(c) "Agent" means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser and includes a common or contract carrier, public warehouseman, or employee thereof.

(d) "Bureau of Narcotics and Dangerous Drugs" means the Bureau of Narcotics and Dangerous Drugs, Department of Justice.

(e) "Control" means to add, remove, or change the placement of a drug, substance, or immediate precursor under title II of this Act.

(f) "Controlled dangerous substance" means a drug, substance, or immediate precursor in schedules I through IV of title II of this Act. The term shall not include distilled spirits, wine, malt beverages, or tobacco as those terms are defined or used in section 26 of the United States Code, subtitle E.

(g) "Counterfeit substance" means a controlled dangerous substance which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, number, or device, or any likeness thereof, of a manufacturer, distributor, or dispenser other than the person or persons who in fact manufactured, distributed, or dispensed such substance and which thereby falsely purports or is represented to be the product of, or to have been distributed by, such other manufacturer, distributor, or dispenser.

(h) "Deliver" or "delivery" means the actual, constructive, or attempted transfer of a controlled dangerous substance, whether or not there exists an agency relationship.

(i) "Department" means the United States Department of Justice. (j) "Depressant or stimulant drug" means

(1) a drug which contains any quantity of (A) barbituric acid or any of the salts of barbituric acid; or (B) any derivative of barbituric acid which has been designated by the Secretary of Health, Education, and Welfare as habit forming under section 502(d) of the "Federal Food, Drug, and Cosmetic Act" (52 Stat. 1050; 21 U.S.C. 352(d));

(2) a drug which contains any quantity of (A) amphetamine or any of its optical isomers; (B) any salt of amphetamine or any salt of an optical isomer of amphetamine; or (C) any substance which the Attorney General, after investigation, has found to be, and by regulation designated as, habit forming because of its stimulant effect on the central nervous system; or (3) lysergic acid diethylamide or any other drug which contains any quantity of a substance which the Attorney General, after investigation, has found to have, and by regulation designates as having, a potential for abuse because of its depressant or stimulant effect on the central nervous system or its hallucinogenic effect.

(k) "Dispense" means to deliver a controlled dangerous substance to the ultimate user or human research subject by or pursuant to the lawful order of a practitioner, including the packaging, labeling, or compounding necessary to prepare the substance for such delivery. "Dispenser" is a practitioner who delivers a controlled dangerous substance to the ultimate user or human research subject.

(1) "Distribute" means to deliver a controlled dangerous substance. "Distributor" means a person who delivers a controlled dangerous substance.

(m) "Drug" means (1) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formularly, or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (4) articles intended for use as a component of any article specified in clause (1), (2), or (3) of this paragraph; but does not include devices or their components, parts, or accessories.

(n) "Manufacture" means the production, preparation, propagation, compounding, or processing of a controlled dangerous substance, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis. "Manufacturer" includes any person who packages, repackages, or labels any container of any controlled dangerous substance, except practitioners who dispense or compound prescription orders for delivery to the ultimate

consumer.

(o) "Net disposal" means the quantity of a controlled dangerous substance in schedule I or II for which the manufacturer is registered, or otherwise dis

posed of (as such or contained in or combined with other drugs compounded by the manufacturer) by the manufacturer during a stated period, less the quantity of any controlled dangerous substance in schedules I and II returned to the manufacturer by a customer and any quantity distributed or dispensed to another registered manufacturer of the same controlled dangerous substance.

(p) "Practitioner" means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted to distribute, dispense, conduct research with respect to, or administer a controlled dangerous substance in the course of professional practice or research by the United States or the jurisdiction in which he practices or does research. (q) "Production" includes the manufacture, planting, cultivation, growing, or harvesting of a controlled dangerous substance.

(r) "Immediate precursor" means a substance which the Attorney General has found to be and by regulation designates as being the principal compound commonly used or produced primarily for use, and which is an immediate chemical intermediary used or likely to be used in the manufacture of a controlled dangerous substance, the control of which is necessary to prevent, curtail, or limit such manufacture.

(s) "State" means any State, territory, possession of the United States (including the District of Columbia and the Commonwealth of Puerto Rico), the Trust Territory of the Pacific Islands and the Canal Zone.

(t) "Ultimate user" means a person who lawfully possesses a controlled dangerous substance for his own use or for the use of a member of his household or for administration to an animal owned by him or by a member of his household. (u) "United States" means all places and waters, continental or insular, subject to the jurisdiction of the United States.

