21 U.S.C. § 356c–1: Annual reporting on drug…

Summary

By March 31 each year, the Secretary must send a report to the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee about drug shortages from the previous calendar year. The report must say how many manufacturers sent shortage notices under section 356c(a); explain how FDA field investigators talk with the Center for Drug Evaluation and Research’s Office of Compliance and Drug Shortage Program and what rules ensure that communication; describe coordination done under section 356d(g); give the number of reports required under section 374(b)(2) and how many were actually sent; list major actions taken to prevent or ease shortages and include counts of expedited application reviews under section 356c(g)(1) and expedited inspections or reinspections under section 356c(g)(2); describe FDA–DEA coordination; identify when FDA used regulatory flexibility to address shortages; list manufacturers who got letters under section 356c(f); and state how many drug shortages occurred that year as identified by the Secretary. The Secretary may hire an outside group to study causes, trends, or solutions for drug shortages. The term "drug shortage" has the meaning given in section 356c.

Title 21, §356c–1

Food and Drugs, Source: USLM XML via OLRC

(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.

(c)Definition

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

Notes & Related Subsidiaries

Editorial Notes

Amendments

2022—Subsec. (a)(3) to (5). Pub. L. 117–328, § 3616(b)(1)(A), (B), added pars. (3) and (4) and redesignated former par. (3) as (5). Former pars. (4) and (5) redesignated (6) and (7), respectively. Subsec. (a)(5)(A). Pub. L. 117–328, § 3616(b)(1)(C), substituted “paragraph (9)” for “paragraph (7)”. Subsec. (a)(6) to (9). Pub. L. 117–328, § 3616(b)(1)(A), redesignated pars. (4) to (7) as (6) to (9), respectively. 2016—Subsec. (a). Pub. L. 114–255, in introductory provisions, substituted “Not later than March 31 of each calendar year,” for “Not later than the end of calendar year 2013, and not later than the end of each calendar year thereafter,” and inserted “, with respect to the preceding calendar year,” after “a report”.

Statutory Notes and Related Subsidiaries

Effective Date

of 2022 Amendment Pub. L. 117–328, div. FF, title III, § 3616(b)(2), Dec. 29, 2022, 136 Stat. 5875, provided that: “The

Amendments

made by paragraph (1) [amending this section] shall apply with respect to reports submitted under section 506C–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c–1) on or after March 31, 2024.”

§356c–1 Annual Reporting on Drug Shortages

Summary

Title 21, §356c–1

Notes & Related Subsidiaries

Editorial Notes

Amendments

Statutory Notes and Related Subsidiaries

Effective Date

Amendments

Citations & Metadata