21 U.S.C. § 826 — Production quotas for controlled sub-

Page 823 TITLE 21—FOOD AND DRUGS § 826 an anabolic steroid or product containing an an- abolic steroid, unless the steroid or product bears a label clearly identifying an anabolic steroid or product containing an anabolic ster- oid by the nomenclature used by the Inter- national Union of Pure and Applied Chemistry (IUPAC). (2)(A) A product described in subparagraph (B) is exempt from the International Union of Pure and Applied Chemistry nomenclature require- ment of this subsection if such product is la- beled in the manner required under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]. (B) A product is described in this subpara- graph if the product— (i) is the subject of an approved application as described in section 505(b) or (j) of the Fed- eral Food, Drug, and Cosmetic Act [21 U.S.C. 355(b), (j)]; or (ii) is exempt from the provisions of section 505 of such Act relating to new drugs because— (I) it is intended solely for investigational use as described in section 505(i) of such Act; and (II) such product is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application. (Pub. L. 91–513, title II, § 305, Oct. 27, 1970, 84 Stat. 1256; Pub. L. 113–260, § 3(a), Dec. 18, 2014, 128 Stat. 2931.) Editorial Notes REFERENCES IN TEXT Schedules I, II, III, and IV, referred to in subsecs. (c) and (d), are set out in section 812(c) of this title. The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (e)(2)(A), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables. AMENDMENTS 2014—Subsec. (e). Pub. L. 113–260 added subsec. (e). Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, but with Attorney General authorized to postpone such effective date for such period as he might determine to be necessary for the efficient administration of this subchapter, see sec- tion 704(c) of Pub. L. 91–513, set out as a note under sec- tion 801 of this title. IDENTIFICATION AND PUBLICATION OF LIST OF PRODUCTS CONTAINING ANABOLIC STEROIDS Pub. L. 113–260, § 4, Dec. 18, 2014, 128 Stat. 2932, pro- vided that: ‘‘(a) IN GENERAL.—The Attorney General may, in the Attorney General’s discretion, collect data and analyze products to determine whether they contain anabolic steroids and are properly labeled in accordance with this Act [see section 1 of Pub. L. 113–260, set out as a Short Title of 2014 Amendment note under section 801 of this title] and the amendments made by this Act. The Attorney General may publish in the Federal Reg- ister or on the website of the Drug Enforcement Ad- ministration a list of products which the Attorney Gen- eral has determined, based on substantial evidence, contain an anabolic steroid and are not labeled in ac- cordance with this Act and the amendments made by this Act. ‘‘(b) ABSENCE FROM LIST.—The absence of a product from the list referred to in subsection (a) shall not con- stitute evidence that the product does not contain an anabolic steroid.’’ § 826. Production quotas for controlled sub- stances (a) Establishment of total annual needs (1) The Attorney General shall determine the total quantity and establish production quotas for each basic class of controlled substance in schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine to be manufactured each calendar year to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the estab- lishment and maintenance of reserve stocks. Ex- cept as provided in paragraph (2), production quotas shall be established in terms of quan- tities of each basic class of controlled substance and not in terms of individual pharmaceutical dosage forms prepared from or containing such a controlled substance. (2) The Attorney General may, if the Attorney General determines it will assist in avoiding the overproduction, shortages, or diversion of a con- trolled substance, establish an aggregate or in- dividual production quota under this subsection, or a procurement quota established by the At- torney General by regulation, in terms of phar- maceutical dosage forms prepared from or con- taining the controlled substance. (b) Individual manufacturing quotas; revised quotas The Attorney General shall limit or reduce in- dividual manufacturing quotas to the extent necessary to prevent the aggregate of individual quotas from exceeding the amount determined necessary each year by the Attorney General under