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21 U.S.C. § 826 — Production quotas for controlled substances
Federal law — U.S. Code and appendices · legal_authorities
**(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 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) Individual manufacturing quotas; revised quotas** 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 limitati
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Source location: Title 21, Chapter 13, § 826; chapter-013-drug-abuse-prevention-and-control.md
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**(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 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) Individual manufacturing quotas; revised quotas** 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) Manufacturing quotas for registered manufacturers** 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) Quotas for registrants who have not manufactured 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 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) 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 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) Incidental production exception** 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) Reference to ephedrine, pseudoephedrine, or phenylpropanolamine** 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) Quotas applicable to drugs in shortage**
(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.
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 substance on the list of drugs in shortage maintained under [section 356e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356e&num=0&edition=prelim);
(B) the request is submitted by the manufacturer 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 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.
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Federal law — U.S. Code and appendices · legal_authorities
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
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 801
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Establishment** The Secretary shall maintain an up-to-date list of drugs that are determined by the Secretary to be in shortage in the United States.
**(b) Contents** For each drug on such list, the Secretary shall include the following information:
(1) The name of the drug in shortage, including the National Drug Code number for such drug.
(2) The name of each manufacturer of such drug.
(3) The reason for the shortage, as determined by the Secretary, selecting from the following categories:
(A) Requirements related to complying with good manufacturing practices.
(B) Regulatory delay.
(C) Shortage of an active ingredient.
(D) Shortage of an inactive ingredient component.
(E) Discontinuance of the manufacture of the drug.
(F) Delay in shipping of the drug.
(G) Demand increase for the drug.
(4) The estimated duration of the shortage as determined by the Secretary.
**(c) Public availability**
(1) **In general** — Subject to paragraphs (2) and (3), the Secretary shall make the information in such list publicly available.
(2) **Trade secrets and confidential information** — Nothing in this section alters or amends [section 1905 of title 18](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1905&num=0&edition=prelim) or [section 552(b)(4) of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552/b/4&num=0&edition=prelim).
(3) **Public health exception** — The Secretary may choose not to make information collected under this section publicly available under paragraph (1) or [section 356c(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356c/c&num=0&edition=prelim) if the Secretary determines that disclosure of such information would advers
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 356e
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** A manufacturer of a drug—
(1) that is—
(A) life-supporting;
(B) life-sustaining; or
(C) intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery or any such drug that is critical to the public health during a public health emergency declared by the Secretary under [section 247d of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d&num=0&edition=prelim); and
(2) that is not a radio pharmaceutical drug product or any other product as designated by the Secretary,
shall notify the Secretary, in accordance with subsection (b), of a permanent discontinuance in the manufacture of the drug or an interruption of the manufacture of the drug that is likely to lead to a meaningful disruption in the supply of that drug in the United States, or a permanent discontinuance in the manufacture of an active pharmaceutical ingredient or an interruption in the manufacture of the active pharmaceutical ingredient of such drug that is likely to lead to a meaningful disruption in the supply of the active pharmaceutical ingredient of such drug, and the reasons for such discontinuance or interruption. Notification under this subsection shall include disclosure of reasons for the discontinuation or interruption, and if applicable, an active pharmaceutical ingredient is a reason for, or risk factor in, such discontinuation or interruption, the source of the active pharmaceutical ingredient and any alternative sources for the active pharmaceutical ingredient known by the manufacturer; whether any associated device used for preparation or administration included in the drug is a reason for, or a risk factor in, such discontinuati
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Federal law — U.S. Code and appendices · legal_authorities
### Statutory Notes
Sections, Pub. L. 86–429, Apr. 22, 1960, 74 Stat. 55, provided for licensing and control of the manufacture of all narcotic drugs and was known as the “Narcotic Manufacturing Act of 1960”. Sections 1 to 3 and 5 to 22 of said Pub. L. 86–429 were classified respectively to sections 501, 501 notes, and 502 to 517 of this title. Section 4 of Pub. L. 86–429 was classified to sections 4702, 4731, and 4731 note of Title 26, Internal Revenue Code. See section 801 et seq. of this title.
#### Effective Date of Repeal
Repeal effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 1105(a) of Pub. L. 91–513, set out as a note under [section 951 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section951&num=0&edition=prelim). For provisions postponing such effective date if the Attorney General postpones the effective date of [section 826 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section826&num=0&edition=prelim), see section 1105(c) of Pub. L. 91–513, set out as an Effective Date note under [section 951 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section951&num=0&edition=prelim).
