§360bbb–7 — Title 21 Food and Drugs | U.S. Code

Summary

The Secretary can require people who handle drugs to notify the Secretary if they know any of these things: the drug’s use in the United States may cause serious injury or death; there has been a significant loss or a known theft of the drug meant for use in the United States; or the drug is being counterfeited and the fake is or could be in U.S. commerce or is being or may be offered for import. The Secretary will say how notices must be sent by rules or guidance. A "regulated person" means someone who must register under section 360 or 381(s), a wholesale drug distributor, or another drug distributor (but not a person who distributes only at retail). This rule does not limit other notification powers the Secretary has under other laws.

Title 21, §360bbb–7

Food and Drugs — Source: USLM XML via OLRC

(a)With respect to a drug, the Secretary may require notification to the Secretary by a regulated person if the regulated person knows—

(1)that the use of such drug in the United States may result in serious injury or death;

(2)of a significant loss or known theft of such drug intended for use in the United States; or

(3)that—

(A)such drug has been or is being counterfeited; and

(B)(i)the counterfeit product is in commerce in the United States or could be reasonably expected to be introduced into commerce in the United States; or

(ii)such drug 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)Notification under this section shall be made in such manner and by such means as the Secretary may specify by regulation or guidance.

(c)Nothing in this section shall be construed as limiting any other authority of the Secretary to require notifications related to a drug under any other provision of this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.].

(d)In this section, the term “regulated person” means—

(1)a person who is required to register under section 360 or 381(s) of this title;

(2)a wholesale distributor of a drug product; or

(3)any other person that distributes drugs except a person that distributes drugs exclusively for retail sale.

Notes & Related Subsidiaries

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.

§360bbb–7 Notification