; findings. Sec. 202. Authority to access and use fees. I Regulation of nonprescription drugs 101. Regulation of certain nonprescription drugs that are marketed without an approved new drug application Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 505F ( 21 U.S.C. 355g ) the following: 505G. Regulation of certain nonprescription drugs that are marketed without an approved new drug application (a) Definitions In this section: (1) Nonprescription drug The term nonprescription drug means a drug, an active ingredient, or a combination of active ingredients that is not subject to section 503(b)(1). (2) Requestor The term requestor means a person or group of persons marketing, manufacturing, processing, or developing a drug. (3) Sponsor The term sponsor means a person or group of persons marketing, manufacturing, or processing a drug and who has a listing in effect under section 510(j) for such drug. (b) Monograph drugs (1) In general With respect to a nonprescription drug that, on or after the date of enactment of the Over-the-Counter Drug Safety, Innovation, and Reform Act , is introduced or delivered for introduction in interstate commerce for which an approved application under section 505 is not required, the following shall apply: (A) A nonprescription drug is deemed to be generally recognized as safe and effective within the meaning of section 201(p)(1) and not a new drug under section 201(p) if— (i) (I) such drug is— (aa) (AA) subject to a final monograph issued under part 330 of title 21, Code of Federal Regulations, as of the date of enactment of the Over-the-Counter Drug Safety, Innovation, and Reform Act ; (BB) in conformity with the conditions for nonprescription use of such monograph and the general requirements specified for nonprescription drugs, including any modifications to those conditions made under subsections (c), (d), and (j)