TITLE II-STANDARDS AND SCHEDULES

AUTHORITY TO CONTROL

SEC. 201. (a) The Attorney General shall control all substances enumerated in section 202 of this Act and he may, pursuant to the procedures of subchapter II of chapter 5 of title 5 of the United States Code, add, delete, or reschedule a substance as a controlled dangerous substance. Before so doing, the Attorney General shall request the advice in writing from the Secretary of Health. Education, and Welfare and from the Scientific Advisory Committee established in title VI of this Act whether a substance should be added, deleted, or rescheduled as a controlled dangerous substance. Such advice shall be rendered to the Attorney General within a reasonable time. The Attorney General shall consider with respect to each substance hereafter controlled:

(1) its actual or relative potential for abuse;

(2) scientific evidence of its pharmacological effect, if known;

(3) state of current scientific knowledge regarding the substance;

(4) its history and current pattern of abuse;

(5) the scope, duration, and significance of abuse;

(6) what, if any, risk there is to the public health;

(7) its psychic or physiological dependence liability; and

(8) whether the substance is an immediate precursor of a substance already controlled under this title.

After considering the above factors, the Attorney General shall make findings with respect thereto and shall issue an order controlling the substance if he finds that the substance has a potential for abuse.

(b) If the Attorney General designates a substance as an immediate precursor, substances which are precursors of the controlled precursor shall not be subject to control solely because they are precursors of the controlled precursor.

(c) When, for the purpose of greater protection of the public, at the time a new drug application is submitted to the Department of Health, Education, and Welfare for any drug having a stimulant, depressant, or hallucinogenic effect on the central nervous system, it appears that such drug has an abuse potential, such information shall be forwarded by the Department of Health, Education, and Welfare to the Bureau of Narcotics and Dangerous Drugs for the review by the Scientific Advisory Committee prior to their advising the Attorney General whether or not to control such drug under this Act.

(d) The Attorney General shall not remove any schedule I substance of this title to schedules III or IV, nor shall he delete such substances from the control of this Act unless specifically authorized by the Congress to do so.

SCHEDULES OF CONTROLLED SUBSTANCES

SEC. 202. The following schedules include the controlled dangerous substances listed or to be listed by whatever official name, common or usual name, chemical name, or trade name designated.

(a) Schedule I-In determining that a substance comes within this schedule, the Attorney General shall find:

(1) a high potential for abuse, and

(2) no accepted medical use in the United States, and

(3) a lack of accepted safety for use under medical supervision.

Included in this schedule is any material, compound, mixture, or preparation which contains any quantity of the following hallucinogenic substances, their salts, isomers, and salts of isomers, unless specifically excepted, whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

(1) Bufotenine.

(2) Diethyltryptamine.

(3) Dimethyltryptamine.

(4) 4-methyl-2,5-dimethoxyamphetamine.

(5) Ibogaine.

(6) Lysergic acid diethylamide.

(7) Mescaline.

(8) Peyote.

(9) Psilocybin.

(10) Psilocyn.

(b) Schedule II-In determining that a substance comes within this schedule, the Attorney General shall find:

(1) a high potential for abuse,

(2) currently accepted medical use in the United States, or currently accepted medical use with severe restrictions, and

(3) abuse may lead to severe psychic or physical dependence.

(c) Schedule III-In determining that a substance comes within this schedule, the Attorney General shall find:

(1) a potential for abuse less than the substances listed in schedules I and II; and,

(2) well documented and approved medical use in the United States; and, (3) abuse may lead to moderate or low physical dependence or high psychological dependence.

The following classes of controlled dangerous substances are included in this schedule:

(A) Any material, compound, mixture, or preparation which contain any quantity of the following substances having a potential for abuse associated with a stimulant effect on the central nervous system:

(1) Amphetamine, its salts, optical isomers, and salts of its optical isomers. (2) Phenmetrazine and its salts.

(3) Any substance which contains any quantity of methaphetamine, including its salts, isomers, and salts of isomers.

(B) Any material, compound, mixture, or preparation which contains any quantity of the following substances having a potential for abuse associated with a depressant effect on the central nervous system:

(1) Any substance which contains any quantity of a derivative of barbituric acid, or any salt of a derivative of barbituric acid, except those substances which are specifically listed in other schedules.

(2) Chloral betaine.

(3) Chloral hydrate.
(4) Chlorhexadol.
(5) Ethchlorvynol.

(6) Ethinamate.

(7) Glutethimide.

(8) Lysergic acid.

(9) Lysergic acid amide.

(10) Methylphenidate.

(11) Methyprylon.

(12) Pareldehyde.

(13) Petrichloral.

(14) Sulfondiethylmethane.

(15) Sulfonethylmethane.

(16) Sulfonmethane.

(C) Nalorphine.

The Attorney General may by regulation accept any compound, mixture, or preparation containing any stimulant or depressant substance listed in paragraphs (A) and (B) of this schedule above from the application of all or any part of this Act if the compound, mixture, or preparation contains one or more active medicinal ingredients not having a stimulant or depressant effect on the central nervous system: Provided, That such admixtures shall 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.

