Sec. 715. NOTIFICATION
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## SEC. 715 NOTIFICATION ###
(a)Prohibited Acts Section 301 (21 U.S.C. 331), as amended by section 714 of this Act, is further amended by adding at the end the following: > > ###### “(bbb) > > The failure to notify the Secretary in violation of section 568.” > . ###
(b)Notification Subchapter E of chapter V (21 U.S.C. 360bbb et seq.) is amended by adding at the end the following: > > ## “SEC. 568 NOTIFICATION > > > ### “(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 Act or the Public Health Service Act. > > > ### “(d) Definition > > In this section, the term ‘regulated person’ means— > > > #### “(1) > > a person who is required to register under section 510 or 801(s); > > > #### “(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.” > .
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