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21 U.S.C. § 356c–1 — Annual reporting on drug shortages
Federal law — U.S. Code and appendices · legal_authorities
**(a) Annual reports to Congress** Not later than March 31 of each calendar year, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report, with respect to the preceding calendar year, on drug shortages that—
(1) specifies the number of manufacturers that submitted a notification to the Secretary under [section 356c(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356c/a&num=0&edition=prelim) during such calendar year;
(2) describes the communication between the field investigators of the Food and Drug Administration and the staff of the Center for Drug Evaluation and Research’s Office of Compliance and Drug Shortage Program, including the Food and Drug Administration’s procedures for enabling and ensuring such communication;
(3) describes the coordination and alignment activities undertaken pursuant to [section 356d(g) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356d/g&num=0&edition=prelim);
(4) provides the number of reports that were required under [section 374(b)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374/b/2&num=0&edition=prelim) to be sent to the appropriate offices of the Food and Drug Administration with expertise regarding drug shortages, and the number of such reports that were sent;
(5)
(A) lists the major actions taken by the Secretary to prevent or mitigate the drug shortages described in paragraph (9);
(B) in the list under subparagraph (A), includes—
(i) the number of applications and supplements for which the Secretary expedited review under [section 356c(g)(1) of this ti
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Stable record: federal_law:legal_authorities:record_usc_2b4219e7cd95e69b78014a8a
Source file: Laws/federal/codes/united-states-code/title-21/section-356c1-annual-reporting-on-drug-shortages--6338ea7f6f.md
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Source location: Title 21, Chapter 9, § 356c–1; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) Annual reports to Congress** Not later than March 31 of each calendar year, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report, with respect to the preceding calendar year, on drug shortages that—
(1) specifies the number of manufacturers that submitted a notification to the Secretary under [section 356c(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356c/a&num=0&edition=prelim) during such calendar year;
(2) describes the communication between the field investigators of the Food and Drug Administration and the staff of the Center for Drug Evaluation and Research’s Office of Compliance and Drug Shortage Program, including the Food and Drug Administration’s procedures for enabling and ensuring such communication;
(3) describes the coordination and alignment activities undertaken pursuant to [section 356d(g) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356d/g&num=0&edition=prelim);
(4) provides the number of reports that were required under [section 374(b)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374/b/2&num=0&edition=prelim) to be sent to the appropriate offices of the Food and Drug Administration with expertise regarding drug shortages, and the number of such reports that were sent;
(5)
(A) lists the major actions taken by the Secretary to prevent or mitigate the drug shortages described in paragraph (9);
(B) in the list under subparagraph (A), includes—
(i) the number of applications and supplements for which the Secretary expedited review under [section 356c(g)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356c/g/1&num=0&edition=prelim) during such calendar year; and
(ii) the number of establishment inspections or reinspections that the Secretary expedited under [section 356c(g)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356c/g/2&num=0&edition=prelim) during such calendar year;
(6) describes the coordination between the Food and Drug Administration and the Drug Enforcement Administration on efforts to prevent or alleviate drug shortages;
(7) identifies the number of and describes the instances in which the Food and Drug Administration exercised regulatory flexibility and discretion to prevent or alleviate a drug shortage;
(8) lists the names of manufacturers that were issued letters under [section 356c(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356c/f&num=0&edition=prelim); and
(9) specifies the number of drug shortages occurring during such calendar year, as identified by the Secretary.
**(b) Trend analysis** The Secretary is authorized to retain a third party to conduct a study, if the Secretary believes such a study would help clarify the causes, trends, or solutions related to drug shortages.
**(c) Definition** In this section, the term “drug shortage” or “shortage” has the meaning given such term in [section 356c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356c&num=0&edition=prelim).
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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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