(d) Schedule IV-In determining that a substance comes within this schedule, the Attorney General shall find:

(1) a low potential for abuse relative to the substances listed in schedule III; and

(2) currently accepted medical use in the United States; and

(3) limited physical dependence and/or psychological dependence liability relative to the substances listed in schedule III.

EXCLUDED SUBSTANCES

SEC. 203. No substance that is subject to any provision of the Internal Revenue Code of 1954, the Narcotic Drugs Import and Export Act, the Opium Poppy Control Act of 1942, or the Narcotics Manufacturing Act of 1960 may be included in any schedule established in section 202.

TITLE III-REGULATION OF MANUFACTURE,

DISTRIBUTION, AND

DISPENSING OF CONTROLLED DANGEROUS SUBSTANCES

RULES AND REGULATIONS

SEC. 301. The Attorney General is authorized to promulgate rules and regulations and to charge reasonable fees relating to the registration and control of the manufacture, distribution, and dispensing of controlled dangerous substances.

REGISTRATION REQUIREMENTS

SEC. 302. (a) Every person who manufactures, distributes, or dispenses any controlled dangerous substance or who proposes to engage in the manufacture, distribution, or dispensing of any controlled dangerous substance, shall obtain annually a registration issued by the Attorney General in accordance with the rules and regulations promulgated by him.

(b) The Attorney General may, by regulation, waive the requirement for registration of certain manufacturers, distributors, or dispensers if he finds it consistent with the public health and safety.

(c) A separate registration shall be required at each principal place of business or professional practice where the applicant manufactures, distributes, or dispenses controlled dangerous substances listed in the schedules in section 202.

(d) The Attorney General is authorized to inspect the establishment of a registrant or applicant for registration in accordance with the rules and regulations promulgated by him.

REGISTRATION

SEC. 303. (a) The Attorney General shall register an applicant to manufacture controlled dangerous substances included in schedule I or II or title II of this Act if he determines that such registration is consistent with the public interest. In determining the public interest, the following factors shall be considered:

(1) maintenance of effective controls against diversion of particular controlled dangerous substances and any schedule I or II substance compounded therefrom into other than legitimate medical, scientific, or industrial channels, by limiting the importation and manufacture of such controlled dangerous substances to a number of establishments small enough to avoid diversion while producing an adequate and uninterrupted supply of these substances at reasonable prices for legitimate medical, scientific, and industrial

purposes;

(2) compliance with applicable State and local law;

(3) promotion of technical advances in the art of manufacturing these substances and the development of new substances;

(4) prior conviction record of applicant under Federal and State laws relating to the manufacture, distribution, or dispensing of such substances; (5) past experience in the manufacture of controlled dangerous substances, and the existence in the establishment of effective control against diversion; and,

(6) such other factors as may be relevant to and consistent with the public health and safety.

(b) The Attorney General shall register an applicant to distribute a controlled dangerous substance included in schedule I or II unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the following factors shall be considered:

(1) maintenance of effective control against diversion of particular controlled dangerous substances into other than legitimate medical, scientific, and industrial channels;

(2) compliance with applicable State and local law;

(3) prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances; (4) past experience in the distribution of controlled dangerous substances; and

(5) such other factors as may be relevant to and consistent with the public health and safety.

(c) Registration granted under subsections (a) and (b) of this section shall not entitle a registrant to manufacture and distribute controlled dangerous substances in schedule I or II other than those specified in the registration, or any quantity of those controlled dangerous substances in excess of the quota assigned pursuant to section 306.

(d) The Attorney General shall register an applicant to manufacture controlled dangerous substances included in schedules III and IV unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the following factors shall be considered:

(1) maintenance of effective controls against diversion of particular controlled dangerous substances and any schedule III or IV substance compounded therefrom into other than legitimate medical, scientific, or industrial channels;

(2) compliance with applicable State and local law;

(3) promotion of technical advances in the art of manufacturing these substances and the development of new substances;

(4) prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances; (5) past experience in the manufacture, distribution, and dispensing of controlled dangerous substances, and the existence in the establishment of effective controls against diversion; and

(6) such other factors as may be relevant to and consistent with the public health and safety.

(e) The Attorney General shall register an applicant to distribute controlled dangerous substances included in schedules III and IV unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the following factors shall be considered:

(1) maintenance of effective controls against diversion of particular controlled dangerous substances into other than legitimate medical, scientific, and industrial channels;

(2) compliance with applicable State and local law;

(3) prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances; (4) past experience in the distribution of controlled dangerous substances; and

(5) such other factors as may be relevant to and consistent with the public health and safety.

(f) Practitioners shall be registered to dispense substances in schedules II through IV if they are authorized to dispense under the law of the State in which they practice. A registration application by a practitioner who wishes to conduct research with schedule I substances shall be referred to the Secretary of Health, Education, and Welfare for advice. The Secretary shall promptly advise the Attorney General concerning the qualifications of each practitioner requesting reg