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.
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.