Sec. 4. Supporting continuous manufacturing to prevent shortages for susceptible drugs

477 words·~2 min read·/bill/118/s/2586/is/section-4

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

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 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 for grants from institutions of higher education or 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, including as determined through notifications submitted to the Secretary under section 506C. As a condition for accepting a grant under this section, an institution of higher education and nonprofit entity shall agree to develop and carrying out a robust plan focused on sustainability of the continuous manufacturing or other advanced manufacturing capabilities supported by the grant.

To carry out this section, in additional to amounts otherwise made available for such purposes, there is authorized to be appropriated $1,000,000,000 for the period of fiscal years 2024 through 2029. 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 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, that is intended for injection for intravenous use of infusion and whose manufacturing, distribution, and administration processes require sterile conditions. .

The Comptroller General of the United States shall conduct a study on including quality management maturity as a factor in prescription drug purchasing by Federal health care programs (as defined in section 1128B(f) of the Social Security Act (42 U.S.C. 1320a–7b(f))), and not later than 2 years after the date of enactment of this Act, shall submit a report on such study to Congress.

Connectionstraces to 5

Traces to 5 documents

U.S. Code