Sec. 712. RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS
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## SEC. 712 RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS Chapter VIII (21 U.S.C. 381 et seq.) is amended by adding at the end the following: > > ## “SEC. 809 RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS > > **[**[21 U.S.C. 384e](/us/usc/t21/s384e)**]** > > > ### “(a) Inspection > > The Secretary— > > > #### “(1) > > may enter into arrangements and agreements with a foreign government or an agency of a foreign government to recognize the inspection of foreign establishments registered under section 510(i) in order to facilitate risk-based inspections in accordance with the schedule established in section 510(h)(3); > > > #### “(2) > > may enter into arrangements and agreements with a foreign government or an agency of a foreign government under this section only with a foreign government or an agency of a foreign government that the Secretary has determined as having the capability of conduction inspections that meet the applicable requirements of this Act; and > > > #### “(3) > > shall perform such reviews and audits of drug safety programs, systems, and standards of a foreign government or agency for the foreign government as the Secretary deems necessary to determine that the foreign government or agency of the foreign government is capable of conducting inspections that meet the applicable requirements of this Act. > > > ### “(b) Results of Inspection > > The results of inspections performed by a foreign government or an agency of a foreign government under this section may be used as— > > > #### “(1) > > evidence of compliance with section 501(a)(2)(B) or section 801(r); and > > > #### “(2) > > for any other purposes as determined appropriate by the Secretary.” > .
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