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21 U.S.C. § 814 — Removal of exemption of certain drugs

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 814 — Removal of exemption of certain drugs

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Source location: Title 21, Chapter 13, § 814; chapter-013-drug-abuse-prevention-and-control.md

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**(a) Removal of exemption** The Attorney General shall by regulation remove from exemption under [section 802(39)(A)(iv) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section802/39/A/iv&num=0&edition=prelim) a drug or group of drugs that the Attorney General finds is being diverted to obtain a listed chemical for use in the illicit production of a controlled substance. **(b) Factors to be considered** In removing a drug or group of drugs from exemption under subsection (a), the Attorney General shall consider, with respect to a drug or group of drugs that is proposed to be removed from exemption— (1) the scope, duration, and significance of the diversion; (2) whether the drug or group of drugs is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance; and (3) whether the listed chemical can be readily recovered from the drug or group of drugs. **(c) Specificity of designation** The Attorney General shall limit the designation of a drug or a group of drugs removed from exemption under subsection (a) to the most particularly identifiable type of drug or group of drugs for which evidence of diversion exists unless there is evidence, based on the pattern of diversion and other relevant factors, that the diversion will not be limited to that particular drug or group of drugs. **(d) Reinstatement of exemption with respect to particular drug products** (1) **Reinstatement** — On application by a manufacturer of a particular drug product that has been removed from exemption under subsection (a), the Attorney General shall by regulation reinstate the exemption with respect to that particular drug product if the Attorney General determines that the particular drug product is manufactured and distributed in a manner that prevents diversion. (2) **Factors to be considered** — In deciding whether to reinstate the exemption with respect to a particular drug product under paragraph (1), the Attorney General shall consider— (A) the package sizes and manner of packaging of the drug product; (B) the manner of distribution and advertising of the drug product; (C) evidence of diversion of the drug product; (D) any actions taken by the manufacturer to prevent diversion of the drug product; and (E) such other factors as are relevant to and consistent with the public health and safety, including the factors described in subsection (b) as applied to the drug product. (3) **Status pending application for reinstatement** — A transaction involving a particular drug product that is the subject of a bona fide pending application for reinstatement of exemption filed with the Attorney General not later than 60 days after a regulation removing the exemption is issued pursuant to subsection (a) shall not be considered to be a regulated transaction if the transaction occurs during the pendency of the application and, if the Attorney General denies the application, during the period of 60 days following the date on which the Attorney General denies the application, unless— (A) the Attorney General has evidence that, applying the factors described in subsection (b) to the drug product, the drug product is being diverted; and (B) the Attorney General so notifies the applicant. (4) **Amendment and modification** — A regulation reinstating an exemption under paragraph (1) may be modified or revoked with respect to a particular drug product upon a finding that— (A) applying the factors described in subsection (b) to the drug product, the drug product is being diverted; or (B) there is a significant change in the data that led to the issuance of the regulation.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 802 — Definitions

As used in this subchapter: (1) The term “addict” means any individual who habitually uses any narcotic drug so as to endanger the public morals, health, safety, or welfare, or who is so far addicted to the use of narcotic drugs as to have lost the power of self-control with reference to his addiction. (2) The term “administer” refers to the direct application of a controlled substance to the body of a patient or research subject by— (A) a practitioner (or, in his presence, by his authorized agent), or (B) the patient or research subject at the direction and in the presence of the practitioner, whether such application be by injection, inhalation, ingestion, or any other means. (3) The term “agent” means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser; except that such term does not include a common or contract carrier, public warehouseman, or employee of the carrier or warehouseman, when acting in the usual and lawful course of the carrier’s or warehouseman’s business. (4) The term “Drug Enforcement Administration” means the Drug Enforcement Administration in the Department of Justice. (5) The term “control” means to add a drug or other substance, or immediate precursor, to a schedule under part B of this subchapter, whether by transfer from another schedule or otherwise. (6) The term “controlled substance” means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of this subchapter. The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in subtitle E of the Internal Revenue Code of 1986. (7) The term “counterfeit substance” means a controlled substance which, or the container or labelin

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 801 — Congressional findings and declarations: controlled substances

The Congress makes the following findings and declarations: (1) Many of the drugs included within this subchapter have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people. (2) The illegal importation, manufacture, distribution, and possession and improper use of controlled substances have a substantial and detrimental effect on the health and general welfare of the American people. (3) A major portion of the traffic in controlled substances flows through interstate and foreign commerce. Incidents of the traffic which are not an integral part of the interstate or foreign flow, such as manufacture, local distribution, and possession, nonetheless have a substantial and direct effect upon interstate commerce because— (A) after manufacture, many controlled substances are transported in interstate commerce, (B) controlled substances distributed locally usually have been transported in interstate commerce immediately before their distribution, and (C) controlled substances possessed commonly flow through interstate commerce immediately prior to such possession. (4) Local distribution and possession of controlled substances contribute to swelling the interstate traffic in such substances. (5) Controlled substances manufactured and distributed intrastate cannot be differentiated from controlled substances manufactured and distributed interstate. Thus, it is not feasible to distinguish, in terms of controls, between controlled substances manufactured and distributed interstate and controlled substances manufactured and distributed intrastate. (6) Federal control of the intrastate incidents of the traffic in controlled substances is essential to the effective control of the interstate incidents

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 814 — Removal of exemption of certain drugs

Page 804 TITLE 21—FOOD AND DRUGS § 813 General had issued a final order in accordance with such paragraph.’’ PLACEMENT OF PIPRADROL AND SPA IN SCHEDULE IV TO CARRY OUT OBLIGATION UNDER CONVENTION ON PSYCHOTROPIC SUBSTANCES Pub. L. 95–633, title I, § 102(c), Nov. 10, 1978, 92 Stat. 3772, provided that: ‘‘For the purpose of carrying out the minimum United States obligations under para- graph 7 of article 2 of the Convention on Psychotropic Substances, signed at Vienna, Austria, on February 21, 1971, with respect to pipradrol and SPA (also known as (-)-1-dimethylamino-1,2-diphenylethane), the Attorney General shall by order, made without regard to sections 201 and 202 of the Controlled Substances Act [this sec- tion and section 811 of this title], place such drugs in schedule IV of such Act [see subsec. (c) of this sec- tion].’’ Provision of section 102(c) of Pub. L. 95–633, set out above, effective on the date the Convention on Psycho- tropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95–633, set out as an Effective Date note under section 801a of this title. § 813. Treatment of controlled substance ana- logues (a) In general A controlled substance analogue shall, to the extent intended for human consumption, be treated, for the purposes of any Federal law as a controlled substance in schedule I. (b) Determination In determining whether a controlled substance analogue was intended for human consumption under subsection (a), the following factors may be considered, along with any other relevant factors: (1) The marketing, advertising, and labeling of the substance. (2) The known efficacy or usefulness of the substance for the marketed, advertised, or la- beled purpose. (3) The difference be

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