Sec. 4. Postmarket reporting requirements for pharmaceuticals
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The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall ensure that each holder of an approved application under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) annually submit, as part of the postmarket annual report required by the Secretary under section 314.81(b)(2) of title 21, Code of Federal Regulations (or any successor regulation), the following information:
The names and addresses of the sources of active and inactive ingredients of the drug. For each active and inactive ingredient of the drug, the percentage of the aggregate amount of such ingredient used in the manufacture of the drug during the reporting period that is from each of the sources identified under paragraph (1). The Secretary of Health and Human Services shall— annually provide the information reported in paragraphs
(1)and
(2)of subsection
(a)to the Secretary of Defense for purposes of understanding the dependency on foreign manufacturers of drugs used by members of the Armed Forces; and publish the information reported under such paragraphs on a publicly available internet website of the Federal Government in a single, aggregate form, without disclosing proprietary information.
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