire
house for items taken in an alleged burglary. The Court invalidated the search as being
unreasonable since, even though it was incidental to a valid arrest, there was no probable
cause. The Court limited a search incidental to an arrest to the arrestee's person and the
area "within his immediate control" - within which he might gain possession of a
weapon or destructible evidence.
124 395 U.S. at 765, quoting United States v. Rabinowitz, 339 U.S. at 83 (dissenting
opinion).
125 Any officer authorized to execute a search warrant relating to offenses involving
controlled dangerous substances the penalty for which is imprisonment for more
than one year may, without notice of his authority and purpose, break open an
outer or inner door or window of a building, or any part of the building or any-
thing therein, if the judge or United States Magistrate issuing the warrant is
satisfied that there is probable cause to believe that (A) the property sought may
and if such notice is given, will be easily and quickly destroyed or disposed of,
or (B) the giving of such notice will immediately endanger the life or safety of
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649
cumstances where the judge or magistrate issuing the warrant is satis-
fied that there is probable cause to believe that, if the officers knocked
and announced their authority and purpose, either the evidence sought
will be quickly destroyed or the officers placed in danger of physical
harm. These warrants may only be issued for offenses relating to con-
trolled dangerous substances, and the warrant must state on its face
that the officers executing it are authorized to dispense with knocking
or announcing their authority and purpose. In addition, there is a
requirement that the officers identify themselves and their purpose as
soon as possible after gaining entry. 126
Strong opposition has been voiced against the proposed no-knock
provision on both constitutional and policy grounds. Critics contended
that the initial language of section 702(b), which authorized the issu-
ance of a no-knock warrant if "there is probable cause to believe that
if such notice were to be given the property at issuance in the case may
be easily and quickly disposed of
"127
,
was too ambiguous and that
it was susceptible to a wide variety of interpretations. 128 Additionally,
they argued that the language did not make clear whether it was the na-
ture of the property that was intended to be a ground for issuance of the
warrant, or whether specific facts demonstrating that the occupants of
the premises to be searched were ready, willing, and able to destroy
the evidence at the first sign of police intrusion were required. 129
The original intent of section 702(b) was to require a two-step
process for obtaining a no-knock warrant. The first was compliance
the executing officer or another person, and has included in the warrant a direc-
tion that the officer executing it shall not be required to give such notice: Pro-
vided, that any officer acting under such warrant, shall, as soon as practicable
after entering the premises, identify himself and give the reasons and authority
for his entrance upon the premises.
S.3246, 91st Cong., 2d Sess. § 702 (1970) (emphasis added).
126 This proviso was included in the Senate Judiciary Committee to insure reasonably
prompt notice to the occupants and thereby minimize the possibility of mistake of in-
tent and potential violence.
127 Before its amendment in the Senate, section 702(b) read: Any officer autho-
rized to execute a search warrant relating to offenses involving controlled dan-
gerous substances the penalty for which is imprisonment for more than one year
may, without notice of his authority and purpose, break open an outer or inner
door or window of a building, or any part of the building, or anything therein,
if the judge or United States Magistrate issuing the warrant is satisfied that
there is probable cause to believe that if such notice were to be given the
property sought in the case may be easily and quickly destroyed or disposed of,
or that danger to the life or limb of the officer or another may result, and has
included in the warrant a direction that the officer executing it shall not be
required to give such notice: Provided, that any officer acting under such war-
rant, shall, as soon as practicable after entering the premises, identify himself
and give the reasons and authority for his entrance upon the premises. (Emphasis
added.)
128 S. REP. No. 613, 91st Cong., 1st Sess. 159 (1969).
129 Id.
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with the requirements necessary for obtaining a conventional search
warrant: that there is probable cause to believe that a crime has been
committed and that evidence or fruits of such crime are located on the
premises to be searched. The next step was that the applicants also
show that there is probably cause to believe that contraband drugs are
located on the premises and that, by their nature, they are capable
of quick destruction, and might in fact be so destroyed should the
occupants be made aware of an imminent police intrusion. In effect,
a number of elements was required: probable cause to believe that
contraband drugs were located on the premises, that such drugs
by their nature could be easily destroyed or disposed of, and that the
occupants of the premises would be likely to destroy such drugs upon
notice by the police of their intent to execute a search warrant. These
requirements clearly satisfied the criteria established in existing law. 130
Nevertheless, the extensive criticism which the original section 702(b)
was subjected to resulted in its amendment on the Senate floor; 131 the
present language - "will be easily and quickly destroyed or disposed
of" and "will immediately endanger the life or safety of the executing
officer"¹³² - reflects this amendment.
An alternative approach would be to require positivity rather than
probable cause in any application for a no-knock authorization. This
would comport with the general standard for the issuance of nighttime
search warrants under rule 41(e) of the Federal Rules of Criminal
Procedure. 133 Simply stated, a positivity standard requires a greater
quantum of factual information than does the probable cause standard.
Under normal probable cause standards, the judge or magistrate does
not have to be positive that the evidence sought is located on the
premises to be searched in order to grant the warrant. Rather, the
applicant need only disclose sufficient facts to warrant an averment that
the evidence sought is likely to be on the premises. However, such
facts would be insufficient to meet the positivity test. 134
130 See notes 21-80 and accompanying text supra.
131 Section 702 was amended pursuant to a provision offered by Senator Robert
Griffin and strongly supported by Senator Joseph Tydings. Senator Tydings had success-
fully inserted similar "will result" language into the proposed District of Columbia
Court Reform and Reorganization Act. In the House version of the latter, H.R. 16196,
the "no-knock" provision merely requires that destruction or disposal be likely to result.
Presumably, this conflict will eventually be resolved.
132 See note 125 supra for the entire text of the proposed subsection.
133 FED. R. CRIM. P. 41(e).
134 Rule 41(e), which governs the issuance of nighttime search warrants, requires
that the affidavit disclose sufficient facts to warrant the affiant in asserting a positive
belief that the evidence is located on the premises to be searched. United States v. Raidl,
250 F. Supp. 278 (N.D. Ohio 1965). An exception is made to rule 41(e) for issuance of
search warrants involving narcotic drugs. By virtue of 18 U.S.C. § 1405 (1964), the execu-
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651
Adoption of a positivity test for the issuance of no-knock warrants
would mean that the applicant would have to disclose facts evidencing
a positive belief that contraband drugs are on the premises to be
searched, and that they are of such a nature that they can be easily dis-
posed of or destroyed. While this test would clearly remedy many of
the ambiguities which the critics have found inherent in the provision,
it would impose a much heavier burden upon officers seeking no-knock
authority. Additionally, it would compel the judiciary to determine
just what standards apply to "positivity" versus "probable cause," - a
question which has been consistently avoided in nighttime warrant
cases. 135 While a compromise, this alternate approach is neither neces-
sary nor recommended in the light of existing law. 136
Critics also assert that the proposed no-knock provision was of
doubtful constitutional validity. Such contentions are based upon the
fourth amendment's prohibition against unreasonable searches and
seizures and the implied right of individual privacy. 137
Taken in a broad context, the right of privacy is the right of an
individual to be left alone, shielded from unwarranted governmental
intrusions. 138 However, in the words of Mr. Justice Stewart,
the Fourth Amendment cannot be translated into a general con-
stitutional "right to privacy." That amendment protects individual
privacy against certain kinds of governmental intrusion, but its
protection goes further, and often has nothing to do with privacy
at all. 139
Some critics of the no-knock provision would find implicit in the right
of privacy the requirement of advanced notice prior to any lawful gov-
ernmental intrusion, such as the execution of a valid search warrant.
However, the dimensions of an individual's right to privacy severely
contract when one is dealing with the execution of a search warrant. For
purposes of conducting a search, the officers authorized to execute the
warrant are legally entitled to entry into the designated premises, with
or without the consent of the occupant. Should an occupant refuse ad-
tion of search warrants relating to offenses involving narcotic drugs at any time of the
day or night is permitted provided there is probable cause to believe that grounds for
the warrant exist. This same exception has been incorporated into section 702(a) of the
proposed Controlled Dangerous Substances Act.
135 Distefano V. United States, 58 F.2d 963 (5th Cir. 1932); United States V. Castle,
213 F. Supp. 52 (D.D.C. 1962).
136 This is especially true in view of the "will be easily and quickly destroyed"
language now engrafted upon section 702(b). The question of evidence required by the
language closely approaches the standard applied under the positivity approach.
137 S. REP. No. 613, 91st Cong., 1st Sess. 159 (1969).
138 United States V. Katz, 389 U.S. 347 (1968).
139 Id. at 349.
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mission to the premises, the officers are also empowered to use the
necessary force to gain entry.140
When the framers of the Constitution made provisions for the
issuance and execution of search warrants, they recognized that there
would be instances in which an individual would have to be deprived
of his substantive right to privacy. In order to protect the individual
when this event should arise, the framers required the element of
reasonableness in the conducting of any search. Hence, what is really
meant by referring to the general rule requiring notice of authority
and purpose prior to execution of a search warrant is a standard of
reasonableness - a balancing of probable cause, need and the indi-
vidual's right to privacy. Reasonableness is not an equivalent for "right
to privacy," the latter being a part of the former and weighed, with
other factors, to determine proper legal equilibrium.
The no-knock provision, requiring court authorization to dispense
with an announcement, reasserts the general principle that reasonable-
ness of a search demands notice of authority and purpose. It is also a
codification of some exceptions to the general rule.¹⁴¹ In effect, it is a
congressional declaration that under certain, specified circumstances,
notice of authority and purpose can be dispensed with and the search
will still remain within the bounds of reasonableness.
Relying upon past experience with narcotic and dangerous drug
law enforcement, Congress could rationally justify these two exceptions
as being necessary for effective law enforcement. It is merely asserting
that under circumstances where prior notice would lead to destruction
of evidence or would endanger the lives of the officers executing the
warrant, an unannounced or forcible entry will not invalidate the search
as unreasonable.
It should be emphasized that the provision does not compel Con-
gress to impose a loose standard. Rather, while Congress will make a
general finding that notice of authority and purpose can lead to de-
struction of evidence or injury to the officers, the provision requires,
in addition, that a neutral judge or magistrate render a specific finding
of either in each individual case. Before notice of authority and pur-
pose can be dispensed with, the judge or magistrate issuing the war-
rant must be satisfied that there is probable cause to believe that such
grounds exist. He must specifically find probable cause to believe
140 Butler v. United States, 275 F.2d 889 (D.C. Cir. 1960).
141 Under the proposed no-knock provisions, the only times unannounced entries
will be permitted are when knocking and announcing authority and purpose would either
lead to the quick destruction of the evidence sought or where the officers executing the
warrant are placed in danger of physical harm.
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653
either destruction of the evidence or injury to the agents will result
if notice of authority and purpose are given. Probable cause requires
more than mere generalities; rather, it requires specific facts. A no-
knock warrant under the proposed provision cannot be issued solely
on the basis that most drug traffickers keep their supply of drugs in a
place where they can be easily disposed of. More specificity is required
by the definition of probable cause. Information relating to the actual
location of the drugs or the propensity of the suspect to be violent will
have to be known by the agents and made available to the judge when
application for the warrant is made.
CONCLUSION
Having traced the historical background, state and federal legis-
lation and case law regarding the requirement of announcing authority
and purpose prior to entering a person's dwelling, the question settles
down to a moral, rather than legalistic, judgment as to whether no-
knock should be permitted. Weighing values of privacy, potential for
violence and the need to preserve evidence in drug cases, it would
seem that no-knock authority is not only necessary but desirable within
the framework of the federal drug proposal. Since the proposed Act
sets out the statutory requirements rather than placing reliance on
common-law doctrines, 142 it would provide law enforcement agencies a
source on which to rely in this area. Furthermore, the bill requires
the interposition of a judge or magistrate before no-knock authority
can be obtained in executing a warrant. This judicial supervision has
been repeatedly favored by the Supreme Court and should be required
in this instant situation. 143
What is needed is meaningful reaction, not rationalization. Only
then will the fourth amendment be upheld and the populace pro-
tected.
142 Note that in many states, federal officers are also considered state peace officers
and can execute state laws under state procedures, e.g., California.
143 Sibron v. United States, 392 U.S. 40 (1968); United States v. Katz, 389 U.S. 347
(1968); McDonald v. United States, 335 U.S. 451 (1948).
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APPENDIX+
STATES REQUIRING ANNOUNCEMENT OF AUTHORITY AND PURPOSE BEFORE FORCED ENTRY
TO EXECUTE SEARCH WARRANTS OR ARRESTS (WITH OR WITHOUT A WARRANT)
Arrests
State
Search Warrant
(with or without warrant)
Alabama
Notice Required
Notice Required
ALA. CODE tit. 15, § 108 (1958).
ALA. CODE tit. 15, §§ 153, 155
(1958).
Alaska
No-Knock Permitted
Notice Required
ALASKA STAT. § 12.35.040 (1962).
ALASKA STAT. § 12.25.100 (1962).
Arizona
Notice Required
Notice Required
ARIZ. REV. STAT. ANN. § 13-1446(B)
ARIZ. REV. STAT. ANN. § 13-1411
(1956).
(1956).
* State v. Mendoza, 454 P.2d 140 (1968) (allowing "No-Knock" for
destruction exception).
Arkansas
No Statute-Common Law
Notice Required
Applies
ARK. STAT. ANN. § 43-414 (1964).
California
Notice Required*
Notice Required*
CAL. PENAL CODE § 1531 (West
CAL. PENAL CODE § 844 (West
Supp. 1969).
Supp. 1969).
*
People v. Maddox, 46 Cal. 2d 301, 204 P.2d 6 (1956); People v.
Gastelo, 67 Cal. 2d 586, 432 P.2d 706 (1967); People v. Rosales, 68 Cal. 2d
299, 437 P.2d 489 (1968) (allows No-Knock for destruction exception).
Colorado
No Statute-Common Law
No Statute-Common Law
Applies
Applies
Connecticut
No Statute-Common Law
No Statute-Common Law
Applies*
Applies
* State V. Marino, 152 Conn. 85, 203 A.2d 305 (1964) (allows No-
Knock for destruction exception to common-law announcement rule).
Delaware
No Statute-Common Law
No Statute-Common Law
Applies*
Applies
*
Dyton v. State, 250 A.2d 383 (1969) (allows No-Knock for destruc-
tion exception to common-law announcement rule).
District of
Notice Required
No Provision-Common Law
Columbia
D.C. CODE ANN. § 25-129(g) (1967)
Applies
(liquor).
D.C. CODE ANN. § 33-414(g) (1967)
(narcotics).
18 U.S.C. § 3109 (Supp. IV, 1969).
But an annotation to D.C. CODE ANN. § 23-301(6) (1967) states that for
search or arrest that the police can break in after an announcement of
identity and purpose. There are no exceptions. "Breaking and entering
premises without an announcement is clearly illegal and an improper
entry renders a subsequent search invalid."
t The citations listed in the following appendix are illustrative only and in no way are
to be considered all-inclusive.
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NO-KNOCK AND NONSENSE
655
APPENDIX (Continued)
Arrests
State
Search Warrant
(with or without warrant)
Florida
Notice Required*
Notice Required
FLA. STAT. § 933.09 (1967).
FLA. STAT. § 901.19 (1967).
*
Benefield V. State, 160 So. 2d 706 (1964) (allows No-Knock for
destruction exception).
Georgia
Notice Required
No-Knock Permitted only with
GA. CODE ANN. § 27-308 (1969).
warrant
GA. CODE ANN. § 27-205 (1969).
The arrest provision states that the police may use force to break into a
building and does not require any announcements prior to the breaking.
The new search statute does require an announcement before breaking.
Hawaii
No-Knock Permitted if door to
Notice Required
house is open. Notice required if
HAWAII REV. LAWS tit. 37, § 708.11
door is closed.
(1968).
HAWAII REV. LAWS tit. 37, § 708.37
(1968).
Idaho
Notice Required
Notice Required
IDAHO CODE ANN. § 19-4409 (1948).
IDAHO CODE ANN. § 19-611 (1948).
Illinois
No-Knock Permitted
No-Knock Permitted
ILL. ANN. STAT. ch. 38, § 108-8
ILL. ANN. STAT. ch. 38, § 107-5(d)
(Smith-Hurd 1964).
(Smith-Hurd 1964).
The arrest statute states that no notice or announcement required for
arrest but People v. Barbee, 35 Ill. 2d 407, 220 N.E.2d 401 (1966) re-
quires announcement before arrest. The search warrant section con-
cludes that notice is not necessary if constitutional standards (of reason-
ableness) are met. See also People V. Macias, 39 Ill. 2d 208, 234 N.E.2d
783 (1968); People v. Hartfield, 94 Ill. App. 2d 421, 237 N.E.2d 193 (1968)
(allowing No-Knock for destruction exception).
Indiana
No Statute-Common Law
Notice Required
applies*
IND. ANN. STAT. § 9-1009 (1956).
* Hadley V. State, 238 N.E.2d 888, 906 (1968) (allows No-Knock for
destruction exception to the common-law rule of announcement).
Iowa
Notice Required
Notice Required
IOWA CODE ANN. § 755.9 (1966).
IOWA CODE ANN. § 751.9 (1966).
Kansas
No Statute-Common Law
Notice Required
applies
KAN. STAT. ANN. § 62-1819 (1964).
Kentucky
No Statute-Common Law
Notice Required
applies
KY. REV. STAT. §§ 70.077, 70.078
(1969).
Louisiana
No-Knock Permitted
Notice Required
LA. CRIM. PRO. CODE ANN. art. 164
LA. CRIM. PRO. CODE ANN. art. 224
(West 1967).
(West 1967).
The new statute on arrests without warrants is broader now and not
limited only to felonies.
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APPENDIX (Continued)
Arrests
State
Search Warrant
(with or without warrant)
Maine
No Statute-Common Law
No Statute-Common Law
applies*
applies*
*
State V. Martelle, 252 A.2d 316 (1969) (allows No-Knock as an
exception to the common-law rule of announcement. "An officer
is bound, on demand to make known his authority, but his omission to
do so can do no more than deprive him of the protection which the
law throws around its ministers, when in the rightful discharge of their
duty.").
Maryland
No Statute-Common Law
No Statute-Common Law
applies*
applies*
*
Henson v. State, 236 Md. 518, 204 A.2d 516 (1969); Waugh v.
State, 3 Md. App. 379, 239 A.2d 596 (1968) (allowing destruction excep-
tion to the common-law rule of announcement).
Massachusetts
No Statute-Common Law
No Statute-Common Law
applies*
applies*
*
Commonwealth V. Rossetti, 211 N.E.2d 658, 665 (1965) (Court
referred to No-Knock for destruction exception to the common-law rule
of announcement in dictum.)
Michigan
Notice Required
Notice Required
MICH. STAT. ANN. § 28.1259(6)
MICH. STAT. ANN. § 28.880 (Cum.
(Cum. Supp. 1970).
Supp. 1970).
The search provision had not been included previously.
Minnesota
No Statute-Common Law
Notice Required
applies*
MINN. STAT. ANN. §§ 639.33, 639.34
(1965).
#
State v. Parker, 283 Minn. 127, 166 N.W.2d 347 (1969).
Mississippi
No Statute-Common Law
Notice Required
applies
MISS. CODE ANN. § 2472 (1957).
Missouri
No-Knock Permitted
Notice Required
Mo. REV. STAT. § 542.390 (1959).
Mo. REV. STAT. § 544.200 (1959).
Montana
No-Knock Permitted
Notice Required
MONT. REV. CODES ANN. § 95-709
MONT. REV. CODES ANN. § 95-901
(1969).
(1969).
*
The general arrest statute and the search statute give the right to
break in without the requirement of notice. The arrest with or without
warrant statutes require notice unless notice would jeopardize the
arrest.
Nebraska
No-Knock Permitted*
No-Knock Permitted*
NEB. REV. STAT. § 29-411 (1965).
NEB. REV. STAT. § 29-411 (1965).
"Warrants: execution; powers of officer; direction for executing.
In executing a warrant for the arrest of a person charged with an
offense, or a search warrant, or when authorized to make an arrest for a
felony without a warrant, the officer may break open any outer or inner
door or window of a dwelling house or other building, if, after notice
of his office and purpose, he is refused admittance; or without giving
notice of his authority and purpose, if the judge or magistrate issuing
search warrant has inserted a direction therein that the officer executing
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657
APPENDIX (Continued)
Arrests
State
Search Warrant
(with or without warrant)
it shall not be required to give such notice, but the political subdivision
from which such officer is elected or appointed shall be liable for all
damages to the property in gaining admission. The judge or magistrate
may so direct only upon proof under oath, to his satisfaction that the
property sought may be easily or quickly destroyed or disposed of, or
that danger to the life or limb of the officer or another may result, if
such notice be given; but this section is not intended to authorize any
officer executing a search warrant to enter any house or building not
described in the warrant."
Nevada
Notice Required
Notice Required
NEV. REV. STAT. § 179.090 (1967).
NEV. REV. STAT. § 171.138 (1967).
New Hampshire
No Statute-Common Law
No Statute-Common Law
applies
applies
New Jersey
No Statute-Common Law
No Statute-Common Law
applies*
applies*
State v. Juliano, 97 N.J. Super. 25, 234 A.2d 236 (1967) (allows No-
Knock for destruction exception to common-law rule of announcement).
New Mexico
No Statute-Common Law
No Statute-Common Law
applies
applies
New York
No-Knock Permitted*
Notice Required
N.Y. CODE CRIM. PROC. § 799
N.Y. CODE CRIM. PROC. §§ 175
(McKinney Supp. 1969).
(arrest with warrant), 178 (arrest
without warrant) (McKinney Supp.
1969).
"The officer may break open an outer or inner door or window
of a building, or any part of the building, or anything therein, to
execute the warrant, (a) if, after notice of his authority and purpose,
he be refused admittance, or (b) without notice of his authority and
purpose, if the judge, justice, or magistrate issuing the warrant has
inserted a direction therein that the officer executing it shall not be
required to give such notice. The judge, justice, or magistrate may so
direct only upon proof under oath, to his satisfaction, that the property
sought may be easily and quickly destroyed or disposed of, or that
danger to the life or limb of the officer or another may result, if such
notice were to be given."
North Carolina
No Statute-Common Law
Notice Required
applies
N.C. GEN. STAT. § 15.44 (Cum.
Supp. 1969).
North Dakota
No-Knock Permitted if judge so
Notice Required
provides
N.D. CENT. CODE § 29-06-14 (1960).
N.D. CENT. CODE § 29-29.1-01
(Supp. 1969).
Ohio
Notice Required*
Notice Required
OHIO REV. CODE § 2935.12
OHIO REV. CODE § 2935.12
(Anderson 1967).
(Anderson 1967).
*
United States V. Blank, 251 F. Supp. 166 (N.D. Ohio 1966) and
State v. Johnson, 16 Ohio Misc. 278, 240 N.E.2d 574 (1968) (allowing
No-Knock for destruction exception).
Reproduced at the Richard Nixon Presidential Library
658
ST. JOHN'S LAW REVIEW
[VOL. 44:626
APPENDIX (Continued)
Arrests
(with or without
State
Search Warrant
warrant)
Oklahoma
Notice Required
Notice Required
OKLA. STAT. ANN. tit. 22, § 1228
OKLA. STAT. ANN. tit. 22, §§ 194
(Supp. 1969).
(arrest with warrant), 197 (arrest
without warrant) (Supp. 1969).
Oregon
Notice Required*
Notice Required
ORE. REV. STAT. § 141.110 (Supp.
ORE. REV. STAT. §§ 133.290 (arrest
1969).
with warrant), 133.320 (arrest
without warrant) (Supp. 1969).
#
State V. Cortman, 466 P.2d 681, 683 (1968) (allows No-Knock for
destruction exception).
Pennsylvania
No Statute-Common Law
No Statute-Common Law
applies*
applies.
*
United States ex rel. Manduchi V. Tracy, 350 F.2d 658 (3d Cir.),
cert. denied, 382 U.S. 943 (1965) (allowed No-Knock for destruction
exception to common-law rule of announcement).
Rhode Island
No Statute-Common Law
No Statute-Common Law
applies*
applies.
* State v. Johnson, 230 A.2d 831 (1967) (allows No-Knock for de-
struction exception to common-law rule of announcement).
South Carolina
No-Knock Permitted
Notice Required
S.C. CODE ANN. § 17-257 (1962).
S.C. CODE ANN. § 53-198 (1962).
South Dakota
No-Knock Permitted
Notice Required
S.D. COMP. LAWS ANN. § 11C2
S.D. COMP. LAWS ANN. § 23-22-19
(1970).
(1967).
Tennessee
Notice Required
Notice Required
TENN. CODE ANN. § 40.509 (1955).
TENN. CODE ANN. § 40.807 (1955).
Texas
No-Knock Permitted
Notice Required
TEX. CODE CRIM. PROC. art. 18.18
TEX. CODE CRIM. PROC. art. 15.25
(1966).
(1966).
Utah
No-Knock Permitted
Notice Required
UTAH CODE ANN. § 77-54-9 (Supp.
UTAH CODE ANN. 1953, § 77-13-12
1969).
(Supp. 1969).
* 1967 Amendment to search warrant provisions reads:
"Officer may break door or window to execute warrant-Authority. The
officer may break open any outer or inner door or window of a house,
or any part of a house or anything therein to execute the warrant:
(1) If, after notice of his authority and purpose, he is refused
admittance; or
(2) Without notice of his authority and purpose, if the judge,
justice, or magistrate issuing the warrant has inserted a direction
therein that the officer executing it shall not be required to give such
notice. The judge, justice, or magistrate may so direct only upon proof
under oath, to his satisfaction, that the property sought is a narcotic,
illegal drug, or other similar substance which may be easily and
quickly destroyed or disposed of, or that danger to the life or limb of
the officer or any other may result, if such notice were to be given."
See also State V. Louden, 15 Utah 2d 64, 387 P.2d 240 (1963).
Reproduced at the Richard Nixon Presidential Library
1970]
NO-KNOCK AND NONSENSE
659
APPENDIX (Continued)
Arrests
(with or without
State
Search Warrant
warrant)
Vermont
No-Knock Permitted
No-Knock Permitted
VT. STAT. ANN. tit. 24, § 302 (1967).
VT. STAT. ANN. tit. 24, § 302 (1967).
Virginia
No Statute-Common Law
No Statute-Common Law
applies
applies
Washington
No Statute-Common Law
Notice Required*
applies*
WASH. REV. CODE ANN. § 10.31.040
(Supp. 1969).
* State v. Young, 76 Wash. 2d 212, 455 P.2d 595 (1969) (allows No-
Knock for destruction exception).
West Virginia
No-Knock Permitted for struc-
No Statute-Common Law
tures other than a "dwelling"
applies
W. VA. CODE ANN. § 62.1A-5
(1966).
Wisconsin
No Statute-Common Law
No Statute-Common Law
applies
applies
Wyoming
Notice Required
Notice Required for arrest with
warrant
WYO. STAT. ANN. § 7-165 (1959).
No statute for arrest without war-
rant-Common Law applies
Reproduced at the Richard Nixon Presidential Library
Form DJ-96a
(Rev. 6-22-66)
DEPARTMENT OF JUSTICE
ROUTING SLIP
TO:
NAME
DIVISION
BUILDING
ROOM
1.
Mr. John Dean
2.
3.
4.
SIGNATURE
COMMENT
PER CONVERSATION
APPROVAL
NECESSARY ACTION
AS REQUESTED
SEE ME
NOTE AND RETURN
NOTE AND FILE
RECOMMENDATION
CALL ME
YOUR INFORMATION
ANSWER OR ACKNOWL-
EDGE ON OR BEFORE
PREPARE REPLY FOR
THE SIGNATURE OF
REMARKS
I just sent this up to Congressman
Corman, at his request.
FROM:
NAME
BUILDING & ROOM
EXT.
DATE
M.R. Sonnenreich
1405 I St
128-4644
8/18/70
Reproduced at the Richard Nixon Presidential Library
The Comprehensive Drug Abuse
Prevention and Control Act of 1970
The Comprehensive Drug Abuse Prevention and Control Act
of 1970, H.R. 18583, represents a consolidation and modernization
of the various Federal enforcement and regulatory laws relating
to the control of narcotics, marihuana, and stimulant and de-
pressant drugs. Existing Federal law in this area has been
inadequate to cope with the mounting problem of drug abuse in
recent years, and in this sense, H.R. 18583 will represent
remedial legislation.
The bill establishes a coordinated system of drug classi-
fication which places drugs in any one of five schedules,
depanding on their degree of abuse potential and medical use.
Provisions are also made to streamline the procedures which
enable the Attorney General to bring new drugs under control
or move drugs within the various schedules.
A closed regulatory system, which requires annual regis-
tration, record keeping, and inventories of controlled
substance stocks, is established for the legitimate manufacture,
distribution, and dispensing of controlled substances. Pro-
duction quotas are imposed on the manufacture of certain
substances, and the flexibility of the drug scheduling scheme
will permit these quotas to be imposed on the manufacture of
other drugs should the need arise.
H.R. 18583 further provides a new penalty scheme for
offenses relating to narcotics, marihuana, and stimulant and
Reproduced at the Richard Nixon Presidential Library
- 2 -
and depressant drugs. With but one exception, no minimum
mandatory sentences are proveded for. Drug users are distin-
guished from drug traffickers in terms of the seventy of the
sentences imposed. Simple possession is treated as a mis-
demeanor with special provisions for first offender treatment
in the event it is the defendant's first conviction for an
offense relating to controlled substances. Special provisions
are also made for imposing severe minimum mandatory sentences on
those persons who traffic in these drugs for profit as part
of a continuing criminal enterprise.
The bill also provides new tools for special agents of
the Bureau of Narcotics and Dangerous Drugs to aid them in
the effective enforcement of the Act. Authorization to
execute search warrants without notice of authority and purpose,
upon approval of a judge or magistrate, will permit the seizure
of evidence which heretofore has been destroyed or disposed of.
New provisions relating to administrative inspection warrants
will permit inspections of premises where drugs are manufactured
or distributed if the person in charge refuses to consent or
there is not imminent danger to the public health or safety.
New forfeiture provisions will permit the seizure of the
vehicles used by drug traffickers to transport and sell illicit
drugs.
The bill further imposes new restrictions on the import-
ation and exportation of controlled substances in order to
Reproduced at the Richard Nixon Presidential Library
- 3 -
insure that the drugs will be used for legitimate purposes
and not diverted into illicit channels. Such new controls
are needed to help in shutting down the flow of these drugs
from abroad, while at the same time allowing the Federal
Government to better monitor the traffic in general.
Reproduced at the Richard Nixon Presidential Library
Admin Drug Bue
August 18, 1970
MEMORANDUM FOR STAN EBNER
Re: No-Knock
In preparing floor speeches for the forthcoming
House debate on the drug bill, the attached
document might serve some purpose. Jeff Donfeld
brought it to my attention. I don't know anything
about the Hudson Institute, but if they are a
"big time" group, the position might be helpful.
I pass this along for any use you can make of it.
John Dean
Reproduced at the Richard Nixon Presidential Library
NEW YORK POST, FRIDAY, AUGUST 21, 1970
U. S. Pressure
He denied as "invention"
the charges in two Paris
news weeklies that Marcellin
began to move only under
pressure from U. S. Attorney
General Mitchell.
The charges published in
U.S. Aids
the satirical but well-informed
Le Canard Enchaine and the
influential. leftist Nouvelle
Observateur said Marcellin's
France in
quick visit to Mitchell in
Washington three weeks ago
was made under duress.
Canard said that U. S. Am-
Drug Push
bassador Arthur K. Watson
had sent Washington reports
on the Marseilles heroin rack-
By MILT FREUDENHEIM
et that the paper charged
PARIS (CDN)-American
Marcellin's ministry had been
and French narcotics agents
sitting on.
have seized heroin worth $3.6
Insinuating that the re-
million since late June in
ports told of "high political
their drive to shut off French
protection coming from per-
sources that supply 80 per
sonalities of the government
cent of the heroin reaching
(Gaullist) party," Canard al-
leged that Watson's predeces-
the U.S.
sor, R. Sargent Shriver, had
Amid opposition needling
"discreetly stifled" them to
alleging politically motivated
avoid embarrassing French
delays and coverups, French
leaders.
authorities increased their
U. S. embassy officials
drug law enforcement man-
deny that any reports alleg-
power in southern France in
ing French government pro-
July from 9 agents to 25.
tection of the heroin racket
Interior Minister Raymond
were received by Shriver or
Marcellin has promised 25
Watson.
more agents for October to
The embassy denial left
scour the French Riviera for
open whether local corrup-
the elusive heroin labora-
tion in the Marseilles area
tories.
had hampered narcotics en-
In 19 years of looking,
forcement.
French police managed to un-
Nouvelle Observateur said
cover only 13 secret labora-
Marcellin's ministry had re-
tories, including 2 last year
ceived reports from Marsel-
and none so far this year.
les police officials more than
But with the new French
a year ago detailing the big-
agents, John T. Cusack, chief
time heroin mobsters and
U. S. narcotics agent for
sites of clandestine labora-
Europe, says enforcement
tories where the morphine
prospects "couldn't be bet-
base smuggled from Turkey
ter."
is refined into heroin.
"In order to act," Observ-
ateur charged, "the Mar-
seilles. police awaited the
orders of the Interior Min-
istry. Although some arrests
were made recently
in
order to prove otherwise
it seems in fact that they
are still waiting."
PRESERVATION COPY
Reproduced at the Richard Nixon Presidential Library
Mr. Ingersoll, distinguished guests, and members of Special
Agent Class #10.
I have had the opportunity and occasion to graduate no less
than five times. Accordingly, I have had some experience at
sitting where yourare sitting. If I have any one conclusion to
draw from that experience it is that I cannot tell you who
addressed the graduation class nor can I tell you what he said.
I have asked others if they can remember what was said at
their graduation and with few exceptions I find that my own
experience is not an uncommon one. So today you are not going to
hear great rhetoric, grand platitudes or a locker room type pep
talk to charge you up before you go into the field. You are
not going to hear it because it is a waste of your time and mine.
Instead, I would like to take just a few minutes to share some
of my own observations about the work you have commenced and the
mission you have undertaken.
First I would like to share a few observations about BNDD.
-- BNDD is the newest of the Federal law enforcement agencies.
What does this mean? Well, it means that you have an unusual
g
opportunity to grow as BNDD grows. It also means that you have a
responsibility to assist in building a strong foundation that has
already been started for the Bureau -- a foundation that will support
an agency charged with a vital mission.
Reproduced at the Richard Nixon Presidential Library
-2-
-- BNDD is the lead agency within the Federal establishment
for enforcing drug laws. Because of the dimensions of your mission
and because of the critical nature of the problem you are dealing
with, you must be the best law enforcement officers in the
only
business. Remember that your effort will not be important for the
effectiveness of the Federal effort, but also your effort and
effectiveness will also serve as a model for state and local efforts.
-- BNDD is also fortunate to have Jack Ingersoll as its
Director. Back in 1968 when the prior Administration sent the
reorganization plan to Con gress to create BNDD, I worked with a
number of Republican Congressmen who were strongly opposed to the
reorganization. There was a sincere concern that placing drug
enforcement in the Department of Justice would result in a weakening
of the Federal effort. Many Republicans were sure that a Democratic
a
appointee would view the drug problem as purely social and medical
problem. Well, Director Ingersoll was appointed by the Democrats --
and obviously he has been reappointed by the Republicans. This is a
tribute to his professionalism in building BNDD and his skraight
strength in enforcing the Federal drug laws.
I need not tell you of the innovation and programs he has
developed -- you should be well aware of them, having just completed
your training school.
I might also note for those of you who haven't made this
observation yourself -- BNDD has some of the most attractive secretaries
in Washington. However, I'm not sure whether the Director can claim
credit for this fact or not.
Reproduced at the Richard Nixon Presidential Library
-3-
I have enjoyed working with the Director the last few years and
have witnessed his tremendous ability to lead the Bureau. We have
worked most closely on the proposed new revisions in the
Federal drug laws. Hopefully this important legislation will be
enacted by Congress in the coming weeks. Its adoption will
provide you with many new and necessary legal tools for carrying on
your law enforcement and regulatory activities. Its adoption will
also be a tribute to the Director and this Bureau which has been
responsible for its development, presentation to the Congress
through repeated public and private appearances. It will, of
course, be your responsibility to implement it.
Gentlemen, the job before you is enormous. The spread of
drug abuse throughout our culture has created a law enforcement
problem that transcends what is routinely considered to be law
enforcement. In a large measure, the problem you are dealing with is
both psychological and sociological. Aside from your most
important function of halting the illicit traffic in these drugs,
you will also be cast into the limemight surrounding all the social
issues confronting our nation today. The drug culture we are
experiencing is in many ways symptomatic of the disenchantment and
rejection of our established values by the youth of this country.
The profession you have chosen will require you to answer some
difficult questions. For example,
Reproduced at the Richard Nixon Presidential Library
Baop
As graduates of the Executive Protective Service
Recruit Training Course, you stand at the threshold
of achievement.
You have been selected because of your honesty,
your integrity and your desire to suppress crime
And you have been trained to do this to the best of
your ability.
Yours is not a small responsibility. Rather it is a
great responsibility not only to the people of our
country, but also to people around the world.
It is a tribute that the law enforcement officer is
not asked if he can do the job. It is presumed that
he can. I am confident that you can do the job and
do it well.
James Q. Rowley
with he daug probh.
James J. Rowley, Director
U.S. Secret Service
good lock r congrahlakes.
Reproduced at the Richard Nixon Presidential Library
I had dinna whilE IN 5m clark with
a Dr. and his wife. Overang the consustorm
he told me hil 21 year old daughter had
be come a hippie; that she had falling
IN low with a mm who used daugs met
had recombly shinling dealing in drugs. She
had come to her fam a few days lar like
and Ask him for $ 500.00. He ANNO what
she wanter the my 6n - for her boy
from hato make a buy from a Mixim contact
he cale malco some Many on an
resale. He did girl an the many, bet
He asked Me - what shwke he do.
Shald he know his claught IN To the police - -
How do cald he disoade her from Mis
activity - i
How covld he - as a Dr. who know the MEdical
effect of Drugs - explan his to her- -
gall you are going to be asks such
Quitions. - and lum tougher questions. your answer
Must be good analys, but shay of he questions
just can't be answered. Indand, your job
IS movimus.
Reproduced at the Richard Nixon Presidential Library
The Bureau of Narcotics and Dangerous Drugs most significantly
represents the Federal Government's crucial responsibility in
providing leadership and direction towards the removal of drug
addiction and drug abuse from our society. Gentlemen, you must
be aware that these substances threaten, in a most profound way,
the very fabric of American society. History will record the
results of the effort upon which each of you is about to embark.
To fail is unthinkable. To succeed, you will be severely tested.
But I am confident you will meet that test; I am confident you
will succeed. For, in the longrun we have no alternative --
not if America is to to survive as a great nation, not if we
are to survive as a great people. Not, in fact, if Western
civilization, as we know it is to survive at all.
Reproduced at the Richard Nixon Presidential Library
HOFFMANN - LA ROCHE INC.
Drugs
NUTLEY . NEW JERSEY . 07110
April 20, 1970
The Honorable John W. Dean, III
Associate Deputy Attorney General
Department of Justice
Washington, D.C.
Dear John,
Enclosed is a copy of the article from the Congressional
Record which carried the poem, Psychedelirium Tremens.
In its own way, it is quite effective, and I hope you
can make good use of it.
I enjoyed being on the Program with you and Mike and
will look forward to seeing you again.
Very truly yours,
John H. Wood
General Attorney
JHW:la
Enclosure
Reproduced at the Richard Nixon Presidential Library
PHARMACEUTICALS FINE CHEMICALS VITAMINS MEDICAL LECTRONICS DIAGNOSTICS
April 18, 1969
CONGRESSIONAL RECORD Extensions of Remarks
E 3103
GEORGE J. GOTTWALD, JR., WHO DIED IN THE
at the intersection of Washington Street and
And making a scene was a rude thing to do?
SERVICE OF HIS COUNTRY
Metropolitan Avenue, by the Cecil W. Fogg
Words once so sensible, sober, and serious,
A Soldier who falls in the line of duty, de-
American Legion Post and Affiliates.
Are making the freak scene like psychedelir-
serves our humble respect and profound
ious.
gratitude.
It's groovy, man, groovy, but English it's not,
George J. Gottwald, Junior, was such a
Methinks that the language has gone straight
soldier.
PSYCHEDELIRIUM TREMENS: POEM
to pot.
His Spirit and Courage, His Dedication (to
BY JANE GOODSELL
JANE GOODSELL.
duty, place him among the hallowed ranks
of Patriotic Americans whose unfailing Love
of Country and Loyalty to their Comrades in
HON. LEE METCALF
Arms; have since the birth of our Country,
OF MONTANA
TRIBUTE TO COUNCILMAN JULIUS
secured the blessings of Liberty for All
Americans.
IN THE SENATE OF THE UNITED STATES
LENHART, OF McKEESPORT, PA.
Specialist Fourth Class George Gottwald
Friday, April 18, 1969
never planned great battles nor did he lead
HON. JOSEPH M. GAYDOS
an Army in the field. He did more than that:
Mr. METCALF. Mr. President, the
He gave his life for his Country.
Senators Neuberger, first Dick, then his
OF PENNSYLVANIA
There is no greater Sacrifice.
gracious widow, Maurine, demonstrated
IN THE HOUSE OF REPRESENTATIVES
There can be no honor paid to his Memory
their ability with words. The ability to
Thursday, April 17, 1969
that can fully express how much we revere it.
write is a Neuberger family trait. Dick's
Yet, the Cecil W. Fogg Post of the American
sister, Jane Goodsell, is at home with
Mr. GAYDOS. Mr. Speaker, during
Legion, of Hyde Park, Massachusetts, and
poetry or prose. Recently I read her
these times of civil unrest, turmoil, and
their Affiliates; is doing what it can by Dedi-
"Psychedelirium Tremens," a light treat-
in some instances, outright revolt
cating the George J. Gottwald, Jr., Square, to
against law and order and the funda-
the memory of this brave boy.
ment of a serious subject.
The Legions National Commander William
I ask unanimous consent that her poem
mental precepts on which this great
C. Doyle has said of the Patriotism exem-
be printed in the RECORD.
country was founded, it is most impor-
plified by George J. Gottwald, Jr.:
There being no objection the poem was
tant that significant activities and af-
"It is a Respect for the Rights of our Fellow
fairs receive due recognition in order
Man. It is a Concern for Freedom of Man, as
ordered to be printed in the RECORD, as
that all Americans will not be misunder-
our God given Rights; but a recognition also
follows:
stood and unjustly criticized. Fortu-
that every Right carries with it an accom-
PSYCHEDELIRIUM TREMENS
nately, there are still individuals and
panying Responsibility."
