Sec. 6. Registry of drugs manufactured outside the United States
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/bill/116/hr/6885/ih/section-6·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 524A of such Act ( 21 U.S.C. 360n–1 ) the following new section: The Secretary shall compile and maintain a registry of all drugs approved under subsection
(c)or
(j)of section 505 of this Act or licensed under sub-section
(a)or
(k)of section 351 of the Public Health Service Act, and any active pharmaceutical ingredients in such drugs, that are manufactured outside of the United States. The Secretary shall update such registry at least biannually. In conjunction with the registry under subsection (a), the Secretary shall compile and maintain a list of those drugs included in the registry for which 50 percent or more of their active pharmaceutical ingredients are manufactured in locations within a single country outside the United States. The list of drugs under paragraph
(1)shall— identify both the drugs and the associated sole-source country; be updated at least bi-annually; and be publicly available. The registry under subsection
(a)shall, with respect to each drug included on the registry, provide information about the drug’s supply chain, including each step in the supply chain that occurs prior to the drug’s importation into the United States. .
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- 21 USC 360n–1
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Sec. 6
Registry of drugs manufactured outside the United States
Cite21 USC 360n–1
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