PRIA, Government Policy, Made Personal

Summary

The Secretary can require a regulated person to tell the Secretary when they know one of three things: that a drug’s use in the United States may cause serious injury or death; that a significant loss or theft of the drug meant for use in the United States has happened; or that the drug is being counterfeited and the fake product is or could be sold in the United States or is being or may be imported into the United States. Notifications must be made in the way the Secretary sets out in rules or guidance. This does not limit other notification powers the Secretary already has. A "regulated person" means (1) someone who must register under section 360 or 381(s) of this title, (2) a wholesale drug distributor, or (3) any other drug distributor except those who distribute only for retail sale.

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