Remember when hippie meant big in the
associations who maintain high princi-
George Gottwald did not shirk that Re-
hips,
sponsibility.
ples, social obligation, and dedication to
And a trip involved travel in cars, planes, and
By his heroic act he has upheld the Honor
ships?
what is good in America. One of these
and Tradition of the Military Services of the
When pot was a vessel for cooking things in,
citizens ils Councilman Julius Lenhart
United States of America.
And hooked was what Grandmother's rug
of McKeesport, Pa., who recently re-
May every Bostonian, as he passes through
might have been?
ceived the first Man of the Year Award
the George J. Gottwald, Jr., Square, remem-
When fix was a verb that meant mend or re-
from the McKeesport Hungarian Social
ber the Man for whom it is named and Sol-
pair,
Club, a nationality fraternal organiza-
diers like him who have Sacrificed in order
And be-in meant simply existing somewhere?
that others can enjoy the blessings of Democ-
tion that has affected the lives of many
When neat meant well organized, tidy and
racy and Freedom.
McKeesporters and numbers among
clean,
My heart goes out to Family and Friends
those associations that love America.
And grass was a ground-cover, normally
assembled at this Dedication.
green?
On Saturday, April 12, 1969, the Mc-
I salute the Cecil W. Fogg Post and their
When lights and not people were switched
Keesport Hungarian Social Club hon-
Affiliates the V.F.W. All Boston Post of Roslin-
on and off,
ored an outstanding public servant and
dale, the William Doyle and Irving K. Adams
And the pill might have been what you took
community leader as the recipient of the
Post of the Legion and the Boston Fire De-
for a cough?
club's first Man of the Year Award. A
partment Band for their participation at this
When camp meant to quarter outdoors in a
worthy, patriotic ceremony.
special banquet provided the setting for
tent,
It is my prayer that this fine American will
the presentation of a distinguished serv-
And pop was what the weasel went?
not have died in vain-that through his
When groovy meant furrowed with channels
ice plaque to Councilman Lenhart, which
heroism we have been brought a little closer
and hollows,
honored his social, political, cultural and
to a just and lasting peace.
And birds were winged creatures, like robins
charitable activities and accomplish-
JOHN W. MCCORMACK,
and swallows?
ments in and among the citizenry of
Speaker, U.S. House of Representatives.
When fuzz was a substance that's fluffy like
McKeesport and the surrounding area.
(By cable.)
lint,
Read by Master of Ceremonies Peter L.
Outstanding dignitaries attended this
And bread came from bakeries, not from the
Caparell at the opening of the Dedication
auspicious occasion to honor Council-
mint?
Ceremonies at the George J. Gottwald, Jr.,
When square meant a 90-degree angled form,
man Lenhart. Mayor Albert Elko of the
Square, Sunday, March 23rd at 2:15 p.m.
And cool was a temperature not quite warm?
city of McKeesport delivered the official
Born: Boston, Mass.
When roll meant a bun, and rock was a stone,
greetings and the president of the Hun-
Educated: Boston Public Schools.
And hang-up was something you did to a
garian Social Club, Steve Breda, pre-
Parish: St. John Chrysostom.
phone?
sented an address of welcome. The well
Enlisted: U.S. Army, October 1966.
Parents: George J. and Caroline Gottwald,
When chicken meant poultry, and bag meant
known and very popular bishop of the
6 Metropolitan Avenue, Roslindale.
a sack,
Free Hungarian Reform Church, Bishop
Specialist Fourth Class George J. Gott-
And junk, trashy cast-offs and old bric-a-
Lewis J. Nagy, served as toastmaster
brac?
wald, Jr., volunteered to lead his Platoon on
a hazardous mission in Viet Nam and was in-
When jam was preserves that you spread on
and the Hungarian Social Club vice pres-
your bread,
ident, Alec S. Meszar, was also present.
tercepted, intermittently, by enemy machine
And crazy meant balmy, not right in the
The national secretary of the William
gun fire, while crawling to the aid of a
head?
Penn Fraternal Association, Albert J.
wounded Medic.
Wounded three times by enemy machine
When cat was a feline, a kitten grown up,
Stelkovics, was present and participated
gun fire, he remained undaunted-and fell
And tea was a liquid you drank from a cup?
in the presentation program. Invocation
mortally wounded under heavy concentrated
When swinger was someone who swings in a
was delivered by Basil Shereghy and con-
enemy fire in his fourth attempt to reach the
swing,
vocation by Rev. Dr. Laszlo Brezeviczy.
side of his Comrade.
And pad was a soft sort of cushiony thing?
Posthumously awarded the Silver Star by
When way out meant distant and far, far
Councilman Lenhart has distinguished
direction of the President of the United
away,
himself in the city of McKeesport and
States, March 8, 1968.
And a man couldn't sue you for calling him
the metropolitan area as a dedicated
This Memoriam Tribute published by his
gay?
public official who has been responsible
Brothers and Sisters, Frederick, William,
When dig meant to shovel and spade in the
for innovating the entire McKeesport
Richard, Thomas, Edward, Caroline, Jean
dirt,
recreation program. The youth of Mc-
and Denise Gottwald and distributed in com-
And put-on was what you would do with a
Keesport now enjoy unprecedented ath-
memoration of the George J. Gottwald, Jr.,
shirt?
letic facilities which have stimulated a
Square.
When tough described meat too unyielding to
rededication to athletic activities of all
Dedication: Sunday, March 23, 1969, 2 p.m.
chew,
kinds including baseball, football, soccer,
Reproduced at the Richard Nixon Presidential Library
HOFFMANN-LA ROCHE INC.
NUTLE
U.S.POSTAGE
NUTLEY
NEW JERSEY 07110
APR 20'70
III 06
" 1
METER
P.D.613744
The Honorable John W. Dean, III
Associate Deputy Attorney General
Department of Justice
Washington, D.C.
Reproduced at the Richard Nixon Presidential Library
SONNENREICH
CHAPTER II-BUREAU OF NARCOTICS
AND DANGEROUS DRUGS,
DEPARTMENT OF JUSTICE
Part
301
Cooperation with States.
302
Importation and exportation of narcotic drugs.
303
Opium poppies.
304
[Reserved]
305
Opiates.
306
Surrender of heroin.
307
Manufacturing of narcotic drugs.
308
[Reserved]
315
Enforcement of the Drug Abuse Control Amendments of 1965 of the Federal
Food, Drug, and Cosmetic Act.
316
Administrative functions, practices, and procedures.
319
Habit-forming drugs.
320
Depressant and stimulant drugs; definitions, procedural and interpretative
regulations.
330
Seizure, forfeiture, and disposition of vessels, vehicles, and aircraft for do-
mestic narcotic and marihuana violations.
CROSS REFERENCES: Application and enforcement of the Harrison Narcotic Act: See Panama
Canal, 35 CFR Part 65.
Bureau of Customs, Department of the Treasury: See Customs Duties, 19 CFR Chapter I.
Manufacture of opium for smoking purposes under the act of January 17, 1914: See Internal
Revenue, 26 CFR Part 150.
Regulations under the Harrison Narcotic Law, as amended: See Internal Revenue, 26 CFR
Part 151.
Regulations under the Marihuana Tax Act of 1937: See Internal Revenue, 26 CFR Part 152.
Regulations of the Public Health Service, Department of Health, Education, and Welfare,
applying to narcotic addicts: See Public Health, 42 CFR Part 33.
NOTE: Other regulations issued by the Department of Justice appear in Title 4, Title 8,
Title 28.
287
Reproduced at the Richard Nixon Presidential Library
Title 21-Chapter II
§ 302.1
§ 301.1
Title 21-Chapter II
rect the attendance of any officer, agent,
Sec.
PART 301-COOPERATION WITH
§ 301.3 Hearings before licensing boards
or employee to testify, relative to the
302.26
Exportation to countries which have
or other State agencies having power
possession of or traffic in drugs in
exceeded estimate.
STATES
to suspend or revoke licenses.
302.27
Sec.
any case where the litigants are private
Records required of exporter.
301.1
State or municipal prosecutions.
The Director may furnish to State
parties or where the object of the pro-
Subpart C-In-Transit Shipments
301.2
Attendance of officers.
licensing boards or other State agencies
spective inquiry, proceeding, or hearing
302.28
In-transit shipments.
301.3 Hearings before licensing boards or
authorized by law to revoke or suspend
is other that that indicated in §§ 301.1-
other State agencies having power
licenses to practice a profession, or en-
301.3.
Subpart D-Special Coca Leaves
to suspend or revoke licenses.
gage in a trade, in the course of which
(b) The Director shall exercise sound
302.29
Importation of special coca leaves.
301.4 General.
narcotic drugs are possessed, controlled,
discretion in executing the authority
302.30
Information required of prospective
AUTHORITY: The provisions of this Part
or dispensed; or to any State board, offi-
granted in this part to the end that
importer.
301 issued under sec. 8, 46 Stat. 587; 21
cer, or agency authorized by law to
no investigation being conducted at any
302.31
Matters to be considered in granting
U.S.C. 198.
grant, suspend, or revoke any license or
time under his direct or indirect super-
permit.
302.32
SOURCE: The provisions of this Part 301
permit when, in the exercise of said
vision shall be prejudiced by the prema-
Approval or disapproval of applica-
tion.
appear at 33 F.R. 14818, Oct. 3, 1968, unless
authority, the narcotic drug addiction
ture disclosure of facts developed by the
302.33
Application for permit to import.
otherwise noted.
of the applicant, licentiate, or permittee,
investigation. The Director shall solicit
302.34
Registration of importer.
or his conviction of a violation of any
the cooperation of appropriate State and
302.35
§ 301.1 State or municipal prosecutions.
Allotment for calendar year not im-
law relating to narcotic drugs, may have
municipal officers in arranging to execute
portable in succeeding year.
The Director of the Bureau of Nar-
a material bearing upon the granting,
the authority granted in this part in
302.36
Issuance of permits.
cotics and Dangerous Drugs, hereinafter
withholding, suspension, or revocation of
any given case, so that there shall be a
302.37
Withdrawal from customs custody.
referred to as "Director," may furnish to
minimum of interference with or inter-
302.38
said license or permit, such information
Manufacturing operation.
State or municipal prosecuting officers a
in the possession of the Bureau of Nar-
ruption to the investigative duties of any
302.39
Residue.
302.40
officer or agent of the Bureau of Narcot-
Samples.
report or statement of such information,
cotics and Dangerous Drugs as the Direc-
302.41
Director's representative to have
obtained from time to time by the Bureau
tor may deem appropriate to the
ics and Dangerous Drugs or with the duty
access to factory.
of Narcotics and Dangerous Drugs con-
enforcement of any State law or regu-
of such officer or agent to present prop-
302.42
Reports to Director.
cerning a violation or suspected violation
lation or municipal ordinance relating
erly and promptly to Federal prosecuting
302.43
Discontinuance of business.
of narcotic laws, as the Director may
to the granting, withholding, suspension.
attorneys, grand juries, and courts such
302.44
Cancellation of permit.
cases as the Director may direct.
302.45
deem cognizable by the said prosecuting
or revocation of State licenses or per.
Compliance with act of December 17,
1914, as amended.
officers for further investigation or prose-
mits: Provided, That no information
302.46
Returns required.
shall be furnished with respect to any
PART 302-IMPORTATION AND EX-
cution in their respective jurisdictions.
302.47
Report of importations.
case in which an offer in compromise has
PORTATION OF NARCOTIC DRUGS
302.48
Report of materials used.
§ 301.2 Attendance of officers.
been accepted under authority of section
302.49
Reports of manufacture.
Subpart A-Imports
302.50
The Director may direct the attend-
7122-Internal Revenue Code (26 U.S.C.
Report of residues destroyed.
Sec.
ance of any officer, agent, or employee of
7122), unless such case involves the re-
302.51
Summary.
302.1
Importation.
ported narcotic drug addiction of a per-
302.2
the Bureau of Narcotics and Dangerous
Who may import.
Subpart E-General
son who is registered or qualified for
302.3
Application for permission to import.
Drugs who may be in possession of perti-
302.52
302.4
Importation or exportation by mail
registration under 26 U.S.C. 4701-4707,
Alternative foreign ports.
prohibited.
nent information, to testify as a witness
4731-4735, 4771, 4774, 4721-4726, 4731-
302.5
Import permit.
302.53
Medical stores on vessels.
in any inquiry or proceeding instituted
4736, or unless the information is re-
302.6
Preparation of import permit.
302.54
Drugs seized to be delivered to col-
by authority of law by or before a grand
quested in a particular case by such State
302.7
Effect of permit.
lector of customs.
302.8
jury, municipal magistrate, or State
licensing board or State agency or duly
Shipments in greater or less amount
302.55
Forwarding drugs to Drugs Disposal
than that authorized.
qualified representative thereof, for use
Committee.
court, where the direct object of such
302.9
Cancellation of permit.
302.56
in the enforcement of any State law or
302.10
Disposition of forfeited drugs.
inquiry or proceeding is to determine
Disposition of copies of permit.
302.57
[Reserved]
whether there has been, in a particular
regulation or municipal ordinance re-
302.12
Examination of shipment by customs
302.58
Permits issued prior to effective date
lating to the granting, withholding, sus-
officer.
case, a violation of the State law or
of regulations.
pension, or revocation of State licenses.
302.13
Duties of appraiser.
302.59
municipal ordinance relating to drugs.
Regulations subject to provisions of
The Director may also direct the attend-
302.14
Purposes for which crude opium and
other pertinent laws and regula-
The Director may also direct any
ance, as a witness, in hearings held by
coca leaves may be entered.
tions.
302.15
such officer, agent, or employee to pro-
Foreign trade zones.
such boards or agencies, of any officer,
302.16
Statements rendered by importers.
SOURCE: The provisions of this Part 302
duce for examination at said inquiry or
agent, or employee of the Bureau of Nar-
appear at 33 F.R. 14819, Oct. 3, 1968, unless
proceeding such record of the Bureau of
cotics and Dangerous Drugs, and the
Subpart B-Exports
otherwise noted.
Narcotics and Dangerous Drugs or copy
production of records or copies thereof,
302.17
Exportation.
of any part thereof as the Director may
subject to the same limitations, so far
302.18
Application for export permit.
Subpart A-Imports
302.19
deem pertinent to the particular case.
as applicable, as provided in § 301.2 with
Foreign import license or permit to
AUTHORITY: The provisions of this Sub-
be submitted.
The officer, agent, or employee so pro-
respect to an inquiry or proceeding insti-
part A issued under sec. 2, 35 Stat. 614, as
302.20
Additional information.
amended; 21 U.S.C. 173.
ducing any permanent record of said
tuted by or before a grand jury, munici-
302.21
Disposition of copies of export
Bureau for examination shall not relin-
pal magistrate, or State court.
permit.
§ 302.1 Importation.
302.22
quish custody or control thereof but,
Shipment from interior port.
§ 301.4 General.
302.23
immediately upon conclusion of the in-
Special conditions relative to export
Crude opium and coca leaves may only
quiry or proceeding, shall promptly re-
(a) Nothing contained in this part
permits.
be imported under formal permit issued
302.24
turn the record to its appropriate official
shall be construed to authorize the Di-
Expiration date.
by the Director, Bureau of Narcotics and
302.25
Who may export.
repository.
rector to furnish information, or to di-
Dangerous Drugs (referred to in this
Reproduced at the Richard Nixon Presidential Library
289
288
§ 302.2
Title 21-Chapter и
Title 21-Chapter II
§ 302.10
part as the Director) pursuant to a duly
drugs as to endanger the efficient admin-
permit is issued pursuant to such appli-
shipment will leave above foreign port,"
executed application therefor, and after
istration of the Narcotic Drugs Import
cation it will bear the names of the two
but such date shall not be later than
a determination by said Director that
and Export Act.
ports in the order given in the applica-
4 months from the date permit is issued
the quantity of crude opium or coca
§ 302.3 Application for permission to
tion and will authorize shipment from
unless, for good cause shown, the Direc-
leaves requested in the application is
necessary to provide for, and will be ap-
import.
either port. Alternate ports in different
tor allows a longer period within which
countries will not be authorized in the
Application for permission to im-
to make the shipment and so specifies on
plied to, medical and legitimate uses
same permit.
only. An exception to so much of this
port crude opium or coca leaves shall
the permit. The maximum quantity of
rule as requires a formal permit may be
be made under oath on a form provided
§ 302.5 Import permit.
crude opium or coca leaves shall be stated
made in the case of an emergency which,
by the Department of Justice and for-
on the permit in terms of pounds.
The import permit shall be prepared in
in the judgment of the Director, so affects
warded to the Director, Bureau of Nar-
quintuplicate upon a form which has
§ 302.8 Shipments in greater or less
the welfare of all or a large proportion
cotics and Dangerous Drugs, Department
been approved by the Director, but such
amount than that authorized.
of the population as to justify such ex-
of Justice, Washington, D.C. 20537. The
permit shall not be valid unless signed
(a) If the shipment made under the
traordinary action. No permit shall be
application shall show, in the spaces
by the Director.
permit is greater than the maximum
granted for the importation of opium
provided thereon, the name of the
to be manufactured into heroin, its salts,
§ 302.6 Preparation of import permit.
amount authorized to be imported under
crude material desired to be imported
the permit as determined at the weigh-
derivatives, or preparations. No permit
(i. e., crude opium or coca leaves), the
Import permits shall be serially num-
ing by the customs officer, such difference
shall be granted for the importation of
number of bales or cases of such crude
bered, the five copies of a given per-
shall be seized and forfeited to the Gov-
opium unless such opium has been pro-
material, the maximum total pounds of
mit all to bear the serial number of that
ernment.
duced in a country permitted such pro-
such material, the total tentative allot-
permit. Each copy of the permit shall
(b) If the shipment made under the
duction by, and which has become a
ment to the importer of such crude ma-
have printed or stamped thereon the dis-
permit is less than the maximum amount
Party to, the 1953 Opium Protocol.
terial for the current calendar year, the
position to be made thereof. Each per-
mit shall bear a notation to the effect
authorized to be imported under the per-
total number of pounds of said allot-
CROSS REFERENCE: For importation of nar-
that the Director is satisfied that the
mit as determined at the weighing by the
cotic drugs for scientific purposes only see
ment for which permits have previously
customs officer, such difference, when
§ 307.151 of this chapter.
been issued, and the total quantity of
consignment proposed to be imported
ascertained by the Director shall be
crude material actually imported during
is required for legitimate purposes. Each
§ 302.2 Who may import.
recredited to the tentative allotment
the current year to date. Information
permit shall also be dated and shall cer-
In exercising the powers and discharg-
under the three subheads last mentioned
tify that the importer named thereon is
against which the quantity covered by
ing the duties conferred and imposed
need only be shown with respect to the
thereby permitted under the provisions
the permit was charged, and the balance
upon him by the act with respect to the
particular crude drug for which applica-
of the Narcotic Drugs Import and Export
of any such tentative allotment with
importation of crude opium and coca
tion for permission to import is being
Act as amended, to import, through the
any such recredits will remain avail-
leaves, the Director shall take such
made. The application shall also show
port named, one shipment of not to ex-
able to the importer to whom made
action as in his opinion will effectuate
the following: The name and address of
ceed the specified quantity of crude
(unless previously revoked in whole or
the intent and purpose of the act; and
the consignor, if known at the time ap-
opium or coca leaves, as the case may
in part) for importations pursuant to
pursuant to this policy, in determining
plication is submitted, but if unknown
be, shipment to be made from a stated
such permit or permits as are requested
whether any applicant shall be permitted
at that time, the fact should be indicated
port before a specified date. All copies
and issued during the remainder of the
to import such crude opium and coca
and the name and address afterwards
of import permits shall bear the signa-
calendar year to which the allotment is
leaves, the Director shall consider the
furnished to the Director as soon as
ture of the Director or his delegate, and
applicable. No permit shall be issued
character and standing of the appli-
ascertained by the importer; the for-
facsimiles of signatures shall not be used.
for importation of a quantity of crude
cant, his production facilities and trade
eign port of exportation (1. e., the place
All permits issued shall be entered in a
opium or coca leaves as a charge against
connections, whether there is reasonable
where the article will begin its journey
register kept by the Director for that pur-
the tentative allotment for a given cal-
probability that he will apply all crude
of exportation to the United States)
pose. No permit shall be altered or
endar year, after the close of such cal-
opium and coca leaves imported and nar-
the port of entry into the United States;
changed by any person after being signed
endar year, unless for good cause shown,
cotic drugs manufactured by him to med-
the latest date said shipment will leave
by the Director, and any change or
the Director decides to make an excep-
ical and legitimate purposes, whether he
said foreign port; and the stock on hand
alteration upon the face of any permit,
tion in a proper case.
may serve the public interests by lower-
of the kind of crude drug desired to be
after it shall have been signed by the
§ 302.9 Cancellation of permit.
imported under the respective subheads
ing costs or improving quality of narcotic
Director, shall render it void and of
provided. If the application is executed
no effect. Permits are not transferable.
A permit may be canceled after being
drugs by the use of improved methods,
and forwarded before the 15th day of a
issued, at the request of the importer,
or any other factors which the Direc-
given month the stock on hand may be
§ 302.7 Effect of permit.
provided no shipment has been made
tor deems appropriate to consider in
shown as of the last day of the penulti-
A permit duly signed and issued shall
thereunder. In the event that a permit
carrying out the policy mentioned. In
mate preceding month, but if the appli-
be authority to import, by the importer
is lost, the Director may upon the
the case of new applicants the Direc-
cation is executed and forwarded on or
named thereon, one shipment only of not
production by the importer of satisfac-
tor shall also consider whether the
after the 15th day of a given month the
allotments to them of shares in the
to exceed the maximum quantity of crude
tory proof, by affidavit or otherwise, is-
stock on hand must be shown as of the
amount of crude opium and coca leaves
opium or coca leaves, as the case may
sue a duplicate permit. Nothing in this
last day of the month immediately
be, specified on the permit, from a speci-
subpart shall affect the right, hereby re-
determined by him to be necessary for
preceding.
medical and legitimate uses would prob-
fled foreign port of export (see §§ 302.3,
served by the Director, to cancel a permit
§ 302.4 Alternative foreign ports.
302.4), said shipment to be made on or
at any time for proper cause.
ably have the effect of so reducing or
before the date indicated for that pur-
§ 302.10 Disposition of copies of per-
rendering uncertain the supply of crude
If desired, alternative foreign ports of
pose upon the permit. This date may,
mit.
opium and coca leaves available from
exportation within the same country may
in the discretion of the Director corre-
If it is decided to approve an ap-
year to year to manufacturers already
be indicated upon the application, thus,
spond with the date given on the appli-
plication for permission to import crude
engaged in the manufacture of narcotic
(a) Calcutta, (b) Bombay. If a formal
cation on the line labeled "Latest date
opium or coca leaves, an import permit
Reproduced at the Richard Nixon Presidential Library
290
291
Title 21-Chapter I'l
§ 302.18
302.12
Title 21-Chapter II
safe transportation of the crude opium
4721-4726, 4731-4736), as amended, and
hall be prepared in quintuplicate, each
§ 302.12 Examination of shipment by
from the appraiser's stores to the im-
regulations thereunder. Any narcotic
opy of which shall be signed by the
customs officer.
porter's premises or to the premises of
drugs not admissible into a zone as pro-
Director. The five copies of each permit
Immediately upon the unlading of
the common carrier if shipment is to be
vided in this section, found within a zone
re designated respectively as original,
crude opium from the importing vessel,
made.
shall be seized and disposed of according
uplicate, triplicate, quadruplicate, quin-
the customs officer shall carefully ex-
(d) Except as specially provided in the
to law.
uplicate. After being signed these copies
amine the cases or packages, note their
regulations in this part, the procedure
CROSS REFERENCE: For regulations under
hall be distributed and shall serve
condition, seal the packages, and if the
in the case of coca leaves shall be the
the act of December 17, 1914, as amended,
urposes as follows:
port of importation as shown on the
same as in the case of other dutiable
see 26 CFR Part 151.
(a) The original copy, together with
permit covering the shipment is the
merchandise.
he quintuplicate copy, shall be trans-
same as the port of first arrival, shall
§ 302.16 Statements rendered by im-
CROSS REFERENCE: For Bureau of Customs
nitted to the importer, who will retain
cause the cases or packages to be trans-
porters.
regulations relating to appraisements, see
he quintuplicate copy on file as his rec-
ported under customs guard and by
19 CFR Part 14.
Whenever required by the Director,
ord of authority for the importation, and
bonded cartman to the appraiser's
importers shall render to him not later
he shall transmit the original copy of
stores, where they shall be placed in a
§ 302.14 Purposes for which crude
opium and coca leaves may be en-
than 30 days after receipt of the request
he permit to the foreign exporter. The
separate and specially protected inclo-
tered.
therefor a statement under oath of the
foreign exporter will submit the original
sure. If the shipment is destined to a
stocks of narcotic drugs on hand as of
copy of the permit to the proper gov-
port of entry other than the port of first
(a) Except as otherwise specifically
the date specified by the Director in his
ernmental authority in the exporting
arrival, it shall be entered for immedi-
authorized by the Attorney General and
request, and, if desired by the Director,
country, if required as a prerequisite to
ate transportation appraise-
arranged by the Director, crude opium
an estimate of the probable requirements
the issuance of an export authorization.
ment, by bonded carrier, to the port of
may be entered only for consumption or
for medical and legitimate uses of the
This copy of the permit will accompany
entry to which destined after examina-
for transportation in bond between the
importer for any subsequent period that
the shipment. Upon arrival of the im-
tion, notation of condition and sealing
port of first arrival and the port of entry
may be designated by the Director. In
by the customs officer at the port of first
specified upon the import permit. No
ported merchandise the collector of cus-
lieu of any special statement that may
arrival. Upon arrival of the shipment
entry of either crude opium or coca
toms at the port of entry will forward
be considered necessary, the Director
at the port of entry to which destined the
leaves shall be permitted except upon
the original copy of the permit with the
may accept the figures given upon the
customs officer shall observe the same
an import permit duly issued by the
monthly return or returns submitted by
bill of lading to the appraiser for the
procedure as to examination, notation of
Director, and any quantity of crude
said importer under the act of December
port, who, after appraising the mer-
condition, and sealing as required at the
opium or coca leaves imported or at-
17, 1914, as amended, and regulations
chandise, will return the original copy of
port of first arrival, shall compare the
tempted to be imported not in accord-
thereunder.
the permit to the Director with a
original copy of the permit accompany-
ance with such permit and the regula-
report on the reverse side of such origi-
ing the shipping documents with the
tions in this part shall be subject to for-
Subpart B-Exports
nal copy, showing the name of the port
copy theretofore furnished to the col-
feiture under the act.
AUTHORITY: The provisions of this Sub-
of importation, date prepared, net quan-
lector of the port in the manner herein-
(b) Coca leaves may be entered either
part B issued under 38 Stat. 275, as amended;
tity and kind, and report of analysis of
before provided, and shall cause the
for consumption or warehouse or for
21 U.S.C. 182.
shipment to be transported under cus-
transportation in bond between the port
the merchandise entered.
§ 302.17 Exportation.
toms guard and by bonded cartman to
of first arrival and the port of entry
(b) The duplicate copy shall be for-
the appraiser's stores, where it shall be
specified on the permit covering the
(a) Except as otherwise provided in
warded to the proper governmental au-
placed in a separate and specially pro-
shipment.
paragraph (b) of this section, no per-
thorities of the exporting country.
tected inclosure.
CROSS REFERENCES: For Bureau of Customs
son shall in any manner export from or
(c) An additional copy shall be for-
CROSS REFERENCES: For transportation in
regulations covering transportation in bond
take out of the United States, or cause
warded to the collector of customs at the
bond and merchandise in transit, see 19 CFR
and merchandise in transit, see 19 CFR Part
to be exported or taken out of the United
United States port of entry, which shall
Part 18. For cartage and lighterage regula-
18. For Bureau of Customs regulations
States any narcotic drug, nor shall any
be the customs port of destination in the
tions, see 19 CFR Part 21.
covering entry for consumption, see 19 CFR
carrier receive for exportation, or export,
8.27-8.29. For Bureau of Customs regula-
or carry out of the United States any
case of shipments transported under
§ 302.13 Duties of appraiser.
tions covering entry for warehouse, see 19
CFR 8.30-8.32.
narcotic drug, unless and until a permit,
immediate transportation entries, in or-
(a) The original copy of the permit,
in due form to export the narcotic drug
der that said collector may compare it
with the bill of lading for the shipment
§ 302.15 Foreign trade zones.
in each instance shall have been issued
with the original copy and the bill of
shall be forwarded to the appropriate
No narcotic drug as defined in the act
by the Director.
lading upon arrival of the merchandise.
appraiser, who shall take action thereon
of May 26, 1922 (42 Stat. 596; 21 U.S.C.
(b) A pharmaceutical preparation,
(d) The other copy of the permit
as provided in § 302.10.
Ch. 6), as amended, shall be permitted to
containing a narcotic drug, conforming
shall be retained on file in the office of
(b) The appraiser shall cause such ar-
be introduced into a foreign trade zone,
to the standards set forth in 26 CFR
the Director.
rangements to be made as will insure
established under the act approved June
151.422 as a Class "M" product may be
the safe-keeping of the crude opium
18, 1934 (48 Stat. 998; 19 U. S. C. 81a-
exported or taken out of the United
If a discrepancy is noted between cor-
while in the appraiser's stores.
responding items upon different copies
81u), except that such quantities of nar-
States without compliance with require-
(c) No delivery of crude opium to the
cotic drugs as are required for direct
of a permit bearing the same serial num-
ments set forth in §§ 302.17-302.27.
importer from the appraiser's stores shall
emergency medical needs within a zone
ber when compared by the United States
be permitted until the collector or his
may be admitted into said zone from cus-
§ 302.18 Application for export permit.
collector of customs, the officer shall
representative and the appraiser or his
toms territory of the United States sub-
A separate permit must be obtained for
refuse to permit entry of the importa-
representative shall be satisfied and so
ject to the requirements of the act of
each consignment of narcotic drugs to be
tion until the facts are communicated
note on the delivery permit, after per-
December 17, 1914 (68A Stat. 549; 26
exported. Application for permission to
to the Director and further instructions
sonal examination, that the importer
are received.
has taken all proper precautions for the
U.S.C. 4701-4707, 4731-4735, 4771-4774,
export narcotic drugs shall be made
Reproduced at the Richard Nixon Presidential Library
293
292
302.19
Title 21-Chapter II
Title 21-Chapter Il
§ 302.28
under oath on an approved form pro-
foreign language) or a certified copy of
export in the space provided on the
tee to the office of the Director for
by the Department of Justice for
any such license or permit, issued by
reverse side of the export permit, the col-
cancellation.
he purpose, and such application shall
competent authorities in the country
lector of customs shall forward the en-
transmitted to the Director, Bureau
of destination, or other documentary
dorsed original copy of the export permit
§ 302.25 Who may export.
Narcotics and Dangerous Drugs, De-
evidence deemed adequate by the Direc-
with the shipment, and return the en-
No export permit will be issued unless
artment of Justice, Washington, D.C.
tor, showing that the merchandise is
dorsed duplicate copy to the office of the
and until the applicant shall be duly
0537. Each application shall show the
consigned to an authorized permittee,
Director.
registered or qualified as an exempt offi-
of execution, the exporter's internal-
that it is to be applied exclusively to
(b) The quadruplicate copy of the ex-
cial in accordance with the act of De-
evenue registry number, and shall
medical and scientific uses within the
port permit shall be forwarded to the
cember 17, 1914, as amended, and the
how in the space provided the name
country of destination, that it will not
collector of customs at the port of ex-
regulations thereunder.
detailed description of the nar-
be reexported from such country, and
port for comparison with the original
CROSS REFERENCE: For regulations under
otic drug or preparation desired to
that there is an actual shortage of and
and to be retained for the customs
the act of December 17, 1914, as amended,
exported, the net quantity thereof,
a demand for the merchandise for med-
record.
see 26 CFR Part 151.
he number and size of packages or
ical and scientific uses within such
(c) The quintuplicate copy of the ex-
country. Verification by an American
port permit shall be sent to the officer in
§ 302.26 Exportation to countries which
ontainers, the name and quantity of
have exceeded estimate.
he narcotic drug contained in any prep-
consular officer of signatures on for-
the country of destination who issued
ration being stated and the quantity of
eign import licenses will be necessary if
the import certificate, or other documen-
No export permit shall be issued for the
solids being given in grams. The
such licenses do not bear the seal of the
tary evidence upon which the export
exportation of any narcotic drug to any
pplication shall contain a printed
officer signing them.
permit is founded.
country when the Director has infor-
tatement to the effect that the applica-
(d) The sextuple copy of the export
mation to show that the estimates
is made for permission to export the
§ 302.20 Additional information.
permit shall be retained on file in the
submitted with respect to that country
arcotics listed therein, pursuant to the
If after careful consideration of the ap-
office of the Director.
for the current period, under the Nar-
rovisions of the Narcotic Drugs Import
plication it is found that approval can-
cotics Limitation Convention of 1931
§ 302.22 Shipment from interior port.
nd Export Act, as amended, and the reg-
not be given, such fact and the reasons
have been, or, considering the quantity
lations thereunder. The application
therefor will be communicated to the
In the event the consignment shall
proposed to be imported, will be ex-
hall include the name, address, and busi-
applicant by the Director. If addi-
proceed from an interior port, the col-
ceeded. If it shall appear, through sub-
of the consignee, the foreign port of
tional information is required, or other
lector of customs at the interior port,
sequent advice received from the Inter-
ntry, the port of exportation, the ap-
action is necessary to correct any mis-
after endorsing the original and dupli-
national Narcotic Control Board that the
roximate date of exportation, the name
take or irregularity in the application or
cate copies of the export permit, shall
estimates of the country of destination
the exporting carrier or vessel (if
accompanying documents, opportunity
forward the original copy with the ship-
have been adjusted to permit further
nown, or if unknown it should be stated
will be afforded the prospective exporter
ment and shall transmit the duplicate
importation of the narcotic drug, an ex-
hether shipment will be made by ex-
by the Director to furnish such ad-
copy of the export permit to the collector
port permit may then be issued if other-
freight, or otherwise, exports of
ditional information or to correct such
of customs at the port of lading on the
wise permissible.
arcotic drugs by mail being prohibited),
mistake or irregularity before the appli-
export vessel or conveyance, and the
§ 302.27 Records required of exporter.
he date and number, if any, of the sup-
cation is finally disapproved.
latter collector of customs, after endors-
The exporter shall keep a record of any
orting foreign import license or permit
§ 302.21 Disposition of copies of ex-
ing the duplicate copy, shall transmit it
serial numbers that might appear on
ccompanying the application, and the
to the office of the Director.
port permit.
packages of narcotic drugs in quantities
uthority by whom such foreign license
permit was issued. The application
If, from the facts presented in the ap-
§ 302.23 Special conditions relative to
of one ounce or more in such a manner
plication, the Director finds it is proper
export permits.
as will identify the foreign consignee.
hall also contain an averment that the
ackages are marked according to the
to permit the requested exportation, an
Each export permit shall be serially
Subpart C-In-Transit Shipments
egulations, and to the best of affiant's
export permit shall be prepared in
numbered, and shall be predicated upon
sextuple in the office of the Director.
§ 302.28 In-transit shipments.
nowledge and belief the narcotics there-
a separate import certificate or other
are to be applied exclusively to medi-
Each of the six copies of the export
(a) Each in-transit shipment under
documentary evidence, and not more
and legitimate uses within the coun-
permit shall be marked as to disposition
section 2 of the act (42 Stat. 597; 21
than one shipment shall be made
and shall be distributed and serve pur-
U.S.C. 180) will be considered by the
to which exported, will not be reex-
orted therefrom, and are needed there-
poses as follows:
thereon. All export permits shall be
Director on its individual merits, but
(a) The original copy, together with
entered in a register kept for that pur-
in general the regulations governing
because there is an actual shortage
the duplicate and triplicate copies, shall
pose in the office of the Director.
hereof and a demand therefor for medi-
exports (§§ 302.17-302.27) will be applied
be transmitted to the exporter who will
Export permits are not transferable.
so far as practicable.
and legitimate uses within such coun-
The application shall be signed by
retain the triplicate copy on file as his
§ 302.24 Expiration date.
(b) Articles in transit manifested
he exporter, or by his duly appointed
record of authority for the exportation.
merely as drugs, medicines, or chemicals,
The exporter shall present to the cus-
An export permit shall not be valid
without evidence to satisfy the collector
gent whose title shall be given in the
provided therefor, and shall con-
toms authorities, at the port of export,
after the date specified therein, which
of customs that they are nonnarcotic,
the address from which the drugs
except when the shipment is to proceed
date shall conform to the expiration date
shall be detained and subjected at the
from an interior port, and then at such
specified in the supporting import cer-
carrier's risk and expense to such exami-
ill be shipped for exportation.
interior port, at the time of shipment,
tificate or other documentary evidence
nation as may be necessary to satisfy the
302.19 Foreign import license or per-
the original and duplicate copies. The
upon which the export permit is founded,
collector whether they are of a narcotic
mit to be submitted.
shipper's export declaration shall be pre-
but in no event shall the date be subse-
character. With a view to avoiding such
inconvenience, the carrier should not
There shall also be submitted with the
sented to the customs authorities at the
quent to three months after the date the
accept in-transit shipments of such ar-
pplication any import license or per-
port of exportation from the United
permit is issued. Any unused export
ticles unless accompanied by properly
(and a translation thereof if in a
States. After customs endorsement of
permit shall be returned by the permit-
verified certificates of the shippers,
294
Reproduced at the Richard Nixon Presidential Library
295
386-408 o 70 2
Title 21-Chapter Il
Title 21-Chapter I'l
$ 302.38
§ 302.29
the estimated quantity of special coca
lowance, except as such allowance shall
§ 302.35 Allotment for calendar year
specifying the items in the shipment
be increased or decreased in accordance
leaves required by the applicant for the
not importable in succeeding year.
and stating whether narcotic or not.
with this section.
(38 Stat. 275, as amended; 21 U. S. C. 182)
calendar year to which the application
No application for a permit or permits
relates is reasonable under all the cir-
§ 302.33 Application for permit to im-
to import received by the Director
Subpart D-Special Coca Leaves
cumstances, taking into consideration,
port.
after the expiration of the calendar year
AUTHORITY: The provisions of this Sub-
among other things, the applicant's
to which any authorized maximum al-
A separate permit must be obtained
part D issued under sec. 6, 46 Stat. 587; 21
trade connections, production facilities,
lowance relates will be approved as a
for each shipment of special coca leaves
U.S.C. 173a.
and financial capacity to perform the
charge against such allowance.
imported by the applicant. Application
§ 302.29 Importation of special coca
indicated manufacturing operation with
for such permit or permits shall be made
§ 302.36 Issuance of permits.
leaves.
such estimated quantity of leaves.
by the applicant on an approved form
Permits to import shall be issued in the
Additional amounts of coca leaves
(b) The applicant shall agree to comply
under oath. Such application shall
form, and importations thereunder shall
(thereinafter designated as special coca
with the provisions of section 6 of the act
show, in spaces provided thereon, the
be made in the manner provided by the
leaves) may be imported only under
of June 14, 1930, and of the regulations
quantity in pounds of special coca leaves
regulations in this part. Section 302.8
formal permit issued pursuant to § 302.33,
in this part, and the provisions of the act
desired to be imported in the shipment
shall govern the procedure in the case of
by persons authorized to import in ac-
of December 17, 1914, as amended, and to
and the number of bales or containers
cordance with the regulations in this
destroy, as hereinafter provided, under
any shipment of a less or greater quan-
thereof; the tentative maximum quan-
the supervision of an authorized repre-
tity of special COCE leaves than the quan-
part. Applications for such authority
tity of special coca leaves allowed the ap-
shall be made in writing to the Direc-
sentative of the Director, all cocaine,
tity authorized by the permit covering
plicant for the calendar year to which
ecgonine, and all salts, derivatives,
such shipment, and § 302.9 shall govern
tor and shall include an estimate of
the application for permit relates, the
the quantity of leaves required by the
and preparations from which cocaine or
the procedure with respect to the cancel-
total number of pounds of such tentative
applicant for the calendar year to which
ecgonine may be synthesized or made,
lation, at the request of the importer, of
contained in and/or produced directly or
maximum quantity for which permits
permits to import special coca leaves.
the application relates.
indirectly from special coca leaves.
have previously been issued, and the total
§ 302.30 Information required of pro-
quantity of leaves actually imported
§ 302.37 Withdrawal from customs cus-
(c) The Director, in the determi-
spective importer.
nation of his action with respect to any
thereunder; and the stock on hand of
tody.
special coca leaves as such and the quan-
Special coca leaves, upon with-
The Director shall take such action
application, may accept the proof fur-
nished in connection with an application
tity of special coca leaves represented
drawal from customs custody, shall be
on any application as in his opinion
by finished stock or extract of coca
removed to the place of manufacture and
will effectuate the intent and purpose
relating to a prior year, and may take
leaves. The figures for stock on
safely stored in a storeroom adequately
of section 6 of the act of June 14, 1930
into consideration any other matter or
(46 Stat. 587; 21 U.S.C. 173a), and of
hand shall be given as of a date ascer-
protected against theft and against en-
thing known to him or discovered by in-
try by any persons other than the im-
the regulations in this part. No authority
vestigation which he may deem appro-
tained in the manner provided for in
porting manufacturer and his duly au-
to import will be granted unless and until
priate to consider in effectuating the in-
§ 302.3. The application shall also show
thorized agents and employees, or the
the applicant shall have furnished proof
tent and purpose of the act of June 14,
the name and address of the consignor,
Director and his duly authorized repre-
satisfactory to the Director.
