PART B-AUTHORITY TO CONTROL:
STANDARDS AND SCHEDULES
Section 201. Authority and criteria for classification of
substances [21 USC 811]
Section 202. [Establishes Schedules and the initial Schedules
of substances] [21 USC 812]
Section 201. Authority and criteria for
classification of substances
Subsection (a) of this section authorizes the Attorney General,
pursuant to the rulemaking provisions of the Administrative
Procedure Act (now subchapter II of 5 U.S.C.), to by rule
add a substance to a schedule or transfer a substance between
schedules. This subsection further permits the Attorney General
to remove a substance entirely from the schedules by rule
if he finds that the substance no longer meets the requirements
for inclusion in any of the schedules. Except as noted below,
such rules are to be made on the record after opportunity
for hearing. The Attorney General may initiate proceedings
to control a substance on his own motion, or he may initiate
proceedings at the request of the Secretary of Health, Education,
and Welfare or on the petition of an interested party.
Subsection (b) requires that, before initiating proceedings
to add a drug or other substance to one of the schedules of
the bill, or to reschedule it or remove it entirely from the
schedules, and "after gathering the necessary data", the Attorney
General shall request from the Secretary of Health, Education,
and Welfare a scientific and medical evaluation and his recommendation
as to whether or not the substance should be added, deleted,
or rescheduled as a controlled substance. The phrase "after
gathering the necessary data" is not intended to authorize
the Attorney General to undertake or support medical and scientific
research for that purpose, which is within the competence
of the Department of Health, Education, and Welfare, or to
limit the Secretary's evaluation to data submitted to him
by the Attorney General but rather to defer submission of
a request to the Secretary until the Attorney General, on
the basis of all the information available to him -- particularly
any information developed by him as to the scope, pattern,
and significance of abuse of a drug or substance in this country
-- has reason to believe that there may be ground for controlling
or decontrolling a drug or other substance. The phrase "after
gathering the necessary data" does, however, envision the
utilization of Bureau of Narcotics and Dangerous Drugs laboratory
facilities for chemical analysis, especially in the case of
substances being abused in the street which require identification.
In making his recommendation and evaluation, the Secretary
must consider certain factors listed in subsection (c) and
more specifically described under that subsection, as to the
substances' pharmacological effect, the state of current knowledge
regarding the substance, the risk to the public health posed
by the substance, the substance's psychic or physiological
dependence liability, and whether or not the substance is
an immediate precursor of a substance already controlled.
The Secretary must also consider any medical and scientific
considerations involved in the substance's potential for abuse,
its history and current pattern of abuse, and the scope of
its abuse. Subsection (a) further provides that the Secretary's
evaluations and recommendations shall be in writing and shall
be binding on the Attorney General as to medical and scientific
matters. The subsection also specifies that a recommendation
by the Secretary that a substance should I not be controlled
is binding on the Attorney General. After receiving' the recommendation
of the Secretary, the Attorney General shall consider it and
all other relevant data to ascertain whether there is substantial
evidence of a potential of abuse such as to warrant the initiation
of a control proceeding. In making this determination, the
Attorney General is to consider the same criteria as the Secretary
considers in making his evaluations and recommendations, subject,
of course, to the above-mentioned requirements as to the effect
to be given the Secretary's recommendations. If the Attorney
General finds that all the relevant data constitutes substantial
evidence of a potential for abuse, he may proceed under the
rulemaking procedures of the Administrative Procedure Act
to control the substance.
Subsection (c) of this section sets out a number of factors
which the Attorney General must consider in making his findings
under subsection (a) of this section and subsection (b) of
section 202. These factors include: (1) a substance's actual
or relative potential for abuse; scientific evidence of the
substance's pharmacological effect, if known; (3)the state
of current scientific knowledge regarding the substance; (4)
the substance's history and current pattern of abuse; (5)
the scope, duration, and significance of abuse of the substance;
(6) the risk to public health posed by the substance; and
(7) the psychic or physiological dependence liability of the
substance. It should also be noted that these factors must
be considered by the Secretary of Health, Education, and Welfare
in making his evaluations and recommendation to the Attorney
General under subsection (b) of this section.
A key criterion for controlling a substance, and the one
which be used most often, is the substance's potential for
abuse. If the Attorney General determines that the data gathered
and the evaluations and recommendations of the Secretary constitute
substantial evidence of potential for abuse, he may initiate
control proceedings under this section. Final control by the
Attorney General will also be based on his findings as to
the substance's potential for abuse.
