3.0.0 383 2024-06-12T18:20:59Z 2024-06-12T18:20:59Z House H HR 2023-01-17 118 [Congressional Record Volume 169, Number 12 (Tuesday, January 17, 2023)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mrs. HARSHBARGER:H.R. 383.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8 of the United States Constitution[Page H244]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2023-01-27T19:13:10Z Referred to 2023-01-17T19:02:30Z Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 118 4368 HR 2023-09-28 Motion to reconsider laid on the table Agreed to without objection. 23:30:16 Related bill CRS 2023-01-27 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2023-01-17 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2023-01-17 Introduced in House IntroReferral Intro-H 9 Library of Congress 2023-01-17 Introduced in House IntroReferral 1000 9 Library of Congress H001086 Rep. Harshbarger, Diana [R-TN-1] Diana Harshbarger R TN 1 N H001082 Rep. Hern, Kevin [R-OK-1] Kevin Hern R OK 1 2023-01-17 True L000564 Rep. Lamborn, Doug [R-CO-5] Doug Lamborn R CO 5 2023-01-17 True B001307 Rep. Baird, James R. [R-IN-4] James Baird R IN R. 4 2023-01-17 True C001103 Rep. Carter, Earl L. "Buddy" [R-GA-1] Earl Carter R GA L. "Buddy" 1 2023-01-17 True W000814 Rep. Weber, Randy K., Sr. [R-TX-14] Randy Weber R TX K. 14 2023-01-17 True M001211 Rep. Miller, Mary E. [R-IL-15] Mary Miller R IL E. 15 2023-01-17 True B001299 Rep. Banks, Jim [R-IN-3] Jim Banks R IN 3 2023-01-17 True J000304 Rep. Jackson, Ronny [R-TX-13] Ronny Jackson R TX 13 2023-01-17 True W000806 Rep. Webster, Daniel [R-FL-11] Daniel Webster R FL 11 2023-01-17 True D000615 Rep. Duncan, Jeff [R-SC-3] Jeff Duncan R SC 3 2023-01-17 True F000446 Rep. Feenstra, Randy [R-IA-4] Randy Feenstra R IA 4 2023-01-17 True S000522 Rep. Smith, Christopher H. [R-NJ-4] CHRISTOPHER SMITH R NJ H. 4 2023-01-17 True G000565 Rep. Gosar, Paul A. [R-AZ-9] Paul Gosar R AZ A. 9 2023-01-17 True S000250 Rep. Sessions, Pete [R-TX-17] PETE SESSIONS R TX 17 2023-01-24 False F000474 Rep. Flood, Mike [R-NE-1] Mike Flood R NE 1 2023-01-24 False G000576 Rep. Grothman, Glenn [R-WI-6] Glenn Grothman R WI 6 2023-01-24 False M001194 Rep. Moolenaar, John R. [R-MI-2] John Moolenaar R MI R. 2 2023-01-24 False B000825 Rep. Boebert, Lauren [R-CO-3] Lauren Boebert R CO 3 2023-01-24 False M001199 Rep. Mast, Brian J. [R-FL-21] Brian Mast R FL J. 21 2023-01-26 False G000594 Rep. Gonzales, Tony [R-TX-23] Tony Gonzales R TX 23 2023-01-26 False Y000067 Rep. Yakym, Rudy [R-IN-2] Rudy Yakym R IN 2 2023-01-26 False B001295 Rep. Bost, Mike [R-IL-12] Mike Bost R IL 12 2023-01-26 False G000591 Rep. Guest, Michael [R-MS-3] Michael Guest R MS 3 2023-02-06 False L000596 Rep. Luna, Anna Paulina [R-FL-13] Anna Paulina Luna R FL 13 2023-03-08 False H001077 Rep. Higgins, Clay [R-LA-3] Clay Higgins R LA 3 2023-03-17 False A000055 Rep. Aderholt, Robert B. [R-AL-4] ROBERT ADERHOLT R AL B. 4 2023-08-11 False Health Health 2023-01-31T16:00:30Z 00 2023-01-17 Introduced in House 2023-05-26T18:41:32Z This bill nullifies certain changes made by the Food and Drug Administration (FDA) to dispensing requirements for mifepristone. (Mifepristone is a drug that is approved to end pregnancies through 10 weeks gestation when used in conjunction with the drug misoprostol. The procedure is often referred to as medication abortion or the abortion pill.)

The FDA regulates the use of mifepristone through the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) program. The program requires health care providers to comply with certain requirements in order to prescribe or dispense mifepristone to end a pregnancy; the program previously included an in-person dispensing requirement that required mifepristone to be directly dispensed to patients in clinics, medical offices, or hospitals. During the COVID-19 public health emergency, the FDA temporarily stopped enforcing the in-person dispensing requirement, which allowed mail-order pharmacies to fill and dispense mifepristone prescriptions.

In January 2023, the FDA modified program requirements so as to (1) remove the in-person dispensing requirement, and (2) require pharmacies to be certified in the program in order to dispense mifepristone. The modifications allow retail pharmacies, after receiving certification, to dispense mifepristone pursuant to prescriptions that are written by program-certified prescribers.

The bill nullifies the January 2023 changes and prohibits any similar changes in the future.

]]> To nullify the modifications made by the Food and Drug Administration in January 2023 to the risk evaluation and mitigation strategy for the abortion pill mifepristone, and for other purposes. Display Title 45 To nullify the modifications made by the Food and Drug Administration in January 2023 to the risk evaluation and mitigation strategy for the abortion pill mifepristone, and for other purposes. 2024-06-12T18:20:59Z Official Title as Introduced 6 To nullify the modifications made by the Food and Drug Administration in January 2023 to the risk evaluation and mitigation strategy for the abortion pill mifepristone, and for other purposes. 2024-03-18T20:12:27Z Introduced in House IH Introduced in House 2023-01-17T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118hr383ih/xml/BILLS-118hr383ih.xml 2023-01-27 Referred to the Subcommittee on Health. 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.