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 between the price at which the substance is sold and the price at which the substance it is purported to be or adver- tised as is normally sold. (4) The diversion of the substance from le- gitimate channels and the clandestine impor- tation, manufacture, or distribution of the substance. (5) Whether the defendant knew or should have known the substance was intended to be consumed by injection, inhalation, ingestion, or any other immediate means. (6) Any controlled substance analogue that is manufactured, formulated, sold, distributed, or marketed with the intent to avoid the pro- visions of existing drug laws. (c) Limitation For purposes of this section, evidence that a substance was not marketed, advertised, or la- beled for human consumption, by itself, shall not be sufficient to establish that the substance was not intended for human consumption. (Pub. L. 91–513, title II, § 203, as added Pub. L. 99–570, title I, § 1202, Oct. 27, 1986, 100 Stat. 3207–13; amended Pub. L. 100–690, title VI, § 6470(c), Nov. 18, 1988, 102 Stat. 4378; Pub. L. 115–271, title III, § 3241, Oct. 24, 2018, 132 Stat. 3950.) Editorial Notes REFERENCES IN TEXT Schedule I, referred to in subsec. (a), is set out in sec- tion 812(c) of this title. AMENDMENTS 2018—Pub. L. 115–271 designated existing provisions as subsec. (a), inserted heading, and added subsecs. (b) and (c). 1988—Pub. L. 100–690 substituted ‘‘any Federal law’’ for ‘‘this subchapter and subchapter II of this chapter’’. § 814. Removal of exemption of certain drugs (a) Removal of exemption The Attorney General shall by regulation re- move from exemption under section 802(39)(A)(iv) of this title 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 ex- emption under subsection (a), the Attorney Gen- eral 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 for- mulated 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 read- ily recovered from the drug or group of drugs. (c) Specificity of designation The Attorney General shall limit the designa- tion of a drug or a group of drugs removed from exemption under subsection (a) to the most par- ticularly identifiable type of drug or group of drugs for which evidence of diversion exists un- less there is evidence, based on the pattern of di- version and other relevant factors, that the di- version 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 par- ticular drug product that has been removed from exemption under subsection (a), the At- torney General shall by regulation reinstate the exemption with respect to that particular drug product if the Attorney General deter- mines that the particular drug product is man- ufactured and distributed in a manner that prevents diversion. (2) Factors to be considered In deciding whether to reinstate the exemp- tion with respect to a particular drug product under paragraph (1), the Attorney General shall consider— (A) the package sizes and manner of pack- aging of the drug product; (B) the manner of distribution and adver- tising of the drug product; (C) evidence of diversion of the drug prod- uct; Page 805 TITLE 21—FOOD AND DRUGS § 822 (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 prod- uct. (3) Status pending application for reinstate- ment A transaction involving a particular drug product that is the subject of a bona fide pend- ing application for reinstatement of exemp- tion 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 At- torney General denies the application, during the period of 60 days following the date on which the Attorney General denies the appli- cation, unless— (A) the Attorney General has evidence that, applying the factors described in sub- section (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 sub- section (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 regula- tion. (Pub. L. 91–513, title II, § 204, as added Pub. L. 103–200, § 2(b)(1), Dec. 17, 1993, 107 Stat. 2334; amended Pub. L. 104–237, title IV, § 401(c), Oct. 3, 1996, 110 Stat. 3108; Pub. L. 109–177, title VII, § 712(a)(2), Mar. 9, 2006, 120 Stat. 263.) Editorial Notes AMENDMENTS 2006—Subsec. (e). Pub. L. 109–177 struck out subsec. (e). Text read as follows: ‘‘Pursuant to subsection (d)(1) of this section, the Attorney General shall by regula- tion reinstate the exemption with respect to a par- ticular ephedrine, pseudoephedrine, or phenyl- propanolamine drug product if the Attorney General determines that the drug product is manufactured and distributed in a manner that prevents diversion. In making this determination the Attorney General shall consider the factors listed in subsection (d)(2) of this section. Any regulation issued pursuant to this sub- section may be amended or revoked based on the fac- tors listed in subsection (d)(4) of this section.’’ 1996—Subsec. (e). Pub. L. 104–237 added subsec. (e). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104–237 not applicable to sale of any pseudoephedrine or phenylpropanolamine prod- uct prior to 12 months after Oct. 3, 1996, except that, on application of manufacturer of particular drug product, Attorney General may exercise sole and judicially unreviewable discretion to extend such effective date up to additional 6 months, see section 401(g) of Pub. L. 104–237, set out as a note under section 802 of this title. EFFECTIVE DATE Section effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as an Effective Date of 1993 Amendment note under section 802 of this title. PART C—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CON- TROLLED SUBSTANCES § 821. Rules and regulations The Attorney General is authorized to promul- gate rules and regulations and to charge reason- able fees relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances and to listed chemicals. (Pub. L. 91–513, title II, § 301, Oct. 27, 1970, 84 Stat. 1253; Pub. L. 103–200, § 3(a), Dec. 17, 1993, 107 Stat. 2336; Pub. L. 108–447, div. B, title VI, § 633(b), Dec. 8, 2004, 118 Stat. 2922.) Editorial Notes AMENDMENTS 2004—Pub. L. 108–447 substituted ‘‘listed chemicals’’ for ‘‘the registration and control of regulated persons and of regulated transactions’’. 1993—Pub. L. 103–200 inserted before period at end ‘‘and to the registration and control of regulated per- sons and of regulated transactions’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1993 AMENDMENT Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title. EFFECTIVE DATE Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title. § 822. Persons required to register (a) Period of registration (1) Every person who manufactures or distrib- utes any controlled substance or list I chemical, or who proposes to engage in the manufacture or distribution of any controlled substance or list I chemical, shall obtain annually a registration issued by the Attorney General in accordance with the rules and regulations promulgated by him. (2) Every person who dispenses, or who pro- poses to dispense, any controlled substance, shall obtain from the Attorney General a reg- istration issued in accordance with the rules and regulations promulgated by him. The Attorney General shall, by regulation, determine the pe- riod of such registrations. In no event, however, shall such registrations be issued for less than one year nor for more than three years. (3)(A) Except as provided in subparagraph (C), the registration of any registrant under this subchapter to manufacture, distribute, or dis- pense controlled substances or list I chemicals terminates if and when such registrant—