1930, and of the regulations in Part 301
if known at the time the application is
sentative (herein referred to as the
(a) That, if an individual, he, or if a
of this chapter. In no event will au-
submitted; if unknown, the application
Director's representative). No special
partnership, each member thereof, or if
thority to import be granted unless the
shall so state, and the name and address
coca leaves shall be withdrawn or
an association or corporation, the man-
Director is satisfied that the appli-
shall be furnished to the Director
removed from said place of storage
ager, each officer and director, and each
cation is made in good faith and not for
as soon as ascertained by the importer;
except in the presence of the Director's
member of any board of control, is of
the purpose of evading the law.
the foreign port of exportation (i. e., the
representative. The importer shall iden-
good character and standing;
§ 302.32 Approval or disapproval of
(b) That the applicant is able, by
place where the article will begin its jour-
tify each bale or other unit package of
application.
means of a definite process and formula
ney of exportation to the United States)
special coca leaves after its importation
The Director shall advise the appli-
by attaching thereto a label or tag
demonstrated to the satisfaction of the
the port of entry into the United States;
Director, to manufacture an extract of
cant of his approval or disapproval of
bearing the number of the permit
and the latest date the shipment will
coca leaves containing no cocaine,
the application, and, in the event of
authorizing the importation, the date
leave the foreign port. The provisions of
ecgonine, or any salt, derivative, or
approval, of the tentative maximum
withdrawn from customs custody, the
302.4 are hereby made applicable to
quantity of special coca leaves allowed
inscription "Special Coca Leaves," and
preparation from which cocaine or
importations of special coca leaves.
an individual serial number. Such bales
or ecgonine may be synthesized or made;
the applicant for importation covering
(c) That the applicant has the finan-
the requirements (as determined by the
§ 302.34 Registration of importer.
or packages shall be kept apart from any
Director) of the applicant for the calen-
bales or packages not containing special
cial standing and responsibility to under-
No permit or permits will be issued un-
dar year to which the application relates.
coca leaves. No special coca leaves shall
take such manufacturing operation with
less and until the applicant shall be duly
reasonable likelihood of successful com-
Such tentative maximum allowances may
be used for any purpose other than the
be increased or decreased in the discre-
registered in accordance with the act of
purpose authorized by the act of June 14,
pliance with the intent and purpose of
December 17, 1914, as amended, and reg-
1930, and the regulations in Part 301 of
section 6 of the act of June 14, 1930,
tion of the Director, either on his own
ulations thereunder, and shall have paid
this chapter.
and of the regulations in this part; and
motion or on application supported by
proof satisfactory to the Director of the
the special tax, have rendered the re-
(d) Of any other matter or thing
§ 302.38 Manufacturing operation.
which the Director deems appropriate to
necessity therefor. No permit or per-
turns and reports, and have kept the
(a) The manufacturer shall notify the
consider.
mits will be issued allowing the applicant,
records now or hereafter required by
Director, at least. 10 days in advance,
in supplying such requirements, to im-
such act and regulations.
of the commencement of the manu-
§ 302.31 Matters to be considered in
granting permit.
port, as a charge against such tentative
CROSS REFERENCE: For regulations under
facturing operation with respect to
(a) The applicant shall also furnish
maximum allowance, a total quantity of
the act of December 17, 1914, as amended, see
special coca leaves, which operation shall
26 CFR Part 151.
special coca leaves in excess of such al-
thereafter be conducted to completion
proof satisfactory to the Director that
Reproduced at the Richard Nixon Presidential Library
296
297
302,39
Title 21-Chapter I'l
Title 21-Chapter II
§ 302,46
entirely separately and independently of
manufacturer shall take a similar sample
any operation not involving special coca
for the purpose of analysis. The residue,
coca leaves represented by such spent
therefrom and such further information
leaves. Nothing contained in this part,
after the taking of such samples, shall
leaves, and the number, and identifying
regarding analytical methods, as the
however, shall be construed to prohibit
be immediately destroyed by the manu-
marks of the original bales or unit pack-
Director may deem necessary.
the manufacture from coca leaves, other
ages of such special coca leaves. The
facturer, by incineration, in the presence
Director's representative shall forward
§ 302.43 Discontinuance of business.
than special coca leaves, of any extract
of the Director's representative. The
such samples and memoranda to the
permitted by law. The manufacturing
same procedure shall be followed, in
In the event that any person by reason
operation involving special coca leaves
Director or to such chemical laboratory
so far as the weighing, taking of sam-
as the Director may designate. Similar
of bankruptcy, insolvency, receivership,
shall be as continuous, and completed
ples, and forwarding of memoranda
or voluntary or involuntary abandon-
as expeditiously, as possible, and shall be
samples of finished extract and of spent
are concerned, with respect to the other
ment or discontinuance (other than
under the observation of the Director's
or used special coca leaves shall be taken
product of the aforementioned primary
mere suspension) of the business of man-
representative.
separation; the residue, however, after
by the manufacturer for the purpose of
ufacturing an authorized extract of coca
(b) Immediately prior to the intro-
the taking of samples, shall be continued
analysis. The spent leaves, after taking
leaves, or by reason of any other cause or
duction into the manufacturing process
in process. The representative may also
of such samples, shall be immediately
condition (for example, see § 302.44 and
of any given quantity of special coca
take and forward samples of recovered
destroyed by the manufacturer by incin-
§ 302.41(b)) is unable in accordance
leaves, the manufacturer or his agent
alcohol.
eration, in the presence of the Director's
with the act of June 14, 1930, and of the
duly authorized for the purpose shall,
representative.
regulations in this part, to make use of
when requested by the Director or his
§ 302.40 Samples.
(b) The Director's representative shall
any special coca leaves or of any of the
representative, furnish therefrom to the
(a) At any other stage in the process
have authority under the direction of
products thereof the destruction of
Director's representative such a sample
where substances containing cocaine,
the Director, to select and forward to
which is not otherwise provided for by
(selected in the presence of the repre-
ecgonine, or salts, derivatives, or prep-
the Director such other samples of
the regulations in this part, such special
sentative) as the latter may require,
arations from which cocaine or ec-
special coca leaves and the products
coca leaves and such products shall be
together with a memorandum dated and
gonine may be synthesized or made,
thereof as are deemed appropriate,
seized by the Director and destroyed by
signed by the manufacturer or his said
are separated from other substances,
whether or not such samples are other-
incineration; Provided, however, That
agent showing the quantity of special
the procedure hereinabove set forth
wise required by the regulations in this
after seizure and before destruction the
coca leaves from which such sample was
shall be followed, including the for-
part.
manufacturer shall be given notice of the
taken and the number, and identifying
warding of samples and memoranda,
§ 302.41 Director's representative to
proposed destruction and the reasons
marks (see § 302.37) of the original bales
relative thereto, the taking of similar
have access to factory.
therefor, and a reasonable opportunity
or unit packages of such leaves. The
samples for the purpose of analysis by
(a) The Director's representative shall
to appear and show cause why such
Director's representative shall forward
the manufacturer, and the destruction,
have access at all times to the fac-
destruction should not be accomplished.
the sample and the memorandum to the
after the taking of such samples, of sub-
tory, storage rooms, and laboratories
§ 302.44 Cancellation of permit.
Director, or to such chemical laboratory
stances required to be destroyed. The
as the Director may designate. A similar
manufacturer or his agent shall also fur-
where any operation, process, or analysis
involving special coca leaves, their salts,
The Director may withdraw any
sample shall be taken at the same time
nish the Director's representative a
authorization and may cancel any permit
by the manufacturer or his agent for the
derivatives, preparations, products, or
sample of finished extract as it is with-
previously granted to any manufacturer,
purpose of analysis.
drawn from process supposedly free from
extracts is taking place, or where any
if such manufacturer, by reason of bad
such special coca leaves, their salts, de-
cocaine, ecgonine, and salts, derivatives,
faith, carelessness, incompetency, the
§ 302.39 Residue.
and preparations from which cocaine or
rivatives, preparations, products, or ex-
causes for seizures specified in § 302.43
At that point in the manufacturing
tracts are situated or found.
ecgonine may be synthesized or made,
or any other cause, fails to comply with
process where the initial extract of
(b) The Director's representative shall
together with a memorandum dated and
signed by the manufacturer or such agent
be afforded a full measure of coopera-
the regulations in this part, or by any
special coca leaves undergoes a pri-
act or omission fails to observe the intent
mary separation into two products,
tion in the performance of his duties
showing the quantity of finished extract,
or purpose of the act of June 14, 1930,
one containing principally flavoring ex-
the quantity of special coca leaves rep-
in order that the intent and purpose of
Provided, however, That the manufac-
tract and the other principally cocaine,
the act of June 14, 1930, may be accom-
resented by such finished extract, and
turer shall be given notice of the Direc-
ecgonine, and their salts and derivatives,
the number, and identifying marks, of
plished. Failure on the part of any im-
tor's proposed action in that regard and
the manufacturer or his duly authorized
the original bales or unit packages of
porting manufacturer or his agent or em-
the reasons therefor, and a reasonable
agent shall, in the presence of the
such leaves. The memorandum relative
ployee to afford such cooperation to the
opportunity to appear and show cause
Director's representative, segregate the
to each quantity of finished extract with-
Director's representative, or to per-
why such action should not be taken.
latter product, remove its content of re-
drawn from process shall include a cer-
mit the access authorized by the preced-
coverable alcohol, and ascertain the
tificate by the manufacturer that the
ing paragraph to the factories, storage
§ 302.45 Compliance with act of Decem-
rooms, or laboratories of such manufac-
ber 17, 1914, as amended.
weight of the residue, and shall sign and
quantity of finished extract of special
deliver to the representative a dated
coca leaves so withdrawn does not con-
turer, shall be grounds for canceling, pur-
Nothing contained in the regulations in
memorandum showing such weight, the
tain any cocaine, ecgonine, or any salt,
suant to § 302.44, both the authority to
this part shall be construed to exempt
quantity of special coca leaves repre-
derivative, or preparation from which
import under the regulations in this part
any manufacturer from compliance with
sented by such residue, and the number,
and the permits granted thereunder.
cocaine or ecgonine may be synthesized
the act of December 17, 1914, as amend-
and identifying marks, of the original
or made. The manufacturer or his
$302.42 Reports to Director.
ed, and regulations thereunder.
bales or unit packages of such leaves.
agent shall also furnish the Director's
The Director's representative shall for-
The manufacturer shall make such ad-
CROSS REFERENCE: For regulations under
representative a sample of the spent
ward such memorandum to the Director
ditional reports to the Director, and
the act of December 17, 1914, as amended,
or used special coca leaves from each
or to such chemical laboratory as the
shall furnish to him by written statement
see 26 CFR Part 151.
factory run, and a memorandum dated
Director may designate, together with
such analytical data relative to the alka-
§ 302.46 Returns required.
and signed by the manufacturer or his
a sample of such residue, and the
loidal content, at any stage in the proc-
agent showing the quantity of special
Every manufacturer using special coca
ess, of special coca leaves or any product
leaves imported into the United States
298
Reproduced at the Richard Nixon Presidential Library
299
§ 302.47
Title 21-Chapter I'l
Title 21-Chapter Il
§ 302.56
pursuant to the act of June 14, 1930, shall
(e) The quantity of leaves put in proc-
(2) The quantity of special coca leaves
pared for smoking shall be seized, how-
render a quarterly return on Form 169
ess, stated in avoirdupois pounds.
imported during the quarter.
ever, whenever and wherever found with-
and its supplements, and shall thereon
(f) The quantity of alcohol used for
(3) The quantity of special coca leaves
in the jurisdiction of the United States.
account for all transactions involving
each extraction or wash of the leaves, by
put into process of manufacture during
such leaves or substances derived there-
alcohol.
the quarter.
CROSS REFERENCE: For allowance of nar-
from which contain cocaine or ecgonine,
(4) The quantity of special coca leaves
cotic drugs in medical stores, see 19 CFR
(g) The quantity of water used for
4.39 (e), 28.9 (h).
or any salts, derivatives, or preparations
each water extraction or dilution.
on hand at the end of the quarter.
from which cocaine or ecgonine may be
(h) The quantity of any other or ad-
(5) Any other transaction during the
§ 302.54 Drugs seized to be delivered to
synthesized or made. This return shall
ditional substance introduced at any
quarter which increased or decreased the
collector of customs.
be signed and sworn to by the manufac-
stage into the process of manufacture.
quantity of raw coca leaves on hand.
All narcotic drugs seized under the
turer or his authorized agent, and
(i) The dry weight of any filter cloth
(b) The summary of coca leaves in
Narcotic Drugs Import and Export Act,
rendered direct to the Director, Bureau
or other absorbent material to be later
process shall show:
as amended, by any Federal officer, other
of Narcotics and Dangerous Drugs on
removed from process after saturation.
(1) The quantity of special coca leaves
than a customs officer, shall be imme-
or before the 12th day of the month
§ 302.49 Reports of manufacture.
in process at the beginning of the
diately delivered into the custody of the
following the period for which the return
quarter.
The reports of substances produced
collector of customs in whose district
is made. Such return shall include a
(2) The quantity of such leaves placed
from special coca leaves, Forms 169c,
the seizure was made, with a full report
report of all importations of special
in process during the quarter.
coca leaves on Form 169a, a report of all
169d, and 169e, shall show, in appropriate
of the circumstances of the seizure, pro-
(3) The quantity of such leaves repre-
columns the following information as to
vided that where the seizure is made by
materials entered into the processes of
sented by lots completed during the
each production lot or dump:
a special agent of the Bureau of Narcotics
manufacture on Form 169b, a report of
quarter.
the various substances produced there-
(a) The lot number.
and Dangerous Drugs in connection with
(4) The quantity of such leaves repre-
from on Forms 169c, 169d, and 169e, a
(b) The quantity of ground leaves en-
an investigation which such agent con-
sented by lots in process at the end of the
tered into process, in terms of avoir-
siders may result in criminal prosecution
report of all such substances destroyed
quarter.
dupois ounces and the quantity, in
under any Federal narcotic law, the
on Form 169f, and a summary of opera-
(5) Any other transaction during the
ounces and grains, of alkaloid contained
drugs so seized shall not be delivered
tions on Form 169g.
quarter which increased or decreased the
therein as determined by analysis.
into the custody of the collector of cus-
quantity of leaves in process.
§ 302.47 Report of importations.
(c) The quantity of substance in proc-
(c) The summary of residues removed
toms, but custody of such drugs shall
The report of importations on Form
ess after each distinct step in the manu-
be retained by the appropriate offi-
from production in processes shall show,
169a shall show in appropriate columns
facturing process and the total alkaloid
in appropriate columns, separately as to
cer of the Bureau of Narcotics and
the following data as to each importa-
contained in each, stated in ounces and
spent leaves, each residue and saturated
Dangerous Drugs until it is determined
grains.
that same will not, or will no longer, be
tion:
material, the following information:
(a) The date of the import permit.
(d) The quantity of exhausted or spent
(1) The quantity of each, on hand at
required as evidence, whereupon dispo-
(b) The serial number of the import
leaves and the quantity of each residue
the beginning of the quarter, awaiting
sition thereof shall be made as provided
permit.
removed from process, and the total al-
destruction.
by law.
(c) The name of the foreign con-
kaloid contained in each, stated in
(2) The quantity of each removed
CROSS REFERENCE: For customs regulations
signor.
ounces and grains.
from process during the quarter.
concerning seizure of narcotic drugs, see 19
(d) The address of the foreign con-
(e) The weight of the used filter cloth
(3) The quantity of each destroyed
CFR 18.31 (b), 28.9.
signor.
or other absorbent material removed,
during the quarter.
§ 302.55 Forwarding drugs to Drugs Dis-
(e) The foreign port of export.
after saturation.
(4) The quantity of each on hand at
posal Committee.
(f) The number of bales imported.
(f) The quantity, in gallons, of finished
the end of the quarter.
All narcotic drugs which have been
(g) The serial numbers of the bales
extract produced.
(5) Any other transaction during the
forfeited to the Government, and are no
imported.
§ 302.50 Report of residues destroyed.
quarter affecting the quantity of such
residues on hand.
longer required for purposes of evidence,
(h) The quantity imported in avoir-
The report of residues destroyed, Form
shall immediately be forwarded to the
dupois pounds.
169f, shall show for each lot destroyed, in
Subpart E-General
Director, Bureau of Narcotics and Dan-
§ 302.48 Report of materials used.
appropriate columns the following data:
AUTHORITY: The provisions of this Sub-
gerous Drugs (Drugs Disposal Commit-
(a) The lot number.
part E issued under 38 Stat. 275, as amended;
tee), for proper disposition.
The report of materials entered into
the processes of manufacture on Form
(b) The quantity of spent leaves, resi-
21 U.S.C. 182.
§ 302.56 Disposition of forfeited drugs.
169b shall show in appropriate columns
dues, and saturated materials destroyed,
§ 302.52 Importation or exportation by
the following information as to each lot
stated separately for each.
Narcotic drugs forfeited to the United
mail prohibited.
(c) The name of the Government offi-
States under the provisions of law may
of leaves dumped:
(a) The lot number or specification, a
cer witnessing the destruction.
Neither importation nor exportation
be delivered to any department, bureau,
of narcotic drugs shall be made by means
or other agency of the U.S. Government
specification to be assigned to each dump
§ 302.51 Summary.
of the regular mails or by parcel post.
upon proper application addressed to the
for identification purposes in order to
Director, Bureau of Narcotics and Dan-
(a) The summary, Form 169g, shall
§ 302.53 Medical stores on vessels.
avoid repeating the serial numbers of
gerous Drugs. The application shall show
include a complete accounting for all
the bales when the lot is subsequently
Collectors of customs may permit nar-
the name, address, and official title, bu-
transactions in raw leaves, leaves in
cotic drugs in reasonable quantities and
referred to.
reau, or agency, and department, of the
process, and residues removed from pro-
properly listed as medical stores of ves-
(b) The date the leaves were put in
person to whom the narcotic drugs are to
duction processes. The summary of raw
sels to remain on such vessels if satis-
be delivered, the kind and quantity of
process of manufacture.
coca leaves shall show:
fied that such drugs are adequately safe-
(c) The number of bales dumped.
narcotics desired, and the purpose for
(1) The quantity of special coca leaves
guarded and used only for medical
(d) The serial numbers of the bales.
which intended. The delivery of such
on hand at the beginning of the quarter.
purposes. Smoking opium or opium pre-
narcotic drugs shall be ordered by the
300
Reproduced at the Richard Nixon Presidential Library
301
§ 302.57
Title 21-Chapter II
Title 21-Chapter Il
§ 303.10
Director, Bureau of Narcotics and Dan-
nership, company, association, or cor-
narcotics drugs shall file an application,
the date of issue, and may be renewed,
gerous Drugs, if in his opinion, there
poration, as well as a natural person or
in duplicate, for a license with the
at the discretion of the Director, for a
exists a medical or scientific need there-
persons.
Director at Washington, D.C. The appli-
like period.
for. The order will be filled by the Drugs
(b) The terms "produce" or "produc-
cation shall show the name and address
§ 303.6 Limitations.
Disposal Committee which will obtain a
tion" include the planting, cultivation,
of the applicant, the quantity, in pounds,
receipt for narcotic drugs delivered.
growth, harvesting, and any other activ-
of opium poppies desired to be produced,
All licenses to produce opium poppies,
ity which facilitates the growth of the
the acreage and exact location of the
issued by the Director, shall be limited
§
302.57
[Reserved]
opium poppy.
land desired to be devoted to opium
to such number, localities, and areas as
§ 302.58 Permits issued prior to effec-
(c) The term "opium poppy" includes
poppy production, the type of soil de-
the Director shall determine to be ap-
tive date of regulations.
the plant Papaver somniferum, any
sired to be devoted to opium poppy
propriate to supply the medical and
Permits to import or export narcotic
other plant which is the source of opium
production, whether such applicant
scientific needs of the United States for
drugs which shall have been issued by
or opium products, and any part of any
owns, rents, or leases such land and the
opium or opium products, with due re-
the Director prior to the effective date
such plant.
type of equipment owned by the appli-
gard to provision for reasonable reserves.
of the regulations in this part shall con-
(d) The term "opium" includes the
cant to be used in cultivating and har-
It shall be the policy of the Director so
tinue in force and effect under the laws
inspissated juice of the opium poppy, in
vesting opium poppies. The applicant
far as practicable, to confine the produc-
shall also submit proof that he is of good
tion of opium poppies to such areas as
and regulations in effect when such au-
crude or refined form.
thorizations were issued, unless specifi-
(e) The term "opium products" in-
moral character, that his financial
will permit efficient and economical en-
cally revoked by the Director.
cludes opium and all substances obtain-
standing and farming experience are
forcement of the narcotic laws and
able from opium or the opium poppy, ex-
such as will reasonably insure that he
regulations.
§ 302.59 Regulations subject to provi-
cept the seed thereof.
can produce the acreage of opium pop-
§ 303.7 Production in excess of quan-
sions of other pertinent laws and
(f) The term "license" means a license
pies called for in the application, that
tities named in licenses.
regulations.
to produce the opium poppy or to manu-
there is or will be, at the time of har-
The regulations in this part shall be
facture opium or opium products, duly
vesting, a market for the opium poppies
If a licensee produces opium poppies
subject to the provisions of the customs,
issued by the Director.
desired to be produced and that the land
in excess of the quantity called for in his
license, such excess quantity may be
internal-revenue, and other pertinent
(g) The term "Director" means the
to be devoted to opium poppy production
laws of the United States and regula-
Director, Bureau of Narcotics and Dan-
is readily accessible to law enforcement
seized and forfeited to the United States,
tions promulgated thereunder.
gerous Drugs.
officers at all times.
or, the Director may, if he deems it
(h) The term "act" means the Opium
appropriate and finds that such excess
CROSS REFERENCES: For regulations of the
Poppy Control Act of 1942.
§ 303.5 Issuance of license to produce.
opium poppies were produced in good
Bureau of Customs, see 19 CFR Chapter I.
(a) The Director shall issue a license
faith, amend the license so as to cover
For regulations of the Bureau of Internal
§ 303.2 Policy.
to produce the opium poppy only when,
all or part of such excess quantity, and
Revenue, see 26 CFR Chapter I.
It shall be the policy of the Direc-
in his opinion, the medical and scien-
allow them to be disposed of under the
tor to administer and enforce the pro-
tific needs of the United States for
act.
PART 303-OPIUM POPPIES
visions of the act in such manner as will
narcotic drugs cannot be met by the
§ 303.8 License to manufacture.
Sec.
carry out the obligations of the United
importation of crude opium. A license
303.1
Definitions.
States under the treaties and conven-
to produce the opium poppy shall be is-
Any person who desires to manufac-
303.2
Policy.
tions mentioned therein. The Director
sued only to a person whom the Direc-
ture opium or opium products from
303.3
Production.
303.4
Application for license to produce.
shall not issue licenses to produce the
tor finds (1) to be of good moral char-
opium poppies shall first obtain the re-
303.5
Issuance of license to produce.
opium poppy unless such production is
acter; (2) to be of suitable financial
quired license and quota for the manu-
303.6
Limitations.
essential to supply narcotic drugs for the
standing and farming experience to
facture of a basic class of narcotic drug
and be subject to all of the provisions
303.7
Production in excess of quantities
medical and scientific needs of the United
render reasonably probable that such
named in licenses.
States. If such production becomes neces-
person will produce the quantity of
and requirements of the Narcotics Man-
303.8
License to manufacture.
sary, the Director shall exercise sound
opium poppies specified in the license;
ufacturing Act of 1960 (Pub. Law 86-429,
303.10
Change of address or other facts
discretion in the issuance of licenses to
(3) to be the owner of or to control
74 Stat. 55), and the regulations issued
shown in application.
Revocation or renewal of licenses.
the end that there shall be no opportu-
suitable farm land to be used as a pro-
pursuant thereto (Part 307 of this chap-
303.11
303.12
Hearing.
nity for the spread of drug addiction.
duction area, in such locality, as will,
ter). No further manufacturing license
303.13 Director not required to issue or
§ 303.3 Production.
in the judgment of the Director, render
shall be required. However, no license to
renew license.
reasonably probable efficient and dili-
manufacture opium or opium products
303.14 Returns required of producers.
No person who is not the holder of a
gent performance of the operations of
from opium poppies shall be issued by
303.15
Returns required of manufacturers.
license shall produce the opium poppy.
producing the opium poppy in the quan-
the Director unless he finds that the
303.16
Disposition of forfeited opium pop-
Licenses shall be issued only for the pro-
tity specified; (4) to have facilities
medical and scientific needs of the
pies.
duction of the opium poppy to supply
for safeguarding the opium poppy crop
United States for narcotic drugs are not
303.17 Penalties.
the medical and scientific needs of the
which will reasonably insure that the
being or cannot be supplied from crude
AUTHORITY: The provisions of this Part 303
United States for narcotic drugs. No li-
opium poppies will not be diverted to
opium obtained by importation.
issued under sec. 11, 56 Stat. 1048; 21 U.S.C.
censes shall be issued for the produc-
illicit channels.
§ 303.10 Change of address or other
188j.
tion of the opium poppy solely for poppy
(b) Each such license shall be non-
facts shown in application.
SOURCE: The provisions of this Part 303
seed.
transferable and shall be valid only to
Any person to whom a license has been
appear at 33 F.R. 14826, Oct. 3, 1968, unless
§ 303.4 Application for license to pro-
the extent of the production area and
issued shall immediately notify the Di-
otherwise noted.
duce.
maximum weight of opium poppy yield
rector of any change of the address or
§ 303.1 Definitions.
Any person who desires to produce
specified in the license, shall state the
any other fact shown in his application,
As used in the regulations in this part:
the opium poppy to supply medical and
locality of the production area, and shall
and of any subsequent change of address
(a) The term "person" includes a part-
scientific needs of the United States for
be effective for a period of one year from
or other fact.
Reproduced at the Richard Nixon Presidential Library
302
303
§ 303,11
Title 21-Chapter Il
Title 21-Chapter Il
§ 305.1
§ 303.11 Revocation or renewal of li-
submitted and to confront and cross-
§ 303.15 Returns required of manufac-
PART 305-OPIATES
censes.
examine any witnesses for the Bureau
turers.
Sec.
(a) The Director may revoke or re-
of Narcotics and Dangerous Drugs.
Every person licensed as a manufac-
305.1 Opiate.
fuse to renew any license issued under
(b) The licensee shall be afforded an
turer of opium or opium products from
305.2 Chronological list of findings.
the act if after due notice to a licensee
opportunity to present all his evidence
and argument on the matter and shall
opium poppies shall render quarterly
AUTHORITY: The provisions of this Part 305
and an opportunity for hearing he finds
returns on forms furnished by the Di-
issued under sec. 4731, 68A Stat. 557, as
that the licensee has failed to comply
have the privilege of being represented
rector, reporting and accounting for all
amended, sec. 17, 74 Stat. 67; 21 U.S.C. 514,
with any of the qualifications found to
by counsel of his own choice. The li-
such manufacturing operations in the
26 U.S.C. 4731.
exist at the time of the issuance of such
censee shall be permitted 15 days from
the date of the conclusion of the hearing
same manner as is required of persons
SOURCE: The provisions of this Part 305
license, if he finds that such licensee has
to submit a written brief to the Director
producing such substances from opium
appear at 33 F.R. 14827, Oct. 3, 1968, unless
failed to comply with the Federal or
imported into the United States (see
otherwise noted.
State narcotic laws and regulations, or
or his duly authorized representative.
(c) If the hearing is conducted by a
26 CFR 151.123-151.132) Provided,
§ 305.1 Opiate.
laws supplementary thereto, or if he finds
representative of the Director, such rep-
however, That the Director may, in
that the revocation or refusal to renew
any instance, specify such changes and
(a) Definition. The word "opiate"
resentative shall file with the Director a
any license shall be in the public interest.
modifications in such forms as the varia-
shall mean any drug (as defined in the
(b) If it is the intention of the Di-
stenographic report of the evidence and
tions in manufacturing procedures and
Federal Food, Drug, and Cosmetic Act
rector to revoke or refuse to renew
the arguments presented and any briefs
other circumstances may require.
(21 U.S.C. 321(g))), and substance pro-
any license, he shall immediately notify
submitted, together with his findings and
claimed by the President, and substance
the licensee thereof and his reasons
recommendation. The Director, after
§ 303.16 Disposition of forfeited opium
declared by administrative regulation, or
considering this report and the briefs
poppies.
therefor by registered letter addressed
other substance found by the Director,
to his last address reported by him to
shall render his decision and communi-
Opium poppies forfeited to the United
Bureau of Narcotics and Dangerous
the Director. The licensee shall be ad-
cate the same to the licensee within 45
States under the provisions of the act
Drugs (after considering the technical
vised by the Director in such registered
days from the date of the conclusion of
shall be destroyed by the Director or his
advice of the Secretary of Health, Educa-
letter that he has 30 days from the
the hearing.
authorized representative or, may be de-
tion, and Welfare, or his delegate, on the
date of the letter in which to submit
§ 303.13 Director not required to issue
livered to any department, bureau, or
subject) to have (1) an addiction-form-
his reasons showing cause why the Di-
or renew license.
other agency of the U.S. Government
ing or addiction-sustaining liability
rector should not revoke or refuse to
upon proper application addressed to the
similar to morphine or cocaine; or (2) to
The Director shall not be required to
renew the license. The licensee shall be
Director. Such application shall show the
be capable of conversion into a drug
issue or renew any license or licenses
further advised in such registered letter
name, address, and official title and de-
having such addiction-forming or addic-
under the provisions of the act: Pro-
that upon his request, filed with the
partment, bureau, or agency of the per-
tion-sustaining liability with relative
vided, however, That the Attorney Gen-
Director within the same 30 days, a
son to whom the narcotics are to be
technical simplicity and degree of yield
eral, on appeal, may require the Director
hearing will be granted. If, within such
delivered, the quantity of opium poppies
as to create a risk of improper use.
to issue or renew a license.
30 days, the licensee fails to submit
desired and the purpose for which they
(b) Finding. Prior to making any
reasons showing cause why the Direc-
§ 303.14 Returns required of producers.
are intended. The delivery of such opium
finding that a drug or other substance
tor should not revoke or refuse to renew
Every person licensed as a producer
poppies may be ordered by the Director
is an "opiate" (as defined in paragraph
the license, the Director may revoke or
of opium poppies shall render an annual
if in his opinion the purpose for which
(a) of this section), the Director, Bureau
refuse to renew his license without fur-
return to the Director on or before the
they are intended is medical or scientific.
of Narcotics and Dangerous Drugs shall
ther proceedings. If, within such 30 days,
§ 303.17 Penalties.
give due notice of his intention to con-
15th day of January, for the annual
the licensee fails to request a hearing,
sider the desirability of making such a
period ending December 31 of the pre-
but submits reasons purporting to show
(a) Persons who violate the act shall
finding and afford an opportunity for a
ceding year, reporting all transfers and
cause, the Director shall consider the
be guilty of a felony and upon convic-
public hearing to all interested parties.
dispositions of opium poppies and fully
reasons and decide the matter and com-
tion thereof, be fined not more than
Not less than twenty days prior to the
accounting for all opium poppies pro-
municate his decision to the licensee
$2,000, or imprisoned not more than 5
date set for a hearing, the Director shall
duced or otherwise obtained. Such re-
within 15 days from the receipt of the
years, or both, in the discretion of the
cause to be published in the FEDERAL
turns shall be prepared on forms fur-
reasons purporting to show cause.
court.
nished by the Director, and shall include,
REGISTER a notice setting forth the date,
(b) Any person who willfully makes,
time and place of the proposed hearing.
§ 303.12 Hearing.
for each such period, (a) a complete
aids, or assists in the making of, or pro-
Any person desiring to be heard shall
(a) If a hearing is requested, the
accounting for all poppy seeds received,
cures, counsels, or advises in the prep-
furnish written notice to the Director not
Director shall notify the licensee of the
planted, produced, harvested, or other-
aration or presentation of, a false or
later than twenty days from the date
time and place where such hearing will
wise acquired or disposed of, and the
fraudulent statement in any application
notice of hearing is published in the
be conducted and held. The hearing shall
seed on hand at the beginning and
for a license under the provisions of the
FEDERAL REGISTER. If no written notice of
be conducted and held at a place deemed
end of the period; (b) a complete re-
act shall (whether or not such false or
a desire to be heard shall be received by
by the Director to be reasonably con-
porting of the areas planted and har-
fraudulent statement is made by or with
the Director within such period of twenty
venient to the licensee. The hearing may
vested and the areas under cultivation at
the knowledge or consent of the person
days, no hearing shall be held, but the
be conducted by the Director or his duly
the beginning and end of the period; and
authorized to present the application)
Director shall proceed to make a finding
authorized representative. The Bureau
(c) a full and complete accounting for
be guilty of a misdemeanor, and, upon
based on all available evidence including
of Narcotics and Dangerous Drugs shall
pharmacological and clinical tests of the
introduce at the hearing the evidence on
all quantities of opium poppies produced,
conviction thereof, be fined not more
drug. If written notice of a desire to be
which reliance is to be had for revoca-
harvested, received, sold, or otherwise
than $2,000 or imprisoned for not more
heard is received by the Director within
tion of or refusal to renew the license.
acquired or disposed of, and those on
than 1 year, or both.
the prescribed period of twenty days, the
The licensee shall have an opportunity
hand at the beginning and end of the
hearing will be held in accordance with
at the hearing to examine the evidence
period.
PART 304-[Reserved]
the original notice. When the Director
Reproduced at the Richard Nixon Presidential Library
304
305
Title 21-Chapter II
§ 307.52
§ 305.2
Title 21-Chapter 11
§ 306.3 Heroin for scientific research
AUTHORITY To SEIZE NARCOTIC DRUGS, ORDER
finds that a drug is an "opiate", he shall
§ 307.61(b) of this chapter. Drugs and
FORMS AND TAX STAMPS
proclaim such finding in the FEDERAL
other substances listed include any salts
purposes.
Sec.
REGISTER after which all of the provisions
thereof.
Any heroin acquired under the provi-
307.111
Sealing and safeguarding of nar-
of the Federal narcotic laws shall apply
JUNE 20, 1962
sions of section 1402 of title 18 of the
cotic drugs.
(Methadone-intermediate) 4-cyano-2-di-
United States Code, shall be available,
307.112
Forfeiture of narcotic drugs.
to such drug.
(c) Termination. The Director may
methylamino-4,4 diphenylbutane.
in the discretion of the Director, Bureau
MANUFACTURING QUOTAS
withdraw any previous finding that a
(Pethidine intermediate A) 4-cyano-1-
of Narcotics and Dangerous Drugs, for
Manufacturing quotas for basic
drug or other substance is an "opiate"
methyl-4-phenylpiperidine.
scientific research purposes in accord-
307.121
whenever he determines that such pre-
(Moramide intermediate) 2 methyl-3-
ance with the provisions of section 4733
classes of narcotic drugs; gener-
morpholino 1,1 diphenylpropanecarboxylic
ally.
vious finding was erroneous. Such de-
of the Internal Revenue Code of 1954.
307.122
Individual manufacturing quotas.
acid.
termination shall take effect immedi-
APRIL 2, 1963
307.123
Formula for fixing individual man-
ately upon publication in the FEDERAL
REGISTER and the particular drug or
(Pethidine-intermediate-C)
1-methyl-4-
PART 307-MANUFACTURING OF
ufacturing quotas.
307.124
NARCOTIC DRUGS
Provisional manufacturing quotas.
phenylpiperidine-4-carboxylic acid.
307.125
Application for individual manu-
other substance shall thereupon cease to
APRIL 7, 1964
GENERAL PROVISIONS
facturing quotas.
be an "opiate". The Director may, al-
307.126
Increase in individual manufactur-
though he is not bound to, consider any
(Norpipanone) 4,4-diphenyl-6-piperidino-
Sec.
ing quotas.
action taken by the World Health Or-
807.51
3-hexanone.
Hearings.
ganization pursuant to Article 3 of the
(Fentanyl) 1-phenethyl-4-N-propionylani-
307.52
Practice before Bureau of Narcotics
INCIDENTAL MANUFACTURE OF NARCOTIC
linopiperidine.
and Dangerous Drugs by former
DRUGS
1948 Protocol in withdrawing a drug or
employees.
other substance previously declared an
MARCH 1966
307.131 Exception from applicability of li-
807.53
Definitions.
cense and quota provisions.
"opiate".
(Piritramide) 1 - cyano-8,3-diphenyl-
307.54
Delegation of functions.
§ 305.2 Chronological list of findings.
propyl)-4-(1-piperidino)
piperidine-4-car-
MANUFACTURE OF NARCOTIC PRECURSORS
INTERNATIONAL CONTROL OF NARCOTIC DRUGS
(a) The following is a chronological
boxylic acid amide.
307.141 Narcotic precursors.
list of the drugs or other substances pro-
JANUARY 14, 1969
307.61
Notifications, findings and decisions
IMPORTATION OF NARCOTIC DRUGS
under 1948 Protocol.
claimed to be opiates by administrative
(Bezitramide) 1-(3-cyano-3,3-diphenylpro-
807.62
Findings by United Nations organs.
307.151 Importation of narcotic drugs for
declaration. Drugs or other substances
pyl) -4-(2-oxo 3 propionyl-1 - benzimida-
307.63
Withdrawal of narcotic drug from
scientific purposes.
listed include any salts thereof.
zolinyl)-piperidine.
international control.
AUTHORITY: The provisions of this Part 307
August 8, 1961
[33 F.R. 14827, Oct. 3, 1968, as amended at
BASIC CLASSES OF NARCOTIC DRUGS
issued under sec. 2, 35 Stat. 614, sec. 6, 56
34 F.R. 496, Jan. 14, 1969]
Stat. 1046, secs. 4, 15, 16, 17, 74 Stat. 57, 66,
Betamethadol (B-4,4-diphenyl-6-dimethyl-
807.71
Modification of list of basic class
67; 21 U.S.C. 173, 188e, 182, 513, 514, 26
amino-3-heptanol or B-6-dimethylamino-
PART 306-SURRENDER OF HEROIN
of narcotic drugs.
U.S.C. 4731.
4,4-diphenyl-3-heptanol).
307.72
Establishment of a new basic class
Etoxeridine (1 - [2 - (2 - hydroxyethoxy)
Sec.
SOURCE: The provisions of this Part 307
of narcotic drug.
ethyl] - 4 - phenylpiperidine-4-carboxylic
306.1 Forfeiture of heroin.
appear at 33 F.R. 14829, Oct. 3, 1968, unless
807.73
List of basic classes of narcotic
acid ethyl ester) (Atenorax, Atenos, Car-
306.2
Disposition of surrendered and for-
otherwise noted.
drugs.
betidine)
feited heroin.
GENERAL PROVISIONS
Levomoramide (1-3-methyl-2,2-diphenyl-4-
306.3 Heroin for scientific research purposes.
MANUFACTURE OF NARCOTIC DRUGS
morpholino-butyryl-pyrrolidine).
AUTHORITY: The provisions of this Part 306
§
307.51
Racemoramide (d,1-3-methyl-2,2-diphenyl-
307.81
Restriction on manufacture of
Hearings.
4-morpholino-butyryl-pyrrolidine)
issued under sec. 1402, 70 Stat. 572; 18 U.S.C.
narcotic drugs.
To the extent that a hearing under
Trimeperidine (1,2,5-trimethyl-4-phenyl-4-
1402.
307.82
Omission of a narcotic drug from
the regulations in this part is required
propionoxypiperidine) (Promedol).
SOURCE: The provisions of this Part 306
a basic class.
pursuant to the provisions of the Ad-
Phenoperidine (1-(3-hydroxy-3-phenylpro-
appear at 33 F.R. 14828, Oct. 3, 1968, unless
307.83
Manufacturing for scientific research
ministrative Procedure Act (60 Stat.
pyl)-4-phenylpiperidine-4-carboxylic acid
otherwise noted.
and testing.
237), such hearing shall be conducted in
ethyl ester).
§ 306.1 Forfeiture of heroin.
MANUFACTURERS' LICENSES
accordance therewith. The Director may
October 5, 1961
specify such procedural rules as may be
All heroin heretofore lawfully pos-
307.90
License to manufacture narcotic
Noracymethadol (α-d1-3-acetoxy-6-methyla-
necessary from time to time to secure
mino-4,4-diphenyl heptane).
sessed by any registrant and not surren-
drugs; generally.
dered in accordance with 18 U.S.C. 1402
807.91
Registration as a prerequisite to
the efficient and expeditious conduct of
December 21, 1961
after the 16th day of November 1956
issuance of a license.
hearings.
Norpethidine (ethyl 4-phenyl-4-piperidine-
shall be seized and forfeited to the
807.92
Requirements for license applica-
§ 307.52 Practice before Bureau of Nar-
United States without compensation.
tions.
carboxylate).
cotics and Dangerous Drugs by
307.93
Action upon applications.
(b) The following is a chronological
§ 306.2 Disposition of surrendered and
307.94
Factors governing issuance of
former employees.
list of drugs or other substances found
forfeited heroin.
licenses.
(a) Matters pending while employed.
by the World Health Organization as
307.95
All heroin acquired by the United
Period of validity of license.
No person having served as an agent,
being capable of producing addiction or
307.96
Assignment or transfer of licenses.
States pursuant to section 1402 of title
Regional Director, administrative officer,
of conversion into a drug or other sub-
307.97
Warning to licensee for failure to
stance capable of producing addiction
18 of the United States Code shall be
comply.
attorney or in any other capacity with
and designated as opiates by the Director
disposed of in accordance with the provi-
307.98
Orders to show cause.
the Bureau of Narcotics and Dangerous
sions of 4733 of the Internal Revenue
307.99
of the Bureau of Narcotics and Danger-
Suspension of licenses.
Drugs shall, within 2 years after the ter-
807.100
Revocation of licenses.
mination of his employment with the
ous Drugs pursuant to the provisions of
Code of 1954.
Reproduced at the Richard Nixon Presidential Library
306
307
Title 21-Chapter II
§ 307.71
§ 307.53
Title 21-Chapter II
Regulating the Distribution of Narcotic
(b) Notification received. When the
views, and argument to the Secretary-
Bureau, practice or in any manner act
as an attorney or agent or as the em-
Drugs, concluded at Geneva, July 13,
United States receives notification from
General of the United Nations in ac-
the Secretary-General of the United
cordance with paragraph (a), the
ployee of an attorney or agent in any
1931, and entered into force with respect
to the United States July 9, 1933.
