3.0.0 6080 2022-02-08T23:15:55Z 2022-02-08T23:15:55Z House HR 2020-03-04 116 [Congressional Record Volume 166, Number 43 (Wednesday, March 4, 2020)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. PETERS:H.R. 6080.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8[Page H1505]]]> hsif00 Energy and Commerce Committee House Standing Referred to 2020-03-04T15:01:45Z Mitigating Emergency Drug Shortages Act 116 2723 S 2019-10-29 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S6245-6246) Related bill CRS 2020-03-04 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2020-03-04 Introduced in House IntroReferral Intro-H 9 Library of Congress 2020-03-04 Introduced in House IntroReferral 1000 9 Library of Congress P000608 Rep. Peters, Scott H. [D-CA-52] Scott Peters D CA H. 52 N E000179 Rep. Engel, Eliot L. [D-NY-16] ELIOT ENGEL D NY L. 16 2020-03-04 True E000215 Rep. Eshoo, Anna G. [D-CA-18] ANNA ESHOO D CA G. 18 2020-03-04 True G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2020-03-04 True S001180 Rep. Schrader, Kurt [D-OR-5] Kurt Schrader D OR 5 2020-03-04 True M001157 Rep. McCaul, Michael T. [R-TX-10] Michael McCaul R TX T. 10 2020-03-04 True H001067 Rep. Hudson, Richard [R-NC-8] Richard Hudson R NC 8 2020-03-04 True B001257 Rep. Bilirakis, Gus M. [R-FL-12] Gus Bilirakis R FL M. 12 2020-03-04 True J000302 Rep. Joyce, John [R-PA-13] John Joyce R PA 13 2020-03-09 False Health Business records Government studies and investigations Health information and medical records Health technology, devices, supplies Manufacturing Prescription drugs Health 00 2020-03-04 Introduced in House 2021-01-28T15:11:24Z Preventing Drug Shortages Act

This bill expands existing manufacturer reporting requirements related to shortages of life-saving drugs and contains other related provisions.

The bill requires a manufacturer of an active pharmaceutical ingredient of a life-saving drug to notify the Food and Drug Administration (FDA) of an interruption that is likely to lead to a meaningful disruption in the ingredient's supply, whereas under current law this requirement generally applies only to the manufacturer of a life-saving drug that faces a supply disruption.

The notification must contain specified information, including any alternative sources for the ingredient.

The bill also requires a manufacturer of a life-saving drug or an active pharmaceutical ingredient for such a drug to include in its annual product registration the specific facilities where the drug or ingredient is manufactured. The FDA may also require the manufacturer to conduct periodic risk assessments to address vulnerabilities in its supply chain.

The Government Accountability Office shall report to Congress on the FDA's intra-agency coordination in assessing drug shortage risks.

]]> Preventing Drug Shortages Act Display Title Preventing Drug Shortages Act Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to reduce drug shortages, and for other purposes. Introduced in House IH Short Title(s) as Introduced Preventing Drug Shortages Act Introduced in House IH Introduced in House 2020-03-04T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr6080ih/xml/BILLS-116hr6080ih.xml 2020-03-04 Referred to the House Committee on Energy and Commerce. 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.