3.0.0 3493 2022-12-30T04:04:47Z 2022-12-30T04:04:47Z Senate S 2022-01-12 117 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2022-01-12T23:29:53Z PREVENT Pandemics Act 117 3799 S 2022-03-15 Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. Related bill CRS Drug Shortages Shelf Life Extension Act 117 7669 HR 2022-05-06 Referred to the House Committee on Energy and Commerce. Related bill CRS 2022-01-12 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S191-192) IntroReferral 2022-01-12 Introduced in Senate IntroReferral 10000 9 Library of Congress C000141 Sen. Cardin, Benjamin L. [D-MD] Ben Cardin D MD N C001035 Sen. Collins, Susan M. [R-ME] Susan Collins R ME M. 2022-01-12 True Health Congressional oversight Drug safety, medical device, and laboratory regulation Government information and archives Health technology, devices, supplies Manufacturing Health 00 2022-01-12 Introduced in Senate 2022-08-05T15:48:33Z Drug Shortages Shelf Life Extension Act

This bill requires the Food and Drug Administration (FDA) to issue or revise guidance to address issues relating to extending drug expiration dates.

Specifically, the guidance must address recommendations to drug companies relating to (1) submitting stability testing data in applications for market approval for drugs or biological products; and (2) establishing on drug labels the longest feasible expiration date supported by such data, taking into consideration how extended expiration dates may help prevent or mitigate drug shortages.

The FDA must also periodically report to Congress certain information about requests to change the expiration date on a drug label, including the number of such requests from the FDA to the manufacturer and the rationale for each request.

]]> Drug Shortages Shelf Life Extension Act Display Title Drug Shortages Shelf Life Extension Act Short Title(s) as Introduced Drug Shortages Shelf Life Extension Act Introduced in Senate IS Official Title as Introduced A bill to require guidance on extending expiration dates for certain drugs, and for other purposes. Introduced in Senate IS Introduced in Senate 2022-01-12T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117s3493is/xml/BILLS-117s3493is.xml 2022-01-12 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S191-192) 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.