Nations pursuant to Article 1 or 2 of the
United States receives a revised finding
matter pending during the period of his
employment therein, unless he shall first
"1946 Protocol" means the protocol
1948 Protocol) based on a decision of the
or decision that the drug in question
World Health Organization or of the
is not capable of producing addiction
obtain the written consent of the Direc-
amending the Conventions of 1912, 1925
Commission on Narcotic Drugs of the
or conversion into a drug capable of pro-
tor. This consent will not be granted
and 1931, signed at Lake Success on De-
Economic and Social Council that a drug
ducing addiction and that the provisions
unless it appears that the applicant for
cember 11, 1946, and entered into force
with respect to the United States, August
which is or may be used for medical or
of the 1931 Convention shall not apply
such consent did not give personal con-
scientific purposes and which is liable
to such drug, the Director, Bureau of
sideration to the matter or gain knowl-
12, 1947.
to the same kind of abuse and productive
Narcotics and Dangerous Drugs shall
edge of the facts involved during and by
"1948 Protocol" means the protocol
of the same kind of harmful effects as
cause such revised findings or decision
reason of his employment in the Bureau
bringing under international control
the drugs specified in Article 1, Para-
to be published in the FEDERAL REGISTER
cf Narcotics and Dangerous Drugs.
drugs outside the scope of the 1931 Con-
graph 2 of the 1931 Convention, and is
within ninety (90) days of receipt there-
(b) Practice before Bureau. For the
vention, signed at Paris, November 19,
not covered by the 1931 Convention, is
of. From the time of such publication,
purpose of this section, practice before
1948, and entered into force with respect
capable of producing addiction or of con-
such drug shall cease to be an "opiate",
the Bureau shall include the preparation
to the United States, September 11, 1950.
version into a drug capable of producing
unless the Director has previously initi-
of any statement, opinion or other paper
§ 307.54 Delegation of functions.
addiction, the Director shall cause to
ated an "opiate" procedure pursuant to
by any attorney, accountant, chemist,
be published in the FEDERAL REGISTER
section 4731(g) of the Internal Revenue
pharmacologist or other expert filed with
Reorganization Plan No. 1 of 1968 is-
the Director.
sued by the President, effective April 8,
such decision of the World Health Or-
Code of 1954, as amended by section 4(b)
1968 (Presidential Documents, 33 F.R.
ganization or Commission on Narcotic
of the Narcotics Manufacturing Act of
5611), provides in part as follows:
Drugs, unless such drug has already been
1960.
§ 307.53 Definitions.
determined to be an "opiate" in accord-
As used in this part:
Section 1. Transfer of functions from
ance with section 4731(g) of the Internal
§ 307.63 Withdrawal of narcotic drug
"Act" means the Narcotics Manufac-
Treasury Department. There are hereby
from international control.
Revenue Code of 1954, as amended by
turing Act of 1960, Pub. Law 86-429 (74
transferred to the Attorney General:
(a) Those functions of the Secretary of the
section 4(b) of the Narcotics Manufac-
General: When the United States re-
Stat. 55).
Treasury which are administered through or
curing Act of 1960. From the time of
ceives a revised finding or decision (un-
"Bureau" means the U.S. Bureau of
such publication, the drug will be subject
der Article 3 of the 1948 Protocol) that a
Narcotics and Dangerous Drugs.
with respect to the Bureau of Narcotics.
"Director" means the Director, Bureau
(b) All functions of the Bureau of Nar-
to the same control as an "opiate" in the
drug already subject to the federal nar-
cotics, of the Commissioner of Narcotics, and
same manner as if it had been so deter-
cotic laws as an "opiate" is not capable
of Narcotics and Dangerous Drugs.
of all other officers, employees and agencies
mined and proclaimed by the Director
of producing addiction or of conversion
"Licensee" means a person granted a
of the Bureau of Narcotics.
pursuant to the procedure set forth in
into a drug capable of producing addic-
license under section 8 of Act to manu-
(c) So much of other functions or parts of
section 4731(g) of the Internal Revenue
tion and that the provisions of the 1931
facture a basis class of narcotic drug.
functions of the Secretary of the Treasury
"Manufacture" means the production
and the Department of the Treasury as is
Code of 1954, as amended by section 4(b)
Convention shall not apply to such drug,
of the Narcotics Manufacturing Act of
the Director, Bureau of Narcotics and
of a narcotic drug, either directly or in-
incidental to or necessary for the performance
of the functions transferred by paragraphs
1960.
Dangerous Drugs may, in his discretion,
directly, by extraction from substances
cause to be published in the FEDERAL
of vegetable origin, or independently by
(a) and (b) of this section.
§ 307.62 Findings by United Nations
REGISTER such revised finding or decision
means of chemical synthesis or by a
INTERNATIONAL CONTROL OF NARCOTIC
organs.
and, from the time of publication, such
combination of extraction and chemical
DRUGS
(a) Arguments opposed to finding or
drug shall cease to be an "opiate". If on
synthesis.
§ 307.61 Notifications, findings and de-
decision. Any person interested in the
the other hand the Director, in his dis-
"Narcotic", "narcotics", or "narcotic
cisions under the 1948 Protocol.
domestic manufacture and distribution
cretion, does not cause such revised find-
drugs" means any of the substances de-
(a) Notification given. The United
for medical or scientific purposes of a
ing or decision to be published in the
fined as narcotic drugs in section 4731(a)
drug which becomes subject to control
FEDERAL REGISTER, the drug in question
of the Internal Revenue Code of 1954, as
States is obligated, as a signatory state
by virtue of the procedure set forth in
shall continue to be an "opiate".
amended by section 4(a) of the Narcotics
Party to the 1948 Protocol to notify the
§ may submit to the Director,
Secretary-General of the United Nations
BASIC CLASSES OF NARCOTIC DRUGS
Manufacturing Act of 1960.
Bureau of Narcotics and Dangerous
"Person" includes an individual, part-
whenever it considers that a drug which
Drugs written data, views, briefs and
§ 307.71 Modification of list of basic
nership, corporation, association, trust,
is or may be used for medical or scientific
or other institution or entity.
purposes is liable to the same kind of
arguments opposed to such finding or
class of narcotic drugs.
decision. The Director shall transmit
"1912 Convention" means the Inter-
abuse and productive of the same kind
(a) Definition of "basic class" of nar-
such written data, views, briefs and
of harmful effects as the drugs specified
cotic drug. The term "basic class" of
national Opium Convention for the Sup-
arguments to the Department of State
pression of the Abuses of Opium and
in Article 1, Paragraph 2 of the 1931 Con-
narcotic drug means any class of nar-
for transmittal to the Secretary-General
other Drugs signed at the Hague, Janu-
vention and is not covered by that Con-
cotic drug which has been included in the
of the United Nations for consideration
vention. The notification to the Secre-
list enumerated in section 3(g) of the
ary 23, 1912, and entered into force with
of the World Health Organization or the
tary-General of the United Nations shall
Narcotics Manufacturing Act of 1960,
respect to the United States, February
Commission on Narcotic Drugs, as the
be made only after the Director has
as such list may be altered from time to
11, 1915.
case may be, (under Article 3 of the 1948
"1925 Convention" means the Inter-
found and proclaimed such drug to be an
time by adding to, subtracting from, or
Protocol) as the written opposition of
national Opium Convention signed at
"opiate" in accordance with the proce-
further defining any such class.
such interested party, and not necessarily
Geneva, February 19, 1925 to which the
dure prescribed by section 4731 (g) of the
(b) Alteration of a basic class.
as the views of the United States.
Internal Revenue Code of 1954, as
Whenever the Director, Bureau of Nar-
United States is not a party.
"1931 Convention" means the Conven-
amended by section 4(b) of the Narcotics
(b) Revised finding or decision. If,
cotics and Dangerous Drugs shall, either
tion for Limiting the Manufacture and
Manufacturing Act of 1960.
after the submission of written data,
upon his own motion or upon the
Reproduced at the Richard Nixon Presidential Library
309
308
Title 21-Chapter II
§ 307.72
Title 21-Chapter II
§ 307.81
right to request a hearing as to the pro-
10. Ethylmorphine.
application of an interested party, de-
(3) Chemical name or description
posed addition of a new basic class to
11. Apomorphine.
termine that a narcotic drug as defined
(structural formula);
the existing classifications. The notice
12. Nalorphine (N-allylnormorphine).
in section 4731 of the Internal Revenue
(4) General description and composi-
shall indicate that in the absence of
13. Hydromorphone (dihydromorphinone)
Code of 1954, as amended by section
tion;
evidence convincing the Director that
14. Metopon (methyldihydromorphinone).
4 of the Narcotics Manufacturing Act of
(5) Therapeutic action and uses;
15. Dihydrocodeine.
such course is inappropriate, he intends
(6) Advantages, if any, over similar
16. Hydrocodone (dihydrocodeinone).
1960, on the basis of its chemical struc-
to grant the application.
ture and content possesses an addiction-
drugs already in use;
17. Oxycodone (dihydrohydroxycodeinone).
(f) Final determination to establish a
18. Cocaine.
forming or addiction-sustaining liability
(7) Known or suspected habituation
new basic class. The Director after hav-
19. Ecgonine.
or convertibility into an addicting drug
or addiction potentials;
ing determined under paragraph (d) or
20. Pethidine (meperidine, isonipecaine) 1-
so great as to present a hazard, if man-
(8) Known side effects, if any, and
(e) of this section that it is consistent
methyl-4-phenylpiperidine-4.
ufactured and distributed, to the public
precautions desirable in its use;
ylic acid ethylester).
with law and the public health and
health and safety, he may alter the
(9) Methods of administration and
21. Alphaprodine (alpha-1, 3-dimethyl-4-
safety to establish a new basic class
classification set forth in section 3(g) of
recommended dosage;
phenyl-4-propionoxypiperidine).
of narcotic drug to the existing classifi-
(10) Nature of applicant's interest in
22. Methadone (amidone) (6-dimethylami-
this Act by subtracting such basic class
cation, shall cause to be published in the
no-4, ,4-diphenyl-3-heptanone).
from existing classification or he may
the drug.
FEDERAL REGISTER a final notice to this
23. Isomethadone (isoamidone) (6-dimethyl-
further define such basic class, as the
(c) Submission of Bureau Form 185.
effect.
amino-5-methyl-4, 4-diphenyl-3-hexa-
case may be. The Director, prior to
The applicant for the establishment of
(g) Denial of application. If, on the
none).
making such alteration, shall cause to
a new basic class of narcotic drug, in
basis of all of the information before
24. Levorphan and racemorphan (3-hydroxy-
be published in the FEDERAL REGISTER a
addition to the filing of Bureau Form
N-methylmorphinan).
him, the Director determines that the
notice as to this proposed subtraction
187, shall prepare and file Bureau Form
25. Levomethorphan and racemethorphan
approval of an application for the
185. The purpose of this form is to pro-
(3-methoxy-N-methylmorphinan).
or further definition of a basic class.
addition of a new basic class to the exist-
vide the Director with whatever infor-
26. Anileridine (Ethyl 1-[2-(p-amino
Such notice shall also apprise interested
ing classification would not be consistent
parties of their right to request a hearing
mation is available respecting the chem-
phenyl)-ethyl]-4-phenyl piperidine-
with law and the public health and
4-carboxylate).
as to the proposed alteration of a basic
ical formulas, physical properties and
safety, he may deny such application.
27. Phenazocine (2'-Hydroxy-5, 9-dimethyl-
class.
general identification of new narcotic
Prior to denying such application, the
2-(2-phen ylethyl)-6,7-benzomor-
(c) Addition of a new basic class to
drugs and their closely related analogs,
Director shall afford the applicant an
phan).
existing classification. No new basic
on which the Bureau is called upon to
opportunity to present any additional
28. Dihydromorphine.
class of narcotic drug shall be added by
take some action, particularly new syn-
evidence relevant to the application. If
29. Diphenoxylate (Ethyl 1-(3-cyano-3, 3-
the Director to the established enu-
thetics and newly prepared opium de-
after such additional evidence is pre-
diphenylpropyl) piperi-
meration unless he shall first have de-
rivatives, whose properties are not yet
dinecarboxylate).
sented, the Director determines that it
termined that;
published in standard chemical or phar-
30. Metazocine (2'-Hydroxy-2, 5, 9-trimethyl-
would now be consistent with law and
(1) Such drug is a narcotic drug as
maceutical reference works.
6, 7-benzomorphan).
the public health and safety to grant
defined by section 4731 of the Internal
(d) Addition of new basic class by
31. Oxymorphone (14-Hydroxydihydromor-
such application, the provisions of para-
Director. Where the Director, on his
phinone).
Revenue Code of 1954, as amended by
graphs (e) and (f) of this section shall
32. Pholcodine
section 4 of the Narcotics Manufactur-
own initiative, determines in accordance
(Morpholinyl-ethylmor-
apply.
phine).
ing Act of 1960, or has caused to be pub-
with paragraph (c) of § 307.71, that
(h) Opportunity for hearing. If the
33. Piminodine (Ethyl-4-phenyl-1-[3-(phe-
lished in the FEDERAL REGISTER a deter-
the addition of a new basic class of
Director continues to be of the opinion
nylamino)-propyl]-4-piperidine car-
mination to this effect pursuant to
narcotic drug to the existing classifi-
that the granting of the application
boxylate).
section 5 of this Act; and
cation would not be contrary to the
would not be consistent with law and
34. Norpethidine (ethyl 4-phenyl-4-piper-
(2) To permit the manufacture of such
public health and safety, he shall cause
idinecarboxylate).
a notice to this effect to be published
the public health and safety, he shall
drug will not be contrary to the public
35. Fentanyl (1-phenethyl-4-N-propionyl-
health and safety.
in the FEDERAL REGISTER. The notice shall
afford the applicant an opportunity for
anilinopiperidine).
also apprise interested parties that they
a hearing, causing a notice to this effect
§ 307.72 Establishment of a new basic
MANUFACTURE OF NARCOTIC DRUGS
class of narcotic drug.
may request a hearing as to the proposed
to be published in the FEDERAL REGISTER.
addition of a new basic class of narcotic
§ 307.81 Restriction on manufacture of
§ 307.73 List of basic classes of narcotic
(a) Request to establish a new basic
drug to the existing classification, as
narcotic drugs.
drugs.
class of narcotic drug. A person inter-
enumerated in section 3(g) of the Act.
General: Except as provided in
ested in having a new basic class of nar-
(e) Granting of application to estab-
The following substances and their
§ 307.83, it shall be unlawful for any
cotic drug established, as provided in
lish a new basic class. If on the basis
salts constitute the list of basic classes
person to engage in the manufacture of
§ 307.71, shall file a formal written re-
of all the information before him, the
of narcotic drugs:
any narcotic drug or cause or permit
quest therefor with the Director, Bureau
Director determines that the ap-
1. Opium, powdered, granulated, or deo-
another to engage in the manufacture
of Narcotics and Dangerous Drugs on
proval of an application for the addition
dorized, or tinctures or extracts of
Bureau Form 187.
of any narcotic drug unless:
of a new basic class to the existing
opium.
(b) Preparation of Bureau Form 187.
classification would be consistent with
(a) Such narcotic drug is included
2. Mixed alkaloids of opium.
The applicant for the establishment of
the law and the public health and safety,
in a "basic class" of narcotic drug (see
3. Morphine.
a new basic class of narcotic drug in
he shall cause to be published in the
§ 307.71) ; and
4. Codeine.
preparing Bureau Form 187 shall, to
FEDERAL REGISTER a notice to the effect
5. Thebaine.
(b) Such person holds a currently ef-
the extent available, render the follow-
that an application to establish a new
6. Narcotine (noscapine).
fective license for the manufacture of
ing information called for on the form:
basic class of narcotic drug has been
7. Papaverine.
such basic class of narcotic drug issued
(1) Generic name for drug;
made by a named applicant, specifying
8. Cotarnine.
pursuant to section 8 of the Act (see
(2) International
non-proprietary
the class of narcotic drug involved and
9. Narceine.
§ 307.90) and
name of the drug;
apprising all interested parties of their
Reproduced at the Richard Nixon Presidential Library
311
310
386-408 0-70-4
§ 307.82
Title 21-Chapter II
Title 21-Chapter II
§ 307.92
(c) Such person holds a currently ef-
Internal Revenue Code of 1954, as
each year, to be submitted not later than
§ 307.92 Requirements for license
fective manufacturing quota with respect
amended, and who otherwise meet the
the 15th of the month following, ac-
applications.
to such basic class of narcotic drug, as
standards for licensing under subsection
counting for the manufacture and use
set forth in section 11 of the Act (see
(a) of section 8 of the Narcotics Manu-
or other disposition of the drugs so
(a) Who may file. Any person may
§ 307.121).
facturing Act of 1960.
manufactured.
file an application for a license to manu-
(c) Application for authorization to
(f) Disposition of drugs manufac-
facture a basic class of narcotic drug
§ 307.82 Omission of a narcotic drug
tured. All such drugs manufactured
under section 8 of the Narcotics Manu-
from a basic class.
manufacture. A person desiring to ob-
tain authorization to manufacture a
under this section of the regulations
facturing Act of 1960.
(a) No narcotic drug shall be manu-
narcotic drug for scientific purposes shall
shall be used in research or otherwise
(b) Filing of applications. All appli-
factured unless it is included within a
file an application therefor on Bureau
disposed of, as authorized by the Direc-
cations for licenses must be filed in the
basic class enumerated in section 3(g)
Form 190 in duplicate, which form is
ter, within 5 years from the date of
office of the Director, Bureau of Nar-
of the Narcotics Manufacturing Act of
available at the office of the Director,
manufacture, unless an extension of
cotics and Dangerous Drugs, Washing-
1960, or established pursuant to section
time for completion of the research has
ton, D.C. 20537. Application shall be
Bureau of Narcotics and Dangerous
6 of the Act.
Drugs, Washington, D.C. 20537. If the
been requested in writing and granted
made on Bureau Form 188 in dupli-
(b) The fact that the Director shall
drug to be manufactured is produced by
by the Director.
cate which form is available at the
have (1) determined that a drug is a
chemical synthesis, whether or not from
(g) Suspension or revocation of au-
above address. If the drug to be manu-
narcotic drug, or (2) caused a finding
narcotic materials, the application shall
thorization. Any authorization granted
factured is produced by chemical syn-
or decision with respect to any drug
be accompanied by an outline of the
by the Director under this section of
thesis, whether or not from narcotic
or other substance to be published in the
process of synthesis on Form 186, iden-
the regulations shall be subject to
materials, the application shall be ac-
FEDERAL REGISTER pursuant to section 5
tifying the substances from which it is
suspension or revocation in accordance
companied by an outline of the process
of the Narcotics Manufacturing Act of
to be made and those resulting from
with the procedure set forth in §§ 307.99
of synthesis on Form 186, identifying
1960 (see § 307.61), shall not require the
and 307.100 as to suspension or revoca-
the substances from which it is to be
each successive step of the process, and
Director to add such narcotic drug to
indicating in each instance whether the
tion of licenses to manufacture.
made and those resulting from each suc-
the classification set forth in section
substance is isloated and weighed or
cessive step of the process, and indicat-
MANUFACTURERS' LICENSES
3(g) of the Act (see § 307.71 as to modi-
ing in each instance whether the sub-
measured or whether it remains in solu-
fication of list of basic class of narcotic
tion in a continuing process of manu-
§ 307.90 License to manufacture nar-
stance is isolated and weighed or
drugs), or to grant a manufacturing
facture. The applicant need not disclose
cotic drugs; generally.
measured or whether it remains in solu-
quota pursuant to section 11 of the Act
tion in a continuing process of manu-
on this form any technical detail of the
(a) Every manufacturer of a basic
(see § 307.121), for such narcotic drug,
facture. The applicant need not disclose
process which he regards as an important
class or classes of narcotic drug shall
if he finds that it would be contrary to
on this form any technical detail of the
trade secret, but in order that the Direc-
obtain a license for each such basic class
the public health and safety.
tor may discharge his responsibility un-
process which he regards as an important
on or before January 1, 1961, if then al-
trade secret, but in order that the Di-
§ 307.83 Manufacturing f o r scientific
der the law with respect to narcotic pre-
ready engaged in such manufacture. All
cursors the applicant must identify each
rector may discharge his responsibility
research and testing.
other persons desiring to engage in the
under the law with respect to nar-
substance used and each substance re-
manufacture of a basic class or classes
(a) Manufacture for scientific re-
sulting from the successive stages of
cotic precursors the applicant must
of narcotic drug after January 1, 1961
search. The Director, Bureau of Nar-
identify each substance used and each
manufacture. Information disclosed on
shall obtain appropriate licenses for each
cotics and Dangerous Drugs shall exempt
Form 186 will be held in confidence by
substance resulting from the successive
such basic class prior to undertaking
from the provisions of § 307.90, any
stages of manufacture. Information dis-
the Bureau.
such manufacture. Issuance of a license
person desirous of the manufacturing a
closed on Form 186 will be held in con-
(d) Limitations on authorization.
narcotic drug exclusively for research
for the manufacture of any one basic
fidence by the Bureau.
Authorization to manufacture under this
in the development of manufacturing
class of narcotic drug shall not entitle
section will be limited to narcotic drugs
(c) Separate applications. An appli-
processes for the drug, or for chemical,
the licensee to engage in any transaction.
not readily available to the researcher
cant who files separate applications to
pharmacological or medical testing of
with respect to any other basic class of
manufacture more than one class of nar-
from sources within the United States,
such drug, for fitness for medical or
except where the development of new
narcotic drug.
cotic drug need not repeat information
scientific use and for determination of
or improved methods of production is
(b) A person desiring to obtain a li-
on each application. He may make ref-
its suitability for general manufacture
the object of the research to be under-
cense as provided in paragraph (a) of
erence on any application to information
and distribution for medical or scientific
taken. In addition, the Director may
this section shall prepare and file an ap-
which he has furnished on another ap-
use.
specify a limitation on the quantity
plication for such a license in accordance
plication, identifying such other appli-
(b) Authorization to manufacture.
of narcotic drug to be manufactured
with the procedure set forth in § 307.92.
cation by either file number, or if there
Written authorization from the Director
under this section of the regulations.
has been no file number assigned, by
to manufacture a narcotic drug for
(e) Reports required. Persons au-
§ 307.91 Registration as a prerequisite
basic class.
scientific purposes must be obtained
thorized to manufacture under this sec-
to issuance of a license.
(d) Subscription of applications.
prior to the undertaking of such manu-
tion of the regulations and who are
In addition to the conditions precedent
Each application, or amendment there-
facture. The Director shall grant such
Class I registrants shall render a quar-
for the issuance of a license to manu-
to, and each written statement of fact
authorization only to those public offi-
terly report to the Director on Bu-
required by the Director from any ap-
facture a particular basic class of nar-
plicant to enable the Director to de-
cials who have evidenced their exemp-
reau Form 810 and its supplements
cotic drug as provided in § 307.90, each
termine whether an application should
tion from registration and payment of
in accordance with 26 CFR 151.261.
applicant for a license must be registered
be granted or denied, shall be personally
tax (26 CFR 151.221) with the District
Those persons who are Class VI regis-
as a Class I registrant pursuant to the
signed by the applicant, if an individual;
Director of the Internal Revenue Service
trants shall render to the Director
provisions of sections 4721 and 4722 of
by a partner of the applicant, if a part-
or to persons registered in Class I
semi-annual reports on Bureau Form
the Internal Revenue Code of 1954, as
nership; or by an officer of the applicant,
or Class VI, under section 4722 of the
192, as of June 30 and December 31 of
amended (see 26 CFR Part 121 et seq.).
if an association or corporation.
312
Reproduced at the Richard Nixon Presidential Library
313
Title 21-Chapter II
Title 21-Chapter II
$ 307,97
$ 307.93
comply with such request will be deemed
a narcotic drug in the basic class to
who has on file an application to manu-
(e) Contents of applications. (1)
Each application shall include all infor-
to render the application defective and
which the application applies or who has
facture the basic class of narcotic drug
the filing of such application will be
a pending application therefor on file.
involved. The Director shall also cause
mation called for by Forms 186 and 188
Within twenty days after the notice is
unless the information called for is in-
cancelled.
to be published in the FEDERAL REGISTER
published in the FEDERAL REGISTER, any
a notice to the same effect.
applicable, in which case this fact shall
(h) Amendments to applications.
interested person may file a written pro-
(1) Any application may be amended as
(e) Joinder of parties and consolida-
be indicated.
test with both the Director and the
(2) The Director may require an
a matter of right prior to the date of the
tion of hearings. All interested persons
applicant against favorable considera-
applicant to submit such documents and
receipt of notice from the Director estab-
are permitted to participate in any hear-
tion of the application. Any such pro-
written statements of fact pertinent to
lishing a date for a hearing as requested
ing under this section and may be com-
test shall specify with particularity the
the subject matter of the application, as
by the applicant in accordance with
pelled by the Director to do so or waive
facts relied upon as showing that a
their rights to be heard. The Director
in the Director's judgment may be neces-
§ 307.93(d).
license if granted to the applicant would
may direct that more than one applica-
sary, or to amend the application to
(2) Requests to amend an application
not be in the public interest. Such in-
tion to manufacture a basic class of
make it more definite and certain.
after it has been designated for hearing
terested person may request a hearing
narcotic drug be consolidated for the
(f) Acceptance of applications for
will be considered only upon written per-
as to his protest. The Director shall,
purpose of a hearing. After consoli-
filing. (1) Applications submitted for
mission by the Director, and will be
within twenty days after the filing of a
dation, an application will be retained
filing are dated by the office of the
granted only for good cause shown.
timely protest, designate a date for a
for hearing notwithstanding that prior to
Director upon receipt and then for-
(i) Withdrawal of applications. (1)
hearing. The Director may require of the
hearing any other application with which
warded to the Office of Compliance
Any application may, upon request of the
applicant that he file with the Director
it has been consolidated has been dis-
where an administrative examination
applicant, be withdrawn as a matter of
and the person making the protest, a
missed, or amended or otherwise removed
is made to ascertain whether the ap-
right prior to the date of receipt of no-
written statement setting forth the
from the hearing.
plications are complete. Applications
tice from the Director establishing a
grounds, if any, for his opposition to the
found to be complete or substantially
date for a hearing as requested by the
protest. If such statement is required
§ 307.94 Factors governing issuance of
complete are accepted for filing and are
applicant in accordance with § 307.93
licenses.
by the Director, the applicant must file
given a file number, which file number
(d). An applicant's request for the re-
it within twenty days after the demand
In determining whether to issue a li-
shall be transmitted to the applicant to
turn of an application that has been
upon him is made by the Director. Fail-
cense to an applicant to manufacture a
be used on all future correspondence re-
accepted for filing will be regarded as a
ure on the part of the applicant to sub-
particular basic class of narcotic drug,
lated to the application. In case of
request to withdraw the application.
mit such statement will be grounds for
under § 307.90, the Director shall be
minor defects as to completeness, the ap-
(2) Requests to withdraw an applica-
denial of the application.
governed by whether the issuance of the
plicant will be requested to supply the
tion after it has been designated for a
(c) Action on denial of license. If
license would tend to achieve the objec-
missing information. Applications
hearing will be granted only for good
upon examination of any application
tives set forth in section 8 of the Nar-
which are not substantially complete will
cause shown.
prepared and filed by the applicant in
cotics Manufacturing Act of 1960.
be returned to the applicant.
(3) Failure to prosecute an applica-
accordance with § 307.92, the Director
(2) Acceptance of an application for
§ 307.95 Period of validity of license.
tion or failure to respond to official cor-
is unable to find that it would be con-
filing merely means that it has been the
respondence or request for additional
sistent with the law and the public
The Director shall designate the form
subject of a preliminary review by the
information will be treated as a request
Director's administrative staff as to
interest to grant the application, he shall
which the license to be issued pur-
by the applicant for withdrawal of his
notify the applicant that he is denying
suant to § 307.90 shall take. The license
completeness and has no relevance to
application.
the application and shall state the
once issued, shall not require any renewal
whether the application will be granted
§ 307.93 Action upon applications.
grounds and reasons for his action.
and shall remain in effect, subject only
or denied. Such acceptance will not
(d) Right of hearing after denial of
to annual renewal of registration as re-
preclude the subsequent request for fur-
(a) Notice of intention to grant ap-
license. Following notice of denial, as
quired in section 8(b) of the Narcotics
ther information.
plication. If after appropriate con-
set forth in paragraph (c) of this section,
Manufacturing Act of 1960, unless other-
(g) Defective applications. (1) Ap-
sideration, the Director finds that it
the applicant within twenty days from
wise revoked or suspended pursuant to
plications which are determined to be
would be consistent with the public
receipt thereof, may present in writing
section 9 of the Act (see §§ 307.99-
patently not in accordance with these
interest to grant any application filed
any reasons for disagreeing with the
307.100), or voluntarily surrendered.
regulations or the Director's specific
pursuant to § 307.92, he shall so notify
Director's denial of the application.
§ 307.96 Assignment or transfer of li-
requirements as to a particular ap-
the applicant. This notification, how-
If the Director thereafter determines
censes.
plicant, unless accompanied by an
ever, shall not be construed as granting
that is appropriate to give favorable
appropriate request for waiver, will be
the application.
No license nor any right granted there-
consideration to the application, the
considered defective and will not be ac-
(b) Protest of grant of application.
under shall be assigned or otherwise
provisions of paragraphs (a) and (b) of
cepted for filing. If it is ascertained
After notification is given to the appli-
transferred except upon such conditions
this section shall apply. If the Director
that an application has been inadvert-
cant, as provided in paragraph (a) of
as the Director may specifically designate
adheres to his decision to deny the
ently accepted for filing, the filing will
this section, the Director shall cause to
and then only pursuant to his written
application, he shall afford the appli-
be cancelled. Requests for waiver or ex-
consent.
be published in the FEDERAL REGISTER a
ception desired shall set forth the rea-
cant an opportunity to be heard. If the
notice to the effect that a named appli-
sons in support thereof, and will be
applicant elects to have a hearing, the
§ 307.97 Warning to licensee for failure
cant has applied for a license to manu-
accepted or rejected in the discretion of
Director shall specify a date for the
to comply.
facture a particular basic class of nar-
the Director.
hearing and shall appropriately notify
(a) Failure to comply, generally.
(2) If an applicant is requested by the
cotic drug, and that such applica-
the applicant and each licensee who
Where a licensee has failed to comply
Director to file any additional docu-
tion is being favorably considered. He
holds an effective license to manufacture
with any of the provisions of these regu-
ments or information pertinent to the
shall at the same time mail a copy of
the basic class of narcotic drug to which
lations or has failed to operate in ac-
application not included in the pre-
this notice to every person who then
the application relates and every person
cordance with any provision of the
scribed application form, a failure to
holds an effective license to manufacture
Reproduced at the Richard Nixon Presidential Library
315
314
§ 307.98
Title 21-Chapter II
Title 21-Chapter II
§ 307.121
federal narcotic laws and regulations,
justification within thirty days of the
AUTHORITY To SEIZE NARCOTIC DRUGS,
who are confiscating the items shall, in
the Director, Bureau of Narcotics and
date of receipt of the order to show cause.
ORDER FORMS AND TAX STAMPS
the presence of the licensee or his rep-
Dangerous Drugs may serve written no-
(e) Any order of revocation issued
§ 307.111 Sealing and safeguarding of
resentative, prepare an inventory in
tice upon such licensee calling his atten-
pursuant to this section of the regula-
narcotic drugs.
triplicate of the items being confiscated.
tion to the facts or conduct of such
tions by the Director shall include a
The original inventory shall be forward-
licensee without serving an order to
statement by him of his findings and
(a) The Director, Bureau of Narcotics
ed to the Director, Bureau of Narcotics
show cause as provided in § 307.98. The
grounds and reasons therefor and shall:
and Dangerous Drugs on or after order-
and Dangerous Drugs, the duplicate copy
licensee may then be accorded an oppor-
(1) Specify the effective date of the
ing the suspension or revocation of
shall be forwarded to the narcotic Re-
tunity to demonstrate or achieve com-
order; and
a licensee's license under § 307.99 or
gional Director of the district wherein
pliance with all lawful requirements, and
(2) Cause such order to be served on
§ 307.100 may order that all narcotic
the confiscation was made and the trip-
to render a full and complete explanation
the licensee.
drugs, whether or not taxes have been
licate copy shall be given to the li-
as to the matter brought to his attention
(f) Any proceeding under this section
paid thereon, owned or possessed by such
censee from whom the confiscation was
by the Director.
shall be independent of, and not in lieu
licensee and all unused order forms and
made, and shall be retained by him for
(b) Willful failure to comply. Where
of, criminal prosecution or other pro-
narcotic tax stamps owned or possessed
a period of not less than 2 years.
the Director, Bureau of Narcotics and
ceedings under this Act or any other law
by such licensee be placed under seal
(d) Representatives of the Bureau of
Dangerous Drugs considers the licensee's
of the United States.
under the supervision of a representative
Narcotics and Dangerous Drugs at the
failure to comply with any of the pro-
of the Bureau of Narcotics and Danger-
§ 307.99 Suspension of licenses.
time of confiscating narcotic drugs pur-
visions of these regulations or his failure
ous Drugs pending final disposition of
suant to this section may, as the Direc-
to operate in accordance with any pro-
(a) The Director may suspend any
the revocation proceeding.
tor, Bureau of Narcotics and Dangerous
vision of the federal narcotic laws and
license, when or at any time after he
(b) The representative of the Bureau
Drugs directs, either destroy accumu-
regulations is willful or contrary to
issues an order to show cause under
referred to in paragraph (a) of this sec-
lated narcotic wastes and undesired
the public health and safety, the Direc-
§ 307.98, in any case where he finds that
tion, shall, in the presence of the licensee
narcotic drugs or dispose of such wastes
tor shall issue an order to show cause,
the public health, safety or interest re-
or his representative, prepare an inven-
and drugs pursuant to the procedures
pursuant to § 307.98.
quires such suspension.
tory, in triplicate, of all items thus placed
set forth in paragraph (e) of this
(b) Where the Director orders a li-
under seal. The original inventory shall
section.
§ 307.98 Orders to show cause.
cense suspended under paragraph (a)
be forwarded to the Director, Bureau of
(e) All confiscated items not destroyed
(a) Before revoking any license, the
of this section, the licensee shall send
Narcotics and Dangerous Drugs, the du-
shall be delivered to the narcotic Re-
Director shall serve upon the licensee an
the license to the Director in Wash-
plicate copy shall be forwarded to the
gional Director of the district wherein
order to show cause why an order of
ington, D.C., promptly upon receipt of
narcotic Regional Director of the dis-
the confiscation takes place. The nar-
revocation should not be issued. Any
the notice of suspension.
trict wherein the sealing takes place and
cotic Regional Director will forward the
such order to show cause shall contain
(c) Any suspension ordered by the
the triplicate copy shall be given to the
narcotic drugs thus confiscated to the
a statement of the basis thereof, and
Director, as provided in this section
affected licensee.
Director, Bureau of Narcotics and Dan-
shall call upon such licensee to appear
of the regulations, shall continue in
(c) A licensee may make no disposi-
gerous Drugs (Drugs Disposal Commit-
before the Director at a time and place
effect until the conclusion of any revoca-
tion of any item placed under seal. The
tee) for proper disposition in accordance
stated in the order, but in no event
tion proceeding, including judicial re-
licensee shall be responsible for safe-
with the provisions of 26 CFR 151.491.
less than thirty days after the date of
view thereof, if any, unless sooner with-
guarding all sealed items to insure
Confiscated unused order forms and tax
receipt of such order, and give evidence
drawn by the Director, or dissolved
against their disposition and to protect
stamps shall be forwarded to the Dis-
upon the matter specified therein.
by a court of competent jurisdiction.
them against being tampered with.
trict Director of the Internal Revenue
(b) In order to avail himself of the
§ 307.100 Revocation of licenses.
§ 307.112 Forfeiture of narcotic drugs.
Service of the district wherein the li-
opportunity to be heard, the licensee
censee was registered for cancellation of
shall within thirty days of the date of the
(a) Any license issued pursuant to
(a) When a revocation order, under
such order forms and for disposition of
receipt of the order file with the Di-
section 8 of the Narcotics Manufacturing
§ 307.100, becomes final, all narcotic
the tax stamps. No refund will be al-
Act of 1960 may be revoked by the Direc-
drugs, unused order forms and tax
rector a written statement that he will
lowed for tax stamps forfeited to the
tor if the licensee
appear in accordance with the order
stamps relating to narcotic drugs, owned
Government under this section of the
(1) Has been convicted of violating or
and will present evidence on the matter
or possessed by the affected licensee, shall
regulations.
conspiring to violate any law of the
be forthwith confiscated, and when con-
specified in the order. If the licensee
fails to file such written statement within
United States or of any State where the
fiscated shall be deemed to be forfeited
MANUFACTURING QUOTAS
offense involves any activity or trans-
to the Government.
the time specified in this paragraph, the
§ 307.121 Manufacturing quotas for
right to a hearing shall be deemed to
action with respect to narcotic drugs; or
(b) Representatives of the Bureau of
basic classes of narcotic drugs; gen-
have been waived.
(2) Has violated or failed to comply
Narcotics and Dangerous Drugs when
erally.
(c) Where a hearing is waived under
with any duly promulgated regulation
confiscating narcotic drugs, unused
(a) In order to carry out the treaty
paragraph (b) of this section, or where
relating to narcotic drugs, and such vio-
order forms and tax stamps, shall deter-
obligations of the United States, the Di-
the licensee has failed to appear after
lation or failure to comply reflects ad-
mine whether there has been any dispo-
sition of or tampering with any such
rector, Bureau of Narcotics and Dan-
having stated that he would do so, the
versely on the licensee's reliability and
items that had been sealed pursuant to
gerous Drugs shall, on or before June 1,
allegations of fact contained in the order
integrity with respect to narcotic drugs.
§ 307.111.
of each year, make determinations of
to show cause will be deemed to be
(b) In the case of a licensee who is
correct.
(c) At the time of confiscating nar-
the total quantity of each basic class of
the holder of more than one license is-
(d) Where a hearing is waived, not
cotic drugs, unused order forms and tax
narcotic drug necessary to be manufac-
under paragraph (b) of this section, but
sued pursuant to section 8 of the Act, the
stamps which have not previously been
tured during that calendar year to pro-
rather by written formal waiver, the
Director may revoke under paragraph
ordered sealed and safeguarded under
vide for the estimated medical and
licensee may submit to the Director
(a) of this section one or all of the
§ 307.111, the representatives of the Bu-
scientific needs of the United States, for
a written statement in mitigation or
licenses issued to such licensee.
reau of Narcotics and Dangerous Drugs
lawful export requirements, and for the
Reproduced at the Richard Nixon Presidential Library
316
317
Title 21-Chapter II
§ 307.125
§ 307.122
Title 21-Chapter II
calendar year or years, the licensee's pro-
less such manufacturer's inventory of
duction cycle and current inventory
such basic class of narcotic drug on De-
establishment and maintenance of re-
ufacturing quota which he has previ-
position, the economic and physical
cember 31 of the preceding calendar
ously fixed, so as to prevent the ag-
availability of raw materials used by the
year.
serve stocks.
(b) In fixing yearly manufacturing
gregate of the manufacturing quotas
licensee in the production of such basic
(f) Manufacturing quotas for new li-
quotas for each basic class of narcotic
outstanding or to be granted from ex-
class of narcotic drug, yield and stability
censees. Subject to the right of the
drug, the Director, Bureau of Narcotics
ceeding the established quota for the
problems, emergency situations such as
Director, Bureau of Narcotics and Dan-
and Dangerous Drugs shall consider the
basic class of narcotic drug.
catastrophes and strikes, and any other
gerous Drugs to reduce, limit, suspend or
total needs for the procurement of such
(c) Production in excess of quota. No
factors which the Director deems ap-
revoke any manufacturing quota, the Di-
drugs for further manufacturing or
person shall knowingly manufacture any
propriate to consider in arriving at the
rector, upon application therefor, shall
processing by registered manufacturers
narcotic drug in any quantity in excess
proper quota under the circumstances).
fix a quota for any licensed manufac-
who do not hold quotas to manufacture
of any quota which he holds. When a
(c) Definition of "net disposal". The
turer of a basic class of narcotic drug
such basic class of narcotic drug. In
licensee who under a quota as originally
term "net disposal" means the quantity
who has not manufactured such basic
order that such information may be
fixed, or as reduced by the Director,
of a basic class of narcotic drug sold,
class of narcotic drug during one or more
available to the director each registered
Bureau of Narcotics and Dangerous
exchanged, given away, used in the pro-
of the three immediately preceding cal-
manufacturer who does not hold a
Drugs under paragraph (b) of this sec-
duction of another basic class of narcotic
endar years, in an amount adequate to
manufacturing quota shall on or before
tion, has already manufactured a basic
drug for which the manufacturer is li-
cover such manufacturer's reasonably
November 30, notify the Director in
class of narcotic drug in excess of the
censed, or otherwise disposed of (as such
anticipated requirements for the cur-
writing on Bureau Form 194 of the
quota, such excess shall be subtracted
or contained in or combined with other
rent calendar year.
amount of each basic class of narcotic
by the Director, Bureau of Narcotics and
drugs compounded by the manufacturer
Dangerous Drugs from the licensee's
§ 307.124 Provisional manufacturing
drug which he desires to procure in the
of such basic class) by the manufac-
following year for further manufactur-
manufacturing quota for the following
quotas.
turer during a stated period, less the
year.
quantity of any such basic class of nar-
(a) A licensed manufacturer, be-
ing or processing. The Director shall
notify each person who has filed Bureau
(d) Proportionate reduction of manu-
cotic drug returned to the manufacturer
tween January 1 of any year and the
Form 194 whether the request thereon
facturing quota. Any reduction of an
by a customer and any quantity sold
time when he receives a quota for such
will be relied upon by the Director in fix-
individual manufacturing quota shall be
or transferred to another licensed man-
year under § 307.123 may manufacture
ing the annual manufacturing quotas.
in the same proportion as the reduction
ufacturer of the same basic class of nar-
a provisional quota of the basic class of
When the Director states that he will
of the aggregate of the established quota
narcotic drug for which he is licensed.
cotic drug.
for the basic class of narcotic drug or in
(b) The provisional quota referred
rely upon any such forms he shall also
(d) Definition of "inventory". The
the proportion that a quota to a new
to in paragraph (a) of this section, ex-
state the amount which he will take into
account and such amount shall be
licensee may require in order to keep the
term "inventory" means all factory and
cept as provided in paragraph (c) of
known as the "purchase quota" of the
aggregate of the individual quotas from
branch stocks (whether held by the man-
this section shall be not more than 75
exceeding the established quota for the
ufacturer under Class I or Class II reg-
per centum of whichever of the follow-
person filing the form. Such purchase
basic class of narcotic drug.
istration as provided in 26 CFR 151.41)
ing is greater:
quotas will be based upon the applicant's
of a basic class of narcotic drug manu-
(1) Such licensee's aggregate net dis-
previous yearly requirements and upon
§ 307.123 Formula for fixing individual
factured or otherwise acquired by a li-
posal of such basic class of narcotic drug
his reasonably anticipated requirements.
manufacturing quotas.
A purchase quota may be increased by
censee, whether in bulk, marketable
during the twelve months immediately
(a) Time for fixing of quotas. Upon
the Director upon request and upon a
packages, or contained in pharmaceutical
preceding September 30 of the preced-
application therefor, the Director, Bu-
preparations in the possession of the li-
ing year; or
showing of need therefor.
reau of Narcotics and Dangerous Drugs
censee and all subsidiary companies, if
(2) Twelve times such licensee's aver-
(c) Notwithstanding the provisions of
(b) of this section, Bureau Form 194
shall, on or before June 1 of each year
fix individual manufacturing quotas for
any, of such licensee.
age monthly net disposal of such basic
need not be filed by any registered man-
the manufacturing of each basic class of
(e) Establishment of manufacturing
class of narcotic drug for the thirty-
three months immediately preceding
ufacturer who uses less than one kilo-
quotas. Subject to the right of the Di-
gram of all basic classes of narcotic
narcotic drug.