subsection (a). The quota of each reg- istered manufacturer for each basic class of con- trolled substance in schedule I or II or for ephed- rine, pseudoephedrine, or phenylpropanolamine shall be revised in the same proportion as the limitation or reduction of the aggregate of the quotas. However, if any registrant, before the issuance of a limitation or reduction in quota, has manufactured in excess of his revised quota, the amount of the excess shall be subtracted from his quota for the following year. (c) Manufacturing quotas for registered manu- facturers On or before December 1 of each year, upon ap- plication therefor by a registered manufacturer, the Attorney General shall fix a manufacturing quota for the basic classes of controlled sub- stances in schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine that the manufacturer seeks to produce. The quota shall be subject to the provisions of subsections (a) and (b) of this section. In fixing such quotas, the Attorney General shall determine the manu- facturer’s estimated disposal, inventory, and other requirements for the calendar year; and, in making his determination, the Attorney Gen- eral shall consider the manufacturer’s current Page 824 TITLE 21—FOOD AND DRUGS § 826 rate of disposal, the trend of the national dis- posal rate during the preceding calendar year, the manufacturer’s production cycle and inven- tory position, the economic availability of raw materials, yield and stability problems, emer- gencies such as strikes and fires, and other fac- tors. (d) Quotas for registrants who have not manu- factured controlled substance during one or more preceding years The Attorney General shall, upon application and subject to the provisions of subsections (a) and (b) of this section, fix a quota for a basic class of controlled substance in schedule I or II for any registrant who has not manufactured that basic class of controlled substance or ephedrine, pseudoephedrine, or phenylpropanola- mine during one or more preceding calendar years. In fixing such quota, the Attorney Gen- eral shall take into account the registrant’s rea- sonably anticipated requirements for the cur- rent year; and, in making his determination of such requirements, he shall consider such fac- tors specified in subsection (c) of this section as may be relevant. (e) Quota increases At any time during the year any registrant who has applied for or received a manufacturing quota for a basic class of controlled substance in schedule I or II or for ephedrine, pseudoephedrine, or phenylpropanolamine may apply for an increase in that quota to meet his estimated disposal, inventory, and other re- quirements during the remainder of that year. In passing upon the application the Attorney General shall take into consideration any occur- rences since the filing of the registrant’s initial quota application that may require an increased manufacturing rate by the registrant during the balance of the year. In passing upon the applica- tion the Attorney General may also take into account the amount, if any, by which the deter- mination of the Attorney General under sub- section (a) of this section exceeds the aggregate of the quotas of all registrants under this sec- tion. (f) Incidental production exception Notwithstanding any other provisions of this subchapter, no registration or quota may be re- quired for the manufacture of such quantities of controlled substances in schedules I and II or ephedrine, pseudoephedrine, or phenylpropanola- mine as incidentally and necessarily result from the manufacturing process used for the manu- facture of a controlled substance or of ephed- rine, pseudoephedrine, or phenylpropanolamine with respect to which its manufacturer is duly registered under this subchapter. The Attorney General may, by regulation, prescribe restric- tions on the retention and disposal of such inci- dentally produced substances or chemicals. (g) Reference to ephedrine, pseudoephedrine, or phenylpropanolamine Each reference in this section to ephedrine, pseudoephedrine, or phenylpropanolamine in- cludes each of the salts, optical isomers, and salts of optical isomers of such chemical. (h) Quotas applicable to drugs in shortage (1) Not later than 30 days after the receipt of a request described in paragraph (2), the Attor- ney General shall— (A) complete review of such request; and (B)(i) as necessary to address a shortage of a controlled substance, increase the aggregate and individual production quotas under this section applicable to such controlled sub- stance and any ingredient therein to the level requested; or (ii) if the Attorney General determines that the level requested is not necessary to address a shortage of a controlled substance, the At- torney General shall provide a written re- sponse detailing the basis for the Attorney General’s determination. The Secretary shall make the written response provided under subparagraph (B)(ii) available to the public on the Internet Web site of the Food and Drug Administration. (2) A request is described in this paragraph if— (A) the request pertains to a controlled sub- stance on the list of drugs in shortage main- tained under section 356e of this title; (B) the request is submitted by the manufac- turer of the controlled substance; and (C) the controlled substance is in schedule II. (i) Strengthening considerations for DEA opioid quotas (1)(A) In establishing any quota under this sec- tion, or any procurement quota established by the Attorney General by regulation, for fentanyl, oxycodone, hydrocodone, oxymorphone, or hydromorphone (in this sub- section referred to as a ‘‘covered controlled sub- stance’’), the Attorney General shall estimate the amount of diversion of the covered con- trolled substance that occurs in the United States. (B) In estimating diversion under this para- graph, the Attorney General— (i) shall consider information the Attorney General, in consultation with the Secretary of Health and Human Services, determines reli- able on rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance in the United States; and (ii) may take into consideration whatever other sources of information the Attorney General determines reliable. (C) After estimating the amount of diversion of a covered controlled substance, the Attorney General shall make appropriate quota reduc- tions, as determined by the Attorney General, from the quota the Attorney General would have otherwise established had such diversion not been considered. (2)(A) For any year for which the approved ag- gregate production quota for a covered con- trolled substance is higher than the approved aggregate production quota for the covered con- trolled substance for the previous year, the At- torney General, in consultation with the Sec- retary of Health and Human Services, shall in- clude in the final order an explanation of why the public health benefits of increasing the Page 825 TITLE 21—FOOD AND DRUGS § 826a quota clearly outweigh the consequences of hav- ing an increased volume of the covered con- trolled substance available for sale, and poten- tial diversion, in the United States. (B) Not later than 1 year after October 24, 2018, and every year thereafter, the Attorney General shall submit to the Committee on the Judiciary, the Committee on Health, Education, Labor, and Pensions, and the Committee on Appropria- tions of the Senate and the Committee on the Judiciary, the Committee on Energy and Com- merce, and the Committee on Appropriations of the House of Representatives the following in- formation with regard to each covered con- trolled substance: (i) An anonymized count of the total number of manufacturers issued individual manufac- turing quotas that year for the covered con- trolled substance. (ii) An anonymized count of how many such manufacturers were issued an approved manu- facturing quota that was higher than the quota issued to that manufacturer for the cov- ered controlled substance in the previous year. (3) Not later than 1 year after October 24, 2018, the Attorney General shall submit to Congress a report on how the Attorney General, when fixing and adjusting production and manufacturing quotas under this section for covered controlled substances, will— (A) take into consideration changes in the accepted medical use of the covered controlled substances; and (B) work with the Secretary of Health and Human Services on methods to appropriately and anonymously estimate the type and amount of covered controlled substances that are submitted for collection from approved drug collection receptacles, mail-back pro- grams, and take-back events. (Pub. L. 91–513, title II, § 306, Oct. 27, 1970, 84 Stat. 1257; Pub. L. 94–273, § 3(16), Apr. 21, 1976, 