1. Short title; table of contents (a) Short title This Act may be cited as the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 . (b) Table of contents The table of contents for this Act is as follows: Sec. 1. Short title; table of contents. TITLE I—OTC Drug Review Sec. 101. Regulation of certain nonprescription drugs that are marketed without an approved drug application. Sec. 102. Misbranding. Sec. 103. Drugs excluded from the over-the-counter drug review. Sec. 104. Treatment of Sunscreen Innovation Act. Sec. 105. Annual update to Congress on appropriate pediatric indication for certain OTC cough and cold drugs. Sec. 106. Technical corrections. TITLE II—User Fees Sec. 201. Short title; finding. Sec. 202. Fees relating to over-the-counter drugs. I OTC Drug Review 101. 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)