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.
Notification under this section shall be made in such manner and by such means as the Secretary may specify by regulation or guidance.
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.].
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.
(June 25, 1938, ch. 675, §568, as added Pub. L. 112–144, title VII, §715(b), July 9, 2012, 126 Stat. 1075.)
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Last modified: October 26, 2015