1. Short title This Act may be cited as the Orally Taken Contraception Act of 2023 or the OTC Act of 2023 . 2. FDA guidance on changing marketing status of contraceptive drugs to over-the-counter (a) In general Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services acting through the Commissioner of Food and Drugs, for purposes of encouraging sponsors of oral contraceptive drugs to submit applications for the approval of oral contraceptive drugs to be marketed without being subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(b)(1) ), shall issue guidance that— (1) provides a detailed description of the review process for the— (A) approval of drugs under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ); (B) marketing authorization of over-the-counter drugs under section 505G of such Act ( 21 U.S.C. 355h ); and (C) licensure of biological products under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ); (2) provides for background information on oral contraceptive drugs, including— (A) the history of approval, marketing authorization, or licensure of oral contraceptive drugs under the provisions of law specified in paragraph (1); (B) the standards used to grant such approval, marketing authorization, or licensure; and (3) specifies the benefit-risk considerations that the Secretary uses to determine whether to approve, authorize for marketing, or license oral contraceptive drugs