Sec. 18. Protecting pharmaceutical access for Americans
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/bill/116/hr/7007/ih/section-18·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Not later than 30 days after the date of enactment of this Act, the Commissioner of Food and Drugs shall submit to the Congress a list of all critical drugs and critical active pharmaceutical ingredients— that are produced in China; and the supply of which would be disrupted for United States consumers if such production were discontinued or interrupted. In this subsection: The term critical active pharmaceutical ingredient means an active pharmaceutical ingredient in a critical drug.
The term critical drug means a product that— is a drug (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 )) for which the approval of an application submitted under subsection
(b)or
(j)of section 505 of such Act ( 21 U.S.C. 355 ) or subsection
(a)or
(k)of section 351 of the Public Health Service Act ( 42 U.S.C. 352 ) remains in effect; and is deemed by the Commissioner of Food and Drugs to be critical to the health and safety of United States consumers. The term produce means manufactured, prepared, propagated, compounded, or processed, in whole or in part. Not later than 180 days after the date of enactment of this Act, the Commissioner of Food and Drugs (in this subsection referred to as the Commissioner ) shall certify to the Congress whether the Chinese pharmaceutical industry is being regulated for safety (including regulation of such industry by Chinese authorities and the Food and Drug Administration) to substantially the same degree as the United States pharmaceutical industry. The Commissioner— shall conduct such investigations as may be necessary to make the certification required by paragraph (1); and in conducting such investigations, may use unannounced inspections and demand all necessary onsite access. If the Commissioner certifies pursuant to paragraph
(1)that the Chinese pharmaceutical industry is not being regulated for safety to substantially the same degree as the United States pharmaceutical industry, the Commissioner shall, not later than 60 days after the Commissioner submits the certification required by paragraph (1), submit a plan to the Congress to protect United States consumers from unsafe Chinese drugs. Not later than 90 days after the date of the enactment of this Act, the Secretary of Defense, in coordination with the Secretary of Health and Human Services and the Commissioner of Food and Drugs, shall submit to the Congress— a plan to ensure that by 2024 no pharmaceutical products purchased for beneficiaries of health care from the Department of Defense or any associated program are made in part or in whole in China; and an assessment of the resilience and capacity of the current supply chain and industrial base to support national defense if no pharmaceutical products purchased for beneficiaries of health care from the Department of Defense or any associated program are made in part or in whole in China, including with respect to— the manufacturing capacity of the United States; gaps in domestic manufacturing capabilities, including non-existent, extinct, threatened, and single-point-of-failure capabilities; and supply chains with single points of failure and limited resiliency. The assessment under paragraph (1)(B) shall include recommendations— to address critical bottlenecks in the supply of pharmaceutical products in the United States; and to mitigate single points of failure and limited resilience of supply chains for pharmaceutical products in the United States.
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- 42 USC 352
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