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Referenced Laws
21 U.S.C. 355–1
21 U.S.C. 355
Section 1
1. Short title This Act may be cited as the Protecting Access to Medication Abortion Act of 2023.
Section 2
2. Modification of REMS The Secretary of Health and Human Services (referred to in this section as the Secretary) shall ensure that the risk evaluation and mitigation strategy under section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1) that applies to mifepristone— does not have an in-person dispensing requirement for such drug; allows for patient access to prescriptions for such drug via telehealth; and allows all pharmacies that are certified to dispense such drug to, at minimum, dispense and mail such drug to patients. Nothing in subsection (a) shall be construed to prevent the Secretary from approving a modification to the risk evaluation and mitigation strategy for mifepristone based on sound scientific evidence and in accordance with section 505–1(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(h)), except that any modifications to such risk evaluation and mitigation strategy made after January 3, 2023, shall be in accordance with the requirements under paragraphs (1), (2), and (3) of subsection (a), unless the Secretary, based on sound scientific evidence and in accordance with section 505–1 of such Act (21 U.S.C. 355–1), determines that a risk evaluation and mitigation strategy for mifepristone is no longer necessary. Nothing in subsection (a) shall be construed to limit the authority of the Secretary to impose the requirements described in paragraphs (1), (2), and (3) of such subsection to a risk evaluation and mitigation strategy under section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1) for any drug other than mifepristone. In this section, the term mifepristone means mifepristone that is— approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); indicated for medical abortion; and subject to a risk evaluation and mitigation strategy under section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1).