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

# §356d. Coordination; task force and strategic plan

- (a) **Task force and strategic plan—**
  - (1) **In general—**
    - (A) **Task force—** As soon as practicable after July 9, 2012, the [Secretary](/usc/21/321.md?p=d) shall establish a task force to develop and implement a strategic plan for enhancing the [Secretary](/usc/21/321.md?p=d)’s response to preventing and mitigating [drug](/usc/21/321.md?p=g-1) shortages.
    - (B) **Strategic plan—** The strategic plan described in [subparagraph (A)](#a-1-A) shall include—
      - (i) plans for enhanced interagency and intra-agency coordination, communication, and decisionmaking;
      - (ii) plans for ensuring that [drug](/usc/21/321.md?p=g-1) shortages are considered when the [Secretary](/usc/21/321.md?p=d) initiates a regulatory action that could precipitate a [drug](/usc/21/321.md?p=g-1) shortage or exacerbate an existing [drug](/usc/21/321.md?p=g-1) shortage;
      - (iii) plans for effective communication with outside stakeholders, including who the [Secretary](/usc/21/321.md?p=d) should alert about potential or actual [drug](/usc/21/321.md?p=g-1) shortages, how the communication should occur, and what types of information should be shared;
      - (iv) plans for considering the impact of [drug](/usc/21/321.md?p=g-1) shortages on research and clinical trials; and
      - (v) an examination of whether to establish a “qualified manufacturing partner program”, as described in [subparagraph (C)](#a-1-C).
    - (C) **Description of program—** In conducting the examination of a “qualified manufacturing partner program” under [subparagraph (B)(v)](#a-1-B-v), the [Secretary](/usc/21/321.md?p=d)—
      - (i) shall take into account that—
        - (I) a “qualified [manufacturer](/usc/21/360hh.md?p=3)”, for purposes of such program, would need to have the capability and capacity to supply [products](/usc/21/360eee.md?p=13) determined or anticipated to be in shortage; and
        - (II) in examining the capability and capacity to supply [products](/usc/21/360eee.md?p=13) in shortage, the “qualified [manufacturer](/usc/21/360hh.md?p=3)” could have a site that manufactures a [drug](/usc/21/321.md?p=g-1) listed under [section 356e of this title](/usc/21/356e.md) or have the capacity to produce [drugs](/usc/21/321.md?p=g-1) in response to a shortage within a rapid timeframe; and
      - (ii) shall examine whether incentives are necessary to encourage the participation of “qualified [manufacturers](/usc/21/360hh.md?p=3)” in such a program.
    - (D) **Consultation—** In carrying out this paragraph, the task force shall ensure consultation with the appropriate offices within the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, including the Office of the [Commissioner](/usc/21/321.md?p=ee), the Center for [Drug](/usc/21/321.md?p=g-1) Evaluation and Research, the Office of Regulatory Affairs, and employees within the [Department](/usc/21/321.md?p=c) of Health and Human Services with expertise regarding [drug](/usc/21/321.md?p=g-1) shortages. The [Secretary](/usc/21/321.md?p=d) shall engage external stakeholders and experts as appropriate.
  - (2) **Timing—** Not later than 1 year after July 9, 2012, the task force shall—
    - (A) publish the strategic plan described in [paragraph (1)](#a-1); and
    - (B) submit such plan to Congress.
- (b) **Communication—** The [Secretary](/usc/21/321.md?p=d) shall ensure that, prior to any enforcement action or issuance of a warning letter that the [Secretary](/usc/21/321.md?p=d) determines could reasonably be anticipated to lead to a meaningful disruption in the supply in the United States of a [drug](/usc/21/321.md?p=g-1) described under [section 356c(a) of this title](/usc/21/356c.md?p=a), there is communication with the appropriate office 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 regarding whether the action or letter could cause, or exacerbate, a shortage of the [drug](/usc/21/321.md?p=g-1).
- (c) **Action—** If the [Secretary](/usc/21/321.md?p=d) determines, after the communication described in [subsection (b)](#b), that an enforcement action or a warning letter could reasonably cause or exacerbate a shortage of a [drug](/usc/21/321.md?p=g-1) described under [section 356c(a) of this title](/usc/21/356c.md?p=a), then the [Secretary](/usc/21/321.md?p=d) shall evaluate the risks associated with the impact of such shortage upon patients and those risks associated with the violation involved before taking such action or issuing such letter, unless there is imminent risk of serious adverse health consequences or death to humans.
- (d) **Reporting by other entities—** The [Secretary](/usc/21/321.md?p=d) shall identify or establish a mechanism by which health care providers and other third-party organizations may report to the [Secretary](/usc/21/321.md?p=d) evidence of a [drug](/usc/21/321.md?p=g-1) shortage.
- (e) **Review and construction—** No determination, finding, action, or omission of the [Secretary](/usc/21/321.md?p=d) under this section shall—
  - (1) be subject to judicial review; or
  - (2) be construed to establish a defense to an enforcement action by the [Secretary](/usc/21/321.md?p=d).
- (f) **Temporary sunset—** [Subsection (a)](#a) shall cease to be effective on the date that is 5 years after July 9, 2012. Subsections [(b)](#b), [(c)](#c), and [(e)](#e) shall not be in effect during the period beginning 5 years after July 9, 2012, and ending on December 29, 2022. Subsections [(b)](#b), [(c)](#c), and [(e)](#e) shall be in effect beginning on December 29, 2022.
- (g) **Coordination—** The [Secretary](/usc/21/321.md?p=d) shall ensure timely and effective internal coordination and alignment among 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 regarding—
  - (1) the reviews of reports shared pursuant to [section 374(b)(2) of this title](/usc/21/374.md?p=b-2); and
  - (2) any feedback or corrective or preventive actions in response to such reports.

## Source credit

(June 25, 1938, ch. 675, § 506D, as added Pub. L. 112–144, title X, § 1003, July 9, 2012, 126 Stat. 1103; amended Pub. L. 117–328, div. FF, title III, § 3616(a), Dec. 29, 2022, 136 Stat. 5874.)

## Notes

### Editorial Notes

### Amendments

2022—Subsec. (f). Pub. L. 117–328, § 3616(a)(2), amended subsec. (f) generally. Prior to amendment, text read as follows: “Subsections (a), (b), (c), and (e) shall cease to be effective on the date that is 5 years after July 9, 2012.”

Subsec. (g). Pub. L. 117–328, § 3616(a)(1), added subsec. (g).