21 U.S.C. § 356c–1 — Annual reporting on drug shortages

submitted 88 years ago by Pub. L. 112-144 to r/title-21-FOOD-AND-DRUGS · 401 words · no verdicts yet

in plain englishAI-generated · not legal advice

Each year by March 31, the Secretary must report to Congress on drug shortages. The report must cover shortage numbers, FDA actions taken, and communication between FDA offices. The Secretary may also hire an outside expert to study the causes of drug shortages.

(a) By March 31 each year, the Secretary must send Congress a report on drug shortages from the previous year. This report must cover several things. It must state how many manufacturers reported a drug shortage to the Secretary. It must describe how FDA field investigators communicate with the drug shortage staff at the Center for Drug Evaluation and Research. It must describe efforts to coordinate shortage responses under section 356d(g) of this title. It must give the number of shortage-related reports required to be sent to the right FDA offices, and how many actually were sent. It must list the major actions the Secretary took to prevent or ease shortages. This includes how many applications got expedited review and how many facility inspections were expedited. It must describe coordination between the FDA and the Drug Enforcement Administration on shortages. It must describe cases where the FDA used regulatory flexibility to prevent or ease a shortage. It must list manufacturers that received warning letters under section 356c(f) of this title. Finally, it must state the total number of drug shortages that occurred that year. (b) The Secretary may hire an outside party to study the causes, trends, or solutions related to drug shortages, if the Secretary believes it would help. (c) In this section, "drug shortage" or "shortage" has the same meaning given to it in section 356c of this title.

facts

- Codified at 21 U.S.C. § 356c–1, titled "Annual reporting on drug shortages." - Originally enacted as § 506C–1 of the Federal Food, Drug, and Cosmetic Act (ch. 675) via Pub. L. 112–144, title X, § 1002, July 9, 2012. - The provision has been amended twice since enactment, by Pub. L. 114–255 (2016) and Pub. L. 117–328 (2022). - The statutory text comprises 401 words across three subsections (a)–(c). - Source credit reflects three total legislative references (one enacting, two amending).

the actual law source: uscode.house.gov ↗public domain

(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 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;

(4)

provides the number of reports that were required under section 374(b)(2) of this title 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 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 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; 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.

In this section, the term “drug shortage” or “shortage” has the meaning given such term in section 356c of this title.

Source credit: (June 25, 1938, ch. 675, § 506C–1, as added Pub. L. 112–144, title X, § 1002, July 9, 2012, 126 Stat. 1102; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(F), Dec. 13, 2016, 130 Stat. 1153; Pub. L. 117–328, div. FF, title III, § 3616(b)(1), Dec. 29, 2022, 136 Stat. 5875.)

history & why it existsrecord from the source credit

1938Enacted · Pub. L. 112-144 · 126 Stat. 1102
2016Amended · Pub. L. 114-255 · 130 Stat. 1153
2022Amended · Pub. L. 117-328 · 136 Stat. 5875

The source credit identifies this section as originating in the Federal Food, Drug, and Cosmetic Act of June 25, 1938 (ch. 675), with the specific provision, § 506C–1, added by Public Law 112–144, title X, § 1002, on July 9, 2012 (126 Stat. 1102). The record further shows two subsequent amendments: one by Public Law 114–255, division A, title III, § 3101(a)(2)(F), enacted December 13, 2016 (130 Stat. 1153), and another by Public Law 117–328, division FF, title III, § 3616(b)(1), enacted December 29, 2022 (136 Stat. 5875). Together these citations indicate a provision created within a broader 1938 regulatory framework but substantively shaped by legislative action in the early 2010s and refined twice more in the following decade. Public Law 112–144 is known as the Food and Drug Administration Safety and Innovation Act of 2012, legislation commonly understood to have reauthorized user-fee programs for drugs and devices while also adding new authorities addressing emerging public health concerns, including drug shortages. The commonly cited purpose of the drug-shortage provisions added by this Act was to improve early notification, tracking, and Congressional oversight of shortages affecting the U.S. drug supply. Beyond this general understanding, the record here does not establish the specific legislative intent behind the annual-reporting requirement itself, nor does it document the particular concerns motivating the 2016 or 2022 amendments. Any more detailed account of Congressional purpose would exceed what the supplied source credit and general historical knowledge can support.

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