---
kind: "section"
citation: "21 U.S.C. § 360bbb–8d"
title: "21"
title_heading: "Food and Drugs"
number: "360bbb–8d"
heading: "Notification, nondistribution, and recall of controlled substances"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360bbb-8d"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part E — General Provisions Relating to Drugs and Devices"
---

# §360bbb–8d. Notification, nondistribution, and recall of controlled substances

- (a) **Order to cease distribution and recall—**
  - (1) **In general—** If the [Secretary](/usc/21/321.md?p=d) determines there is a reasonable probability that a controlled substance would cause serious adverse health consequences or death, the [Secretary](/usc/21/321.md?p=d) may, after providing the appropriate [person](/usc/21/321.md?p=e) with an opportunity to consult with the agency, issue an order requiring [manufacturers](/usc/21/360hh.md?p=3), importers, distributors, or pharmacists, who [distribute](/usc/21/360eee.md?p=5) such controlled substance to immediately cease [distribution](/usc/21/360eee.md?p=5) of such controlled substance.
  - (2) **Hearing—** An order under [paragraph (1)](#a-1) shall provide the [person](/usc/21/321.md?p=e) subject to the order with an opportunity for an [informal hearing](/usc/21/321.md?p=x), to be held not later than 10 days after the date of issuance of the order, on whether adequate evidence exists to justify an amendment to the order, and what actions are required by such amended order pursuant to subparagraph (3).
  - (3) **Order resolution—** After an order is issued according to the process under paragraphs [(1)](#a-1) and [(2)](#a-2), the [Secretary](/usc/21/321.md?p=d) shall, except as provided in [paragraph (4)](#a-4)—
    - (A) vacate the order, if the [Secretary](/usc/21/321.md?p=d) determines that inadequate grounds exist to support the actions required by the order;
    - (B) continue the order ceasing [distribution](/usc/21/360eee.md?p=5) of the controlled substance until a date specified in such order; or
    - (C) amend the order to require a recall of the controlled substance, including any requirements to notify appropriate [persons](/usc/21/321.md?p=e), a timetable for the recall to occur, and a schedule for updates to be provided to the [Secretary](/usc/21/321.md?p=d) regarding such recall.
  - (4) **Risk assessment—** If the [Secretary](/usc/21/321.md?p=d) determines that the risk of recalling a controlled substance presents a greater health risk than the health risk of not recalling such controlled substance from use, an amended order under subparagraph [(B)](#a-3-B) or [(C)](#a-3-C) of paragraph (3) shall not include either a recall order for, or an order to cease [distribution](/usc/21/360eee.md?p=5) of, such controlled substance, as applicable.
  - (5) **Action following order—** Any [person](/usc/21/321.md?p=e) who is subject to an order pursuant to subparagraph [(B)](#a-3-B) or [(C)](#a-3-C) of paragraph (3) shall immediately cease [distribution](/usc/21/360eee.md?p=5) of or recall, as applicable, the controlled substance and provide notification as required by such order.
- (b) **Notice to persons affected—** If the [Secretary](/usc/21/321.md?p=d) determines necessary, the [Secretary](/usc/21/321.md?p=d) may require the [person](/usc/21/321.md?p=e) subject to an order pursuant to paragraph (1) or an amended order pursuant to subparagraph (B) or (C) of paragraph (3) to provide either a notice of a recall order for, or an order to cease [distribution](/usc/21/360eee.md?p=5) of, such controlled substance, as applicable, under this section to appropriate [persons](/usc/21/321.md?p=e), including [persons](/usc/21/321.md?p=e) who manufacture, [distribute](/usc/21/360eee.md?p=5), import, or offer for sale such [product](/usc/21/360eee.md?p=13) that is the subject of an order and to the public. In providing such notice, the [Secretary](/usc/21/321.md?p=d) may use the assistance of health professionals who prescribed or dispensed such controlled substances.
- (c) **Nondelegation—** An order described in [subsection (a)(3)](#a-3) shall be ordered by the [Secretary](/usc/21/321.md?p=d) or an official designated by the [Secretary](/usc/21/321.md?p=d). An official may not be so designated under this section unless the official is the Director of the Center for [Drug](/usc/21/321.md?p=g-1) Evaluation and Research or an official senior to such Director.
- (d) **Savings clause—** Nothing contained in this section shall be construed as limiting—
  - (1) the authority of the [Secretary](/usc/21/321.md?p=d) to issue an order to cease [distribution](/usc/21/360eee.md?p=5) of, or to recall, any [drug](/usc/21/321.md?p=g-1) under any other provision of this chapter or the Public Health Service Act [[42 U.S.C. 201](/usc/42/201.md) et seq.]; or
  - (2) the ability of the [Secretary](/usc/21/321.md?p=d) to request any [person](/usc/21/321.md?p=e) to perform a voluntary activity related to any [drug](/usc/21/321.md?p=g-1) subject to this chapter or the Public Health Service Act.

## Source credit

(June 25, 1938, ch. 675, § 569D, as added Pub. L. 115–271, title III, § 3012(b), Oct. 24, 2018, 132 Stat. 3935.)

## Notes

### Editorial Notes

### References in Text

The Public Health Service Act, referred to in subsec. (d), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.