---
kind: "section"
citation: "21 U.S.C. § 356e"
title: "21"
title_heading: "Food and Drugs"
number: "356e"
heading: "Drug shortage list"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/356e"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §356e. Drug shortage list

- (a) **Establishment—** The [Secretary](/usc/21/321.md?p=d) shall maintain an up-to-date list of [drugs](/usc/21/321.md?p=g-1) that are determined by the [Secretary](/usc/21/321.md?p=d) to be in shortage in the United States.
- (b) **Contents—** For each [drug](/usc/21/321.md?p=g-1) on such list, the [Secretary](/usc/21/321.md?p=d) shall include the following information:
  - (1) The name of the [drug](/usc/21/321.md?p=g-1) in shortage, including the National Drug Code number for such [drug](/usc/21/321.md?p=g-1).
  - (2) The name of each [manufacturer](/usc/21/360hh.md?p=3) of such [drug](/usc/21/321.md?p=g-1).
  - (3) The reason for the shortage, as determined by the [Secretary](/usc/21/321.md?p=d), selecting from the following categories:
    - (A) Requirements related to complying with good manufacturing practices.
    - (B) Regulatory delay.
    - (C) Shortage of an active ingredient.
    - (D) Shortage of an inactive ingredient component.
    - (E) Discontinuance of the manufacture of the [drug](/usc/21/321.md?p=g-1).
    - (F) Delay in shipping of the [drug](/usc/21/321.md?p=g-1).
    - (G) Demand increase for the [drug](/usc/21/321.md?p=g-1).
  - (4) The estimated duration of the shortage as determined by the [Secretary](/usc/21/321.md?p=d).
- (c) **Public availability—**
  - (1) **In general—** Subject to paragraphs [(2)](#c-2) and [(3)](#c-3), the [Secretary](/usc/21/321.md?p=d) shall make the information in such list publicly available.
  - (2) **Trade secrets and confidential information—** Nothing in this section alters or amends [section 1905 of title 18](/usc/18/1905.md) or [section 552(b)(4) of title 5](/usc/5/552.md?p=b-4).
  - (3) **Public health exception—** The [Secretary](/usc/21/321.md?p=d) may choose not to make information collected under this section publicly available under [paragraph (1)](#c-1) or [section 356c(c) of this title](/usc/21/356c.md?p=c) if the [Secretary](/usc/21/321.md?p=d) determines that disclosure of such information would adversely affect the public health (such as by increasing the possibility of hoarding or other disruption of the availability of [drug products](/usc/21/321.md?p=dd) to patients).
- (d) **Interagency notification—** Not later than 180 days after March 27, 2020, and every 90 days thereafter, the [Secretary](/usc/21/321.md?p=d) shall transmit a report regarding the [drugs](/usc/21/321.md?p=g-1) of the current [drug](/usc/21/321.md?p=g-1) shortage list under this section to the [Administrator](/usc/21/321.md?p=hh) of the Centers for Medicare & Medicaid Services.

## Source credit

(June 25, 1938, ch. 675, § 506E, as added Pub. L. 112–144, title X, § 1004, July 9, 2012, 126 Stat. 1104; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(G), Dec. 13, 2016, 130 Stat. 1153; Pub. L. 116–136, div. A, title III, § 3112(c), Mar. 27, 2020, 134 Stat. 362.)

## Notes

### Editorial Notes

### Amendments

2020—Subsec. (d). Pub. L. 116–136 added subsec. (d).

2016—Subsec. (b)(3)(E). Pub. L. 114–255, which directed substitution of “discontinuance” for “discontinuation”, was executed by substituting “Discontinuance” for “Discontinuation” to reflect the probable intent of Congress.

### Statutory Notes and Related Subsidiaries

### Effective Date of 2020 Amendment

Amendment by Pub. L. 116–136 effective 180 days after Mar. 27, 2020, see section 3112(g) of Pub. L. 116–136, set out as a note under section 356c of this title.