---
kind: "section"
citation: "21 U.S.C. § 356c–1"
title: "21"
title_heading: "Food and Drugs"
number: "356c–1"
heading: "Annual reporting on drug shortages"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/356c-1"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part 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](/usc/21/321.md?p=d) shall submit to the Committee on Energy and [Commerce](/usc/21/360hh.md?p=4) 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](/usc/21/321.md?p=g-1) shortages that—
  - (1) specifies the number of [manufacturers](/usc/21/360hh.md?p=3) that submitted a notification to the [Secretary](/usc/21/321.md?p=d) under [section 356c(a) of this title](/usc/21/356c.md?p=a) during such calendar year;
  - (2) describes the communication between the field investigators of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration and the staff of the Center for [Drug](/usc/21/321.md?p=g-1) Evaluation and Research’s Office of Compliance and [Drug](/usc/21/321.md?p=g-1) Shortage Program, including the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) 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](/usc/21/356d.md?p=g);
  - (4) provides the number of reports that were required under [section 374(b)(2) of this title](/usc/21/374.md?p=b-2) to be sent to the appropriate offices of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration with expertise regarding [drug](/usc/21/321.md?p=g-1) shortages, and the number of such reports that were sent;
  - (5)
    - (A) lists the major actions taken by the [Secretary](/usc/21/321.md?p=d) to prevent or mitigate the [drug](/usc/21/321.md?p=g-1) shortages described in [paragraph (9)](#a-9);
    - (B) in the list under [subparagraph (A)](#a-5-A), includes—
      - (i) the number of applications and supplements for which the [Secretary](/usc/21/321.md?p=d) expedited review under [section 356c(g)(1) of this title](/usc/21/356c.md?p=g-1) during such calendar year; and
      - (ii) the number of establishment inspections or reinspections that the [Secretary](/usc/21/321.md?p=d) expedited under [section 356c(g)(2) of this title](/usc/21/356c.md?p=g-2) during such calendar year;
  - (6) describes the coordination between the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration and the [Drug](/usc/21/321.md?p=g-1) Enforcement Administration on efforts to prevent or alleviate [drug](/usc/21/321.md?p=g-1) shortages;
  - (7) identifies the number of and describes the instances in which the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration exercised regulatory flexibility and discretion to prevent or alleviate a [drug](/usc/21/321.md?p=g-1) shortage;
  - (8) lists the names of [manufacturers](/usc/21/360hh.md?p=3) that were issued letters under [section 356c(f) of this title](/usc/21/356c.md?p=f); and
  - (9) specifies the number of [drug](/usc/21/321.md?p=g-1) shortages occurring during such calendar year, as identified by the [Secretary](/usc/21/321.md?p=d).
- (b) **Trend analysis—** The [Secretary](/usc/21/321.md?p=d) is [authorized](/usc/21/360eee.md?p=2) to retain a third party to conduct a study, if the [Secretary](/usc/21/321.md?p=d) believes such a study would help clarify the causes, trends, or solutions related to [drug](/usc/21/321.md?p=g-1) shortages.
- (c) **Definition—** In this section, the term “[drug](/usc/21/321.md?p=g-1) shortage” or “shortage” has the meaning given such term in [section 356c of this title](/usc/21/356c.md).

## 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.)

## Notes

### 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.”