#### Savings Provision
Prosecutions for any violation of law occurring, and civil seizures or forfeitures and injunctive proceedings commenced, prior to the effective date of repeal of these sections by section 1101 of Pub. L. 91–513 not to be affected or abated by reason thereof, see section 1103 of Pub. L. 91–513, set out as a note under sections 171 to 174 of this title.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Manufacturers of controlled substances in schedule I or II** The Attorney General shall register an applicant to manufacture controlled substances in schedule I or II if he determines that such registration is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. In determining the public interest, the following factors shall be considered:
(1) maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule I or II compounded therefrom into other than legitimate medical, scientific, research, or industrial channels, by limiting the importation and bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, 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 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) Distributors of controlled substances in schedule I or II** The Attorney General shall register an applicant to distribute a controlled substance in schedule I or II unless he determines that the issuance of such registration is inconsist
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 823
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Grounds** A registration pursuant to [section 823 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823&num=0&edition=prelim) to manufacture, distribute, or dispense a controlled substance or a list I chemical may be suspended or revoked by the Attorney General upon a finding that the registrant—
(1) has materially falsified any application filed pursuant to or required by this subchapter or subchapter II;
(2) has been convicted of a felony under this subchapter or subchapter II or any other law of the United States, or of any State, relating to any substance defined in this subchapter as a controlled substance or a list I chemical;
(3) has had his State license or registration suspended, revoked, or denied by competent State authority and is no longer authorized by State law to engage in the manufacturing, distribution, or dispensing of controlled substances or list I chemicals or has had the suspension, revocation, or denial of his registration recommended by competent State authority;
(4) has committed such acts as would render his registration under [section 823 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823&num=0&edition=prelim) inconsistent with the public interest as determined under such section; or
(5) has been excluded (or directed to be excluded) from participation in a program pursuant to [section 1320a–7(a) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1320a–7/a&num=0&edition=prelim).
A registration pursuant to [section 823(h) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823/h&num=0&edition=prelim) to dispense a narcotic drug for maintenance treatment or detoxification tr
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Federal law — U.S. Code and appendices · legal_authorities
Not later than 6 months after July 9, 2012, and annually thereafter, the Attorney General shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on the Judiciary of the Senate a report on drug shortages that—
(1) identifies the number of requests received under [section 826(h) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section826/h&num=0&edition=prelim) (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 section, 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section826&num=0&edition=prelim) when such a drug is determined by the Secretary to be in shortage.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 826a
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Unlawful acts** It shall be unlawful for any person—
(1) who is subject to the requirements of part C to distribute or dispense a controlled substance in violation of [section 829 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section829&num=0&edition=prelim);
(2) who is a registrant to distribute or dispense a controlled substance not authorized by his registration to another registrant or other authorized person or to manufacture a controlled substance not authorized by his registration;
(3) who is a registrant to distribute a controlled substance in violation of [section 825 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section825&num=0&edition=prelim);
(4) to remove, alter, or obliterate a symbol or label required by [section 825 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section825&num=0&edition=prelim);
(5) to refuse or negligently fail to make, keep, or furnish any record, report, notification, declaration, order or order form, statement, invoice, or information required under this subchapter or subchapter II;
(6) to refuse any entry into any premises or inspection authorized by this subchapter or subchapter II;
(7) to remove, break, injure, or deface a seal placed upon controlled substances pursuant to section 824(f) or 881 of this title or to remove or dispose of substances so placed under seal;
(8) to use, to his own advantage, or to reveal, other than to duly authorized officers or employees of the United States, or to the courts when relevant in any judicial proceeding under this subchapter or subchapter II, any information acquired in the course of an inspection authorized by this subchapter concerning any method or process which
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Federal law — U.S. Code and appendices · legal_authorities
**(a)** For purposes of this subchapter—
(1) The term “import” means, with respect to any article, any bringing in or introduction of such article into any area (whether or not such bringing in or introduction constitutes an importation within the meaning of the tariff laws of the United States).
(2) The term “customs territory of the United States” has the meaning assigned to such term by general note 2 of the Harmonized Tariff Schedule of the United States.
**(b)** Each term defined in [section 802 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section802&num=0&edition=prelim) shall have the same meaning for purposes of this subchapter as such term has for purposes of subchapter I.
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Federal law — U.S. Code and appendices · legal_authorities
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). Pu
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 826
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