September 30 of the preceding year.
(b) Sufficiency of manufacturing quo-
rector, Bureau of Narcotics and Danger-
(c) The Director, Bureau of Narcotics
drugs annually.
tas. Subject to the right of the Director,
ous Drugs to reduce, limit, suspend or
and Dangerous Drugs, may, for good
§ 307.122 Individual manufacturing
Bureau of Narcotics and Dangerous
revoke any manufacturing quota, the
cause, raise or lower the provisional quota
quotas.
Drugs to reduce, limit, suspend or revoke
quota for each licensed manufacturer
percentage provided for in paragraph
any manufacturing quota, any quota
shall not be less than the sum of-
(b) of this section. Any increase or de-
(a) Fixing of individual manufactur-
ing quotas. The Director, Bureau of Nar-
established for a licensee for the manu-
(1) Such licensed manufacturer's net
crease in percentage provided for by the
cotics and Dangerous Drugs shall upon
facture of a basic class of narcotic drug
disposal of such basic class of narcotic
Director shall apply to the provisional
application fix annual manufacturing
shall be sufficient to cover the licensee's
drug during the immediately preceding
quotas of all licenses for the basic class
quotas for each licensee holding a license
estimated requirement for the calendar
calendar year or the average of the
of narcotic drug involved.
to manufacture each basic class of nar-
year in question as to—
three immediately preceding calendar
(1) His "net disposal" (as defined in
§ 307.125 Application for individual
cotic drug and in so doing shall be gov-
years in which such manufacturer pro-
manufacturing quotas.
erned by the provisions of section 11 of
paragraph (c)) for such calendar year;
(2) His inventory at the close of such
duced such basic class of narcotic drug,
the Narcotics Manufacturing Act of
(a) Each person desirous of manufac-
calendar year; and subject to such other
whichever is greater; and
turing a basic class of narcotic drug
1960.
factors as the Director may determine
(2) One-half of such manufacturer's
for which he holds a currently effective
(b) Reducing individual manufactur-
should be taken into consideration in
net disposal of such basic class of nar-
manufacturing license, shall file an ap-
ing quotas. The Director, Bureau of Nar-
cotics and Dangerous Drugs, after hav-
arriving at a proper quota under all
cotic drug during the immediately pre-
plication for an individual manufac-
ing established individual manufactur-
the circumstances (i.e., licensee's cur-
ceding calendar year;
turing quota on Bureau Form 189 for
ing quotas for a basic class of narcotic
rent net disposal rate, the trend of such
net disposal rate during Reproduced the preceding at the Richard Nixon Presidential Library
319
drug may reduce an individual man-
386-408
O - 70 - 5
318
Title 21-Chapter II
§ 307.126
Title 21-Chapter II
§ 307.151
INCIDENTAL MANUFACTURE OF NARCOTIC
cotics and Dangerous Drugs, authorized
which has been declared a narcotic pre-
each such basic class of narcotic drug.
Bureau Form 189 shall be filed with the
DRUGS
by the Director, Bureau of Narcotics
cursor shall keep for a period of not less
and Dangerous Drugs, to witness such
than two years such records as will en-
Director, Bureau of Narcotics and Dan-
§ 307.131 Exception from applicability
destruction.
able him to supply the Director accu-
gerous Drugs no later than March 1 of
of license and quota provisions.
(e) A manufacturer may retain a re-
rate information as to the quantity of
each year in which the licensee desires to
manufacture such basic class of narcotic
(a) Any licensee who, incidentally
sulting narcotic drug within the mean-
such precursor manufactured or other-
drug.
but necessarily, manufactures a narcotic
ing of paragraph (a) or (b) of this sec-
wise acquired by him, his dispositions
drug as a result of his manufacture of
tion only for such period of time as is
thereof, the names and addresses of the
(b) Any person who is not desirous of
a basic class of narcotic drug for which
reasonably necessary for him to make
persons to whom supplied, the quantity
manufacturing a basic class of narcotic
he holds a license and manufacturing
disposition of such drug in the manner
supplied to each and the use for which
drug for which he holds a currently
quota under the regulations in this part,
provided in this section.
intended. The annual report on Form
effective manufacturing license, shall
notify the Director, Bureau of Narcotics
shall be exempt from the require-
MANUFACTURE OF NARCOTIC PRECURSORS
193 shall include a summary of this in-
ment of a license and quota under the
formation for the calendar year.
and Dangerous Drugs no later than
March 1 of any year in which he does not
regulations in this part as to such result-
§ 307.141 Narcotic precursors.
IMPORTATION OF NARCOTIC DRUGS
desire to manufacture such basic class
ing narcotic drug.
(a) Definition of "narcotic precursor."
§ 307.151 Importation of narcotic drugs
of narcotic drug.
(b) No license or quota shall be re-
The term "narcotic precursor" means a
(c) Any person who after having filed
quired for any quantity of narcotic drug
substance other than a narcotic drug
for scientific purposes.
which incidentally but necessarily re-
which the Director has found to be
(a) Exemption for scientific purposes
an application for an individual manu-
facturing quota under paragraph (a) of
sults from the manufacture of any non-
(1) An immediate chemical precursor
Notwithstanding the provisions of § 302.1
narcotic substance not covered by the
this section, decides not to manufacture
of a narcotic drug;
of this chapter, the Director of Narcotics
such basic class of narcotic drug or to
regulations in this part.
(2) Produced primarily for use in the
and Dangerous Drugs may issue a formal
discontinue the manufacture of such
(c) Any incidentally but necessarily
manufacture of a narcotic drug; and
permit to certain classes of persons de-
basic class of narcotic drug, shall forth-
resulting narcotic drug, within the
(3) Used or likely to be used, in the
siring to import any narcotic drug or
meaning of paragraphs (a) or (b) of
manufacture of a narcotic drug by per-
drugs (including crude opium and coca
with notify the Director, Bureau of Nar-
this section which is a basic class of nar-
sons other than persons licensed under
leaves) for scientific purposes only.
cotics and Dangerous Drugs in writing.
cotic drug, shall be disposed of in the
section 8 of the Narcotics Manufactur-
(b) Application for import permit
to this effect.
following ways only:
ing Act of 1960, to manufacture such
Application for a permit to import shall
§ 307.126 Increase in individual manu-
(1) By transfer to another manufac-
narcotic drug.
be made to the Director on Bureau Form
facturing quotas.
turer who holds a license to manufacture
Before finding a substance to be a nar-
191. The applicant for such import per-
(a) Any licensee who holds a manu-
such basic class of narcotic drug. Before
cotic precursor, the Director shall give
mit shall also prepare and submit to
such transfer can be made, however, the
due notice in the FEDERAL REGISTER and
the Director, Bureau Form 185 (Drug
facturing quota for a basic class of nar-
manufacturer desirous of making such
cotic drug may file an application on
transfer shall first apply to the Director,
afford an opportunity for public hearing
Identification Sheet), where the sub-
Bureau Form 189 with the Director, Bu-
Bureau of Narcotics and Dangerous
to interested persons.
stance to be imported is a narcotic drug
Drugs, in writing for approval to trans-
(b) Requirements as to persons en-
not described in the standard reference
reau of Narcotics and Dangerous Drugs
for an increase in such manufacturing
fer specified quantities of such resulting
gaging in transactions with respect to
works on drugs and chemicals.
quota in order for him to meet his esti-
narcotic precursors. Any person who is
(c) Limitation on authorization to
narcotic drugs to a specified transferee or
engaged in the manufacture, compound-
import. Imports under this section will
mated net disposal, inventory and other
transferees. No transfer is authorized
ing, packaging, selling, dealing in or
be limited to narcotic drugs not readily
requirements during the remainder of
unless the Director approves such trans-
such calendar year.
fer in writing in advance thereof.
giving away of a narcotic precursor, as
available to the applicant from source
(b) The Director, Bureau of Narcotics
(2) By shipment to the narcotic Re-
defined in paragraph (a) of this section,
within the United States, unless ques
gional Director as excess and undesired
shall:
tions of origin, types or particula
and Dangerous Drugs, in passing upon a
narcotic drugs pursuant to 26 CFR 151.-
(1) Maintain records as prescribed in
methods of production are elements o
licensee's application for an increase in
474; or
paragraph (d) of this section; and
the research objectives. Each importa
his manufacturing quota, shall take into
tion desired must be separately applied
(3) By destruction in the presence of
(2) Prepare and submit an annual re-
consideration any occurrences since the
for and be covered by a separate im
a representative of the Bureau of Nar-
port on Bureau Form 193 on or before
port permit. Applicants for import per
filing of such licensee's initial quota ap-
cotics and Dangerous Drugs authorized
February 15 of each year.
mits licensed under section 8 of the Nar
plication that may require an increased
by the Director, Bureau of Narcotics
(c) Exception to applicability of para-
cotics Manufacturing Act of 1960, wh
manufacturing rate by such licensee dur-
and Dangerous Drugs, to witness such
graph (b). The provisions of paragraph
as part of their manufacturing busines
ing the balance of the calendar year. In
destruction.
(b) of this section shall not apply to a
maintain branch or subsidiary manufac
passing upon such application the Direc-
(d) Any incidentally but necessarily
person manufacturing a narcotic pre-
turing establishments in foreign coun
tor may also take into consideration the
resulting narcotic drug within the mean-
cursor who holds a license to manufac-
tries, or are themselves a branch o
amount, if any, by which his determina-
ing of paragraph (a) or (b) of this sec-
ture a basic class of narcotic drug under
subsidiary of a foreign parent organiza
tion of the total quantity for the basic
tion which is not a basic class of nar-
section 8 of the Narcotics Manufacturing
tion, may be issued import permits fo
class of narcotic drug to be manufac-
cotic drug, may be disposed of in one of
Act of 1960, provided that the narcotic
occasional imports of samples of th
the following ways only:
precursor manufactured by such licensee
tured under § 307.121, exceeds the ag-
products of these foreign branches
(1) By shipment to the narcotic Re-
is to be used exclusively by him for the
gregate of all the individual manufac-
subsidiaries or parent organizations fo
gional Director as excess and undesired
manufacture of the basic class of nar-
turing quotas for the basic class of
narcotic drugs pursuant to 26 CFR 151.-
cotic drug for which he holds a license.
the purpose of research or spot checl
narcotic drug, and the equitable distri-
474; or
(d) Procedure as to maintenance of
analyses to establish or maintain prope
bution of such excess among other
(2) By destruction in the presence of
records and preparation of annual re-
chemical and therapeutical standards o
licensees.
a representative of the Bureau of Nar-
port. The manufacturer of a substance
their products. However, an applican
320
321
Reproduced at the Richard Nixon Presidential Library
§ 315.1
Title 21-Chapter 11
Title 21-Chapter II
§ 316.52
will not be granted import permits to
be presented by letter or in person by the
PUBLIC HEARINGS AND NOTICE THEREOF
Subparts A-E-[Reserved]
make continuous or regular imports of
person to whom the notice was given, or
Sec.
samples of recurring batches or lots of
by his representative.
316.68 Hearings under section 701(e) of the
Subpart F-Public Hearings
the same product for routine factory
(b) Upon request, seasonably made,
act.
§ 316.48 Purpose of holding public
controls.
by the person to whom a notice ap-
316.69 Notice of hearing.
hearings.
(d) Disposition. All drugs imported
pointing a time and place for the pres-
316.70 Time and place of hearing.
under this section shall be used in re-
Procedure for the issuance, amend-
entation of views under section 305 of
DESIGNATION, POWERS, RESPONSIBILITIES, AND
search or otherwise disposed of as au-
ment, or repeal of regulations under sec-
DUTIES OF PRESIDING OFFICER
thorized by the Director, within 5 years
the act has been given, or his represen-
tions 201(v) (2) (C) and (3) (procedure
tative, such time or place or both such
316.71 Presiding officer.
from the date of their import, unless an
for listing habit-forming drugs and drugs
316.72 Commencement of functions.
extension of time for completion of the
time and place, may be changed if the
having a potential for abuse), and
316.73 Authority of presiding officer.
research has been granted by the
request states reasonable grounds there-
502(d) (habit-forming drugs) of the
PREHEARING AND OTHER CONFERENCES
Director.
of. Such request shall be addressed to
Federal Food, Drug, and Cosmetic Act,
(e) Reports. Persons importing nar-
the office of the Bureau of Narcotics and
316.74 Prehearing conference.
is described in section 701(e) (1) of the
cotic drugs under this section shall ren-
316.75 Exclusion of witnesses and docu-
Dangerous Drugs which issued the
Federal Food, Drug, and Cosmetic Act.
mentary evidence.
der to the Director semiannual reports
Public hearings contemplated by this
notice.
316.76
Prehearing order.
on Bureau Form 192, as of June 30 and
Subpart F arise only through the rule-
(Sec. 305, 52 Stat. 1045, as amended; 21 U.S.C.
316.77
Other conferences.
December 31 of each year, to be sub-
making provisions cited and will be
mitted not later than the 15th of the
335 and Reorg. Plan No. 1 of 1968)
HEARING PROCEDURES
granted only where adverse effect and/or
month following, accounting for the im-
316.78
Statements of position.
reasonable grounds can be shown. Hear-
portation and use or other disposition of
PART 316-ADMINISTRATIVE FUNC-
316.79
Evidentiary purpose of hearing.
ings will be limited to the issues raised
the narcotic drug or drugs so imported.
TIONS, PRACTICES, AND PROCE-
316.80
Submission of documentary evidence
by the objections filed within the statu-
and identification of witnesses
DURES
tory time limits, or extended as specified
subsequent to prehearing con-
in order of the Director.
PART 308-[Reserved]
Subparts A-E-[Reserved]
ference.
316.81
Submission and receipt of evidence.
RULES OF PRACTICE AND PROCEDURE FOR
PART 315-ENFORCEMENT OF THE
Subpart F-Public Hearings
316.82
Inspection of documents.
FILING PROPOSALS, PETITIONS, OBJEC-
DRUG ABUSE CONTROL AMEND-
Sec.
316.83
Objections.
TIONS, AND HOLDING PUBLIC HEARINGS
MENTS OF 1965 OF THE FED-
316.48 Purpose of holding public hearings.
316.84
Affidavits.
UNDER SECTION 701 OF THE FEDERAL
RULES OF PRACTICE AND PROCEDURE FOR FILING
316.85
Samples.
ERAL FOOD, DRUG, AND COS-
FOOD, DRUG, AND COSMETIC ACT WITH
PROPOSALS, PETITIONS, OBJECTIONS, AND
316.86 Exceptions to rulings.
METIC ACT
316.87
HOLDING PUBLIC HEARINGS UNDER SECTION
Official notice.
RESPECT TO DRUG ABUSE CONTROL
316.88
701 OF THE FEDERAL FOOD, DRUG, AND Cos-
Offer of proof.
AMENDMENTS OF 1965
Sec.
315.1 General regulation.
METIC ACT WITH RESPECT TO THE DRUG
316.89 Appeal from ruling of presiding
GENERAL INFORMATION
ABUSE CONTROL AMENDMENTS OF 1965
officer.
315.2 Presentation of views under section
§ 316.51 Scope of rules.
305 of the act.
GENERAL INFORMATION
THE RECORD
SOURCE: The provisions of this Part 315
316.51
316.90 Official transcript; indexing of record.
The sections in this Subpart F gov-
Scope of rules.
316.91
Exhibits.
ern the practice and procedures in pro-
appear at 33 F.R. 14836, Oct. 8, 1968, unless
316.52
Definitions.
otherwise noted.
316.92 Record of the hearing.
ceedings and hearings conducted pur-
316.53 Filing; address; hours; papers to be
316.93 Correction of record.
suant to section 701 of the Federal Food,
filed.
§ 315.1 General regulation.
316.94 Record for decision.
Drug, and Cosmetic Act (52 Stat. 1040,
316.54 Inspection of records.
(a) The provisions of regulations pro-
316.55 Information; special instructions.
BRIEFS, REQUESTS FOR FINDINGS, DECISIONS,
et seq., as amended; 21 U.S.C. 301-392).
mulgated under the act with respect to
316.56
Use of gender and number.
EXCEPTIONS, ORAL ARGUMENT; FINAL ORDER
§ 316.52 Definitions.
the doing of any act shall be applicable
316.57 Waiver, suspension, amendment of
316.95 Briefs.
As used in this Subpart F the following
also to the causing of such act to be done.
rules.
316.96 Decisions.
316.97 Tentative order.
terms shall have the meanings specified:
(b) The definitions and interpreta-
APPEARANCE, PRACTICE, AND BURDEN OF PROOF
tions of terms contained in section 201
316.98 Final order.
(a) The term "act" means the Federal
316.58 Appearance.
Food, Drug, and Cosmetic Act.
of the act shall be applicable also to such
JUDICIAL REVIEW
316.59 Authority for representation.
(b) The term "Department" means
terms when used in regulations promul-
316.60
Written appearance.
316.101 Copies of petitions for judicial
the Department of Justice.
gated under the act.
316.61 Practice defined.
review.
(c) The term "Attorney General"
(Sec. 701, 52 Stat. 1055, as amended; 21 U.S.C.
316.62 Conduct at hearings.
JUDICIAL STANDARDS OF PRACTICE
means the Attorney General of the
371; Reorg. Plan No. 1 of 1968, 33 F.R. 5611)
316.63 Burden of proof.
316.102 Conduct.
United States, and any officer, employee
§ 315.2 Presentation of views under sec-
316.64 Form of written appearance.
316.104 Ex parte communications.
or agency of the Department of Justice
tion 305 of the act.
FILING PETITIONS, PUBLICATION OF PROPOSALS
duly authorized by the Attorney General
AND PETITIONS, FILING OBJECTIONS, AND RE-
AUTHORITY: The provisions of this Sub-
(a) Presentation of views under sec-
QUESTS FOR HEARINGS
part F issued under sec. 3(a) (2), 74 Stat.
(directly or indirectly by means of one or
tion 305 of the act shall be private and
374; 15 U.S.C. 1262 and Reorganization Plan
more redelegations of authority) to act
316.65 Procedure for filing petitions.
informal. These views presented shall be
No. 1 of 1968 (33 F.R. 5611).
in his stead.
316.66 Proposals and petitions.
SOURCE: The provisions of this Part 316
(d) The term "Director" means the
confined to matters relevant to the con-
316.67 Objections to the Director's order and
appear at 33 F.R. 14836, Oct. 3, 1968, unless
Director of the Bureau of Narcotics and
templated proceeding. Such views may
requests for hearings.
otherwise noted.
Dangerous Drugs.
322
Reproduced at the Richard Nixon Presidential Library
323
Title 21-Chapter II
Title 21-Chapter II
§ 316.65
§ 316.53
(e) The term "person" includes an
§ 316.56 Use of gender and number.
proceeding or hearing conducted pur-
(A) (Give a specific statement of the in-
individual, partnership, corporation, and
Words importing the singular number
suant to section 701 of the act (21 U.S.C.
terest of the undersigned in the proceed-
371).
ing.)
association.
may extend and be applied to the plural.
(B) (Set forth the specific objection or
(f) The term "presiding officer" means
Words importing the masculine gender
§ 316.62 Conduct at hearings.
issue concerning which the undersigned de-
the Director or a hearing examiner ap-
may be applied to the feminine gender.
sires to be heard.)
Disrespectful, disorderly, or contuma-
pointed as provided in the Administra-
§ 316.57 Waiver, suspension, amend-
cious language or contemptuous conduct,
All notices to be sent pursuant to this ap-
tive Procedure Act (60 Stat. 235; 5 U.S.C.
pearance should be addressed to:
ment of rules.
refusal to comply with directions, con-
1001 et seq.).
The Director or the presiding officer
tinued use of dilatory tactics, or refusal
(Name)
(g) The term "Hearing Clerk" means
the hearing clerk of the Department.
(with respect to matters pending before
to adhere to reasonable standards of
him) may modify or waive any rule in
orderly and ethical conduct at any hear-
(Street address)
(h) The term "FEDERAL REGISTER"
means the publication provided for by
this Subpart F, by announcement at the
ing before the Director or a presiding
the Federal Register Act of July 26, 1935,
hearing or by notice in advance of the
officer, shall constitute grounds for im-
(City and State)
and acts supplementary thereto and
hearing, if he determines that no party
mediate exclusion from the hearing.
(Signature of principal)
will be unduly prejudiced and the ends of
amendatory thereof (44 U.S.C. 301-314).
§ 316.63 Burden of proof.
justice will thereby be served.
(Signature of authorized
(i) The term "proceeding" means any
(a) At any hearing held as provided
counsel or
action taken pursuant to section 701 (e)
APPEARANCE, PRACTICE, AND BURDEN OF
in section 701 of the act, the originator
representative)
(1) of the act for the issuance, amend-
PROOF
of the proposal or petition for the issu-
ment, or repeal of any regulation issued
§ 316.58 Appearance.
ance, amendment, or repeal of any regu-
FILING PETITIONS, PUBLICATION OF PRO-
pursuant to sections 201(v) (2) (C) and
lation contemplated under section 701
POSALS AND PETITIONS, FILING Овлес-
(3), and 502(d).
Any interested person may appear in
(e) (1) of the act, shall be, within the
TIONS AND REQUESTS FOR HEARINGS
(j) The term "hearing" means any
person or by or with counsel or other
meaning of section 7(c) of the Adminis-
§ 316.65 Procedure for filing petitions.
hearing held pursuant to section 701(e)
duly qualified representative in any pro-
trative Procedure Act (5 U.S.C. 1006(c)),
ceeding or hearing and may be heard
(a) Petitions for the issuance, amend-
(3) of the act.
the proponent of the rule or order, and
with respect to matters relevant to the
ment, or repeal of any regulation sub-
(k) Any term not defined in this sec-
accordingly shall have the burden of
tion shall have the definition set forth
issues under consideration.
ject to the provisions of section 701 (e) of
proof.
the act shall be submitted in quintupli-
in section 201 of the act.
§ 316.59 Authority for representation.
(b) Any adversely affected person fil-
cate to the Director. If any part of the
§ 316.53 Filing; address; hours; papers
Any individual acting in a representa-
ing an objection pursuant to section 701
material submitted is in a foreign lan-
to be filed.
tive capacity in any proceeding may be
(e) (2) of the act, which objection pro-
guage it shall be accompanied by an ac-
Documents required or permitted to
required by the Director or the presiding
poses the substitution of a new provision
curate and complete English translation.
be filed in, and correspondence relating
officer to show his authority to act in
for that provision objected to, shall have
The petition shall state the petitioner's
to, proceedings governed by the regula-
such capacity.
the burden of proof in relation to the
mailing address to which a copy of the
new provision so proposed.
notice contemplated by section 701 (e) (2)
tions in this Subpart F shall be filed with
§ 316.60 Written appearance.
of the act may be sent.
the Hearing Clerk, Bureau of Narcotics
Any interested person desiring to ap-
§ 316.64 Form of written appearance.
(b) Petitions shall include the follow-
and Dangerous Drugs, Room 613, 633 In-
pear at any hearing or prehearing con-
DEPARTMENT OF JUSTICE
ing data and be submitted in the fol-
diana Avenue, Washington, D.C. 20537.
ference shall, within the time specified
BUREAU OF NARCOTICS AND DANGEROUS DRUGS
lowing form:
This Office is open Monday through Fri-
in the notice of hearing, file with the
day from 8:30 a.m. to 5 p.m., eastern
presiding officer a written notice of ap-
In the matter of:
(Date)
standard or daylight saving time, which-
pearance as specified in § 316.64 setting
(Identify the matter in which the appear-
forth his name, address, and interest. If
ance is being filed, as set forth in the notice
DIRECTOR BUREAU OF NARCOTICS AND DAN-
ever is effective in the District of Colum-
of hearing.)
GEROUS DRUGS,
bia at the time, except on national legal
any interested person desires to be heard
Docket No.
written appearance.
Post Office Box 2079,
through a representative, such person or
Pursuant to the provisions of § 316.60 of the
South Eads Street Station,
holidays.
such representative shall file with the
regulations governing the procedure in the
Arlington, Va. 22202.
§ 316.54 Inspection of records.
presiding officer a written appearance
referenced matter, please enter the appear-
DEAR SIR: The undersigned
Subject to the provisions of law re-
setting forth the name, address, and em-
ance of the undersigned,
submits this petition pursuant
stricting public disclosure of informa-
ployment of such person. The written
to section 701 (1) (B) of the Federal Food,
tion, all documents filed in the docket in
notice of appearance shall conform to
(Name. Please type
Drug, and Cosmetic Act with respect to the
the form set forth in § 316.64. Any person
or print)
issuance (amendment or repeal) of a regu-
any proceeding may be inspected and
lation under
or representative shall state with par-
(the
copied in the office of the Hearing Clerk.
(Street address)
blank to be filled in with the appropriate
ticularity in the notice of appearance his
section of the Federal Food, Drug, and Cos-
§ 316.55 Information; special instruc-
interest in the proceeding and shall set
(City and State)
metic Act: Sections (v) (2), 502(d)
tions.
forth the objection or issue concerning
appearing in behalf of,
Attached hereto, in quintuplicate and con-
Information regarding procedure un-
which such person desires to be heard.
stituting a part of this petition, are the fol-
(Name)
lowing:
der these rules and instructions supple-
§ 316.61 Practice defined.
(A) The proposed regulation in the form
menting these rules in special instances
(Street address)
proposed by the petitioner.
will be furnished on application to the
Practice before the Director shall com-
(B) A statement of the grounds upon
Hearing Clerk.
prehend all matters connected with any
(City and State)
which the petitioner relies for the issuance
324
325
Reproduced at the Richard Nixon Presidential Library
§ 316.66
Title 21-Chapter II
Title 21-Chapter II
§ 316.73
(amendment or repeal) of the regulation.
(c) As soon as practicable after the
(Such grounds shall include a reasonably
expiration of the time for filing views
of the order that have been stayed by
of hearing, but thereafter it may be
precise statement of the facts relied upon
and comments the Director shall publish
the filing of objections or, if no objec-
moved to a different place and may be
by the petitioner. If it appears that reason-
in the FEDERAL REGISTER his order acting
tions have been filed, stating that fact.
continued from day to day or recessed
able grounds for the action proposed are not
upon such proposal or petition. Except as
to a later day without other notice than
stated in the petition, the petition will be
PUBLIC HEARINGS AND NOTICE THEREOF
provided in § 316.67, this order shall be-
announcement thereof by the presiding
denied.)
come effective at such time as may be
§ 316.68 Hearings under section 701 (e)
officer at the hearing.
(C) If the petition seeks the amendment
specified therein, but not prior to the
of the act.
or repeal of an existing regulation, a refer-
DESIGNATION, POWERS, RESPONSIBILITIES,
ence to the section of Title 21. Chapter II
day following the last day on which ob-
(a) Under the authority delegated to
AND DUTIES OF PRESIDING OFFICER
of the Code of Federal Regulations where
jections may be filed under this section.
him by the Attorney General (28 CFR
it appears.
§ 316.67 Objections to the Director's
0.201), the Director on his own initiative
§ 316.71 Presiding officer.
Very truly yours,
order and requests for hearings.
or upon a petition of any interested per-
A presiding officer shall preside over
son adversely affected stating reasonable
all hearings held pursuant to section 701
(Petitioner)
(a) On or before the 30th day after
ground therefor, shall hold a public hear-
of the act. The presiding officer shall be
Per
the date of the publication of the Direc-
ing for the purpose of receiving evidence
either the Director or a hearing examiner
tor's order in the FEDERAL REGISTER as
(Indicate authority)
relevant and material to the issues raised
qualified under section 11 of the Admin-
Mail address
specified in § 316.66(c), any person who
by objections filed pursuant to § 316.67
istrative Procedure Act and designated
will be adversely affected by such order,
This petition must be signed by the peti-
to any proposal to issue, amend, or re-
by the Director to conduct the hearing.
if placed in effect, may submit objections
tioner or by his attorney or authorized rep-
peal any regulation contemplated by any
thereto to the Director and request a
§ 316.72 Commencement of functions.
resentative, or (if a corporation) by an
of the following sections of the act: Sec-
authorized official.
public hearing on the stated objections.
tions 201(v) (2) (C) and (3), 502(d).
The functions of the presiding officer
All petitions shall be submitted in quin-
(b) These objections shall be accepted
(b) Concurrently, with the action
shall commence upon his designation and
tuplicate. A single copy will not be accepted
for filing only when they comply with
taken pursuant to § 316.67, if a proceed-
terminate upon the certification of the
for filing.
all the following provisions:
(c) The Director shall notify the peti-
(1) Objections shall be received by the
ing is stayed by the filing of objections,
record to the Director.
and a public hearing is requested, the
Hearing Clerk if postmarked on or be-
§ 316.73 Authority of presiding officer.
tioner promptly after its receipt of ac-
Director shall cause to be published in
fore the 30th day after the date of publi-
ceptance or nonacceptance of a petition,
the FEDERAL REGISTER a notice reciting
Hearings shall be conducted in an in-
cation of the Director's order in the
the receipt of objections, those parts of
formal but orderly manner in accordance
and if not accepted the reason therefor.
A petition shall not be accepted for fil-
FEDERAL REGISTER.
the order that have been stayed by the
with this Subpart F and the requirements
ing if any of the data prescribed in para-
(2) Each objection to a provision of
filing of objections, and announcing that
of the Administrative Procedure Act, and
graph (b) of this section are lacking or
the Director's order shall be separately
a public hearing will be held to receive
where such sections or the Administra-
tive Procedure Act are inapplicable or
are not set forth so as to be readily un-
numbered.
evidence on the issues raised by such
derstood. If petitioner desires, he may
(3) Objections must establish that the
objections.
incomplete, in accordance with the direc-
supplement a deficient petition after
objector will be adversely affected by the
tions of the presiding officer. The presid-
notification of deficiency. The proposal
order.
§ 316.69 Notice of hearing.
ing officer shall have the duty to conduct
contained in any petition filed with the
(4) Objections must specify with par-
(a) As soon as practicable after a re-
a fair hearing, to take all necessary ac-
Director for the issuance, amendment, or
ticularity the provisions of the order to
quest for a public hearing has been filed,
tion to avoid delay, and to maintain
repeal of any regulation subject to the
which objection is taken.
the Director shall cause to be published
order. He shall have all powers necessary
provisions of section 701(e) of the act,
(5) Objections must be supported by
in the FEDERAL REGISTER a notice of
to these ends, including (but not limited
and any proposal initiated by the Direc-
reasonable grounds which, if true, are
hearing.
to) the power to:
tor under section 701(e) (1) (A) shall be
adequate to justify the relief sought.
(b) The notice of hearing shall set
(a) Arrange and issue notice of the
published in the FEDERAL REGISTER as
(c) If the statement of objections is not
forth the following information:
date, time, and place of hearings and pre-
provided in § 316.66.
accepted for filing because of failure to
(1) A statement of the provisions of
hearing conferences, and, upon proper
comply with paragraph (b) of this sec-
the order to which objections have been
notice to change the date, time, and
§ 316.66 Proposals and petitions.
tion, the Director shall so inform the ob-
filed, and a summary of the objections.
place of hearings and prehearing confer-
(a) The Director, under the authority
jector and state the reasons for refusing
(2) A statement of the issues raised
ences previously set.
delegated to him by the Attorney Gen-
to file the objections.
by the objections.
(b) Hold conferences to settle, sim-
eral (28 CFR 0.200), on his own initi-
(d) If objections to the Director's or-
(3) The designation of the presiding
plify, or fix the issues in a proceeding,
ative or upon petition filed with him by
der issued pursuant to a petition are filed
or to consider other matters that may
officer to conduct the hearing.
any interested person stating reasonable
by a person other than the petitioner,
aid in the expeditious disposition of the
(4) The place where the hearing will
grounds therefor, shall publish in the
the Bureau of Narcotics and Dangerous
be held.
proceeding.
FEDERAL REGISTER any proposal or peti-
(c) Require parties to state their posi-
Drugs shall mail a copy of the objections
(5) The time within which written
tion to issue, amend, or repeal any regu-
tion with respect to the various issues in
to the petitioner at the address given in
appearances must be filed.
lation contemplated under the following
(6) The time (not earlier than 30
the proceeding.
sections of the act: Sections 201 (v) (2)
the petition. Petitioner shall have 2 weeks
(d) Administer oaths and affirmations.
(C) and (3), and 502(d).
from the date of receipt of the objections
days after the date of publication of the
(e) Regulate the course of the hear-
(b) Such published notice will pro-
to make written reply.
notice of hearing in the FEDERAL REGIS-
TER) when the hearing will commence.
ing and the conduct of counsel therein.
vide for a time period of not less than
(e) As soon as practicable after the
(f) Examine witnesses and direct wit-
30 days within which all interested per-
time for filing objections has expired,
§ 316.70 Time and place of hearing.
the Director shall publish a notice in the
nesses to testify.
sons may present their views and com-
The hearing will commence at the
(g) Receive, rule on, exclude, or limit
ments thereon in writing.
FEDERAL REGISTER specifying those parts
place and time announced in the notice
evidence.
Reproduced at the Richard
Nixon
Presidential
Library
326
327
§ 316.74
Title 21-Chapter II
Title 21-Chapter II
§ 316.85
(h) Fix the time for filing motions,
and shall make an order reciting the
jection thereto is filed with the presiding
(3) The notice of receipt of objections
petitions, briefs, findings, or other items
action taken at the conference, the
officer upon notice to the other parties
in matters pending before him.
within the time specified by the presid-
as published in the FEDERAL REGISTER,
agreements made by the parties or their
described in § 316.67(e).
(i) Rule on motions and other proce-
representatives, the schedule of wit-
ing officer in accordance with this sec-
dural items pending before him.
nesses, and a statement of the issues
tion, except that a party will be permitted
(4) The notice of public hearing as
to challenge such authenticity at a later
published in the FEDERAL REGISTER, de-
(j) Take any action permitted to the
for hearing. Such order shall control the
scribed in § 316.69
presiding officer as authorized by this
subsequent course of the proceeding
time upon a showing of good cause for
Subpart F or in conformance with the
unless modified for good cause by subse-
failure to have filed such written
(5) The prehearing order, if any, as
described in § 316.76.
provisions of the Administrative Proce-
quent order.
objection.
(c) Any witness identification not
(6) Any other document necessary to
dure Act (5 U.S.C. 1001 to 1011)
§ 316.77 Other conferences.
show the basis for the hearing.
submitted at the prehearing conference
PREHEARING AND OTHER CONFERENCES
The presiding officer may also direct
shall be submitted to the presiding offi-
§ 316.82 Inspection of documents.
§ 316.74 Prehearing conference.
all parties and their representatives to
cer as soon as available, with a showing
All documents constituting the record
appear at conferences at any reasonable
that the offering party had good cause
The presiding officer on his own mo-
bearing on the matter or matters in con-
time during the hearing, with a view to
for failing to produce the identification
tion, or on the motion of any party or
troversy, and not entitled to protection
simplification, clarification, or shorten-
at the prehearing conference. If the pre-
his representative, may direct all parties
under section 301(j) of the act, accumu-
ing of the hearing.
siding officer determines that good cause
or their representatives to appear at a
does exist, the identification shall be sub-
lated up to the start of the hearing
specified time and place for a conference
HEARING PROCEDURES
shall be open for inspection by interested
mitted to the parties to the hearing as
for:
persons during office hours in the office
§ 316.78 Statements of position.
soon as possible.
(a) The simplification of the issues.
of the hearing clerk.
(b) The possibility of obtaining stip-
The presiding officer may require par-
§ 316.81 Submission and receipt of evi-
§ 316.83 Objections.
ulations, admission of facts, and
ties to exchange written statements of
dence.
documents.
position, with copies to all other parties,
If any person objects to the admission
prior to the beginning of a hearing. These
(a) Witnesses. The presiding officer
or rejection of any evidence or to other
(c) The possibility of limitation of
may direct that summaries of the direct
statements should include a showing of
limitation of the scope of any examina-
the number of expert witnesses.
testimony of witnesses be prepared in
the theory of the party submitting this
tion or cross-examination, he shall state
(d) The identification, and if prac-
writing and served in advance of the
ticable, the scheduling of witnesses to
statement and will not be subject to
hearing. If so directed, such summaries
briefly the grounds for such objection,
be called.
cross-examination.
and the transcript shall not include
shall be served on all parties, a copy to
extended argument or debate there-
(e) The advance submission at the
§ 316.79 Evidentiary purpose of hearing.
the presiding officer as directed. Wit-
nesses will not be permitted to read sum-
on except as ordered by the presiding
prehearing conference of all documen-
The hearing is directed to receiving
officer. A ruling of the presiding officer
tary evidence in quintuplicate to be
maries of their testimony into the record
marked for identification. (When por-
factual evidence and expert opinion tes-
and all witnesses shall be available for
on any such objection shall be a part of
timony related to the issues, in the pro-
the transcript, together with such offer
tions only of a document are to be relied
cross-examination. Each witness shall,
or proof as has been made.
upon, the offering party shall prepare
ceeding. Argument will not be received
before proceeding to testify, be sworn or
the pertinent excerpts thereof, ade-
into evidence; rather, it should be pre-
make affirmation.
§ 316.84 Affidavits.
quately identified, and shall supply copies
sented in opening or closing statements
(b) Scope of testimony. When neces-
Upon a showing of their relevancy,
of such excerpts together with the origi-
of counsel, memoranda, or briefs, as de-
sary to prevent undue prolongation of
materiality, and competency, affidavits
nal document to the presiding officer for
termined by the presiding officer.
the hearing, the presiding officer may
may be marked as exhibits at the pre-
examination and study by all other par-
limit the number of times any witness
hearing conference. Every interested
ties and for use by opposing counsel for
§ 316.80 Submission of documentary
may testify, the repetitious examination
person shall be permitted to examine all
purpose of cross-examination.)
evidence and identification of wit-
and cross-examination of witnesses, or
affidavits that have been so filed and to
(f) Such other matters as may aid
nesses subsequent to prehearing con-
the amount of corroborative or cumula-
in the expeditious disposition of the
ference.
tive evidence.
file counteraffidavits with the presiding
(a) All documentary evidence not sub-
(c) Evidence. The presiding officer
officer, within a period of time to be fixed
proceeding.
shall admit only evidence that is rele-
by the presiding officer, not more than 15
§ 316.75 Exclusion of witnesses and doc-
mitted at the prehearing conference shall
vant, material, reliable, and not unduly
days following the close of the hearing.
umentary evidence.
be submitted to the presiding officer as
repetitious.
Subject to the provisions of section 7(c)
soon as possible, with a showing that the
The failure to identify witnesses and
(d) Opinion testimony. Opinion testi-
of the Administrative Procedure Act (5
offering party had good cause for failing
submit documentary evidence at the pre-
to produce the documents at the pre-
mony shall be admitted when the pre-
U.S.C. 1006), these affidavits may be ad-
hearing conference in accordance with
siding officer is satisfied that the wit-
mitted into evidence. If so admitted, the
hearing conference. If the presiding offi-
the requirements of § 316.74 of this Sub-
ness is properly qualified.
Director and presiding officer will con-
cer determines that good cause does
part F may result in the testimony or
(e) Documents to be filed. The pre-
sider the lack of opportunity for cross-
exist, the documents shall be submitted
documents not being heard or received
siding officer shall file as exhibits copies
examination in determining the weight
to the parties sufficiently in advance of
in evidence, in the absence of a showing
of the following documents:
to be attached to statements made in the
the offer of such documents for intro-
that the offering party had good cause
(1) The proposal to issue, amend,
form of affidavits.
duction into the record to permit study
for the failure to produce the documents
or repeal a regulation as published
and preparation of cross-examination
in the FEDERAL REGISTER, described in
§ 316.85 Samples.
or identify the witnesses.
and rebuttal evidence.
§ 316.66(a).
Samples may be displayed at the hear-
§ 316.76 Prehearing order.
(b) The authenticity of all published
(2) The order of the Director as pub-
The presiding officer may have the pre-
documents submitted in advance shall
lished in the FEDERAL REGISTER, described
ing and may be described for purposes
in § 316.66(c).
of the record, but shall not be admitted
hearing conference reported verbatim
be deemed admitted unless written ob-
in evidence as exhibits.
Reproduced at the Richard
Nixon Presidential Library
328
329
§ 316.86
Title 21-Chapter II
Title 21-Chapter II
§ 316,102
§ 316.86 Exceptions to rulings.
any part thereof shall be entitled to the
same upon application to the official re-
ing any exhibits, together with any
ings of fact and conclusions upon which
Exceptions to rulings of the presiding
written arguments, briefs, or memo-
it is based.
officer are unnecessary. It is sufficient
porter and upon payment of the costs
randa of law filed with the presiding
thereof.
(b) The tentative order shall specify
that a party, at the time the ruling of
officer. As soon as practicable after the
(b) Indexing of record. (1) Whenever
a reasonable time (ordinarily not to
the presiding officer is sought, makes
close of the hearing, the complete record
it appears to the presiding officer that
exceed 60 days), within which any party
known the action that he desires the
of the hearing shall be filed in the office
the record of hearing will be of such
of record may file exceptions to the pro-
presiding officer to take, or his objection
length that an index to the record will
of the hearing clerk.
posed order. The exceptions shall point
to an action taken, and his grounds
permit a more orderly presentation of
§ 316.93 Correction of record.
out with particularity the alleged errors
therefor.
the evidence and reduce delay, the presid-
in said order and shall contain a specific
At the close of the hearing, the presid-
§ 316.87 Official notice.
ing officer shall require counsel for the
reference to the pages of the transcript
ing officer shall afford witnesses and
Where official notice is taken or is
parties to prepare a daily topical index
of the testimony or to exhibits on which
their counsel time (not longer than 30
to be taken of a material fact not ap-
which will be available to the presiding
exceptions are based. Such exceptions
days, except in unusual cases) in which
pearing in the evidence of record, any
officer and all parties. Preparation of
may be accompanied by a memorandum
to submit written proposed corrections
such an index shall be apportioned
or brief in support thereof and if oral
party, on timely request, shall be af-
of the transcript, pointing out errors
forded opportunity to show the contrary.
among all counsel present in such man-
argument on the exceptions is desired,
that may have been made in transcrib-
such a request shall be made with the
ner as appears just and proper in the
ing the testimony. The presiding officer
§ 316.88 Offer of proof.
exceptions. The Director will grant or
circumstances.
shall promptly thereafter order such
(2) The index should include each
deny oral argument in his discretion.
