1. Short title This Act may be cited as the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 . I OTC Drug Review 101. Regulation of certain nonprescription drugs that are marketed without an approved new drug application (a) In general Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 505F of such Act ( 21 U.S.C. 355g ) the following: 505G. Regulation of certain nonprescription drugs that are marketed without an approved new drug application (a) Nonprescription drugs marketed without an approved application Nonprescription drugs marketed without an approved new drug application under section 505, as of the date of the enactment of the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 , shall be treated in accordance with this subsection. (1) Drugs subject to a final monograph; category I drugs subject to a tentative final monograph A drug is deemed to be generally recognized as safe and effective within the meaning of section 201(p)(1), not a new drug under section 201(p), and not subject to section 503(b)(1), if— (A) the drug is— (i) in conformity with the requirements for nonprescription use of a final monograph issued under part 330 of title 21, Code of Federal Regulations (except as provided in paragraph (6)), the general requirements for nonprescription drugs, and requirements under subsections (b), (c), and (k); and (ii) except as permitted by an order issued under subsection (b) or, in the case of a minor change in the drug, in conformity with an order issued under subsection (c), in a dosage form that, immediately prior to the date of the enactment of this section, has been used to a material extent and for a material time within the meaning of section 201(p)(2); or (B) the drug is— (i) classified in category I for safety and effectiveness under a tentative final monograph that is the most recently applicable proposal or determination issued under part 330 of title 21, Code of Federal Regulations