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21 U.S.C. § 826a — Attorney General report on drug shortages
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.
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Source file: Laws/federal/codes/united-states-code/title-21/section-826a-attorney-general-report-on-drug-shortages--79730112c8.md
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Source location: Title 21, Chapter 13, § 826a; chapter-013-drug-abuse-prevention-and-control.md
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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.
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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
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 356c
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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
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 826
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Federal law — U.S. Code and appendices · legal_authorities
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
St
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 826a
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