An offer of proof made in connection
corrections made as in his judgment are
with an objection taken to any ruling of
topic of testimony upon which evidence
required to make the transcript conform
§ 316.98 Final order.
the presiding officer rejecting or exclud-
is taken, the name of each witness testi-
to the testimony.
As soon as practicable after the time
ing proffered oral testimony shall con-
fying upon the topic, the page of the
§ 316.94 Record for decision.
for filing exceptions has passed, the
sist of a statement of the substance of
record at which each portion of his testi-
Director shall cause to be published in
the evidence which counsel contends
mony appeared, and the number of each
The transcript of testimony and ex-
the FEDERAL REGISTER his final order in
would be adduced by such testimony;
exhibit relating to the topic. The in-
hibits together with any written argu-
the proceeding, which shall set forth
and, if the excluded evidence consists
dex should also contain the name of each
ments that may have been filed in the
detailed findings of fact and conclusions
of evidence in documentary or written
witness, followed by the topics upon
proceeding, including rulings, shall con-
upon which the order is based. This order
form, a copy of such evidence shall be
which he testified and the page of the
stitute the exclusive record for decision.
shall specify the date on which it shall
marked for identification and shall ac-
record at which such testimony appears.
BRIEFS, REQUESTS FOR FINDINGS, DECISIONS,
take effect. (Sec. 701(e) (3), Federal
company the record as the offer of proof.
§ 316.91 Exhibits.
EXCEPTIONS, ORAL ARGUMENT: FINAL
Food, Drug, and Cosmetic Act.)
§ 316.89 Appeal from ruling of presid-
All written statements, charts, tabu-
ORDER
JUDICIAL REVIEW
ing officer.
lations, reports, documents, and similar
§ 316.95 Briefs.
§ 316.101 Copies of petitions for judi-
Rulings of the presiding officer may
data offered in evidence at the hearing
The time for filing briefs and reply
cial review.
not be appealed to the Director prior to
shall be marked for identification, and
upon a showing satisfactory to the pre-
briefs (if permitted) with the presiding
The Chief Counsel, Bureau of Nar-
his consideration of the entire proceed-
siding officer of the authenticity, rele-
officer shall be fixed by him. The person
cotics and Dangerous Drugs, Department
ing, except with the consent of the pre-
siding officer and where he certifies on
vancy, materiality, and reliability, shall
submitting a brief shall file five copies
of Justice has been designated as the
the record or in writing that the allow-
be received in evidence, subject to sec-
with the hearing clerk. Briefs shall in-
officer upon whom copies of petitions for
ance of an interlocutory appeal is clearly
tion 7(c) of the Administrative Proce-
clude a statement of position on each
judicial review, filed pursuant to section
necessary to prevent exceptional delay,
dure Act (5 U.S.C. 1006(c)) Exhibits
issue as supported by the evidence of
(f) (1) of the act, shall be served.
expense, or prejudice to any party or
shall be submitted in quintuplicate. In
record, together with specific and com-
Such officer shall be responsible for filing
substantial detriment to the public inter-
case the required number of copies are
plete citations of the pages of the tran-
in the court the record of the proceedings
est. If an appeal is allowed, any party
not made available, the presiding officer
on which the final order is based. The
script and exhibits, together with cita-
shall exercise his discretion in determin-
record of the proceeding shall be certified
may file a brief with the Director within
such period that the presiding officer
ing whether the exhibit will be read in
tions of authorities relied upon. Briefs
by the Director.
shall contain proposed findings of fact
directs. No oral argument will be heard
evidence or whether additional copies
unless the Director directs otherwise.
will be required to be submitted within
and conclusions of law when requested
JUDICIAL STANDARDS OF PRACTICE
a time to be specified by the presiding
by the presiding officer.
§ 316.102 Conduct.
THE RECORD
officer. Where relevant and material
§ 316.96 Decisions.
Parties and their representatives ap-
§ 316.90 Official transcript; indexing of
matter offered into evidence is embraced
pearing in hearings held pursuant to
As soon as practicable after the time
record.
in a report or document containing im-
section 701 of the act, whether or not
(a) Official transcript. Testimony
material and irrelevant matter, such
for filing of briefs has expired, the pre-
members of the bar, are expected to con-
given at a public hearing shall be re-
immaterial and irrelevant matter will
siding officer shall prepare a report and
duct themselves with honor and dignity
shall certify the record together with his
ported verbatim. The Department will
be excluded and will be segregated inso-
and observe judicial standards of prac-
report to the Director.
tice and ethics. They should not indulge
make provision for a stenographic record
far as practicable, subject to the direction
of the testimony and for such copies of
of the presiding officer.
§ 316.97 Tentative order.
in offensive personalities, unseemly
wrangling, or intemperate accusations or
the transcript thereof as it requires for
§ 316.92 Record of the hearing.
(a) As soon as practicable thereafter
characterizations. A representative of
its own purposes. Any person desiring a
the Director shall prepare and cause to
copy of the transcript of the testimony
The record of the hearing will include
any party should use his best efforts to
be published in the FEDERAL REGISTER his
and exhibits taken at the hearing or of
the transcript of the testimony, includ-
restrain his client from improprieties in
tentative order, including detailed find-
connection with proceeding.
330
Reproduced at the Richard Nixon Presidential Library
331
Title 21-Chapter Il
§ 320.1
Title 21-Chapter Il
§ 316.104
PARENT SUBSTANCE-BARBITURIC Acm-Continued
§ 316.104 Ex parte communications.
PART 319-HABIT-FORMING DRUGS
§ 319.1 Habit-forming drugs which are
Common or official name of
Some trade or other names
If any official of the Bureau of Nar-
chemical derivatives of barbituric
Chemical description of derivative
chemical derivative or its salts
of chemical derivative or
cotics and Dangerous Drugs is contacted
its salts 1
acid, a substance specified in section
by any individual in private or public
502(d) of the Federal Food, Drug,
life concerning any matter which is the
5-Ethyl-5-(1-methyl-1-butenyl)-barbituric acid
Vinbarbital
Delvinal Sodium.
and Cosmetic Act.
5-Ethyl-5-phenylbarbituric acid
Phenobarbita
Barbenyl.
subject of a public hearing, the official
Phenobarbit,one.
Barbiphenyl.
Each of the following substances is a
Phenylethyl'malonylurea.
Dormiral.
who is contacted shall prepare a memo-
derivative of barbituric acid, a chemical
Euneryl.
randum setting forth the substance of
Gardenal.
derivative of a substance named in sec-
Luminal.
the conversation and shall file this
tion 502(d) of the Federal Food, Drug,
Nunol.
and Cosmetic Act is hereby designated
Neurobarb.
memorandum in the appropriate public
Phenonyl.
as habit-forming:
Somonal.
docket file.
5-Ethyl-5-phenyl-1-methylbarbituric acid
Mephorbarbital
Mebaral.
Phemitone.
PARENT SUBSTANCE-BARBITURIC ACID
Prominal.
5-Ethy 1-5-(1-piperidyl)-barbituric acid
Eldoral.
Common or official name of
Some trade or other names
5-Isopropyl-5-(2-bromoallyl)-barbituric acid
Propallylonal
Noctal.
chemical derivative or its salts
of chemical derivative or
Nostal.
Chemical description of derivative
its salts
5-Methyl-5-phenylbarbituric acid
Phenylmethylbarbituric acid
Rutonal.
All lithium, sodium, potassium, magnesium,
calcium, strontium, and ammonium salts of
Cyclopal.
the foregoing chemical derivatives of barbituric
5-Allyl-5-cyclopentenylbarbituric acid
Cyclopen.
acid.
Allylbarbituric acid
Sandoptal.
Sodium-5-allyl-5-(1-methylbutyl)-barbiturate
Secobarbital sodium
Seconal Sodium.
5-Allyl-5-isobutylbarbituricacid
Allylisobutylbarbituric acid.
Soluble secobarbital.
Evronal Sodium
Aprobarbital
Alurate.
All salts of the foregoing chemical derivatives
5-Allyl-5-isopropylbarbituric acid
Allylisopropylbarbituric acid.
Numal.
formed by replacing the sodium with lithium,
Allylisopropylmalonylurea.
potassium, magnesium, calcium, strontium, or
Narconumal.
ammonium radical.
5-Allyl5-isopropyl-1-methylbarbituricacid
Eunarcon.
5-(2-Bromoall)-5-ispropyl-1-methylbarbituric
ß-Bromoallyl sec-amylbarbituric
Sigmodal.
This list of trade or other names is not a complete list of the many proprietary names under which the desig-
Rectidon.
acid.
nated habit-forming chemical derivatives are distributed.
acid.
R239.
Butallylonal
Pernoston.
(Sec. 502, 52 Stat. 1050, as amended; 21 U.S.C. 352) [33 F.R. 14841, Oct. 3, 1968]
5-sec-Butyl-5-(2-bromoalyl)-barbituricacid
Pernocton.
Diallyl barbituric acid
Dial.
5,5-Diallylbarbituric acid
Allobarbital.
Allobarbitone.
PART 320-DEPRESSANT AND STIM-
Sec.
320.19
Advisory committees; appointment;
Curral.
ULANT DRUGS; DEFINITIONS, PRO-
Diadol.
procedure; fees.
Deba.
CEDURAL AND INTERPRETATIVE
320.20
Exportation.
Barbital
5,5-Diethylbarbituric acid
Dormonal.
Barbitone.
REGULATIONS
AUTHORITY: The provisions of this Part
Diethylbarbituric acid.
Hypnogene.
Diethylmalonylurea.
Malonal.
320 issued under secs. 201(v), 511, 701, 52
Medinal.
Sec.
Stat. 1055, as amended, 79 Stat. 227 et seq.;
Sedeval.
320.1
Definitions and interpretations.
21 U.S.C. 321 (v), 360a, 371, and Reorg. Plan
Veronal.
320.2
Criteria applicable to terms used or
Uronal.
No. 1 of 1968 (33 F.R. 5611).
defined in § 320.1.
Vesperal.
acid
Hexobarbital
sodium
Cyclonal Sodium.
320.3
Listing of drugs defined in section
SOURCE: The provisions of this Part 320
1,5-Dimethyl-5-(1-cyclohexenyl)-barbituric
Dorico Soluble.
201 (v) of the act.
appear at 33 F.R. 14842, Oct. 3, 1968, unless
Evipal Sodium.
320.4
Procedure for the issuance, amend-
otherwise noted.
Evipan Sodium.
ment, or repeal of regulations de-
Hexanastab.
§ 320.1 Definitions and interpretations.
Hexobarbitone Sodium.
fining substances as habit form-
Methenexyl Sodium.
ing or has having a potential for
(a) The term "act" means the Federal
Dipropylbarbituric acid
Proponal.
abuse.
Food, Drug, and Cosmetic Act approved
5,5-Dipropylbarbituric acid
5-Ethyl-5-butylbarbituric acid
Butethal
Etoval.
Neonal Butobarbital.
320.5
Substances exempt from the defini-
June 25, 1938 (52 Stat. 1040 et seq., as
Butobarbital.
Soncryl.
tion of depressant or stimulant
amended; 21 U.S.C. 301-392).
Butabarbital sodium
Butisol Sodium.
drug.
(b) "Department" means the Depart-
5-Ethyl-5-sec-butylbarbituric ac id
Cyclobarbital
Cyclobarbitone.
320.6
Registration of producers and cer-
5-Ethyl-5-(1-cyclohexenyl)-barb ituric acid
Namuron.
ment of Justice.
Palinum.
tain wholesalers of depressant or
(c) "Attorney General" means the At-
Phanodorm.
stimulant drugs.
Phanodorn.
320.7
Procedures for exempting depressant
torney General of the United States, and
Tetrahydrophenobarbital.
or stimulant drugs from the pro-
any officer, employee or agency of the
Pentenal.
5-Ethyl-5-cyclopentenyl-barbituric acid
Hebaral.
visions of section 511 of the act.
Department of Justice duly authorized
5-Ethyl-5-hexylbarituric acid
Hexethal sodium
Ortal Sodium
320.8
Combination drugs; exemptions
by the Attorney General (directly or in-
Amobarbital
Amytal.
from section 511 of the act.
directly by means of one or more redele-
5-Ethyl-5-isoamylbarbituric acid
Probarbital
Ipral.
5-Ethyl-5-isopropylbarituric acid
Pentobarbital sodium
844.
320.16
Records required to be maintained
gations of authority) to act in his stead.
5-Ethy15-(1-methylbutyl)-barbituric acid
Soluble pentobarbital.
Embutal.
under section 511(d) of the act.
(d) "Director" means the Director of
Nembutal.
320.17
Napethal.
Persons required to establish, pre-
the Bureau of Narcotics and Dangerous
Pentyl.
pare, and maintain records speci-
Drugs.
5-Ethyl-5-(1-methylbutyl)-2thiobarbituric acid.
Thiopental sodium
Intraval Sodium.
Nesdonal Sodium.
fied in section 511(d) (1) of the
(e) "Person" includes individuals,
Thiopentone sodium.
Pentothal Sodium.
act.
partnerships, corporations, and associa-
Thiothal Sodium:
320.18
Label symbol.
tions.
Reproduced at the Richard Nixon Presidential Library
333
332
§ 320.2
Title 21-Chapter II
Title 21-Chapter II
§ 320.3
(f) The Bureau of Narcotics and Dan-
lant drug to any person who is not the
(2) Euphoria (exaggerated sense of
safety of other individuals or of the
gerous Drugs is the organizational unit
ultimate user or consumer of the drug.
well-being).
community; or
established within the Department of
Wholesalers include jobbers and medical
(3) Personality changes.
(2) There is significant diversion of
Justice charged with the administration
supply houses who may not be required to
(4) Transient psychoses, deliria, twi-
the drug or drugs containing such a
of the Drug Abuse Control Amendments
obtain licenses as drug wholesalers un-
light state, or hallucinoses.
substance from legitimate drug channels;
of 1965 (Public Law 89-74, 79 Stat. 226
der some state laws.
(5) Chronic brain syndrome.
or
et seq.).
(j) The term "controlled substance"
(6) Increased tolerance or a need or
(3) Individuals are taking the drug or
(g) The term "depressant or stimu-
means those drugs or substances desig-
desire to increase the drug dosage.
drugs containing such a substance on
lant drug" means any drug which con-
nated under section 201(v) of the act
(7) Physical dependence or a psychic
their own initiative rather than on the
tains any quantity of:
and the regulations thereunder as sub-
dependence evidenced by a desire to con-
basis of medical advice from a practi-
(1) Barbituric acid or any of the salts
ject to the Drug Abuse Control Amend-
tinue taking the drug for the sense of
tioner licensed by law to administer such
of barbituric acid.
ments of 1965 (Public Law 89-74, 79 Stat.
improved well-being that it engenders.
drugs in the course of his professional
(2) Any derivative of barbituric acid
226 et seq.), and includes such substances
(8) Pharmacological activity similar
practice; or
which has been designated by the Direc-
in bulk, in finished form, semiprocessed
or identical to that of drugs previously
(4) The drug or drugs containing such
tor under section 502(d) of the act as
form, in finished packages, and prepara-
designated as habit forming.
a substance are new drugs so related in
tions containing any amounts of such
habit-forming.
(d) In determining whether a drug
their action to a drug or drugs already
(3) Amphetamine or any of its optical
substance.
has a "hallucinogenic effect", the Direc-
listed as having a potential for abuse to
§ 320.2 Criteria applicable to terms used
tor will consider, among other relevant
make it likely that the drug will have the
isomers.
or defined in § 320.1.
factors, whether there is substantial evi-
(4) Any salt of amphetamine or any
same potentiality for abuse as such drugs,
dence that it may produce hallucina-
salt of an optical isomer of amphetamine.
thus making it reasonable to assume that
(a) In determining whether a drug
tions, illusions, delusions, or alteration
there may be significant diversions from
(5) Any substance which the Director,
has a "stimulant effect" on the central
of any of the following:
legitimate channels, significant use con-
after investigation, has found to be, and
nervous system, the Director will con-
(1) Orientation with respect to time
trary to or without medical advice, or
by regulation designated as, habit-form-
sider, among other relevant factors,
or place.
that it has a substantial capability of
ing because of its stimulant effect on the
whether there is substantial evidence
(2) Consciousness, as evidenced by
creating hazards to the health of the
central nervous system.
that the drug may produce any of the
confused states, dreamlike revivals of
user or to the safety of the community.
(6) Any substance which the Direc-
following:
past traumatic events, or childhood
tor, after investigation, has found to
(1) Extended wakefulness.
memories.
§ 320.3 Listing of drugs defined in sec-
have, and by regulation designates as
(2) Elation, exhilaration, or euphoria
(3) Sensory perception, as evidenced
tion 201 (v) of the act.
having, a potential for abuse because of
(exaggerated sense of well-being).
by visual illusions, synesthesia, distor-
(a) The Director designates all drugs,
its depressant or stimulant effect on the
(3) Alleviation of fatigue.
tion of space and perspective.
unless exempted by regulations in this
central nervous system or its hallucino-
(4) Insomnia, irritability, or agitation.
(4) Motor coordination.
part, containing any amount of the fol-
genic effect.
(5) Apprehension or anxiety.
(5) Mood and affectivity, as evidenced
lowing substances as depressant or stim-
(h) The terms "manufacture, com-
(6) Flight of ideas, loquacity, hypo-
by anxiety, euphoria, hypomania, ec-
ulant drugs:
pounding, or processing of a drug",
"manufacturing, compounding, or proc-
mania, or transient deliria.
stasy, autistic withdrawal.
(1) Barbituric acid or any salt of
(6) Ideation, as evidenced by flight of
barbituric acid.
essing of a depressant or stimulant
(b) In determining whether a drug
has a "depressant effect" on the central
ideas, ideas of reference, impairment of
(2) Derivatives of barbituric acid
drugs", and "manufacture, compound, or
nervous system, the Director will con-
concentration and intelligence.
which have been designated in § 319.1
process any depressant or stimulant
sider, among other relevant factors,
(7) Personality, as evidenced by de-
of this chapter as habit forming pursu-
drug" as used in sections 301 (q) (1), 304
whether there is substantial evidence
personalization and derealization, im-
ant to section 502(d) of the act.
(a) (2) (D), and 511(a) of the act mean
that the drug may produce any of the
pairment of conscience and of acquired
(3) Dextroamphetamine, levoamphe-
the manufacture, preparation, propaga-
social and cultural customs.
tamine, or amphetamine (racemic) or
tion, compounding, or processing of a
following:
(e) The Director may determine that
any salt of dextroamphetamine, levo-
drug by chemical, physical, biological, or
(1) Calming effect or relief of emo-
a subtance has a potential for abuse
amphetamine, or amphetamine (race-
by any other means, including manipula-
tional tension or anxiety.
because of its depressant or stimulant
mic). Amphetamine is known chemi-
tion, sampling, testing, or control pro-
(2) Drowsiness, sedation, sleep, stupor,
effect on the central nervous system or
cally as d-, 1- or dl-α-methylphenethyla-
cedures applied to the final product or to
coma, or general anesthesia.
its hallucinogenic effect if:
mine. It has been declared by such desig-
any part of the process. The terms in-
(3) Increase of pain threshold.
(1) There is evidence that individuals
nations as d-amphetamine, l-ampheta-
clude labeling, relabeling, repackaging, or
(4) Mood depression or apathy.
are taking the drug or drugs containing
mine, or dl-amphetamine followed by
otherwise changing the container, wrap-
(5) Disorientation, confusion, or loss
such a substance in amounts sufficient to
the name of the salt. The following is a
per, or labeling of any drug package in
of mental acuity.
create a hazard to their health or to the
partial list of amphetamine products:
furtherance of the distribution of the
(c) In determining whether a drug
drug from the original place of manu-
is "habit forming", the Director will con-
facture to the person who makes final
sider, among other relevant factors,
Established name or other non-
delivery or sale to the ultimate consumer.
whether there is substantial evidence
proprietary designation
Some trade or other names
(i) The term "wholesaling, jobbing, or
that the drug may produce any of the
Amphetamine phosphate
Actemin, Aktedron, Amphate, Biphetamine, Dieta-
distributing of depressant or stimulant
following:
mine, Monophos, Profetamine Phosphate, Race-
(1) A psychological or physical de-
phen, Raphetamine Phosphate.
drugs" covers any system of selling or
pendence on the drug (compulsive use).
Amphetamine salts or optical isomers
distributing of any depressant or stimu-
of amphetamine salts.
334
Reproduced at the Richard Nixon Presidential Library
335
Title 21-Chapter II
§ 320.4
§ 320.3
Title 21-Chapter II
Established
Some trade and other
A ⁸ tetrahydrocannabinol, and its optical
name
names
isomers.
Established name or other non-
proprietary designation
Some trade or other names
Methylphenidate
Methyl a-Phenyl-2-pi-
(Since nomenclature of these substances is
and its salts.
peridine acetate; a-
Amphetamine sulfate
Alentol, Amphoids-S, Benzedrine Sulfate, Linamph-
not internationally standardized, compounds
Phenyl-2-piperidine
of these structures, regardless of numerical
eta, Psychoton, Simpamina, Amphedrine Sulfate.
acetic acid methyl-
designation of atomic positions are covered.)
Dextroamphetamine carboxymethyl-
ester; a-Phenyl-a-(2-
cellulose salt.
piperidyl) acetic acid
The listing of peyote in this subpara-
Dextroamphetamine hydrochloride.
methyl ester; Methyl
graph does not apply to nondrug use in
Dextroamphetamine phosphate
Dextro-Profetamine.
a-Phenyl-a-(2-piper-
bona fide religious ceremonies of the
Dextroamphetamine sulfate
Adrizine, Am-Dex, D-Amfetasul, Amitrene, Amphe-
idyl) acetate; Methyl-
Native American Church; however, per-
phenidyl
Acetate;
drine, Ampherex, Amphex, Amsustain, D-Ate Ph.
747, Betafedrina, d-Betaphedrine, Cendex Cenules,
Ritalin (R) hydro-
sons supplying the product to the Church
chloride;
Ritalin;
are required to register and maintain
D-Citramine, Cradex, Dadex, D.A.S., Dexalone,
Phenidylate; 4311/b;
appropriate records of receipts and dis-
Dexamphetamine, Dexedrine, Dex-OB, Dex-Sule,
Centedrin; c 43-IIC:
bursements of the article.
Dexten, Dextrosule, Diocurb, Domafate, Evrodex,
Meridil.
[33 F.R. 14842, Oct. 3, 1968, as amended at
Hetamine, Lowedex, Maxiton, Medex, Nilox, Obe-
34 F.R. 4888, 4889, Mar. 6, 1969; 34 F.R. 15295,
sedrin, Obesonil, Pellcaps, Pomadex, Simpamina-
(3) Hallucinogenic effect:
Oct. 1, 1969]
D, Sympamin, Tydex, Zamitam Plateau.
Some trade and
Dextroamphetamine tannate
Tamphetamin, Synatan.
NOTE: The provisions of § 320.3(c) as they
Established name
other names
Dibasic amphetamine phosphate
Bar-Dex.
apply to any drug because it contains any
Dibasic dextroamphetamine phos-
Bufotenine and its
3-($-Dimethylamino-
amount of chlordiazepoxide or its salts, or
salts.
ethyl)-5-hydroxyin-
diazepam were stayed, 31 F.R. 7174, May 17,
phate.
dole; 3-(2-dimethyl-
1966. Meprobamate was similarily stayed, 33
Levoamphetamine
Ad-Nil, Amphedrine-M, Lavabo, Levamphetamine,
aminoethyl) -5-in-
F.R. 3635, Mar. 1, 1968.
Levonor.
dolol; N,N-dimethyl-
Levoamphetamine succinate
Cydril.
serotonin; 5-hydroxy-
§ 320.4 Procedure for the issuance,
N-dimethyltrypta-
amendment, or repeal of regulations
mine; mappine.
defining substances as habit forming
DET and its salts
N,N-Diethyltryptamine.
or as having a potential for abuse.
(b) The Director has investigated and
Established name
DMT
Dimethyltryptamine.
designates all drugs, unless exempted by
or other
4-Methyl-2,5-dimeth-
(a) Under the provisions of section
DOM (STP)
nonproprietary
Some trade and other
oxyamphetamine; 4-
201 (v) (2) and (3) of the act, the Di-
regulations in this part, containing any
designation
names
methyl-2,5-dimeth-
rector, under authority delegated to him
amount of the following substances as
Lysergic acid.
oxy- α -methylphen-
by the Attorney General (28 CFR 0.200),
having potential for abuse and habit-
Lysergic acid
ethylamine and
is authorized to conduct investigations
forming because of their stimulant effect
amide.
"STP".
and promulgate regulations for the pur-
Meprobamate
Apascil, Atraxin, Bioba-
on the central nervous system:
Ibogaine and its
7-Ethyl-6,6a,7,8,9,10,
mat, Calmiren, Cir-
pose of:
salts.
12,13-octahydro-2-
Some trade and other
pon, Cyrpon, Ecuanil,
methoxy-6,9-meth-
(1) Designating any drug containing
Established name
names
Equanil, Equanil LA,
ano-5H-pyrido (1',
any quantity of any substance as habit
d-, dl Metham-
d-, dl-Desoxyephedrine
Harmonin, Mepantin,
2':1,2 azepino (4,5-
forming because of its stimulant effect
phetamine a n d
and their salts.
Mepavlon, Meproleaf,
b) indole; taber-
on the central nervous system; or
their salts.
Meprosin, Meprospan,
nanthe iboga.
(2) Designating any drug containing
Phenmetrazine and
Preludin.
Meprotabs, Miltown,
LSD-25; LSD
d-Lysergic acid diethyl-
Nervonus, Neura-
any quantity of any substance as having
its salts.
amide.
mate, Oasil, Pameco,
a potential for abuse because of its de-
Mescaline and its
(c) The Director has investigated and
Panediol, Perequil,
pressant or stimulant effect on the cen-
salts.
designates all drugs, unless exempted by
Perquietil, Pertran-
tral nervous system or its hallucinogenic
Peyote.
quil, Placidon, Pro-
regulations in this part, containing any
Phencyclidine and
1-(1-Phenylcyclohexyl)
effect.
bamyl, Quanil, Qui-
amount of the following substances as
its salts.
Piperidine; Sernyl;
(b) Proceedings for the issuance,
late, Sedabamate, Se-
Sernylan;
GP-121;
amendment, or repeal of regulations is-
having a potential for abuse because of
dazil, Urbil, Vioba-
CI-395; PCP: "Peace
mate.
sued pursuant to section 201(v) of the
their:
Pill."
(1) Depressant effect on the central
Methyprylon
Noludar.
act are subject to the public procedures
Psilocybin; psilo-
Paraldehyde
provided in section 701(e) of the act and
nervous system:
cibin.
Petrichloral
Periclor.
the provisions for judicial review set
Psilocyn; psilocin.
Established name
Phencyclidine
1- 1-Phenycyclohexy
forth in sections 701 (f) and (g).
or other
and its salts.
Piperidine; Sernyl;
Synthetic equivalents of the substances
(c) The procedures to be followed for
nonproprietary
Some trade and other
Sernylan; GP-121;
contained in the plant, or in the resinous
filing petitions requesting the issuance,
designation
names
CI-395; PCP; "Peace
extractives of Cannabis, sp. and/or synthetic
amendment, or repeal of any regulation
Chloral betaine
Beta-Chlor.
Pill."
substances, derivatives, and their isomers
provided for in section 201 (v) (2) and
Chloral hydrate
Chloral.
Sulfondiethyl-
Tetronal.
with similar chemical structure and pharma-
(3) of the act, publication of proposals
Chlordiazepoxide
Librium.
methane.
cological activity such as the following:
in the FEDERAL REGISTER, comments
and its salts.
Sulfonethylmeth-
Trional.
41 cis or trans tetrahydrocannabinol, and
thereon, publication of orders, filing ob-
Chlorhexadol
Lora.
ane.
their optical isomers.
jections, requests for a public hearing,
Diazepam
Valium.
Sulfonmethane
Sulfonal.
2 cis or trans tetrahydrocannabinol, and
procedures governing public hearings,
Ethchlorvynol
Placidyl.
(2) Stimulant effect on the central
their optical isomers.
proposed orders, exceptions, final orders,
Ethinamate
Valmid.
Glutethimide
Doriden.
nervous system:
337
Reproduced at the Richard Nixon Presidential Library
336
§ 320.5
Title 21-Chapter II
Title 21-Chapter II
§ 320.8
and judicial review are set forth in Part
by any interested person. Any interested
EXEMPTED OVER-THE-COUNTER DRUGS-Continued
316 of this chapter.
person may file a petition seeking such
exemption, stating reasonable grounds
Trade name or other
Composition
§ 320.5 Substances exempt from the
therefor. Upon receipt of such a petition,
designation
Manufacturer or supplier
definition of depressant or stimulant
drug.
or on his own initiative at any time, the
Primatene
Director will publish a notice of proposed
Tablet: Phenobarbital, 1/8 gr.; ephedrine, 3/8 gr
Tedral
Whitehall Laboratories.
Any substance now included or which
Tablet: Phenobarbital, 8 mg.; theophylline, 130
rulemaking and invite written comments.
Warner-Chilcott Laboratories.
mg.; ephedrine hydrochloride, 24 mg.
may be hereafter included within the
After consideration of all available data,
Tedral Anti-H
Tablet: Phenobarbital, 8 mg.; chlorpheniramine
Do.
classification stated in section 4731 of
including any comments submitted, the
moleate, 2 mg.; theophylline, 130 mg.; ephedrine
hydrochloride, 24 mg.
the Internal Revenue Code of 1954 (26
Director may issue a regulation granting
Tedral one-half Strength
Tablet: Phenobarbital, 4mg.; theophylline, 65 mg.;
Do.
U.S.C. 4731) and marihuana as defined
or refusing the exemption effective on a
ephedrine hydrochloride, 12 mg.
in section 4761 of the Internal Revenue
Tedra 1 Pediatric Suspension
Suspension (5 cc): Phenobarbital, 4 mg.; ephe-
Do.
date specified therein. Whenever the Di-
drine hydrochloride, 12 mg.; theophylline, 65 mg.
Code of 1954 (26 U.S.C. 4761) is not a
rector concludes, either at the time of
Tedral suppositories double
Suppository :Phenobarbital, 16 mg.; theophylline,
Do.
depressant or stimulant drug as defined
strength.
publication of the notice of proposed
260 mg.; ephedrine hydrochloride, 48 mg.
Tedral suppositories regular
Suppository: Phenobarbital, 8 mg.; theophylline,
Do.
in this part.
rulemaking or after considering the writ-
strength.
130 mg.; ephedrine hydrochloride, 24 mg.
Verequad
ten comments submitted, that granting
Tablet: Phenobarbital, 8 mg.; theophylline cal-
Knoll Pharmaceutical Co.
§ 320.6 Registration of producers and
cium salicylate, 130 mg.; ephedrine hydro-
certain wholesalers of depressant or
or refusing the exemption requires a
chloride, 24 mg.; glyceryl guaiacolate, 100 mg.
more thorough development of the facts
Verequad
stimulant drugs.
Suspension (5 cc): Phenobarbital, 4 mg.; theophyl-
Do.
line calcium salicylate, 65 mg.; ephedrine hydro-
than is possible in a written presentation,
Section 510 of the act requires every
chloride, 12 mg.; glyceryl guaiacolate, 50 mg.
he may call a public hearing for that pur-
person who owns or operates any estab-
pose. When such a public hearing is
lishment in any State engaged in the
(b) The following drugs in unit dosage
called, the procedural regulations for
which are restricted by law to dispensing
manufacture, preparation, propagation,
form, and any other drug of the quanti-
on prescription, are exempt from the re-
public hearings contained in Part 316 of
compounding, processing, wholesaling,
tative composition shown below for one
this chapter shall apply. If the Director
quirements of section 511 (c) and (e)
jobbing, selling, or distributing of any
of the following drugs or which is the
and the recordkeeping requirements of
for good cause finds; and incorporates
depressant or stimulant drug to register
same except that it contains a lesser
section 511(d) (1) of the act:
the finding and a brief statement of the
with the Commissioner of Food and
quantity of controlled substances, and
Drugs his name, place of business, and
reasons therefor in an order, that notice
and public procedure thereon are imprac-
EXEMPTED PRESCRIPTION DRUGS
all such establishments. The procedure
ticable, unnecessary, or contrary to the
for registration is prescribed in Part 132
public interest, he may issue the final
Trade name or other
Composition
Manufacturer or supplier
of Title 21, Chapter I.
designation
regulation forthwith.
§ 320.7 Procedures for exempting de-
§ 320.8 Combination drugs; exemptions
A.E.A
pressant or stimulant drugs from the
Tablet: Amobarbital, 25 mg.; aminophylline,
Haack Laboratories, Inc.
from section 511 of the act.
120 mg.; ephedrine hydrochloride, 25 mg.
provisions of section 511 of the act.
Alased
Tablet: Phenobarbital, 16.2 mg.; homatropine
Norgine Laboratories, Inc.
The following combination drugs are
methylbromide, mg.; aluminum hydroxide
(a) Section 511 (f) (1) of the act au-
exempt from the requirements of sec-
gel, dried, 71/2 gr.; magnesium trisilicate, 21/2 gr.
Alcitex
thorizes the Director, under authority
Tablet: Phenobarbital, 1/8 gr.; atropine sulfate,
tion 511 of the act:
Paul B. Elder Co., Inc.
1/6000 gr.; calcium carbonate, 31/2 gr.; magne-
delegated to him by the Attorney General
(a) The following drugs in unit-dosage
sium carbonate, 2½ gr.; cerium oxalate, 1/2 gr.
to exempt by regulation any depressant
Algoson
form, and any other drug of the quanti-
Tablet: Butabarbital sodium, 7.5 mg.; acetami-
McNeil Laboratories Inc.
or stimulant drug from all or part of
nophen, 300 mg.
tative composition shown below for one
Alhydrox
Tablet: Phenobarbital, 1/8 gr.; aluminum hy-
Physicians Supply Co.
section 511 of the act upon a finding that
of the following drugs or which is the
droxide, 5 gr.; atropine sulfate, 1300 gr.
Alkasans
regulation of the manufacture, com-
Tablet: Phenobarbital, 8.0mg.; atropine sulfate,
P. J. Noyes Co.
same except that it contains a lesser
0.06 mg.; kaolin-alumina gel, 500 mg.
pounding, processing, possession, or dis-
Alsical
quantity of controlled substances, and
Powder (60 gr.): Phenobarbital, 1/4 gr.; bel-
Dorsey Laboratories.
tribution of such drug is not necessary
ladonna extract, 1/6 gr.; calcium carbonate, 24
which may be lawfully sold over-the-
for the protection of the public health.
gr.; magnesium trisilicate, 15 gr.; magnesium
counter without a prescription, are ex-
oxide, 10 gr.; aluminum hydroxide gel, dried,
(b) A proposal to exempt any depres-
10 gr.
empt from the requirements of section
Alubelap
sant or stimulant drug from the appli-
Tablet: Phenobarbital, 8 mg.; aluminum hy-
Haack Laboratories, Inc.
511 (b), (c), and (e) and the recordkeep-
droxide gel, dried, mg.; belladonna extract,
cation of all or part of section 511 of the
ing requirements of section 511(d) (1) of
4 mg.
Aludrox SA Suspension
Suspension (5 cc.): Butabarbital, 8 mg.; ambu-
Wyeth Laboratories.
act may be initiated by the Director or
the act:
Aludrox SA Tablets
tonium bromide, 2.5 mg.
Tablet: Butabarbital, 8 mg.; ambutonium bro-
Do.
EXEMPTED OVER-THE-COUNTER DRUGS
mide, 2.5 mg.
Alu-Mag
Tablet: Phenobarbital, 1/8 gr.; aluminum hy-
Norsal Laboratories, Inc.
droxide gel, dried, 2½ gr.; magnesium trisili-
Trade name or other
Composition
Manufacturer or supplier
Alumazen
cate, 21/2 gr.; belladonna leaf extract, 1/8 gr.
designation
Tablet: Phenobarbital, 8 mg.; atropine sulfate,
The Zemmer Co.
0.06 mg.; magnesium trisilicate, 500 mg.;
aluminum hydroxide gel, dried, 250 mg.;
Amodrine
Tablet: Phenobarbital, 8 mg. aminophylline, 100
G. D. Searle & Co.
Aluminum hydroxide, mag-
saccharin sodium, 0.12 mg.
mg.; racephedrine hydrochloride, 25 mg.
Tablet: Phenobarbital, 1/8 gr.; aluminum hy-
Buffalo Pharmaceutical
Bronkaid
Tablet: Phenobarbital, 8 mg.; ephedrines 24
Drew Pharmacal Co., Inc.
nesium trisilicate, and kaolin
mg.; glyceryl gualacolate, 100 mg.; theophyl-
with phenobarbital and atro-
droxide, 2 gr.; magnesium trisilicate, 4 gr.;
Supply Corp.
pine sulfate.
kaolin, colloidal, 2 gr.; atropine sulfate, 1/800
line, 100 mg.; thenyldiamine, 10 mg.
gr.
Bronkotab Elixir
Elixir (5 cc): Phenobarbital, 4 mg.; ephedrine sul-
Breon Laboratories Inc.
Aminodrox with Phenobarbital.
Tablet: Phenobarbital, 15 mg.; aminophylline,
The S. E. Massengill Co.
fate, 12 mg.; glyceryl gualacolate, 50 mg.; theo-
0.1 gm.; aluminum hydroxide gel, dried, 0.12
phylline, 15 mg.; chlorpheniramine maleate, 1
gm.
Aminodrox-Forte with Pheno-
mg.
Tablet: Phenobarbital, 8 mg.; ephedrine sulfate,
Do.
barbital.
Tablet: Phenobarbital, 15 mg.; aminophylline,
Do.
Bronkotabs
200 mg.; aluminum hydroxide gel, dried, 250
24 mg.; glyceryl gualacolate, 100 mg.; theophyl-
mg.
line, 100 mg:; thenyldiamine, 10 mg.
Aminophylline and Amytal
Capsule: Amobarbital, 32 mg.; aminophylline,
Eli Lilly and Co.
Reproduced at the Richard Nixon Presidential Library
0.1 gm.
338
339
Title 21-Chapter II
§ 320.8
§ 320.8
Title 21-Chapter II
EXEMPTED PRESCRIPTION DRUGS-Continued
EXEMPTED PRESCRIPTION DRUGS-Continued
Trade name or other
Composition
Manufacturer or supplier
Trade name or other
Composition
Manufacturer or supplier
designation
designation
Bardase
Tablet or elixir (4 cc.): Phenobarbital, 16.2
Parke, Davis & Co.
Aminophylline with pentobar-
Suppository: Pentobarbital sodium, 100 mg.;
G. D. Searle & Co.
mg.; hyoscyamine sulfate, 0.1 mg.; hyoscine
bital.
aminophylline, 500 mg.
hydrobromide, 0.007 mg.; atropine, 0,020 mg.;
Aminophylline and phenobar-
Tablet: Phenobarbital, 15 mg.; aminophylline,
The Zemmer Co.
Taka-Diastase, 162.0 mg.
bital.
100 mg.
Bar-Don Elixir
Elixir (30 cc.): Phenobarbital, 100 mg.; hyoscy-
Warren-Teed Pharmaceuticals
Do
Tablet: Phenobarbital, 1/4 gr.; aminophylline,
The Blue Line Chemical Co.
amine hydrobromide, 0.60 mg.; hyoscine
Inc.
100 mg.
hydrobromide, 0.042 mg.; atropine sulfate,
Aminophylline with phenobar-
Tablet: Phenobarbital, 16 mg.; aminophylline,
H. E. Dubin Laboratories, Inc.
0.12 mg.
bital.
100 mg.
Bar-Don Tablets
Tablet: Phenobarbital, 16.670 mg.; hyoscy-
Do.
Do
Tablet: Phenobarbital, 15 mg.; aminophylline,
G. D. Searle & Co.
amine hydrobromide, 0.10 mg.; hyoscine
100 mg.
hydrobromide, 0.007 mg.; atropine sulfate,
Do
Tablet: Phenobarbital, 15 mg.; aminophylline,
Do.
0.020 mg.
200 mg.
Belap No. 0
Tablet: Phenobarbital, 8 mg.; belladonna
Haack Laboratories, Inc.
Aminophylline with pheno-
Tablet: Phenobarbital, 30 mg.; aminophylline,
Do.
extract, 8 mg.
barbital.
200 mg.
Belap No. 1
Tablet: Phenobarbital, 15 mg.; belladonna
Do.
Amobarbital and PETN
Capsule: Amobarbital, 50 mg.; pentaerythritol
Meyer Laboratories, Inc.
extract, 8 mg.
tetranitrate, 30 mg.
Belap Ty-Med
Tablet: Amobarbital, 50 mg.; homatropine
Do.
Ampyrox with Butabarbital
Tablet: Butabarbital sodium, 15 mg.; scopola-
Paul B. Elder Co., Inc.
methylbromide, 7.5 mg.
Sodium (AMPYROX).
mine methylnitrate, 2 mg.
Belladenal
Tablet: Phenobarbital, 50 mg.; bellafoline,
Sandoz Pharmaceuticals.
Ampyrox with Butabarbital
Elixir cc.): Butabarbital sodium, 10 mg.; sco-
Do.
0.25 mg.
Sodium, Elixir.
polamine methylnitrate, 1 mg.
Do
Elixir (15 cc.): Phenobarbital, 15.6 mg.; bella-
Do.
Amsed (NAP-37)
Tablet: Phenobarbital, 1/4 gr.; hyoscine hydro-
North American Pharmacal,
foline, 0.078 mg.
bromide, 0.0072 mg.; atropine sulfate, 0.024
Inc.
Bellatol Elixir
Elixir (5 cc.): Butabarbital sodium, 20 mg.;
The Zemmer Co.
mg. hyoscyamine hydrobromide, 0.128 mg.
tincture belladonna, 0.83 cc.
Amsodyne
Tablet: Phenobarbital, 1/4 gr.; extract belladon-
Paul B. Elder Co., Inc.
Bellergal
Tablet: Phenobarbital, 20 mg.; ergotamine tar-
Sandoz Pharmaceuticals.
na leaves, 1/8 gr.; aspirin, 5 gr.; caffeine, 1/4 gr.
trate, 0.3 mg.; levorotatory alkaloids of bella-
Antacia No. 3 with Pheno-
Tablet: Phenobarbital, 1/8 gr.; atropine sulfate,
Meyers and Co.
donna, 0.1 mg.
barbital and Atropine.
1/300 gr.; calcium carbonate, 5 gr.; magnesium
Do
Tablet: Phenobarbital, 40 mg.; ergotamine tar-
Do.
hydroxide, 5 gr.
trate, 0.6 mg.; levorotatory alkaloids of bella-
Antispasmodic.
