Sec. 4. Additional risk factors for consideration during inspections of drug and device establishments
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Section 510(h)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(h)(4) ) is amended— by redesignating subparagraph
(G)as subparagraph (J); and by inserting after subparagraph
(F)the following: Whether the establishment has been inspected by an entity that carries out inspections on behalf of a foreign government determined to be a foreign adversary under section 7.4 of title 15, Code of Federal Regulations (or successor regulations). The particular drugs or devices (with a focus on drugs and devices included on the list of essential medicines pursuant to section 3(c) of Executive Order 13944 (85 Fed. Reg. 49929)) manufactured, prepared, propagated, compounded, or processed in the establishment, with particular attention to the number of other establishments globally that also manufacture, prepare, propagate, compound, or process the same drug or device from which the United States sources such drug or device. Whether the establishment is located in a country with a history or 1 or more previous instances of exporting illicit drugs or precursor chemicals to the United States, as determined by the Secretary by reference to the most recent report submitted to Congress pursuant to section 489 of the Foreign Assistance Act of 1961. .
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- 85 FR 49929
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Sec. 4
Additional risk factors for consideration during inspections of drug and device establishments
Fed. Reg.85 FR 49929
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