Sec. 713. STANDARDS FOR ADMISSION OF IMPORTED DRUGS
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## SEC. 713 STANDARDS FOR ADMISSION OF IMPORTED DRUGS Section 801 (21 U.S.C. 381) is amended— ####
(1)in subsection (o), by striking “drug or”; and ####
(2)by adding at the end the following: > > ### “(r) > > > ####
(1)> > The Secretary may require, pursuant to the regulations promulgated under paragraph (4)(A), as a condition of granting admission to a drug imported or offered for import into the United States, that the importer electronically submit information demonstrating that the drug complies with applicable requirements of this Act. > > > #### “(2) > > The information described under paragraph
(1)may include— > > > ##### “(A) > > information demonstrating the regulatory status of the drug, such as the new drug application, abbreviated new drug application, or investigational new drug or drug master file number; > > > ##### “(B) > > facility information, such as proof of registration and the unique facility identifier; > > > ##### “(C) > > indication of compliance with current good manufacturing practice, testing results, certifications relating to satisfactory inspections, and compliance with the country of export regulations; and > > > ##### “(D) > > any other information deemed necessary and appropriate by the Secretary to assess compliance of the article being offered for import. > > > #### “(3) > > Information requirements referred to in paragraph (2)(C) may, at the discretion of the Secretary, be satisfied— > > > ##### “(A) > > through representation by a foreign government, if an inspection is conducted by a foreign government using standards and practices as determined appropriate by the Secretary; > > > ##### “(B) > > through representation by a foreign government or an agency of a foreign government recognized under section 809; or > > > ##### “(C) > > other appropriate documentation or evidence as described by the Secretary. > > > #### “(4) > > > #####
(A)> > Not later than 18 months after the date of enactment of the Food and Drug Administration Safety and Innovation Act, the Secretary shall adopt final regulations implementing this subsection. Such requirements shall be appropriate for the type of import, such as whether the drug is for import into the United States for use in preclinical research or in a clinical investigation under an investigational new drug exemption under 505(i). > > > ##### “(B) > > In promulgating the regulations under subparagraph (A), the Secretary— > > > ###### “(i) > > may, as appropriate, take into account differences among importers and types of imports, and, based on the level of risk posed by the imported drug, provide for expedited clearance for those importers that volunteer to participate in partnership programs for highly compliant companies and pass a review of internal controls, including sourcing of foreign manufacturing inputs, and plant inspections; and > > > ###### “(ii) > > shall— > > > ###### “(I) > > issue a notice of proposed rulemaking that includes the proposed regulation; > > > ###### “(II) > > provide a period of not less than 60 days for comments on the proposed regulation; and > > > ###### “(III) > > publish the final regulation not less than 30 days before the effective date of the regulation. > > > ##### “(C) > > Notwithstanding any other provision of law, the Secretary shall promulgate regulations implementing this subsection only as described in subparagraph (B).” > .
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Sec. 713
STANDARDS FOR ADMISSION OF IMPORTED DRUGS
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