21 U.S.C. § 360bbb–7 — Notification

(a) Notification to Secretary For a given drug, the Secretary can require a "regulated person" to notify the Secretary whenever that person knows: (1) using the drug in the United States could cause serious injury or death; (2) a significant amount of the drug meant for U.S. use has been lost or is known to have been stolen; or (3) (A) the drug has been or is being counterfeited, and (B) either (i) the counterfeit version is already in U.S. commerce or could reasonably be expected to get there, or (ii) the real drug has been or is being imported into the United States, or could reasonably be expected to be offered for import. (b) Manner of notification The Secretary decides, by regulation or guidance, exactly how and in what form this notification must be made. (c) Savings clause This section doesn't limit any other authority the Secretary already has to require drug-related notifications under other parts of this chapter or the Public Health Service Act. (d) Definition A "regulated person" is (1) anyone required to register under section 360 or 381(s) of this title; (2) a wholesale distributor of a drug product; or (3) any other drug distributor — except one that distributes exclusively for retail sale.