3.0.0 2595 2023-01-01T20:17:48Z 2023-01-01T20:17:48Z Senate S 2021-08-04 117 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2021-08-04T15:51:12Z 2021-08-04 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2021-08-04 Introduced in Senate IntroReferral 10000 9 Library of Congress C000141 Sen. Cardin, Benjamin L. [D-MD] Ben Cardin D MD N S001203 Sen. Smith, Tina [D-MN] Tina Smith D MN 2021-08-04 True Health Health 00 2021-08-04 Introduced in Senate 2022-08-15T17:41:12Z Drug Shortages Prevention and Quality Improvement Act

This bill addresses shortages of essential drugs and related issues. (Generally, an essential drug is one that is life-supporting, life-sustaining, or intended to treat or prevent a debilitating condition.)

The Food and Drug Administration (FDA) may require a manufacturer of an essential drug to (1) submit data, or conduct studies to gather data, to determine the longest supported expiration date of a drug; or (2) make labeling changes regarding a drug's expiration period based on data provided under this bill or otherwise available to the FDA.

The bill establishes civil monetary penalties for a manufacturer that (1) refuses such a request to provide data or modify a drug label's expiration information, or (2) fails to meet certain requirements to provide to the FDA timely information about essential drug shortages.

The Government Accountability Office must conduct a study examining the process by which prescription drug manufacturers provide shelf life data to the FDA.

The FDA must establish a pilot program to assess the facilities and processes of participating manufacturers of prescription sterile injectable drugs that have been deemed essential under a specified executive order. The assessment shall cover topics including supply chain management, manufacturing strategy and operations, and workforce management.

Furthermore, the FDA must provide grants to certain nonprofit entities and institutions of higher education that agree to participate in the above pilot program. The grant funds must be used to upgrade the recipient's drug manufacturing facilities to utilize advanced manufacturing capabilities.

]]> Drug Shortages Prevention and Quality Improvement Act Official Title as Introduced A bill to address prescription drug shortages and improve the quality of prescription drugs, and for other purposes. Introduced in Senate IS Display Title Drug Shortages Prevention and Quality Improvement Act Short Title(s) as Introduced Drug Shortages Prevention and Quality Improvement Act Introduced in Senate IS Introduced in Senate 2021-08-04T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117s2595is/xml/BILLS-117s2595is.xml 2021-08-04 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.