3.0.0 2740 2023-08-04T14:45:19Z 2023-08-04T14:45:19Z Senate S 2021-09-14 117 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2021-09-14T20:51:35Z PREPARE ACT of 2021 117 5388 HR 2021-09-28 Referred to the Subcommittee on Health. Related bill CRS 2021-09-14 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2021-09-14 Introduced in Senate IntroReferral 10000 9 Library of Congress B000944 Sen. Brown, Sherrod [D-OH] Sherrod Brown D OH N C001075 Sen. Cassidy, Bill [R-LA] Bill Cassidy R LA 2021-09-14 True C001070 Sen. Casey, Robert P., Jr. [D-PA] Bob Casey D PA 2021-10-18 False B001243 Sen. Blackburn, Marsha [R-TN] Marsha Blackburn R TN 2021-10-18 False K000384 Sen. Kaine, Tim [D-VA] Timothy Kaine D VA M. 2021-10-25 False C001047 Sen. Capito, Shelley Moore [R-WV] Shelley Capito R WV Moore 2021-10-25 False W000805 Sen. Warner, Mark R. [D-VA] Mark Warner D VA R. 2022-12-08 False Health Child health Congressional oversight Drug safety, medical device, and laboratory regulation Emergency medical services and trauma care Government information and archives Government studies and investigations Health technology, devices, supplies Manufacturing Prescription drugs Public contracts and procurement Public-private cooperation Strategic materials and reserves Health 00 2021-09-14 Introduced in Senate 2023-08-03T17:47:46Z Promoting Readiness and Ensuring Proper Active pharmaceutical ingredient Reserves of Essential medicines Act of 2021 or the PREPARE Act

This bill establishes the Strategic Active Pharmaceutical Ingredient Reserve.

The Department of Health and Human Services (HHS) must annually publish a public list of essential generic medicines that are medically necessary to have available at all times.

HHS must report and implement a plan to establish the reserve, which must be designed to minimize the impact of an interruption or reduction in imports of (1) key starting materials (including active pharmaceutical ingredients) for essential generic medicines, and (2) finished dosage forms of essential generic medicines for which key starting materials are not imported. The plan must also contain provisions to strengthen domestic capacity for active pharmaceutical ingredient production, storage, and conversion.

Within one year of this bill's enactment, the plan must include at least 25 of the essential generic medicines on the required list. The plan must add at least 25 medicines each year until the full list is covered.

HHS must prioritize domestically manufactured key starting materials for the reserve to the maximum extent possible.

A manufacturer of an essential generic medicine that switches to an active pharmaceutical ingredient sourced through the reserve shall not have to update the approved application for that medicine.

The Government Accountability Office must report to Congress on active pharmaceutical ingredient manufacturing, including the time and costs needed to develop domestic manufacturing capabilities.

]]> PREPARE Act Official Title as Introduced A bill to establish a strategic active pharmaceutical ingredient reserve to maintain a domestic supply of active pharmaceutical ingredients and key starting materials needed for the manufacturing of essential generic medicines, and to build a pipeline for domestic active pharmaceutical ingredient production. Introduced in Senate IS Display Title PREPARE Act Short Title(s) as Introduced PREPARE Act Introduced in Senate IS Short Title(s) as Introduced Promoting Readiness and Ensuring Proper Active pharmaceutical ingredient Reserves of Essential medicines Act of 2021 Introduced in Senate IS Introduced in Senate 2021-09-14T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117s2740is/xml/BILLS-117s2740is.xml 2021-09-14 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.