; references in division (a) Short title This division may be cited as the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 . (b) References Except as otherwise specified, any reference to this Act contained in this division shall be treated as referring only to the provisions of this division. I OTC Drug Review 1001. Regulation of certain nonprescription drugs that are marketed without an approved 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 drug application (a) Nonprescription drugs marketed without an approved application Nonprescription drugs marketed without an approved drug application under section 505, as of the date of the enactment of this section, 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 under 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 (2)), the general requirements for nonprescription drugs, and conditions or 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 under section 201(p)(2)