Tablet (purple): Phenobarbital, 16.2 mg.; hyos-
Hydrex Co., Inc.
donna, 0.2 mg.
cyamine sulfate, 0.1037 mg.; homatropine
Beplete with Belladonna
Elixir (4 cc.): Phenobarbital, 15 mg.; vitamin B1,
Wyeth Laboratories.
methylbromide, 0.567 mg.; hyoscine hydro-
Elixir.
1.5 mg.; vitamin B₂, 1 mg.; vitamin B₆, 0.33
bromide, 0.0065 mg.
mg.; vitamin B₁₂, 1.66 mg.; niacinamide, 10
Antispasmodic-Enzyme
Tablet: Phenobarbital, 8.1 mg.; hyoscyamine
Do.
mg.; pantothenol, 0.2 mg.; belladonna alka-
sulfate, 0.0519 mg.; homatropine methylbro-
loids, 0.2 mg.
mide, 0.2885 mg.; hyoscine hydrobromide,
Bexadonna
Tablet: Phenobarbital, 16 mg.; homatropine
Bexar Pharmaceuticals.
0.0033 mg.; pancreatin, 100 mg.; pepsin, 150 mg.
methylbromide, 10 mg.; hyoscine hydrobro-
Antrocol
Tablet or capsule: Phenobarbital, 16 mg.; atro-
Wm. P. Poythress & Co., Inc.
mide, 0.0065 mg.; hyoscyamine sulfate, 0.1 mg.
pine sulfate, 0.324 mg.; colloidal sulfur, 22 mg.
Bilamide
Tablet: Phenobarbital, 1/8 gr.; dried ox bile, 2 gr.;
Norgine Laboratories, Inc.
Aqualin-Plus, Children
Suppository: Pentobarbital sodium, gr.; theo-
The Wm. A. Webster Co.
dehydrocholicacid, 2 gr.; homatropine methyl-
phylline, 17/8 gr.
bromide, 1/48 gr.
Suppository: Pentobarbital sodium, 3/4 gr.; theo-
Do.
Binitrin
Tablet: Butabarbital sodium, 15.0 mg.; nitro-
The Vale Chemical Co., Inc.
Aqualin-Plus No. 1
phylline, 33/4 gr.
glycerin, 0.3 mg.; pentaerythritol tetranitrate,
Aqualin-Plus No. 2,
Suppository: Pentobarbital sodium, 11/2 gr.;
Do.
10.0 mg.
theophylline, 7½ gr.
Bioxatphen
Tablet: Phenobarbital, 8 mg.; atropine sulfate,
The Zemmer Co.
Aqualin-Plus No. 2A
Suppository: Pentobarbital sodium, 3/4 gr.; theo-
Do.
0.06 mg.; bismuth subnitrate, 120 mg.; cerium
phylline, 7½ gr.
oxalate, 120 mg.
Asmabar
Tablet: Butabarbital, 20 mg.; ephedrine sulfate,
The Blue Line Chemical Co.
Bismuth, belladonna, and
Capsule: Phenobarbital, 1/4 gr.; bismuth sub-
The Bernard Co.
25 mg.; theophylline hydroxide, 130 mg.
phenobarbital.
gallate, 5 extract belladonna leaf, 16 gr.
Asmacol
Tablet: Butabarbital, 15 mg.; aminophylline,
The Vale Chemical Co., Inc.
Buffadyne A-S
Tablet: Amobarbital, 15 mg.; aspirin, 300 mg.;
Lemmon Pharmacal Co.
180 mg.; phenylpropanolamine hydrochloride,
phenacetin, 150 mg.; caffeine, 30 mg.; homa-
25 mg.; chlorpheniramine maleate, 2 mg.;
tropine methylbromide, 2.5 mg.; aluminum
aluminum hydroxide gel, dried, 60 mg.; mag-
hydroxide gel, 75 mg.; magnesium hydroxide,
nesium trisilicate, 60 mg.
45 mg.
Asperease, Modified with
Tablet: Phenobarbital, 0.008 gm.; acetylsali-
P. J. Noyes Co.
Buffadyne with Barbiturates.
Tablet: Secobarbital sodium, 8 mg.; amobarbi-
Do.
Phenobarbital.
cyclic acid, 0.5 gm.
tal, 8 mg.; aspirin, 300 mg.; phenacetin, 150
Atropal
Tablet: Phenobarbital, 1/8 gr.; atropine sulfate,
Neisler Laboratories, Inc.
mg.; caffeine, 30 mg.; aluminum hydroxide
1500 gr.; magnesium trisilicate, 21/2 gr.; alumi-
gel, 75 mg.; magnesium hydroxide, 45 mg.
Bunesia
num hydroxide gel, dried, 21/2 gr.
Tablet: Butabarbital sodium, 10 mg.; homatro-
McNeil Laboratories, Inc.
Atrosilital
Tablet: Phenobarbital, 15 mg.; atropine sulfate,
The Zemmer Co.
pine methylbromide, 2.5 mg.; magnesium
0.12 mg.; magnesium trisilicate, 0.5 gm.; sac-
hydroxide, 300 mg.
Buren
Tablet: Butabarbital, 15 mg.; phenazopyridine
B. F. Ascher & Co., Inc.
charin sodium, 0.12 mg.
Banthine with Phenobarbital
Tablet: Phenobarbital, 15 mg.; methantheline
G. D. Searle & Co.
hydrochloride, 150 mg.; scopolamine hydro-
bromide, 50 mg.
bromide, 0.0065 mg.; atropine sulfate, 0.0194
Barbatro No. 1
Tablet: Phenobarbital, 15 mg.; atropine sulfate,
The S. E. Massengill Co.
mg.; hyoscyamine sulfate, 0.1037 mg.
Burrizem
Tablet: Butabarbital sodium, 10 mg.; reserpine,
The Zemmer Co.
0.12 mg.
Barbatro No. 2
Tablet: Phenobarbital, 15 mg.; atropine sulfate,
Do.
0.1 mg.; rutin, 20 mg.; mannitol hexanitrate,
30 mg.
0.25 mg.
Tablet: Amobarbital sodium, 20 mg.; hyoscy-
The Vale Chemical Co., Inc.
Butabarbital and hyoscya-
Tablet or elixir (5 cc.): Butabarbital, 15 mg.;
Meyer Laboratories, Inc.
Barbeloid
mine sulfate.
amine sulfate, 0.125 mg.; hyoscine hydro-
hyoscyamine sulfate, 0.125 mg.
Do
bromide, 0.007 mg.; homatropine methyl-
Capsule: Butabarbital, 45 mg.; hyoscyamine
Do.
sulfate, 0.375 mg.
bromide, 0.5 mg.
Mallinckrodt Pharmaceuticals,
Butibel
Tablet or elixir (5 cc.): Butabarbital sodium,
Do.
Barbidonna Elixir
Elixir (5 cc.): Phenobarbital, 16 mg.; hyoscy-
amine sulfate, 0.1286 mg.; atropine sulfate,
Division of Mallinckrodt
15 mg.; belladonna extract, 15 mg. (hyoscya-
0.0250 mg.; scopolamine hydrobromide, 0.0074
Chemical Works.
mine sulfate, 0.138 mg.; hyoscine hydrobro-
mide, 0.027 mg.; atropine sulfate, 0.067 mg.).
mg.
Butibel R-A
Barbidonna Tablets
Tablet: Phenobarbital, 16 mg.; hyoscyamine
Do.
Tablet: Butabarbital sodium, 30 mg.; bella-
Do.
sulfate, 0.1286 mg.; atropine sulfate, 0,0250
donna extract, 30 mg.
Butibel-Gel Suspension
mg.; scopolamine hydrobromide, 0.0074 mg.
Suspension (15 cc.): Butabarbital sodium, 7.5
Do.
Barboma Elixir
Elixir (100 cc.): Phenobarbital, 0.4 gm.; homa-
The Blue Line Chemical Co.
mg.; belladonna extract, 7.5 mg. (total alka-
tropine methylbromide, 33.8 mg.
loids 0.187 mg.); activated attapulgite, 1.5 gm.;
Barboma Tablets
Tablet: Phenobarbital, 1/4 gr.; homatropine
Do.
pectin, 75 mg.
methylbromide, 1/48 gr.
Reproduced at the Richard Nixon Presidential Library
341
340
Title 21-Chapter II
§ 320.8
§ 320,8
Title 21-Chapter II
EXEMPTED PRESCRIPTION DRUGS-Continued
EXEMPTED PRESCRIPTION DRUGS-Continued
Trade name or other
Composition
Manufacturer or supplier
Trade name or other
Composition
Manufacturer or supplier
designation
designation
Donabarb
Tablet: Phenobarbital, 1/4 gr.; powder extract
Paul B. Elder Co., Inc.
Butibel-Gel Tablets
Tablet: Butabarbital sodium, 7.5 mg.; bella-
Do.
belladonna, 1/6 gr.
donna extract, 7.5 mg. (total alkaloids 0.0935
Donaphen, New Special Dona-
Tablet: Phenobarbital, 15 mg.; atropine sulfate,
Burt Krone Co.
mg.); activated attapulgite, 500 mg.; pectin,
phen.
0.024 mg.; scopolamine hydrobromide, 0.0072
mg.
mg.; hyoscyamine hydrobromide, 0.128 mg.
Butibel-Zyme.
Tablet: Butabarbital sodium, 15 mg.; bella-
Do.
Donna-Sed Elixir
Elixir (5 cc.): Phenobarbital, 16.2 mg.; hyoscya-
North American Pharmacal,
donna extract, 15 mg. (total alkaloids 0.187
mine hydrobromide, 0.1037 mg.; atropine sul-
Inc.
mg.); proteolytic enzyme standardized, 10mg.;
fate, 0.0194 mg.; hyoscine hydrobromide,
amylolytic enzyme standardized, 20 mg.; cel-
0.0065 mg.
lulolytic enzyme standardized, 5 mg.; lipolytic
Donnasep
Tablet: Phenobarbital, 8.1 mg.; phenazopyri-
A. H. Robins Co., Inc.
enzyme standardized, 100mg.; iron ox bile (45%
dine hydrochloride, 50.0 mg., methenamine
cholic acid), 30 mg.
mandelate, 500 mg.; hyoscyamine sulfate,
Butizetic
Tablet: Butabarbital sodium, 15 mg.; acetami-
Do.
0.0519 mg.; atropine sulfate, 0.0097 mg.; hyo-
nophen, 200 mg.; phenacetin, caffeine,
scine hydrobromide, 0.0033 mg.
30 mg.
Donphen
Tablet: Phenobarbital, 15 mg.; hyoscyamine
Lemmon Pharmacal Co.
Cafergot P-B
Tablet: Phenobarbital sodium, 30 mg.; ergota-
Sandoz Pharmaceuticals.
sulfate, 0.1 mg.; atropine sulfate, 0.02 mg.;
mine tartrate, 1 mg.; caffeine, 100 mg.; levoro-
scopolamine hydrobromide, 6 µg.
tatory alkaloids of belladonna, 0.125 mg.
Dormitol-HM
Tablet: Phenobarbital, 1/4 gr.; homatropine
Buffington's Inc.
Do
Suppository: Pentobarbital, mg.; ergotamine
Do.
methylbromide, 164 gr.; strontium bromide,
tartrate, 2 mg.; caffeine, 100 mg.; levorotatory
1gr.
alkaloids of belladonna, 0.25 mg.
Dynapin with Phenobarbital
Tablet: Phenobarbital, 15 mg.; nitroglycerin,
Key Pharmacal Co.
Cal-Ma-Phen
Tablet: Phenobarbital, 1/4 gr.; calcium-carbon-
Physicians Supply Co.
0.5 mg.; pentaerythritol tetranitrate, 15 mg.
ate, 5 gr.; magnesium hydroxide, 5 gr.; atropine
Edrisal
Tablet: Dextroamphetamine sulfate, 2.5 mg.;
Smith Kline & French
sulfate, 1800 gr.
aspirin, 0.16 phenacetin 0.16 gm.
Laboratories.
Cantil with Phenobarbital
Tablet: Phenobarbital, 16 mg.; mepenzolate
Lakeside Laboratories, Inc.
Elmaloin with Phenobarbital
Capsule: Phenobarbital, 15 mg.; diphenyl-
Paul B. Elder Co., Inc.
bromide, 25 mg.
hydantoin, 11/2 gr.
Carbonates No. 3 with Pheno-
Tablet: Phenobarbital, 8 mg.; atropine sulfate,
P. J. Noyes Co.
Ephedrine and sodium
Tablet: Sodium phenobarbital, 1/4 gr.; ephedrine
The Vale Chemical Co., Inc.
barbital and Atropine.
0.11 mg.; calcium carbonate, 224 mg.; magne-
phenobarbital.
sulfate, 3/8 gr.
sium carbonate, 160 mg.; bismuth subcarbo-
Ephedrine sulfate and
Tablet: Phenobarbital, 15 mg.; ephedrine sul-
The Zemmer Co.
nate, 32 mg.
phenobarbital.
fate, 25 mg.
Cardalin-Phen
Tablet: Phenobarbital, 1/4 gr.; aminophylline,
Neisler Laboratories, Inc.
Ephedrine with Pheno-
Tablet: Phenobarbital, 1/4 gr.; ephedrine sul-
P. J. Noyes Co.
5 gr.; aluminum hydroxide gel, dried, 21/2 gr.;
barbital.
fate, 3/8 gr.
benzocaine, 1/2 gr.
Ercafital
Tablet: Phenobarbital, 7.5 mg.; erqotamine
The Blue Line Chemical Co.
Cardilate-P
Tablet: Phenobarbital, 15 mg.; erythrityl tetra-
Burroughs Wellcome & Co.
tartrate, 0.5 mg.; caffeine, 50 mg.
nitrate, 10 mg.
(U.S.A.) Inc.
Ethrava-trate
Tablet: Mephobarbital, 10 mg.; pentaerythrityl
North American Pharmacal,
Cholarace
Tablet: Pentobarbital, 27.5 mg.; oxtriphylline,
Warner-Chilcott Laboratories.
tetranitrate, 20 mg.; ethaverine hydrochloride,
Inc.
200 mg.; racephedrine, 20 mg.
30 mg.
Co-Elorine 25
Capsule: Amobarbital, 8 mg.; tricyclamol chlo-
Eli Lilly and Co.
Eu-Phed-Amin
Tablet: Phenobarbital, 30 mg.; aminophylline,
Warren-Teed Pharmaceuticals
ride, 25 mg.
0.1 gm.; ephedrine sulfate, 30 mg.; extract eu-
Inc.
Co-Elorine 100.
Capsule: Amobarbital, 16 mg.; tricyclamol chlo-
Do.
phorbia, 0.1 gm.
ride, 100 mg.
Eu-Phed-Ital
Tablet: Phenobarbital sodium, 30 mg. ephedrine
Do.
Cold Preparation, Special
Tablet: Phenobarbital, 8.1 mg.; chlorphenira-
Knight Pharmacal Co.
sulfate, extract euphorbia, 0.12
mine maleate, 2 mg.; pseudoephedrine hydro-
Fensobel
Tablet: Phenobarbital, 8.1 mg.; belladonna ex-
United States Vitamin &
chloride, mg.; salicylamide, powder, 300 mg.
tract, 2.95 mg.; aluminum ydrochloride gel,
Pharmaceutical Corp.
Corenil
Tablet: Racemic methamphetamine hydro chlo-
McNeil Laboratories, Inc.
dried, 63 mg.; magnesium trisilicate, 63 mg.;
ride, 1.25 mg.; clistin (carbinoxamine maleate),
bismuth subcarbonate, 32.5 mg.; magnesium
2 mg.; belladonna extract, 8 mg.
carbonate, 252 mg.; precipitated calcium car-
Covadil
Tablet: Butabarbital sodium, 20 mg.; pentae-
The Blue Line Chemical Co.
bonate, 203. 5 mg. malt diastase, 12.5 mg.; pep-
rythritol tetranitrate, 15 mg.
permint oil, 3 mg.
Dactil with Phenobarbital
Tablet: Phenobarbital, 16 mg.; piperidolate hy-
Lakeside Laboratories, Inc.
Franol
Tablet: Phen obarbital, 8 mg.; theophylline, 130
Winthrop Laboratories.
drochloride, 50 mg.
mg.; benzylephedrine hydrochloride, 32 mg.
Dainite
Tablet: Pentobarbital sodium, 1/4 gr. aminophyl-
Neisler Laboratories, Inc.
Genegesic Capsules
Capsule: Met hamphetamine hydrochloride, 1.2
General Pharmaceutical
line, 3 gr.; ephedrine hydrochloride, 1/4 gr.;
mg.; chlorp heniramine maleate, 3.8 mg.; phe-
Products, Inc.
aluminum hydroxide gel, dried, 2½ gr.; benzo-
nacetin, 120.0 mg.; salicylamide, 180.0 mg.;
caine, 1/4 gr.
caffeine, 30.0 mg.; ascorbic acid, 50.0 mg.
Dainite-KI
Tablet: Phenobarbital, 1/4 gr.; aminophylline,
Do.
Homechol
Tablet: Pentobarbital sodium, 8.0 mg.; homa-
Lemmon Pharmacal Co.
3 gr.; ephedrine hydrochloride, 1/4 gr.; potas-
tropinemethylbromide, dehydrocholic
sium iodide, 5 gr.; aluminum hydroxide gel,
acid, 60.0mg.; ox extract,
dried, 21/2 gr.; benzocaine, 1/4 gr.
Homadonna
Tablet or elixir (5 cc.): Phenobarbital, 16 mg.;
Mallinckrodt Pharmaceuticals,
Dainite Night
Tablet: Phenobarbital, 3/8 gr.; pentobarbital
Do.
homatropine methylbromide, 2.5 mg.
Division of Mallinckrodt
sodium, 1/2 gr.; aminophylline, 4 gr.; alumi-
Chemical Works.
num hydroxide gel, dried, 2½ gr.; benzocaine,
Homopent
Tablet: Pentobarbital sodium, 15 mg.; homa-
Lemmon Pharmacal Co.
1/4 gr.
tropine methylbromide, 2.5 mg.; magnesium
Dainite Pediatric
Tablet: Phenobarbital, 1/8 gr.; aminophylline,
Do.
trisilicate, 300 mg.
1 gr.; ephedrine hydrochloride, 1/12 gr.; alumi-
Hovizyme
Tablet: Methamphetamine hydrochloride, 0.5
Ayerst Laboratories.
num hydroxide gel, dried, 1/2 gr.; benzocaine,
mg conjugated estrogen-equine, 0.125 mg.;
1/8 gr.
methyl testosterone, 1,25 mg.; amylase, 10.0
Daricon PB
Tablet: Phenobarbital, 15 mg.; oxyphencycli-
Pfizer Laboratories.
mg.; protease, 5.0 mg.; cellulase, 2.0 mg.;
mine hydrochloride, 5 mg.
nicotinyl alcohol tartrate, 7.5 mg.; dehydro-
Diatraegus
Tablet: Diallylbarbituric acid, 1/4 gr.; nitroglyc-
Buffington's, Inc.
cholic acid, 50.0 mg.; ascorbic acid, 50.0 mg.;
erin, 1/250 gr.; sodium nitrite, 1 gr.; tincture
ferrous fumarate, 6.0 mg.
crataegus, 2 minims
H-P-A (Modified)
Tablet: Phenobarbital, 1/4 gr.; aspirin, 5 gr.;
Paine Drug Co.
Dia-Tropine
Tablet: Diallylbarbituric acid, 1/4 gr.; atropine
Do.
extract hyoscyamus, 1/8 gr.
sulfate, 1/800 gr.; magnesium carbonate, 21/2 gr.;
Hybephen
Tablet: Phenobarbital, 15 mg.; hyoscyamine
The S. E. Massengil Co.
calcium carbonate, 3½ gr.; bismuth subcar-
sulfate, 0.1277 mg.; atropine sulfate, 0,0233 mg.;
bonate, 1 gr.
hyoscine hydrobromide, 0.0094 mg.
Dilantin with Phenobarbital
Capsule: Phenobarbital, 1/4 gr.; diphenylhydan-
Parke, Davis & Co.
Hybephen Elixir
Elixir (5 cc.): Phenobarbital, 15 mg.; hyoscy-
Do.
toin sodium, 0.1 gm.
amine sulfate, 0.1277 mg.; atropine sulfate,
Do
Capsule: Phenobarbital, 1/2 gr.; diphenylhydan-
Do.
0.0233 mg.; hyoscine hydrobromide, 0.0094 mg.
toin sodium, 0.1 gm.
Hydrochol Plus
Tablet: Amobarbital, 15 mg.; dehydrocholic
Paul B. Elder Co., Inc.
Dolonil
Tablet: Butabarbital, 15 mg.; phenazopyridine
Warner-Chilcott Laboratories.
acid, 200 mg.; scopolamine methylnitrate, 0.8
hydrochloride, 150 mg.; hyoscyamine hydro-
mg.; OX bile desiccated, 50 mg.
bromide, 0.3 mg.
Reproduced at the Richard Nixon Presidential Library
343
342
§ 320.8
Title 21-Chapter II
Title 21-Chapter II
§ 320.8
EXEMPTED PRESCRIPTION DRUGS-Continued
EXEMPTED PRESCRIPTION DRUGS-Continued
Trade name or other
Composition
Manufacturer or supplier
Trade name or other
Composition
designation
Manufacturer or supplier
designation
Hytrona Antispasmodic Elixir
Elixir (5 cc.): Phenobarbital, 16mg.; belladonna
Pitman-Moore.
Nactisol
Tablet: Butabarbital sodium, 15 mg.; poldine
McNeil Laboratories, Inc.
alkaloids, 0.2 mg.
methylsulfate, 4 mg.
Hytrona Antispasmodic
Tablet: Phenobarbital, 16 mg.; belladonna
Do.
Natrona Compound
Tablet: Phenobarbital, 15 mg.; extract haw-
The Zemmer Co.
Tablets.
alkaloids, 0.2 mg.
thorn berries, 30 mg.; extract mistletoe, 15 mg.;
Ilocalm
Tablet: Mephobarbital, 30 mg.; methscopola-
Warren-Teed Pharmaceuticals
sodium nitrite, 60 mg.; sodium bicarbonate,
mine nitrate, 2.5 mg.; d-calcium pantothenate,
Inc.
0.2 gm.
25 mg.
Neocholan
Tablet: Phenobarbital, 8 mg.; dehydrocholic
Pitman-Moore.
Isordil with Phenobarbital
Tablet: Phenobarbital, 15 mg.; isosorbide di-
Ives Laboratories Inc.
acid, 250mg.; bile extract, 15 mg.; homatropine
nitrate, 10 mg.
methylbromide, 1.2 mg.
Isufranol
Tablet: Phenobarbital, 8 mg.; theophylline,
Winthrop Laboratories.
Nergestic
Tablet: Phenobarbital, 8 mg.; atropine sulfate,
The S. E. Massengill Co.
130 mg.; benzylephedrine, 32 mg.; isopro-
0.10mg.; magnesium trisilicate, 0.5gm.
terenol hydrochloride, 10 mg.
Nitrased
Tablet: Secobarbital, 15 mg.; nitroglycerin, 0.4
Lemmon Pharmacal Co.
Isufranol, Mild
Tablet: Phenobarbital, 8 mg.; theophylline, 130
Do.
mg.; pentaerythrityl tetranitrate, 15 mg.
mg.; benzylephedrine, 32 mg.; isoproterenol
Nophesan Tablets
Tablet: Phenobarbital, 8 mg.; acetylsalicylic
P. J. Noyes Co.
hydrochloride, 5 mg.
acid, 300 mg.
Isuprel Compound Elixir
Elixir (15 cc.): Phenobarbital, 6 mg.; isoprotere-
Do.
Novalene
Tablet: Phenobarbital, 16 mg.; ephedrine sul-
Lemmon Pharmacal Co.
nol hydrochloride, 2.5 mg.; ephedrine sulfate,
fate, 24 mg.; potassium iodide, 162 mg.; calcium
12 mg.; theophylline, 45 mg.; potassium iodide,
lactate, 162 mg.
150 mg.
Oxsorbil-PB
Capsule: Phenobarbital, 7.5 mg.; belladonna
Ives Laboratories, Inc.
Kaphebel
Tablet: Phenobarbital, 1/8 gr.; belladonna root,
Paul B. Elder Co., Inc.
extract, 7.5 mg.; dehydrochloic acid, 32 mg.;
1/4 gr.; kaolin colloidal, 71/2 gr.
desoxycholic acid, 32 mg.; ox bile extract, 65
Kanumodic.
Tablet: Pentobarbital, 8 mg.; methscopolamine
Dorsey Laboratories.
mg.; sorbitan monooleate, 160 mg.; oleic acid,
nitrate, 2 mg.; cellulase, 9 mg.; pancreatin,
180 mg.
500 mg.; glutamic acid hydrochloride, 200 mg.;
Paminal Elixir
Elixir (5cc.): Phenobarbital, 8 mg.; methscopol-
The Upjohn Co.
OX bile extract, 100 mg.; pepsin, 150 mg.
amine bromide, 1.25 mg.
Kavatrate
Tablet: Phenobarbital sodium, ¼ gr.; veratrum
Key Pharmacal Co.
Pamine PB Elixir
Elixir (5 cc.): Phenobarbital, 8 mg.; meth-
Do.
veride, 1/4 gr.; mistletoe, ½ gr.; hawthorn
scopolamine bromide, 1.25 mg.
tincture, 30 minims; sodium nitrite, 1 gr.
Pamine PB, Half Strength
Tablet: Phenobarbital, 8 mg.; methscopolamine
Do.
Kie with Phenobarbital
Tablet: Phenobarbital, 16 mg.; potassium io-
Laser Inc.
bromide, 1.25 mg.
dide, 400 mg.; ephedrine sulfate, 24 mg.
Pediatric Piptal Antipyretic
Solution (0.6 cc.): Phenobarbital 3 mg.; pipen-
Lakeside Laboratories, Inc.
Kiophyllin
Tablet: Phenobarbital, 15 mg.; aminophyllin,
G. D. Searle & Co.
zolate bromide, 5 mg.; acetaminophen, 60mg.
150 mg.; potassium iodide, 125 mg.
Pediatric Piptal with Pheno-
Solution (0.5 cc.): Phenobarbital, 3 mg.; pipen-
Do.
Luftodil Suspension
Suspension (5 cc.): Phenobarbital, 8 mg.; theo-
Mallinckrodt Pharmaceuticals,
barbital.
zolate bromide, 2 mg.
phylline, 50 mg.; ephedrine hydrochloride, 12
Division of Mallinckrodt
Pencetylon
Tablet: Phenobarbital, 1/4 gr.; acetylsalicylic
Paul B. Elder Co., Inc.
mg.; glyceryl guaiacolate, 100 mg.
Chemical Works.
acid, 5 gr.
Luftodil Tablets
Tablet: Phenobarbital, 16 mg.; theophylline,
Do.
Pentaerythrityl tetranitrate
Tablet: Phenobarbital, 16 mg.; pentaerythrityl
P. J. Noyes Co.
100 mg.; ephedrine hydrochloride, 24 mg.; gly-
with phenobarbital.
tetranitrate, 10 mg.
ceryl guaiacolate, 200 mg.
Do
Tablet: Phenobarbital, 16 mg.; pentaerythrityl
Do.
Lufyllin-EP
Tablet: Phenobarbital, 6mg.; lufyllin (dyphyl-
Do.
tetranitrate, 20 mg.
line), 100 mg.; ephedrine hydrochloride; 16 mg.
Pentatrol with Phenobarbital
Tablet: Phenobarbital, 15 mg.; pentaerythrityl
North American Pharmacal
Magnesium hydroxide-pheno-
Tablet: Phenobarbital sodium, 15 mg.; magne-
McNeil Laboratories, Inc.
tetranitrate, 10 mg.
Co.
barbital compound.
sium hydroxide, 300 mg.; atropine sulfate with
Pentraline
Tablet: Butabarbital sodium, 10 mg.; reserpine,
McNeil Laboratories, Inc.
aromatics, 0.12 mg.
0.05 mg.; pentaerythrityl tetranitrate, 10 mg.
Malglyn Compound
Tablet or suspension 5 cc.): Phenobarbital, 16.2
Brayten Pharmaceutical Co.
Perbuzem
Tablet: Butabarbital sodium, 15 mg.; penta-
The Zemmer Co.
mg.; belladonna alkaloids, 0.162 dihydroxy
erythrityl tetranitrate, 10 mg.
aluminum aminoacetate, 0.5 gm.
Peribar L-A No. 1
Tablet: Phenobarbital, 48.6 mg.; pentaeryth-
Whittier Laboratories, Inc.
Manniphen
Tablet: Phenobarbital, 16 mg.; mannitol hexa-
The Vale Chemical Co., Inc.
rityl tetranitrate, 30 mg.
nitrate, 32 mg.
Peritrate with Phenobarbital
Tablet: Phenobarbital, 15 mg.; pentaerythrityl
Warner-Chilcott Laboratories.
Manniphen with Rutin
Tablet: Phenobarbital, 16 mg.; mannitol hexa-
Do.
tetranitrate, 10 mg.
nitrate, 32 mg.; rutin, 20 mg.
Do
Tablet: Phenobarbital, 15 mg.; pentaerythrityl
Do.
Mannitol hexanitrate with
Tablet: Phenobarbital, 1/4 gr.; mannitol hexa-
P. J. Noyes Co.
tetranitrate, 20 mg.
phenobarbital.
nitrate, 1/2 gr.
Peritrate with Phenobarbital
Tablet: Phenobarbital, 45 mg.; pentaerythrityl
Do.
Do
Tablet: Phenobarbital, 1/4 gr.; mannitol hexa-
The Blue Line Chemical
SA.
tetranitrate, 80 mg.
nitrate, 1/2 gr.
Co.
Phedorine
Tablet: Diallylbarbituric acid, 16 mg.; extract
Buffington's, Inc.
Maxitol
Tablet: Phenobarbital, 15 mg.; mannitol hex-
Burt Krone Co.
stramonium, mg. (alkaloids 0. 0015 gr.); ephed-
anitrate, 15 mg.; rutin, 15 mg.; ascorbic acid,
rine, 8 mg.; theophylline, 100 mg.
15 mg.
Phenaphen Plus
Tablet: Phenobarbital, 16.2 mg.; phenacetin, 194
A. H. Robins Co., Inc.
Mediatric
Tablet or capsule: Methamphetamine hydro-
Ayerst Laboratories.
mg.; aspirin, 162 mg.; hyoscyamine 0.031
chloride, 1 mg.; conjugated estrogens-equine,
mg.; pheniramine maleate, 12. 5 mg.; phenyl-
0.25 mg.; methyltestosterone, 2.5. mg.
ephrine hydrochloride, 10 mg.
Mediatric Liquid
Solution (15 cc.): Methamphetamine hydro-
Do.
Phenobarbital and atropine
Tablet: Phenobarbital, 1/4 gr.; atropine sulfate,
The Blue Line Chemical Co.
chloride, 1 mg.; conjugated estrogens-equine,
1/500 gr.
0.25 mg.; methyltestosterone, 2.5. mg.
Do
do
Meyers & Co.
Meprane Phenobarbital
Tablet: Phenobarbital, 16 mg.; promethestrol
Reed & Carnrick.
Do
do
Paine Drug Co.
dipropionate, 1 mg.
Do
Tablet: Phenobarbital, 1/4 gr.; atropine sulfate,
The Vale Chemical Co., Inc.
Mesopin-PB
Tablet or elixir (5 cc.): Phenobarbital, 15 mg.;
Endo Laboratories Inc.
1/250 gr.
homatropine methylbromide, 5 mg.
Phenobarbital with atropine
Tablet: Butabarbital, 16.2 mg.; trolnitrate phos-
sulfate
Tablet: Phenobarbital, 8 mg.; atropine sulfate,
The Zemmer Co.
Metamine with Butabarbital
Pfizer Laboratories.
mg.
phate, 2 mg.
Phenobarbital with atropine
Tablet: Phenobarbital, 15 mg.; atropine sulfate,
Do.
Do
Tablet: Butabarbital, 48.6mg.; trolnitrate phos-
Do.
sulfate No. 2
0.12 mg.
phate, 10 mg.
Phenobarbital and atropine
Tablet: Phenobarbital, 16 mg.; mannitol hexa-
The S. E. Massengill Co.
sulfate.
Tablet: Phenobarbital, 1/4 gr.; atropine sulfate,
Buffington's, Inc.
Mexal
1/200 gr.
nitrate, 32 mg.
Phenobarbital & Atropine No.
Tablet: Phenobarbital, 16 mg.; atropine sulfate,
Pitman-Moore.
Monomeb
Tablet: Mephobarbital, 32 mg.; penthienate
Winthrop Laboratories.
1.
0. 13 mg.
bromide, mg.
Phenobarbital & Atropine No.
Mudrane
Tablet: Phenobarbital, 21 mg.; potassium iodide,
2.
Tablet: Phenobarbital, 8 mg.; atropine sulfate,
Do.
Wm. P. Poythress & Co., Inc.
0. 65 mg.
195 mg.; aminophylline, 130 mg.; ephedrine
Phenobarbital and Atropine
hydrochloride, 16 mg.
Tablets.
Tablet: Phenobarbital, 8 mg.; atropine sulfate
P. J. Noyes Co.
11000 gr.
Mudrane GG Elixir
Elixir (5 cc.): Phenobarbital, 5.4 mg.; theophyl-
Do.
Do
Tablet: Phenobarbital, 16 mg.; atropine sulfate,
Do.
line, 20 mg.; ephedrine hydrochloride, 4 mg.;
1/500 gr.
glyceryl guaiacolate, 26 mg.
Phenobarbital and Atropine
Tablets No: 2.
Tablet: Phenobarbital, 1/4 gr.; atropine sulfate,
Do:
1/200 gr.
Reproduced at the Richard Nixon Presidential Library
344
345
Title 21-Chapter II
§ 320.8
§ 320.8
Title 21-Chapter II
EXEMPTED PRESCRIPTION DRUGS-Continued
EXEMPTED PRESCRIPTION DRUGS-Continued
Trade name or other
Composition
Manufacturer or supplier
Trade name or other
Composition
Manufacturer or supplier
designation
designation
Sebella
Tablet: Phenobarbital, 1/8 gr.; aluminum hy-
Wyeth Laboratories.
Phenobarbital and Atropine
Tablet: Phenobarbital, 1/2 gr.; atropine sulfate,
Do.
droxide, 5 gr.; belladonna extract, 1/8 gr.
Tablets No. 3.
1300 gr.
Sed-Tens
Tablet (12 hr.): Amobarbital, 50 mg.; hom-
Lemmon Pharmacal Co.
Phenobarbital and belladonna,
Tablet: Phenobarbital, 1/4 gr.; belladonna leaves
The Vale Chemical
atropine methylbromide, 7.5 mg.
1/2 gr. (total alkoids 0. 0015 gr.).
Co., Inc.
Sibena
Tablet: Butabarbital sodium, 16 mg.; simethi-
Plough Laboratories, Inc.
Do
Tablet: Phenobarbital, 1/4 gr.; belladonna ex-
Paine Drug Co.
cone, 25 mg.; belladonna extract, 16 mg. (total
tract, 1/8 gr.
alkaloids 0.20 mg.).
Do
Tablet: Phenobarbital, 16 mg.; belladonna ex-
Eli Lilly and Co.
Sodium nitrite with phenobar-
Tablet: Phenobarbital sodium, 1/8 gr.; sodium
Paine Drug Co.
tract, 8 mg.
bital.
nitrite, 1 gr.; sodium bicarbonate, 2 gr.; haw-
Phenobarbital and Belladonna
Tablet: Phenobarbital, 1/4 gr.; belladonna ex-
The Upjohn Co.
thorn berries, fluid extract, 1/2 minim.
No. 2.
tract, 1/8 gr. (alkaloids 0. 00156 gr.).
Do
Tablet: Phenobarbital, 1/4 gr.; sodium nitrite,
Buffalo Pharmaceutical Sup-
Phenobarbital with mannitol
Tablet: Phenobarbital, 7.5 mg., mannitol hex-
Paul B. Elder Co., Inc.
1 gr.
ply Corp.
hexanitrate.
anitrate, 15 mg.; ascorbic acid powder, 25 mg.;
(Harold M. Harter, D.V.M.)
Spasticol PB
Tablet: Phenobarbital, 15 mg.; homatropine
Key Pharmaceuticals, Inc.
rutin, 25 mg.
methylbromide, 2.5 mg.
Phenobarbital and mannitol
Tablet: Phenobarbital, 1/4 gr.; mannitol hex-
Meyer Drug & Surgical
Spastosed
Tablet: Phenobarbital, 8 mg.; atropine sulfate,
North American Pharmacal,
hexanitrate.
anitrate, 1/2 gr.
Supply Co.
0.13 mg.; calcium carbonate, 227 mg.; magne-
Inc.
Phenobarbital Sodium Atro-
Tablet: Phenobarbital sodium, 8 mg.; atropine
McNeil Laboratories, Inc.
sium hydroxide, 162 mg.
pine No. 1.
sulfate, 60 µg.
Special Formula 711
Tablet: d-Amphetamine sulfate, 2.5 mg.; me-
Detroit First Aid Co.
Phenobarbital Sodium Atro-
Tablet: Phenobarbital sodium, 15 mg.; atropine
McNeil Laboratories, Inc.
phenesin, 500 mg.; salicylamide, 300 mg.
pine No. 2.
sulfate, 120 µg.
Synirin
Tablet: Pentobarbital, 8 mg.; aspirin, 324 mg
Wm. P. Poythress & Co., Inc.
Phenobarbital Sodium Atro-
Tablet: Phenobarbital sodium, 20 mg.; atropine
Do.
TCS
Tablet: Phenobarbital 16, mg.; theobromine
Do.
pine No. 3.
sulfate, 200 µg.
salicylate, 0.4 gm.; calcium salicylate, 0.06 gm.
Phenobarbital and sodium ni-
Tablet: Phenobarbital, 1/4 gr.; sodium nitrite,
P. J. Noyes Co.
Tedral-25
Tablet: Butabarbital, 25 mg.; theophylline, 130
Warner-Chilcott Laboratories.
trite.
1 gr.
mg.; ephedrine hydrochloride, 24 mg.
Phenobarbital Theocalcin
Tablet: Phenobarbital, 15 mg.; theobromine
Knoll Pharmaceutical Co.
Tedral S.A
Tablet: Phenobarbital, 25 mg.; theophylline,
Do.
calcium salicylate, 0.5 gm.
180 mg.; ephedrine hydrochloride, 48 mg.
Phenodonna Tablets
Tablet: Phenobarbital, 1/4 gr.; tincture bella-
Flint Medical & Surgical
Tensodin
Tablet: Phenobarbital, 15 mg.; ethaverine hy-
Knoll Pharmaceutical Co.
donna, 6 minims.
Supply Co.
drochloride, 30 mg.; theophylline calcium
Phenodrox
Tablet: Phenobarbital, 1/4 gr.; atropine sulfate,
North American Pharmacal
salicylate, 200 mg.
1500 gr.; magnesium trisilicate, gr.; aluminum
Inc.
Tensophen
Tablet: Phenobarbital, 16 mg.; nitroglycerin,
P. J. Noyes Co.
hydroxide gel, dried, 4 gr.
0.26 mg.; sodium nitrite, 32 mg.; podophyllin,
Phyldrox
Tablet: Phenobarbital, 15 mg.; neothylline, 100
Lemmon Pharmacal Co.
1 mg.; extract beef bile, 16 mg.
Thedrizem
mg.; ephedrine sulfate, 25 mg.
Tablet: Phenobarbital, 8 mg.; theophylline,
The Zemmer Co.
Piptal PHB Elixir
Elixir (5cc.): Phenobarbital, 16 mg.; pipenzolate
Lakeside Laboratories, Inc.
hydrous, 100 mg.; ephedrine hydrochloride,
bromide, 5 mg.
25 mg.
Piptal PHB Tablets
Theobarb
Tablet: Phenobarbital, 16 mg.; pipenzolate bro-
Do.
Tablet: Phenobarbital, 32 mg.; theobromine,
Mallinckrodt Pharmaceuticals,
mide, 5 mg.
325 mg.
Division of Mallinckrodt
Prantal with Phenobarbital
Tablet: Phenobarbital, 16 mg.; diphemanil
Schering Corp.
Chemical Works.
Theobarb-R
methylsulfate, 100 mg.
Tablet: Phenobarbital, 10 mg.; reserpine, 0.1
Do.
Premarin with Phenobarbital
Tablet: Phenobarbital, 32 mg.; conjugated es-
Ayerst Laboratories.
mg.; theobromine, 324 mg.
trogens-equine, 0.625 mg.
Theobarb Special
Tablet: Phenobarbital, 16 mg.; theobromine,
Do.
Probanthine with pheno-
Tablet: Phenobarbital, 15 mg.; probanthine,
G. D. Searle & Co.
325 mg.
barbital.
15 mg.
Theobromine and phenobar-
Tablet: Phenobarbital, 16 mg.; theobromine,
P. J. Noyes Co.
Probital
Tablet: Phenobarbital, 15 mg.; probanthine,
Do.
bital.
0.3 gm.
Theobromine-Phenobarbital
7.5 mg.
Tablet: Phenobarbital, 30 mg.; theobromine,
The S. E. Massengill Co.
Propenite
Tablet: Pentobarbital sodium, 12 mg.; sodium
The Zemmer Co.
0.3 gm.
Do
nitrite, 60 mg.; hawthorn berries extract, 120
Tablet: Phenobarbital, 32 mg.; theobromine,
The Upjohn Co.
mg.; mistletoe extract, 60 mg.
324 mg.
Prydonnal Spansule
Smith Kline & French Labora-
Theobromine-Phenobarbital
Capsule: Phenobarbital, 65 mg.; belladonna
Tablet: Phenobarbital, 1/4 gr.; theobromine,
Do.
alkaloids, 0.4 mg. (hyoscyamine sulfate, 0.305
tories.
Compound.
21/2 gr.; potassium iodide, 2½ gr.; potassium
mg.; atropine sulfate, 0.06 mg., scopolamine
bicarbonate, 2 gr.
Theobromine with Phenobar-
hydrobromide, 0.035 mg.).
Tablet: Phenobarbital, 15 mg.; theobromine,
Buffington's Inc.
Quadrinal
Tablet: Phenobarbital, 24 mg.; ephedrine hy-
Knoll Pharmaceutical Co.
bital No. 1.
324 mg.
Theobromine and sodium ace-
drochloride 24 mg.; theophylline calcium salic-
Tablet: Phenobarbital, 1/4 gr.; theobromine and
Paul B. Elder Co., Inc.
ylate, 130 mg.; potassium iodide, 300 mg.
tate with phenobarbital.
sodium acetate, 3 gr.
