Sec. 3. Domestic manufacturing to end over-dependence of the United States on Chinese drugs
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The Secretaries of Health and Human Services, Defense, and Veterans Affairs, acting jointly and in consultation with the Commissioner of Food and Drugs, shall— not later than 180 days after the date of enactment of this Act, develop a procurement strategy, including for long-term contracts, to strengthen and mobilize the Public Health Industrial Base to increase the manufacture in the United States of essential medicines, medical countermeasures, and critical inputs, including the 227 essential medicines, medical countermeasures, and critical inputs published on October 30, 2020, by the Food and Drug Administration in accordance with Executive Order 13944; and beginning as soon as feasible after the development of such strategy, and not later than 5 years after the development of such strategy, implement such strategy.
The strategy under subsection
(a)shall— be consistent with all applicable Federal law; identify essential components, including key starting materials, active ingredients, and critical inputs, necessary for manufacturing the essential medicines and medical countermeasures published on October 30, 2020, by the Food and Drug Administration in accordance with Executive Order 13944; and address the capacity of the supply chain and industrial base to strengthen and mobilize the Public Health Industrial Base to increase the manufacture in the United States of essential medicines, medical countermeasures, and critical inputs. In this section: The term critical inputs means active pharmaceutical ingredients, active pharmaceutical ingredient starting material, and other ingredients of drugs and components of medical devices that the Commissioner of Food and Drugs determines to be critical in assessing the safety and effectiveness of essential medicines and medical countermeasures. The term essential medicine means medicine— that is needed to protect the American public at all times, including from outbreaks of emerging infectious diseases, such as COVID–19, as well as chemical, biological, radiological, and nuclear threats; and of which sufficient and reliable, long-term domestic production of these products, mostly generic drugs, their active pharmaceutical ingredients, and key starting materials, is needed to minimize potential shortages by reducing the Nation’s dependence on foreign manufacturers of these products. The term medical countermeasure means— a qualified countermeasure (as defined in section 319F–1 of the Public Health Service Act ( 42 U.S.C. 247d–6a )); a qualified pandemic or epidemic product (as defined in section 319F–3 of such Act ( 42 U.S.C. 247d–6d )); a security countermeasure (as defined in section 319F–2 of such Act ( 42 U.S.C. 247d–6b )); or personal protective equipment (such as gloves, respirators (face masks), and ventilators). The term Public Health Industrial Base means the facilities and associated workforces within the United States, including research and development facilities, that help produce essential medicines, medical countermeasures, and critical inputs for the health care and public health sector.
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- 42 USC 247d–6a
- 42 USC 247d–6d
- 42 USC 247d–6b
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Sec. 3
Domestic manufacturing to end over-dependence of the United States on Chinese drugs
Cite42 USC 247d–6a
Cite42 USC 247d–6d
Cite42 USC 247d–6b
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