The term "potential for abuse" is found in the definition
of a "depressant or stimulant drug" contained in section 201(v)
of the Federal Food, Drug, and Cosmetic Act and is characterized
further in the regulations (21 CFR 166.2(c)) promulgated under
that section as follows:
The Director may determine that a substance has a potential
for abuse because of its depressant or stimulant effect on
the central nervous system or its hallucinogenic effect if:
(1) There is evidence that individuals are taking the drug
or drugs containing such a substance in amounts sufficient
to create a hazard to their health or to the safety of other
individuals or of the community; or
(2) There is significant diversion of the drug or drugs containing
such a substance from legitimate drug channels; or
(3) Individuals are taking the drug or drugs containing such
a substance on their own initiative rather than on the basis
of medical advice from a practitioner licensed by law to administer
such drugs in the course of his professional practice; or
(4) The drug or drugs containing such a substance are new
drugs so related in their action to a drug or drugs already
listed as having a potential for abuse to make it likely that
the drug will have the same potentiality for abuse as such
drugs, thus making it reasonable to assume that there may
be significant diversions from legitimate channels, significant
use contrary to or without medical advice, or that it has
a substantial capability of creating hazards to the health
of the user or to the safety of the community.
These regulations follow and extend the suggestions contained
in the report of this committee accompanying H.R. 2, 89th
Congress, which became the Drug Abuse Control Amendments of
1965 (House Report No. 130, 89th Congress, first session,
page 7 (1965)).
The report went further in its discussion of the "potential"
aspect of the term. It stated that it did not intend that
potential for abuse be determined on the basis of "isolated
or occasional non-therapeutic purposes. "The committee felt
that there must exist "a substantial potential for the occurrence
of significant diversions from legitimate channels, significant
use by individuals contrary to professional advice, or substantial
capability of creating hazards to the health of the user or
the safety of the community" (at page 7).
With respect to the question of the extent to which actual,
as distinguished from potential, abuse was required to be
established, that report stated that "the Secretary of Health,
Education, and Welfare should not be required to wait until
a number of lives have been destroyed or substantial problems
have already arisen before designating a drug as subject to
controls of the bill" (at page 7).
In speaking of "substantial" potential the term "substantial"
means more than a mere scintilla of isolated abuse, but less
than a preponderance. Therefore, documentation that, say,
several hundred thousand dosage units of a drug have been
diverted would be "substantial" evidence of abuse despite
the fact that tens of millions of dosage units of that drug
are legitimately used in the same time period. The normal
way in which such diversion is shown is by accountability
audits of the legitimate sources of distribution, such as
manufacturers, wholesalers, pharmacies, and doctors.
Misuse of a drug in suicides and attempted suicides, as well
as injuries resulting from unsupervised use are regarded as
indicative of a drug's potential for abuse.
Aside from the criterion of actual or relative potential
for abuse, subsection (c) of section 201 lists seven other
criteria, already referred to above, which must be considered
in determining whether a substance meets the specific requirements
specified in section 202(b) for inclusion in particular schedules
and accordingly should be designated a controlled substance
under a given schedule (including transfer from any other
schedule) or removed entirely from the schedules. A brief
discussion of each of these criteria follows.
(1) Scientific evidence of its pharmacological effects.
-- The state of knowledge with respect to the effects of uses
of a specific drug is, of course, a major consideration, e.
g., it is vital to know whether or not a drug has an hallucinogenic
effect if it is to be controlled because of that effect. The
best available knowledge of the pharmacological properties
of a drug should be considered.
(2) The state of current scientific knowledge regarding
the substance. -- Criteria (1) and (2) are closely related.
However, (1) is primarily concerned with pharmacological effects
and (2) deals with all scientific knowledge with respect to
the substance.
(3) Its history and current pattern of abuse. -- To
determine whether or not a drug should be controlled, it is
important to know the pattern abuse of that substance, including
the social, economic, and ecological characteristics of the
segments of the population involved in such abuse
(4) The scope, duration, and significance of abuse.
-- In evaluating existing abuse, not only must the Attorney
General know the pattern of abuse but he must know whether
the abuse is widespread. He must also know whether it is a
passing fad, or whether it is a significant chronic abuse
problem like heroin addiction. In reaching his decision, the
Attorney General should consider the economics of regulation
and enforcement attendant to such a decision. In addition,
he should be aware of the social significance and impact of
such a decision upon those people, especially the young, that
would be affected by it.
(5) What if any, risk there is to the public health.
-- If a drug creates no danger to the public health, it would
be inappropriate to control drug under this bill.
(6) Its psychic or physiological dependence liability.
-- There must be assessment of the extent to which a drug
is physically addictive or psychologically habit forming,
if such information is known.
(7) Whether the substance is an immediate precursor of
a substance already controlled. -- The bill allows inclusion
of immediate precursors on this basis alone into the appropriate
schedule and thus safeguards against possibilities of clandestine
manufacture.
It should be noted that the above-mentioned factors do not
require specific findings to be made with respect to control
under or removal from, schedules, but rather are factors to
be considered in making the special findings required under
section 202(b) for control under such schedules.
Under subsection (d), where control of a drug or other substance
by the United States is required by reason of its obligations
under an international treaty, convention, or protocol which
is in effect on the effective date of part B of the bill (i.
e., the date of its enactment), the bill does not require
that the Attorney General seek an evaluation and recommendation
by the Secretary of Health, Education, and Welfare, or pursue
the procedures for control prescribed by the bill but he may
include the drug or other substance under any of the five
schedules of the bill which he considers most appropriate
to carry out the obligations of the United States under the
international instrument, and he may do so without making
the specific findings otherwise required for inclusion of
a drug or other substance in that schedule. The reference
to treaties, conventions, or protocols in effect upon enactment
of the bill is intended to refer to the Single Convention
on Narcotic Drugs, 1961, and to those predecessor conventions
or protocols as to which the United States may still have
an obligation. This would include any obligations of the United
States that might arise after enactment of the bill by reason
of changes in the schedules of the Single Convention by the
international organs specified in the convention under the
authority of the provisions of the convention in effect as
to the United States on the date of enactment of the bill.