Do
Suspension (5 cc.): Phenobarbital, 12mg.; ephed-
Do.
Theobromine sodium salicylate
Tablet: Phenobarbital, 15 mg.; theobromine
The Zemmer Co.
rine hydrochloride, 12 mg.; theophylline
with phenobarbital.
sodium salicylate, 300 mg.
Theocardone No. 1
calcium salicylate, 65 mg.; potassium iodide,
Tablet: Phenobarbital, 15 mg.; theobromine,
Haack Laboratories, Inc.
160 mg.
300 mg.
Quintrate with Nitroglycerin
Tablet: Phenobarbital, 15 mg.; pentaerythrityl
Paul B. Elder Co., Inc. (Glynn
Theocardone No. 2
Tablet: Phenobarbital, 30 mg.; theobromine,
Do:
and Phenobarbital.
tetranitrate, 20 mg.; nitroglycerin, 0.4 mg.
A. Beard).
300 mg.
Quintrate with Phenobarbital
Tablet: Phenobarbital, 15 mg.; pentaerythrityl
Do.
Theodide
Tablet: Phenobarbital, 1/4 gr.; potassium iodide,
The Vale Chemical Co., Inc.
tetranitrate, 10 mg.
21/2 gr.; theobromine sodium salicylate, 21/2 gr.
Do
Tablet: Phenobarbital, 15 mg.; pentaerythrityl
Do.
Theoglycinate with Phenobar-
Tablet: Phenobarbital, 16 mg.; theophyllin-so-
Brayten Pharmaceutical Co.
tetranitrate, 20 mg.
bital.
dium glycinate, 324 mg.
Rheastat
Suspension (1 fluid ounce (32 cc.)): Phenobarbi-
Mallinckrodt Pharmaceuticals
Theoglycinate with Racephe-
Tablet: Phenobarbital, 16 mg.; theophylline-so-
Do.
tal, 16 mg.; hyoscyamine sulfate, 0.1286 mg.;
Division of Mallinckrodt
drine and Phenobarbital.
dium glycinate, 324 mg.; racephedrine hydro-
atropine sulfate, 0.0250 mg.; scopolamine
Chemical Works.
chloride, 24 mg.
hydrobromide, 0.0074 mg.; kaolin, colloidal,
Theoplaphen
Tablet: Phenobarbital, 15 mg.; theobromine so-
The S: E: Massengill Co.
5.76 gm.; pectin, 320 mg.; sodium (as Cl), 6
dium salicylate, 0.2 gm.; calcium lactate, 0.1
meq.; potassium (as C1), 4 meq.
gm:
Robinul-PH
Tablet: Phenobarbital, 16.2 mg.; glycopyrrolate,
A. H. Robins Co., Inc.
Theominal
Tablet: Phenobarbital, 32 mg.; theobromine,
Winthrop Laboratories.
1.0 mg.
320 mg:
Robinul-PH Forte
Tablet: Phenobarbital, 16.2 mg.; glycopyrrolate,
Do.
Theominal M.
Tablet: Phenobarbital, 15 mg.; theobromine,
Do:
2.0 mg.
320 mg.
Ruhexatal
Tablet: Phenobarbital, 15 mg.; mannitol hexani-
Lemmon Pharmacal Co.
Theominal RS
Tablet: Phenobarbital, 10 mg.; theobromine,
Do:
trate, 30 mg.; ascorbic acid, 10 mg.; rutin, 20
320 mg.; alseroxylon, 1.5 mg:
mg.
Theophen
Tablet: Phenobarbital, 1/4 gr.; theobromine so-
The Vale Chemical Co., Inc.
Rutol
Tablet: Phenobarbital, 8.0 mg.; mannitol hexa-
Pitman-Moore:
dium salicylate, 5 gr.; calcium carbonate, 21/2
nitrate, 16 mg.; rutin, 10 mg:
gr:
Salisil with Phenobarbital
Tablet: Phenobarbital, 1/4 gr.; acetylsalicylic
Pau Elder Co., Inc.
Theorate
Tablet: Phenobarbital, 16.2 mg.; theobromine,
Whittier Laboratories, Inc.
acid, 5 gr.; magnesium trisilicate, 2 gr:
324 mg.
Reproduced at the Richard Nixon Presidential Library
347
346
§ 320.8
Title 21-Chapter II
Title 21-Chapter II
§
320.16
EXEMPTED PRESCRIPTION DRUGS-Continued
EXEMPTED PRESCRIPTION DRUGS-Continued
Trade name or other
Trade name or other
Composition
Manufacturer or supplier
Composition
designation
Manufacturer or supplier
designation
Thora-Dex No. 1
No. 111
Tablet: Dextroamphetamine sulfate, 2 mg.,
Smith Kline & French
Tablet: Phenobarbital, 1/2 gr.; ephedrine sulfate,
Do.
chlorpromazine hydrochloride, 10 mg.
3/8 gr.
Laboratories.
Thora-Dex No. 2.
No. 136,
Tablet: Dextroamphetamine sulfate, 5 mg.;
Do.
Tablet: Phenobarbital, 20 mg.; homatropine
Do.
chlorpromazine hydrochloride, 25 mg.
methylbromide, 5 mg.
Thymodyne
No. 643,
Tablet: Phenobarbital, 32 mg.; theophylline
P. J. Noyes Co.
Tablet: Phenobarbital, 1/8 gr.; theophylline, 2
Do.
anhydrous, 130 mg.; ephedrine sulfate, 24 mg.
gr.; ephedrine hydrochloride, 3/8 gr.
Trocinate with Phenobarbital
Rx. No. 4104
Tablet: Phenobarbital, 16 mg.; thiphenamil
Wm. P. Poythress & Co., Inc.
Tablet: Phenobarbital, 1/4 gr.; calcium carbonate,
The Zemmer Co.
hydrochloride, 100 mg.
7½ gr.; magnesium oxide, 4 gr.; atropine sul-
Tricoloid
Tablet: Phenobarbital, 16 mg.; tricyclamol
Burroughs Wellcome & Co.
fate, 1/800 gr.
Rx. No. 4105,
chloride, 50 mg.
Tablet: Phenobarbital, 1/4 gr.; calcium carbonate,
Do.
Triophen
Tablet: Phenobarbital, 1/8 gr.; atropine sulfate,
The Vale Chemical Co., Inc.
10 gr.; atropine sulfate, 1/300 gr.
Rx. No. 4108,
1/500 gr.; magnesium trisilicate, 7 gr.
Capsule: Phenobarbital, 1/4 gr.; atropine sulfate,
Do.
Unitensen-Phen
Tablet: Phenobarbital, 15 mg.; cryptenamine,
Neisler Laboratories, Inc.
1/800 gr.; calcium carbonate, 612 gr.; magnesium
1 mg.
oxide, heavy, 2 gr.
Valpin-PB
Rx. No. 4123,
Tablet or elixir (5 cc.): Phenobarbital, 8 mg.;
Endo Laboratories Inc.
Capsule: Phenobarbital, 1/4 gr.; bismuth subgal-
Do.
anisotropine methylbromide, 10 mg.
late, 5 gr.; extract belladonna, 1/6 gr.
Vasorutin
Rx. No. 4126
Tablet: Diallylbarbituric acid, 1/4 gr.; nitroglyc-
Buffington's, Inc.
Capsule: Pentabarbital sodium, 15 mg.; extract
The Zemmer Co.
erin, 1/250 gr.; sodium nitrite, 1 gr.; tincture
belladonna, 10 mg.
Rx. No. 4143
crataegus, 2 minims; rutin, 20 mg.
Capsule: Phenobarbital, 1/4 gr.; aminophylline,
Do.
Veraflex
Tablet: Phenobarbital, 15 mg.; cryptenamine,
Neisler Laboratories, Inc.
1.5 gr.; potassium iodide, 1 gr.
Rx. No. 4152
65 CSR (carotid sinus reflex) units; rutin, 20
Tablet: Phenobarbital, 1/4 gr.; atropine sulfate,
Do.
mg.
1/200 gr.
Veralzem
Rx. No. 4155
Tablet: Phenobarbital, 15 mg.; veratrum viride,
The Zemmer Co.
Tablet: Phenobarbital, 1/8 gr.; atropine sulfate,
Do.
50 mg.; sodium nitrite, 60 mg.
1/1000 gr.; aluminum hydroxide gel. 33/4 gr.;
Veratrite
Tablet: Phenobarbital, 1/4 gr.; cryptenamine, 40
kaolin, 33/4 gr.
Neisler Laboratories, Inc.
Rx. No. 4170
CSR (carotid sinus reflex) units; sodium
Tablet: Phenobarbital, 1/2 gr.; atropine sulfate,
Do.
nitrite, 1 gr.
1/200 gr.; calcium carbonate, 10 gr.
Veritag
Rx. No. 4184
Tablet: Phenobarbital, 16 mg.; veratrum viride,
S. J. Tutag and Co.
Capsule: Sodium butabarbital, 15 mg.; bella-
Do.
40 mg.; sodium nitrite, 65 mg.
donna extract, 15 mg.
Vertegus
Tablet: Phenobarbital, 1/4 gr.; veratrum viride,
Burt Krone Co.
3/4 gr.; sodium nitrite, 1 gr.; mistletoe, 1/2 gr.;
hawthorn berries, 1/2 gr.
§ 320.16 Records required to be main-
such drug manufactured, compounded,
Veruphen
Tablet: Phenobarbital, 15 mg.; rutin, 20 mg.;
The Zemmer Co.
tained under section (d) of the
veratrum viride, 15 mg.; sodium nitrite, 60 mg.
or processed and the date of such manu-
Viritin
act.
Tablet: Phenobarbital, 15 mg.; mannitol hexa-
Lemmon Pharmacal Co.
facture, compounding, or processing; and
nitrate, 30 mg.; veratrum viride alkaloids,
1.5 mg.; rutin, 20 mg.
(a) Types of records-(1) Initial in-
that every person selling, delivering, or
Weytabs No. 1
Tablet: d1-Desoxyephedrine hydrochloride, 5
The Vale Chemical Co., Inc.
ventory. Section 511(d) (1) of the act re-
otherwise disposing of any such drug
mg.; thyroid, 60 mg.; atropine sulfate, 0.125
mg.; aloin, 15 mg.
quires every person engaged in manufac-
shall prepare or obtain and keep for not
Weytabs No. 2
Tablet: d1-Desoxyephedrine hydrochloride, 5
Do.
turing, compounding, processing, selling,
less than 3 years a complete and accurate
mg.; thyroid, 60 mg.; atropine sulfate, 0.125
mg.
delivering, or otherwise disposing of any
record of the kind and quantity of each
Weytabs No. 3
Tablet: Phenobarbital, 15 mg.; d1-desox yephe-
Do.
depressant or stimulant drug, as defined
such drug received, sold, delivered, or
drine hydrochloride, 5 mg.; thyroid 60 mg.
in section 201 (v) of the act, to prepare
otherwise disposed of, the name and ad-
W-T
Powder (4 gm.): Phenobarbital, 15 mg.; bella-
Warren-Teed Pharmaceuticals
donna extract, 10 mg. (0.12 mg. belladonna
Inc.
upon the effective date of the section a
dress of the person, and the registration
alkaloids); benzocaine, 15 mg.; calcium carbon-
complete and accurate record of all
number, if any, assigned to such person
ate, 1.55 gm.; magnesium oxide, 0.5 gm.; alu-
minum hydroxide gel, dried, 60 mg.
stocks of each such drug on hand and to
pursuant to section 510(e) of the act,
W-T
Tablet: Phenobarbital, 1/16 gr.; belladonna ex-
Do.
keep such records for 3 years.
from whom such drug was received, and
tract, 1/24 gr.; benzocaine, 1/16 gr.; calcium car-
(i) An inventory is required as of Feb-
to whom it was sold, delivered, or other-
bonate, 6 gr.; magnesium trisilicate, 33/4 gr.;
aluminum hydroxide gel, dried, 21/2 gr.; chloro-
ruary 1, 1966, of each drug containing
wise disposed of, including the date of
phyll extract, 1%.
Xaniophen
any amount of barbiturate or ampheta-
such transaction.
Tablet: Phenobarbital, 16.2 mg.; theobromine,
Pitman-Moore.
mine, unless exempted by regulation in
(b) Contents of records. The records
162 mg.; ethylenediamine dihydriodide, 32.4
mg.
this part.
required under section 511(d) (1) of the
Zallogen Compound
Tablet: Phenobarbital, 8 mg.; tocamphyl, 75
The S. E. Massengill Co.
mg.; homatropine methylbromide, 2.5 mg.
(ii) An inventory is required of any
act, and by regulations in this part, shall
Zantrate
Tablet: Cyclopentenylallylbarbituric acid, 1/2
The Upjohn Co.
drug on the effective date of an order is-
be considered incomplete and inadequate
gr.; ephedrine sulfate, 3/8 gr.; theophylline an-
hydrous, 2 gr.
sued after February 1, 1966, that desig-
unless such records contain sufficient in-
Zem-Dab
Tablet: Butabarbital sodium, 10 mg.; dehydro-
The Zemmer Co.
nates such drug under section 201(v) of
formation to clearly show the kind and
cholic acid, 60 mg.; ox bile desiccated, 120 mg.;
the act as a depressant or stimulant
quantity of all stocks of each drug sub-
homatropine methylbromide, 2.5 mg.
No. 23
Tablet: Phenobarbital, 1/2 gr.; aminophylline,
Stayner Corp.
drug subject to control, unless exempted
ject to these record-keeping require-
3 gr.
by regulation in this part.
ments including, but not limited to, the
No. 35
Tablet: Phenobarbital, 1/8 gr.; aminophylline,
Do.
(2) Continuing records. Section 511
following information:
1.5 gr.; ephedrine sulfate, 3/8 gr.
No. 36
Tablet: Pentabarbital sodium, 3/4 gr.; ephedrine
Do.
(d) (1) of the act also requires that on
(1) Information required in initial in-
sulfate, 36 gr.; aminophylline, 3 gr.
No. 65
and after February 1, 1966, every per-
ventory record. (i) The kind and quan-
Tablet: Phenobarbital, 1/4 gr.; extract bella-
Do.
donna, 1/4 gr.
son manufacturing, compounding, or
tity, to the nearest unit weight consistent
No. 66
Tablet: Phenobarbital, 1/4 gr.; extract bella-
Do.
processing any depressant or stimulant
with the unit size, of all bulk depressant
donna, 1/4 gr.
No. 75
Tablet: Phenobarbital, 1/4 gr.; belladonna, 1/6 gr.
Bariatric Corp.
drug, as defined in section 201 (v) of the
or stimulant drugs used in or capable of
No. 88
Tablet: Phenobarbital, 1/4 gr.; aminophylline,
Stayner Corp.
act, shall prepare and keep for not less
use in the production of drugs as defined
1.5 gr.
No. 89
Tablet: Phenobarbital, ½ gr.; aminophylline,
Do.
than 3 years a complete and accurate
in section 201 (v) of the act, on hand as
½ gr.
record of the kind and quantity of each
of February 1, 1966.
348
Reproduced at the Richard Nixon Presidential Library
349
§ 320.16
Title 21-Chapter II
Title 21-Chapter II
§ 320.18
(ii) The kind and quantity of drugs
date, quantity, and kind of the material
age or container (for example, 10-milli-
(a) Persons engaged in manufactur-
in production on February 1, 1966, iden-
received.
gram tablet), resulting in the following
ing, preparation, propagation, com-
tified by batch number or other appro-
(iii) Production records shall show
type of quantity designation (fifty 100-
pounding, or processing of such drugs in
priate identifying number including the
date of manufacture, compounding, or
tablet bottles of 10-milligram tablets;
bulk, tablet, capsule, liquid, or other
physical form which such in-process
processing, theoretical and actual yield,
two 50-pound drums of 10-milligram tab-
finished form.
drugs are intended to take upon comple-
the quantity of loss during manufacture,
lets; 3 dozen 25-tablet bottles of 10-milli-
(b) Persons, other than those ex-
tion of the manufacturing process; for
if any, the quantity used for quality con-
gram tablets). If the semiprocessed con-
empted under section 511(d) (3) of the
example, granulations, tablets, capsules,
trol, the identity by batch number or
trolled substance is a granulation, a
meaningful quantitative statement of the
act, engaged in selling, transporting, de-
solutions, etc.
other appropriate identification and
livering, wholesaling, jobbing, warehous-
(iii) The kind and quantity of all such
quantity of any product reworked for
amount of such substance present is
required.
ing, distributing, or otherwise disposing
drugs in finished form on hand on Feb-
any reason and such other information
ruary 1, 1966, including returned mer-
as is necessary to account for all con-
(iv) With regard to the records re-
of such drugs to any person who is not
chandise, transfers from other locations,
trolled substances used in the manufac-
quired by section 511(d) (1) of the act,
the ultimate user or consumer of the
drug.
orders prepared for shipment or delivery,
turing process.
the law states "no separate records nor
or otherwise within the control of the
set form or forms for any of the fore-
(c) Persons, other than those ex-
(3) Information required in continu-
registrant; for example, drugs in any
ing records of wholesaling, jobbing, dis-
going records shall be required as long
empted under section 511(d) (3) of the
controlled warehouse, or drugs in pos-
as records containing the required in-
act, engaged in manipulation, sampling,
tributing, retailing, or other disposition.
session of employees and intended for
The records required by section 511(d)
formation are available." Ordinary
testing, repackaging, or otherwise chang-
distribution as professional samples.
business records kept by legitimate busi-
ing the container, wrapper, or labeling
of the act to be kept by each person sell-
of such drugs in furtherance of the dis-
These records shall describe the finished
ing, delivering, or otherwise disposing of
nessmen are maintained SO that inspec-
form (for example, 10-milligram tablets
any depressant or stimulant drug shall
tion of the records is possible and prac-
tribution of such drugs from the orig-
or 10-milligram concentration per fluid
include the following information:
ticable in a reasonable length of time.
inal place of manufacture to the person
ounce, if liquid), the number of units or
Among others, an automatic data proc-
who makes final delivery or sale to the
(i) The kind and quantity of each
ultimate consumer.
volume in each package or container
such drug received including imports,
essing system will be considered ade-
(for example, 100-tablet bottle or 3
the name and address of the person from
quate providing the system is capable of
(d) Pharmacies, hospitals, clinics, and
fluid ounces), and the location of stocks.
whom the drug is received, and the reg-
separating and identifying all records
public health agencies who have on hand
(2) Information required in continu-
istration number, if any, assigned to any
containing the specific information re-
or maintain a stock of such drugs for
ing records of receipt or manufacture,
quired by section 511(d) of the act and
dispensing by registered pharmacists
such person pursuant to section 510(e)
compounding, or processing of controlled
the regulations contained in this part in
upon prescriptions, or for use by or un-
of the act, and the date any such drug
drugs. (1) The kind and quantity, ex-
a reasonable time, or provided the sys-
der the supervision of practitioners
was received.
tem itself is capable of producing such
licensed by law to administer such drugs
pressed in the nearest unit weight con-
(ii) The kind and quantity of each
sistent with the unit size, of all bulk
such drug sold, delivered, or otherwise
information in a reasonable time. Other
in the course of their professional
practice.
depressant or stimulant drugs in or ca-
disposed of, including the name and ad-
recordkeeping systems that permit the
dress of the person to whom such drug
records specified in section 511(d) (1) of
(e) Laboratories or research or edu-
pable of use in the production of drugs,
as defined in section 201(v) of the act,
was sold, delivered, or otherwise disposed
the act to be identified and reviewed or
cational institutions who use such drugs
on hand and in production, including the
of, the identity of any common carrier or
copied in a reasonable time also will be
in research, teaching, or chemical
transportation firm used in effecting
regarded as adequate. To account for
analysis.
name and address of the person or firm
such delivery, and the registration num-
controlled drugs dispensed on prescrip-
(f) Practitioners licensed by law to
from whom the drugs or substance is
received and the date and quantity of
ber, if any, assigned to any such person
tion, either the usual consecutively num-
prescribe or administer such drugs, while
material received. If any of this material
pursuant to section 510(e) of the act,
bered prescription file, or a separate
acting in the course of their professional
is disposed of in any manner, or in any
and the date any such sale, delivery, or
prescription file, will be acceptable.
practice, who regularly engage in dis-
pensing any such drug or drugs to their
form, the details of disposition, includ-
other disposition took place, including
§ 320.17 Persons required to establish,
patients for which the patients are
ing the name and address of the person
drugs exported to other countries.
prepare, and maintain records speci-
charged, either separately or together
to whom delivered, the date, quantity,
(iii) (a) The term "kind" as used in
fied in section 511 (1) of the act.
with charges for other professional serv-
and form in which disposed.
this section means the established name,
Pursuant to the provisions of section
ices. The maintaining of small supplies
(ii) The kind and quantity of any de-
chemical name, or trade name for drugs
511 (a) and (d) (1) of the act, persons
of these drugs for dispensing or admin-
pressant or stimulant drug as defined in
which contain a single active ingredient,
engaged in one or more or any combina-
istering in the course of professional
section of the act, in tablet, cap-
and for those drugs (for which there is
sule, liquid, or any other finished form
tion of the following activities in rela-
practice in emergency or special situa-
no established or trade name) contain-
ing more than one active component, the
tion to depressant or stimulant drugs,
tions (for example, as a stopgap measure
produced that is on hand, in production,
or received. These records shall describe
established name, chemical name, or
as defined in section 201(v) of the act
to tide patients over until a regular sup-
the form (tablet, capsule, etc.), the
trade name for each active ingredient.
and regulations thereunder, are required
ply of drugs can be obtained by prescrip-
strength or potency per unit (for ex-
to establish and maintain the initial in-
tion from a pharmacy, or dispensing
(b) The word "quantity" as used in
ample, 10-milligram tablets), and the
this section means the number of indi-
ventory records and the continuing
as trial doses to patients), will not be
number of units in each package or con-
vidual packages or containers of the con-
records described in this part:
considered as regularly engaged in dis-
tainer (for example, 100-tablet bottle),
trolled substance (for example, 100 bot-
pensing for a fee.
tles, 5 dozen bottles), a description of
¹The purpose of this provision as shown
and the date of production, receipt, re-
§ 320.18 Label symbol.
the quantity of contents of each indi-
by reports of the Congressional Committee
packaging, or relabeling. These records
vidual package or container (for ex-
that considered the legislation is to insure
(a) All depressant and stimulant drugs
shall include the name and address of
ample, 100-tablet bottle, 50-pound
that the ordinary business records kept by
within the meaning of section 201(v) of
the person from whom any such con-
drum), and a statement of the potency of
legitimate businessmen will be considered
the act, which have not been exempted
trolled substance was received and the
as adequate records.
a single unit within the individual pack-
by the Director from the requirements
350
Reproduced at the Richard
Nixon Presidential Library
351
Title 21-Chapter II
Title 21-Chapter II
§ 320.19
§ 320.19
or (3) of the act should be proposed, is-
committee to act. The date of acknowl-
of section 511 (c) and (e) and the
(5) The chairman of the committee,
recordkeeping requirements of section
sued, amended, or repealed, whether such
edgment of receipt of such information
after consultation with the committee
(d) (1) of the act, shall bear the
referral is made upon the Director's own
shall be considered the beginning of the
members, will inform the National Acad-
initiative or upon the request of an inter-
period allowed for consideration by the
following symbol or modification:
emy of Sciences of the committee's opin-
ested person, the Director will request
committee. A copy of this acknowledge-
ion concerning the member who may best
the National Academy of Sciences to se-
ment shall be forwarded by the chair-
represent the committee at a hearing,
Rx
Rx
R
lect qualified experts willing to serve on
man of the committee to the interested
if one occurs.
the advisory committee. All such ex-
person requesting referral of the matter
(6) More than one referral may be
perts shall have had sufficient training
to the committee. When the Director on
handled by a committee concurrently.
and experience in pharmacology, psy-
his own initiative has referred to an ad-
(7) An interested person whose re-
chiatry, internal medicine, anesthesi-
visory committee any matter concerning
quest for a referral of a matter to an ad-
The symbol in outline form is for use as
ology, organic chemistry, sociology, psy-
a drug which is the subject of a new-drug
visory committee has been granted in
a large, open-letter overprint.
chology, or in other appropriate science
application, the chairman shall forward
accordance with the provisions of this
(b) This symbol shall be prominently
to qualify them on the subject matter
a copy of the acknowledgement to any
section, as well as representatives of the
placed on the principal panel of the label
to be referred to them. The Director
holder of such an application.
Department of Justice, shall have a right
and/or on the panel normally displayed
will request the National Academy of
(2) A secretariat to the advisory com-
to consult with the committee in con-
on the shelf by users of the immediate
Sciences, when it furnishes the names of
mittees will be established by the Di-
nection with such referred matter. Such
container and on any retail carton or
such experts, to supply a biographical
rector. The secretariat shall furnish
person shall notify the chairman and, if
wrapper for such container of each such
sketch showing the background of their
members of the committee with copies of
practicable, make appointments through
drug: Provided, however, That:
experience and their connection, if
any data received by the chairman. If the
him. If any interested person discusses
(1) The symbol is not required on the
any, with academic and commercial
chairman of the committee believes that
with or offers information to a committee
retail carton or wrapper if it is easily
institutions.
a meeting of the committee is necessary
member concerning a referred matter,
legible through such carton or wrapper;
(2) Each advisory committee shall
before making a recommendation, he
such committee member shall make a
consist of not less than three experts
shall so inform the Director. Such meet-
written report of the discussion or offer
or
(2) In the case of ampules or other
qualified in the subject matter to be re-
ings shall be held in Washington, D.C.,
and submit it to the committee to be
containers too small or otherwise un-
ferred to the committee and of adequately
or at such other place as the Director
made a part of the file of the committee.
able to accommodate a label, the symbol
diversified professional backgrounds.
shall furnish a suitable meeting place
(8) Except for discussions with au-
may appear on the outer container from
The Director may specify a larger num-
for the committee. If a meeting is held,
thorized persons, the committee shall not
which they are removed for dispensing
ber to serve. He shall appoint one member
the secretariat shall keep the minutes
disclose information, material, or data
or use.
of the committee as chairman, and the
and provide clerical assistance.
referred to it prior to publication of a
(c) The symbol shall be of contrasting
chairman shall be the spokesman for
(3) As soon as practicable, the ad-
regulation unless such disclosure is speci-
color to the background on which it ap-
the committee responsible for receiving
visory committee shall make an inde-
fically authorized by the Director.
pears (no particular color is required),
and forwarding reports and for other
pendent study of the data, and not later
(c) Fees. (1) In the event of a re-
large enough for easy identification,
functions of the Committee.
than 60 days after acknowledged receipt
ferral of a matter under section 511(g)
placed preferably to the right of the title
(3) The Director shall appoint the
of such materials and information (un-
of the act to an advisory committee, the
and adjacent to it, and at least as large
experts so selected and fix their compen-
less the time has been extended as pro-
costs shall be borne by the person who
as the largest letter in the title of the
sation not to exceed the maximum per-
vided in subparagraph (4) of this para-
requests the referral of the matter to the
drug. Large open-letter overprinting of
graph), the chairman shall certify to
committee.
mitted by other authority per day for
the symbol will be regarded as meeting
each day or part thereof spent in com-
the Director the report and recommen-
(2) The cost of the advisory commit-
the requirements.
mittee meetings and in traveling to and
dations of the committee, including any
tee shall include expenses of the secre-
(d) Compliance with the requirements
from committee meetings held outside
minority report, together with all under-
tariat, compensation of members, neces-
of this section shall be as follows:
the city of their residence, plus neces-
lying data and a statement of the rea-
sary travel and subsistence expenses of
(1) All drugs subject to control on
sary traveling and subsistence expenses
sons or basis for the recommendations.
members, costs of duplicating documents
February 1, 1966, as set forth in para-
The report will include copies of all
referred to the committee, and other ex-
while the experts are serving away from
graph (a) of this section, and packaged
material considered by the committee,
penses arising by reason of referrals to
their place of residence. Subsistence ex-
penses shall not exceed $30 per day.
except that in the case of scientific
the committee.
after September 1, 1966, must bear the
symbol.
literature readily available in scientific
(3) An advance deposit shall be made
(b) Procedure. (1) The Director shall
(2) All drugs brought under control
in the amount of $2,500 to cover the
submit to the chairman of the advisory
libraries proper reference may be made
after February 1, 1966, as set forth in
committee all available materials and
to it instead of furnishing actual copies.
costs. Further advance deposits of $2,500
paragraph (a) of this section, which are
information relevant to the matter that
A copy of the report of the advisory
each shall be made upon request of the
packaged on or after 180 days from the
has been referred to the committee. If
committee will be supplied to the inter-
Director when necessary to prevent
effective date of such control, shall bear
the referral of a matter to an advisory
ested person who requested the referral
arrears in the payment of such costs. Any
the symbol.
committee is made upon the request of
to the advisory committee, if any there
deposits in excess of actual expenses will
be.
be refunded to the depositor.
§ 320.19 Advisory committees; appoint-
an interested person, the Director shall
ment; procedure; fees.
furnish such person with copies of all
(4) If at any time within 60 days the
(4) All deposits and fees required by
materials and information that are
chairman believes that the advisory
the regulations in this section shall be
(a) Selection, appointment, qualifica-
furnished to the committee, except those
committee needs more time, he shall so
paid by money order, bank draft, or cer-
tions, compensation. (1) Whenever the
materials which may have been trans-
inform the Director in writing, in which
tified check drawn to the order of the
Director deems necessary the referral
mitted to the Director by such person and
case he shall certify to the Director such
Treasurer of the United States, collectible
to an advisory committee of any matter,
report as provided for in subparagraph
at par at Washington, D.C. All deposits
such scientific libraries. The chairman of
with regard to determining whether a
(3) of this paragraph within an addi-
and fees shall be forwarded to the Finan-
the committee shall acknowledge receipt
of the information and readiness of the
tional 30 days.
cial Management Division, Bureau of
regulation under section 201 (v) (2) (C)
Reproduced at the Richard Nixon Presidential Library
352
353
§ 320.20
Title 21-Chapter II
Title 21-Chapter II
§ 330.6
§ 330.1 Definitions.
Narcotics and Dangerous Drugs, Wash-
ing the consignee, at his agent, within the
erty is freely offered for sale. If there is
ington, D.C. 20537, for deposit to the
United States.
As used in the regulations in §§ 330.1
no market for the property at the place
appropriation "Salaries and Expenses;
(2) The "U.S. Exporter" may ship the
through 330.11, except as otherwise indi-
of seizure, the domestic value shall be
Bureau of Narcotics and Dangerous
controlled substances to a "forwarding
cated by the content:
considered the value in the principal
Drugs."
agent" as defined in 15 CFR 379.4(f),
(a) The term "Act" means the Act
market nearest the place of seizure.
(5) The Director may waive or refund
who will execute the required Shipper's
of August 9, 1939 (53 Stat. 1291; 49 U.S.C.
(Sec. 606, 46 Stat. 754, 19 U.S.C. 1606)
such fees in whole or in part when in
Export Declaration and further act as an
781-788).
§ 330.5 Advertisement.
his judgment such action will promote
exporting agent for the principal. When
(b) The term "custodian" means the
the public interest.
a "forwarding agent" is utilized, a copy
officer required under § 330.3 to take cus-
(a) If the appraised value does not
(6) Any person who believes that pay-
of the invoice describing the controlled
tody of particular property which has
exceed $2,500, the custodian shall cause
ment of these fees will work a hardship
substance must be attached to each copy
been seized pursuant to the Act.
a notice of the seizure and of the inten-
on him may petition the Director to
of the Shipper's Export Declaration and
(c) The term "property" means a ves-
tion to forfeit and sell or otherwise dis-
waive or refund the fees.
these documents must accompany the
sel, vehicle, or aircraft within the scope
pose of the property to be published once
§ 320.20 Exportation.
shipment. A "forwarding agent" may not,
of the Act.
a week for at least three (3) successive
under any circumstances, release a ship-
(d) The terms "seizing officer," "offi-
weeks in a newspaper of general circu-
(a) The provisions of section 801(d)
ment of controlled substances to any-
cer seizing," etc., mean any officer, au-
lation in the judicial district in which
of the act (21 U.S.C. 381 (d)), provide
one, including the consignee, or his agent,
the seizure occurred.
thorized and designated by $ 330.2 to
that a drug intended for export shall not
within the United States. The "forward-
carry out the provisions of the Act, who
(b) The notice shall: (1) Describe the
be deemed to be adulterated or mis-
ing agent" must either deliver the con-
initially seizes property or adopts a sei-
property seized and show the motor and
branded but that if such an article is sold
trolled substances to the port or border,
zure initially made by any other officer
serial numbers, if any; (2) state the
or offered for sale in domestic commerce,
or deliver the controlled substances to a
or by a private person.
time, cause, and place of seizure; and (3)
it is not exempt from control. The provi-
bonded carrier approved by the principal
(e) The term "regional director"
state that any person desiring to claim
sions of Part 370 of Title 15 of the Code
for delivery to the port or border.
means the regional director of the Bu-
the property may, within 20 days from
of Federal Regulations (15 CFR 370.2),
(b) In the event that controlled sub-
reau of Narcotics and Dangerous Drugs,
the date of first publication of the notice,
contain the following definition: "U.S.
stances intended for export by a "U.S.
U.S. Department of Justice.
file with the custodian a claim to the
Exporter. That person who, as the prin-
Exporter" or a "forwarding agent" are
property and a bond with satisfactory
cipal party in interest in the export
introduced or delivered into domestic
§ 330.2 Officers who will make seizures.
sureties in the sum of $250.
transaction, has the power and respon-
commerce before they are exported, such
For the purpose of carrying out the
(Sec. 607, 46 Stat. 754, as amended, 19 U.S.C.
sibility for determining and controlling
introduction or delivery shall be con-
1607)
provisions of the Act, all special agents of
the sending of the commodities and tech-
sidered a domestic sale, delivery, or other
the Bureau of Narcotics and Dangerous
§ 330.6 Requirements as to claim and
nical data out of the United States."
disposition of a controlled substance
Drugs of the Department of Justice are
bond.
Therefore, such exporter, who may be the
under 21 U.S.C. 360a, and a prohibited
authorized and designated to seize such
(a) The bond shall be rendered to the
manufacturer, compounder, processor,
act under 21 U.S.C. 331 (2).
property as may be subject to seizure.
wholesaler, or distributor of the con-
United States, with sureties to be ap-
[34 F.R. 19654, Dec. 13, 1969]
§ 330.3 Custody and other duties.
proved by the custodian, conditioned
trolled substances will be deemed the
that in the case of condemnation of the
"U.S. Exporter" under 15 CFR 370.2, and
must comply with one of the following
PART 330-SEIZURE, FORFEITURE,
An officer seizing property under the
property the obligor shall pay all costs
AND DISPOSITION OF VESSELS,
Act shall store the property in a location
and expenses of the proceedings to ob-
alternative procedures in order to insure
designated by the custodian in the judi-
that controlled substances "intended for
VEHICLES, AND AIRCRAFT FOR
tain such condemnation. When the claim
cial district of seizure. The regional di-
DOMESTIC NARCOTIC AND MARI-
and bond are received by the custodian,
export" are in fact exported:
rectors of the Bureau of Narcotics and
he shall, after finding the documents in
(1) The "U.S. Exporter" will execute
HUANA VIOLATIONS
Dangerous Drugs are designated as cus-
proper form and the sureties satisfac-
the Shipper's Export Declaration, Form
Sec.
todians to receive and maintain in stor-
tory, transmit the documents, together
7525-V, if required by 15 CFR 379.1-
330.1
Definitions.
age all vessels, vehicles, and aircraft
with a description of the property and a
379.13, and have the controlled sub-
330.2
Officers who will make seizures.
seized pursuant to the Act. The regional
complete statement of the facts and cir-
stances delivered to a bonded carrier for
330.3
Custody and other duties.
directors are also authorized to dispose
cumstances surrounding the seizure, to
delivery to the port or border for ship-
330.4
Appraisement.
of any property pursuant to the Act, and
the United States Attorney for the judi-
ment directly to the consignee in the
330.5
Advertisement.
any other applicable statutes or regula-
cial district in which the seizure was
foreign country without shipping the
330.6
Requirements as to claim and bond.
tions relative to disposal, and to perform
330.7
Summary forfeiture.
made for the purpose of proceeding to a
substances to a "forwarding agent." A
330.8
such other duties regarding such seized
Judicial forfeiture.
condemnation of the property in the
copy of the invoice describing the con-
330.9
Petitions for remission or mitigation
property as are imposed on the collectors
manner prescribed by law. If the docu-
trolled substance must be attached to
of forfeiture.
of customs and appraisers with respect
ments are not in satisfactory condition
each copy of the Shipper's Export Dec-
330.10
Time for filing petitions.
to seizures under the customs laws.
when first received, a reasonable time for
laration and these documents must ac-
330.11
Handling of petitions.
(Sec. 605, 46 Stat. 754, 19 U.S.C. 1605; Sec.
correction may be allowed. If correction
company the shipment. Form 7525-V
AUTHORITY: The provisions of this Part 330
609, 46 Stat. 755, 19 U.S.C. 1609)
is not made within a reasonable time the
may be obtained at a cost of $1 per 100
issued under sec. 8, 53 Stat. 1293, 49 U.S.C.
from any local Customs or Department
§ 330.4 Appraisement.
documents may be treated as nugatory,
788; 5 U.S.C. 301; 28 U.S.C. 509, 510; and
and the case shall proceed as though
of Commerce Field Office, and assistance
Reorganization Plan No. 1 of 1968-33 F.R.
The custodian shall appraise the prop-
they had not been tendered.
in the execution of such Forms is also
5611. Other statutory provisions interpreted
erty to determine the domestic value at
(b) The filing of the claim and the
available at such offices. A "U.S. Ex-
or applied are cited to text in parentheses.
the time and place of seizure. The do-
porter" may not, under any circum-
posting of the bond does not entitle the
SOURCE: The provisions of this Part 330
mestic value shall be considered the re-
stances, physically release a shipment of
claimant to possession of the property,
appear at 33 F.R. 16559, Nov. 14, 1968, unless
tail price at which such or similar prop-
controlled substances to anyone, includ-
otherwise noted.
however, it does stop the summary for-
Reproduced at the Richard Nixon Presidential Library
355
354
$ 330.7
Title 21-Chapter II
feiture proceedings. The bond posted to
lowing: (1) A complete description of the
cover costs may be in cash, certified
property, including motor and serial
check, or on Treasury Department Form
numbers, if any, and the date and place
171 with satisfactory sureties. The costs
of seizure; (2) the petitioner's interest
and expenses secured by the bond are
in the property, which shall be supported
such as are incurred after the filing of
by bills of sale, contracts, mortgages, or
the bond, including storage cost, safe-
other satisfactory documentary evidence;
guarding, court fees, marshal's costs, etc.
and, (3) the facts and circumstances, to
(Sec. 608, 46 Stat. 755, 19 U.S.C. 1608)
be established by satisfactory proof, re-
§ 330.7 Summary forfeiture.
lied upon by the petitioner to justify re-
mission or mitigation.
If the appraised value does not exceed
(c) Where the petition is for restora-
$2,500, and a claim and bond are not
tion of the proceeds of sale, or for value
filed within the 20 days hereinbefore
of the property placed in official use, it
mentioned, the custodian shall declare
must be supported by satisfactory proof
the property forfeited. The custodian
that the petitioner did not know of the
shall prepare the Declaration of Forfeit-
seizure prior to the declaration of con-
ure and forward it to the Director of the
demnation of forfeiture and was in such
Bureau of Narcotics and Dangerous
circumstances as prevented him from
Drugs as notification of the action he
knowing of the same.
has taken. Thereafter, the property shall
(Secs. 613, 618, 46 Stat. 756, 757, as amended,
be retained in the custodian's district or
19 U.S.C. 1613, 1618)
delivered elsewhere for official use, or
otherwise disposed of, in accordance with
§ 330.10 Time for filing petitions.
official instructions received by the
(a) In order to be considered as sea-
custodian.
sonably filed, a petition for remission or
(Sec. 609, 46 Stat. 755, as amended, 19 U.S.C.
mitigation of forfeiture should be filed
1609)
within 30 days of the receipt of the
§ 330.8 Judicial forfeiture.
notice of seizure. If a petition for remis-
sion or mitigation of forfeiture has not
If the appraised value is greater than
been received within 30 days of the notice
$2,500 or a claim and satisfactory bond
of seizure, the property will either be
have been received for property appraised
placed in official Government service or
at $2,500 or less, the custodian shall
sold as soon as it is forfeited. Once prop-
transmit a description of the property
erty is placed in official use, or is sold,
and a complete statement of the facts
a petition for remission or mitigation of
and circumstances surrounding the
forfeiture can no longer be accepted.
seizure to the U.S. Attorney for the
(b) A petition for restoration of pro-
judicial district in which the seizure was
ceeds of sale, or for the value of property
made for the purpose of instituting con-
placed in official use, must be filed within
demnation proceedings. The U.S. Attor-
90 days of the sale of the property, or
ney shall also be furnished the newspaper
within 90 days of the date the property
advertisements required by § 330.5.
is placed in official use.
(Sec. 610, 46 Stat. 755, 19 U.S.C. 1610)
(Secs. 613, 618, 46 Stat. 756, 757, as amended;
§ 330.9 Petitions for remission or miti-
19 U.S.C. 1613, 1618)
gation of forfeiture.
§ 330.11 Handling of petitions.
(a) Any person interested in any prop-
Upon receipt of a petition, the custo-
erty within the scope of the Act and the
dian shall request an appropriate investi-
regulations in §§ 330.1 through 330.11
gation. The petition and the report of
which has been seized, or forfeited either
investigation shall be forwarded to the
summarily or by court proceedings, may
Director of the Bureau of Narcotics and
file a petition for remission or mitiga-
Dangerous Drugs. If the petition involves
tion of the forfeiture. Such petition shall
a case which has been referred to the
be filed in triplicate with the regional
U.S. Attorney for the institution of court
director for the judicial district in which
proceedings, the custodian shall transmit
the seizure occurred. It shall be addressed
the petition to the U.S. Attorney for the
to the Director of the Bureau of Narcotics
judicial district in which the seizure oc-
and Dangerous Drugs and executed and
curred. He shall notify the petitioner of
sworn to by the person alleging interest
this action.
in the property.
(Sec. 618, 46 Stat. 757, as amended, 19 U.S.C.
(b) The petition shall include the fol-
1618)
356
U. S. GOVERNMENT PRINTING OFFICE : 1970 o - 386-408
Reproduced at the Richard Nixon Presidential Library