[USC02] 21 USC 356c-1: Annual reporting on drug shortages
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21 USC 356c-1: Annual reporting on drug shortages Text contains those laws in effect on January 16, 2020
From Title 21-FOOD AND DRUGSCHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACTSUBCHAPTER V-DRUGS AND DEVICESPart A-Drugs and Devices

§356c–1. Annual reporting on drug shortages

(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)(A) lists the major actions taken by the Secretary to prevent or mitigate the drug shortages described in paragraph (7);

(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;


(4) describes the coordination between the Food and Drug Administration and the Drug Enforcement Administration on efforts to prevent or alleviate drug shortages;

(5) 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;

(6) lists the names of manufacturers that were issued letters under section 356c(f) of this title; and

(7) 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.

(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 .)

Amendments

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".