§826 — Title 21 Food and Drugs | U.S. Code

Summary

The Attorney General must set the total amount and yearly production limits for each basic class of drugs in Schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine. Those limits are meant to meet medical, scientific, research, industrial, export, and reserve needs. Quotas are usually set by the basic drug class, not by pill or dosage form, unless using dosage forms will help avoid too much production, shortages, or illegal diversion. If the total allowed amount is lowered, each maker’s limit is cut by the same percent. If a maker already made more than their new limit before the cut, the extra amount is taken off next year’s quota. Makers must apply by December 1 for the next year’s quota, and the Attorney General will consider their expected sales, inventory, recent national trends, supply problems, strikes, fires, and other relevant factors. Makers who did not produce in past years can still get a quota based on expected needs. Makers may ask for more quota during the year if needed. Small amounts that are created accidentally during a lawful manufacturing process do not need a separate registration or quota, though the Attorney General can make rules about keeping or disposing of them. Ephedrine, pseudoephedrine, and phenylpropanolamine include their salts and optical isomers. If a Schedule II drug is listed as being in shortage and its manufacturer asks for more, the Attorney General must review the request and act within 30 days—either increase the quotas as needed or explain in writing why not. For five named opioids (fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone), the Attorney General must estimate how much is being diverted for illegal use, consult with the Secretary of Health and Human Services about overdose and abuse data, and cut quotas to account for that diversion. If a quota for one of those opioids is raised above the prior year, the Attorney General must explain why the public health benefit outweighs the risk of more drug supply. Starting within one year after October 24, 2018, and each year after, the Attorney General must send Congress reports (including anonymized counts of manufacturers and quota increases) to the listed congressional committees and must, within one year after October 24, 2018, report how quota decisions will reflect changes in medical use and how the Attorney General will work with HHS to estimate drugs collected by take-back programs.

Title 21, §826

Food and Drugs — Source: USLM XML via OLRC

(a)(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 establishment and maintenance of reserve stocks. Except as provided in paragraph (2), production quotas shall be established in terms of quantities 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 controlled substance, establish an aggregate or individual production quota under this subsection, or a procurement quota established by the Attorney General by regulation, in terms of pharmaceutical dosage forms prepared from or containing the controlled substance.

(b)The Attorney General shall limit or reduce individual 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 registered manufacturer for each basic class of controlled substance in schedule I or II or for ephedrine, 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)On or before December 1 of each year, upon application therefor by a registered manufacturer, the Attorney General shall fix a manufacturing quota for the basic classes of controlled substances 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 manufacturer’s estimated disposal, inventory, and other requirements for the calendar year; and, in making his determination, the Attorney General shall consider the manufacturer’s current rate of disposal, the trend of the national disposal rate during the preceding calendar year, the manufacturer’s production cycle and inventory position, the economic availability of raw materials, yield and stability problems, emergencies such as strikes and fires, and other factors.

(d)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 phenylpropanolamine during one or more preceding calendar years. In fixing such quota, the Attorney General shall take into account the registrant’s reasonably anticipated requirements for the current year; and, in making his determination of such requirements, he shall consider such factors specified in subsection (c) of this section as may be relevant.

(e)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 requirements during the remainder of that year. In passing upon the application the Attorney General shall take into consideration any occurrences 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 application the Attorney General may also take into account the amount, if any, by which the determination of the Attorney General under subsection (a) of this section exceeds the aggregate of the quotas of all registrants under this section.

(f)Notwithstanding any other provisions of this subchapter, no registration or quota may be required for the manufacture of such quantities of controlled substances in schedules I and II or ephedrine, pseudoephedrine, or phenylpropanolamine as incidentally and necessarily result from the manufacturing process used for the manufacture of a controlled substance or of ephedrine, pseudoephedrine, or phenylpropanolamine with respect to which its manufacturer is duly registered under this subchapter. The Attorney General may, by regulation, prescribe restrictions on the retention and disposal of such incidentally produced substances or chemicals.

(g)Each reference in this section to ephedrine, pseudoephedrine, or phenylpropanolamine includes each of the salts, optical isomers, and salts of optical isomers of such chemical.

(h)(1)Not later than 30 days after the receipt of a request described in paragraph (2), the Attorney 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 substance 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 Attorney General shall provide a written response detailing the basis for the Attorney General’s determination.

(2)A request is described in this paragraph if—

(A)the request pertains to a controlled substance on the list of drugs in shortage maintained under section 356e of this title;

(B)the request is submitted by the manufacturer of the controlled substance; and

(C)the controlled substance is in schedule II.

(i)(1)(A)In establishing any quota under this section, or any procurement quota established by the Attorney General by regulation, for fentanyl, oxycodone, hydrocodone, oxymorphone, or hydromorphone (in this subsection referred to as a “covered controlled substance”), the Attorney General shall estimate the amount of diversion of the covered controlled substance that occurs in the United States.

(B)In estimating diversion under this paragraph, the Attorney General—

(i)shall consider information the Attorney General, in consultation with the Secretary of Health and Human Services, determines reliable 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 reductions, 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 aggregate production quota for a covered controlled substance is higher than the approved aggregate production quota for the covered controlled substance for the previous year, the Attorney General, in consultation with the Secretary of Health and Human Services, shall include in the final order an explanation of why the public health benefits of increasing the quota clearly outweigh the consequences of having an increased volume of the covered controlled substance available for sale, and potential 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 Appropriations of the Senate and the Committee on the Judiciary, the Committee on Energy and Commerce, and the Committee on Appropriations of the House of Representatives the following information with regard to each covered controlled substance:

(i)An anonymized count of the total number of manufacturers issued individual manufacturing quotas that year for the covered controlled substance.

(ii)An anonymized count of how many such manufacturers were issued an approved manufacturing quota that was higher than the quota issued to that manufacturer for the covered 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 programs, and take-back events.

Notes & Related Subsidiaries

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), designated existing provisions as par. (1), substituted “Except as provided in paragraph (2), production” for “Production” in second sentence, and added par. (2). Subsec. (b). Pub. L. 115–271, § 3282(a)(2), substituted “reduce individual manufacturing” for “reduce individual 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 phenylpropanolamine” after “for each basic class of controlled 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 schedule 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 phenylpropanolamine” after “the manufacture of a controlled substance”, 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 “October” 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 section 704(c) of Pub. L. 91–513, set out as a note under section 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 section 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 section 830, 842, 952, 960, and 971 of this title], the Attorney General shall consult with the United States Trade Representative to ensure implementation complies with all applicable international treaties and obligations of the United States.”

§826 Production Quotas for Controlled Substances

Summary

Title 21, §826

Notes & Related Subsidiaries

Editorial Notes

References in Text

Amendments

Statutory Notes and Related Subsidiaries

Effective Date

Effective Date

Citations & Metadata