90 Stat. 377; Pub. L. 109–177, title VII, § 713, Mar. 9, 2006, 120 Stat. 264; Pub. L. 112–144, title X, § 1005, July 9, 2012, 126 Stat. 1105; Pub. L. 115–271, title III, § 3282(a), Oct. 24, 2018, 132 Stat. 3954.) Editorial Notes REFERENCES IN TEXT Schedules I and II, referred to in text, are set out in section 812(c) of this title. AMENDMENTS 2018—Subsec. (a). Pub. L. 115–271, § 3282(a)(1), des- ignated existing provisions as par. (1), substituted ‘‘Ex- cept as provided in paragraph (2), production’’ for ‘‘Pro- duction’’ in second sentence, and added par. (2). Subsec. (b). Pub. L. 115–271, § 3282(a)(2), substituted ‘‘reduce individual manufacturing’’ for ‘‘reduce indi- vidual production’’. Subsec. (c). Pub. L. 115–271, § 3282(a)(3), substituted ‘‘December’’ for ‘‘October’’. Subsec. (i). Pub. L. 115–271, § 3282(a)(4), added subsec. (i). 2012—Subsec. (h). Pub. L. 112–144 added subsec. (h). 2006—Subsec. (a). Pub. L. 109–177, § 713(1), inserted ‘‘and for ephedrine, pseudoephedrine, and phenyl- propanolamine’’ after ‘‘for each basic class of con- trolled substance in schedules I and II’’. Subsec. (b). Pub. L. 109–177, § 713(2), inserted ‘‘or for ephedrine, pseudoephedrine, or phenylpropanolamine’’ after ‘‘for each basic class of controlled substance in schedule I or II’’. Subsec. (c). Pub. L. 109–177, § 713(3), inserted ‘‘and for ephedrine, pseudoephedrine, and phenylpropanolamine’’ after ‘‘for the basic classes of controlled substances in schedules I and II’’. Subsec. (d). Pub. L. 109–177, § 713(4), inserted ‘‘or ephedrine, pseudoephedrine, or phenylpropanolamine’’ after ‘‘that basic class of controlled substance’’. Subsec. (e). Pub. L. 109–177, § 713(5), inserted ‘‘or for ephedrine, pseudoephedrine, or phenylpropanolamine’’ after ‘‘for a basic class of controlled substance in sched- ule I or II’’. Subsec. (f). Pub. L. 109–177, § 713(6), inserted ‘‘or ephedrine, pseudoephedrine, or phenylpropanolamine’’ after ‘‘controlled substances in schedules I and II’’, ‘‘or of ephedrine, pseudoephedrine, or phenylpropanola- mine’’ after ‘‘the manufacture of a controlled sub- stance’’, and ‘‘or chemicals’’ after ‘‘such incidentally produced substances’’. Subsec. (g). Pub. L. 109–177, § 713(7), added subsec. (g). 1976—Subsec. (c). Pub. L. 94–273 substituted ‘‘Octo- ber’’ for ‘‘July’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, but with Attorney General authorized to postpone such effective date for such period as he might determine to be necessary for the efficient administration of this subchapter, see sec- tion 704(c) of Pub. L. 91–513, set out as a note under sec- tion 801 of this title. CHANGE TO EDITORIAL HEADING IN UNITED STATES CODE Pub. L. 115–271, title III, § 3282(b), Oct. 24, 2018, 132 Stat. 3955, provided that: ‘‘The Law Revision Counsel is directed to amend the heading for subsection (b) of sec- tion 826 of title 21, United States Code, by striking ‘Production’ and inserting ‘Manufacturing’.’’ COORDINATION WITH UNITED STATES TRADE REPRESENTATIVE Pub. L. 109–177, title VII, § 718, Mar. 9, 2006, 120 Stat. 267, provided that: ‘‘In implementing sections 713 through 717 and section 721 of this title [amending this section and sections 830, 842, 952, 960, and 971 of this title], the Attorney General shall consult with the United States Trade Representative to ensure imple- mentation complies with all applicable international treaties and obligations of the United States.’’ § 826a. Attorney General report on drug short- ages Not later than 6 months after July 9, 2012, and annually thereafter, the Attorney General shall submit to the Committee on Energy and Com- merce of the House of Representatives and the Committee on the Judiciary of the Senate a re- port on drug shortages that— (1) identifies the number of requests received under section 826(h) of this title (as added by section 1005 of this Act), the average review time for such requests, the number of requests granted and denied under such section, and, for each of the requests denied under such sec- tion, the basis for such denial; (2) describes the coordination between the Drug Enforcement Administration and Food and Drug Administration on efforts to prevent or alleviate drug shortages; and (3) identifies drugs containing a controlled substance subject to section 826 of this title when such a drug is determined by the Sec- retary to be in shortage.