Subsection (e) of this section provides that if the Attorney
General designates a substance as an immediate precursor,
he may place it in the same schedule in which the controlled
substance of which it is an immediate precursor is placed,
or in a schedule with a higher numerical designation, whichever
the Attorney General deems appropriate. For example, under
section 202, lysergic acid, which is the immediate precursor
of lysergic acid diethylamide (LSD-25), is contained in schedule
III, while lysergic acid diethylamide is contained in schedule
I. In determining in which schedule to place an immediate
precursor, the Attorney General need not follow the procedures
prescribed by section 201(a) and (b), or make the findings
required by sections 201(a) and 202(b), for placement of a
controlled substance in a schedule.
Subsection (f) provides that if at the time a new-drug application
is submitted to the Secretary of Health, Education, and Welfare
for a drug having a stimulant, depressant, or hallucinogenic
effect on the central nervous system, it appears that such
drug has an abuse potential, such information is to be forwarded
by the Secretary to the Attorney General.
Subsection (g) (1) requires the Attorney General to exclude
any non-narcotic substance from a schedule if the substance
may be sold over the counter without a prescription under
the Federal Food, Drug, and Cosmetic Act.
Subsection (g) (2) provides that the drug dextromethorphan
is not to be deemed included in any of the schedules contained
in section 202 unless subsequently controlled after the date
of enactment of part B pursuant to the provisions of section
201. This section is merely designed to insure that dextromethorphan,
which is used in a number of cough syrups sold over the counter
without a prescription, will not be controlled by virtue of
its relationship to drugs already listed in the schedules
on the date of enactment. However, this subsection is not
intended to prevent control of the drug in the future should
an abuse potential be found.
Section 202
Subsection 202(a) establishes five schedules and provides
that these schedules shall initially consist of the substances
listed in section 202. The subsection further provides for
a semiannual updating and republishing of the schedules during
the 2-year period beginning 1 year after the date of enactment
of title II of the act. After the expiration of this 2-year
period, the schedules are to be updated and republished on
an annual basis.
Subsection (b) sets out the criteria for each schedule of
controlled drugs. However, findings with respect to these
criteria are not required for placement of a substance in
a schedule to carry out a U. S. obligation under a treaty,
convention, or protocol in effect on the date of controlled
substance in a schedule.
The criteria for those substances listed in schedule I are:
a high potential for abuse, no currently accepted medical
use in treatment in the United States, and a lack of accepted
safety for use under medical supervision.
The criteria for substances listed in schedule II are: a
high potential for abuse, a currently accepted medical use
in treatment in the Unit States, or a currently accepted medical
use with severe restrictions, and that abuse may lead to severe
psychological or physical dependence.
The criteria for substances listed in schedule III are-.
a potential for abuse less than that for substances in schedules
I and II, a currently accepted medical use in treatment in
the United States, and that abuse of the substance may lead
to moderate or low physical dependence high or psychological
dependence.
The criteria for substances listed in schedule IV are: a
low potential for abuse relative to the substances listed
in schedule III, a currently accepted medical use in treatment
in the United States, and that abuse of the substance may
lead to limited physical or psychological dependence relative
to the substances in schedule III.
The criteria for the substances listed in schedule V are:
a low potential for abuse relative to the substances in schedule
IV, a currently accepted medical use in treatment in the United
States, and that abuse may lead to limited physical or psychological
dependence relative to the substances listed in schedule IV.
Subsection (c) sets out the various narcotics, marihuana,
stimulant depressants, hallucinogens, and immediate precursors
controlled under existing law and lists them in one of the
five schedules. The listing of a drug by the bill under one
schedule or another is not intended to affect the extent to
which it is regulated under other laws. Methadone, listed
in schedule II, for example, is used today in a number of
programs for treatment of narcotic addicts and the adoption
of this bill will not, itself, lead to any change in the extent
to which such use is permitted today.
Subsection (d) authorizes the Attorney General to except
any compound, mixture, or preparation containing any, stimulant
or depressant substance contained in paragraph (a) or (b)
of schedule III or in schedule IV or V from the application
of all or any part of title II, if the substance contains
one or more active medicinal ingredients not having a stimulant
or depressant effect on the central nervous system provided
that such admixtures shall not be included therein in such
combinations, quantity, proportion, or concentration as to
vitiate the potential for abuse of the substances which do
have a stimulant or depressant effect on the central nervous
system.
Citation: United States Code, Congressional and Administrative
News. 91st Congress -- Second Session, 1970. St. Paul, MM:
West Publishing Co. pg. 4599- 4605.
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