Sec. 5. Supporting continuous manufacturing to prevent shortages for susceptible drugs
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Subtitle B of title III of the 21st Century Cures Act is amended by inserting after section 3016 ( 21 U.S.C. 399h ) the following: The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall solicit and, beginning not later than one year after the date of enactment of the Drug Shortages Prevention and Quality Improvement Act , receive, requests from institutions of higher education and nonprofit entities engaged in the manufacture of sterile injectable drugs for the purpose of upgrading drug establishment to continuous manufacturing or other advanced manufacturing capabilities.
An institution of higher education or a nonprofit entity shall be eligible for a grant under this section if such institution or entity manufactures a drug that— is categorized as an essential medicine under Executive Order 13944; is a sterile injectable drug; and is vulnerable to shortage. As a condition for accepting a grant under this section, an institution of higher education and nonprofit entity shall agree to participate in the Quality Management Maturity Sterile Injectable Drug Pilot Program established under section 3 of the Drug Shortages Prevention and Quality Improvement Act .
To carry out this section, there is authorized to be appropriated $1,000,000,000 for the period of fiscal years 2022 through 2027. In this section: The term advanced manufacturing means an approach for the manufacturing of drugs that incorporates novel technology, or uses an established technique or technology in a new or innovative way (such as continuous manufacturing where the input materials are continuously transformed within the process by 2 or more unit operations) that enhances drug quality or improves the manufacturing process.
The term continuous manufacturing — means a process where the input materials are continuously fed into and transformed within the process, and the processed output materials are continuously removed from the system; and consists of an integrated process that consists of a series of 2 or more unit operations. The term sterile injectable drug means a drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), a biological product licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ), or a combination product (as described in section 503(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(g) ) whose primary mode of action is that of a drug or biological product, whose manufacturing, distribution, and administration processes require sterile conditions. .
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Sec. 5
Supporting continuous manufacturing to prevent shortages for susceptible drugs
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