---
kind: "section"
citation: "21 U.S.C. § 360bbb–7"
title: "21"
title_heading: "Food and Drugs"
number: "360bbb–7"
heading: "Notification"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360bbb-7"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part E — General Provisions Relating to Drugs and Devices"
---

# §360bbb–7. Notification

- (a) **Notification to Secretary—** With respect to a [drug](/usc/21/321.md?p=g-1), the [Secretary](/usc/21/321.md?p=d) may require notification to the [Secretary](/usc/21/321.md?p=d) by a regulated [person](/usc/21/321.md?p=e) if the regulated [person](/usc/21/321.md?p=e) knows—
  - (1) that the use of such [drug](/usc/21/321.md?p=g-1) in the United States may result in serious injury or death;
  - (2) of a significant loss or known theft of such [drug](/usc/21/321.md?p=g-1) intended for use in the United States; or
  - (3) that—
    - (A) such [drug](/usc/21/321.md?p=g-1) has been or is being counterfeited; and
    - (B)
      - (i) the counterfeit [product](/usc/21/360eee.md?p=13) is in [commerce](/usc/21/360hh.md?p=4) in the United States or could be reasonably expected to be introduced into [commerce](/usc/21/360hh.md?p=4) in the United States; or
      - (ii) such [drug](/usc/21/321.md?p=g-1) has been or is being imported into the United States or may reasonably be expected to be offered for import into the United States.
- (b) **Manner of notification—** Notification under this section shall be made in such manner and by such means as the [Secretary](/usc/21/321.md?p=d) may specify by regulation or guidance.
- (c) **Savings clause—** Nothing in this section shall be construed as limiting any other authority of the [Secretary](/usc/21/321.md?p=d) to require notifications related to a [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.].
- (d) **Definition—** In this section, the term “regulated [person](/usc/21/321.md?p=e)” means—
  - (1) a [person](/usc/21/321.md?p=e) who is required to register under section [360](/usc/21/360.md) or [381(s)](/usc/21/381.md?p=s) of this title;
  - (2) a [wholesale distributor](/usc/21/360eee.md?p=29) of a [drug product](/usc/21/321.md?p=dd); or
  - (3) any other [person](/usc/21/321.md?p=e) that [distributes](/usc/21/360eee.md?p=5) [drugs](/usc/21/321.md?p=g-1) except a [person](/usc/21/321.md?p=e) that [distributes](/usc/21/360eee.md?p=5) [drugs](/usc/21/321.md?p=g-1) exclusively for retail sale.

## Source credit

(June 25, 1938, ch. 675, § 568, as added Pub. L. 112–144, title VII, § 715(b), July 9, 2012, 126 Stat. 1075.)

## Notes

### Editorial Notes

### References in Text

The Public Health Service Act, referred to in subsec. (c), 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.