21 U.S. Code § 360bbb–7 - Notification

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(a) Notification to Secretary
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) Manner of notification
Notification under this section shall be made in such manner and by such means as the Secretary may specify by regulation or guidance.
(c) Savings clause
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) Definition
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.

Source

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

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21 CFR - Food and Drugs

21 CFR Part 4 - REGULATION OF COMBINATION PRODUCTS

21 CFR Part 5 - ORGANIZATION

21 CFR Part 7 - ENFORCEMENT POLICY

21 CFR Part 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES

21 CFR Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

21 CFR Part 12 - FORMAL EVIDENTIARY PUBLIC HEARING

21 CFR Part 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

21 CFR Part 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

21 CFR Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER

21 CFR Part 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

21 CFR Part 20 - PUBLIC INFORMATION

21 CFR Part 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS

21 CFR Part 312 - INVESTIGATIONAL NEW DRUG APPLICATION

 

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