Two regulatory mechanisms exist for the legal marketing of OTC drug products:
- NDA (regulations described in 21 CFR Part 314)
- OTC drug monograph (regulations described in 21 CFR Part 330)
OTC drug products marketed under either mechanism must meet established standards for safety and effectiveness. Although we assess compliance with these standards differently under the two mechanisms, neither mechanism establishes higher standards for safety or effectiveness than the other. Under both mechanisms, products must be manufactured according to current good manufacturing practices (cGMPs) as defined in 21 CFR Part 210 and must comply with the labeling content and format requirements in 21 CFR Part 201 Subpart C.
- NDA. Legal marketing is under the authority of an approved product-specific new drug application (NDA) or an abbreviated new drug application (ANDA). An OTC drug product with active ingredient(s), dosage form, dosage strength, or route of administration new to the OTC marketplace is regulated under the NDA process. For example, a drug product previously available only by prescription (Rx) can be marketed OTC under an approved “Rx-to-OTC switch” NDA.
FDA must approve the NDA for an OTC drug product before that product can be marketed OTC. A drug manufacturer submits data in an NDA demonstrating a drug product is safe and effective for use by consumers without the assistance of a healthcare professional. FDA must review the data within an established timeframe, and the data submitted in an NDA remains confidential.
The drug manufacturer can only market the product with the specific formulation and exact labeling approved by FDA. To make a change, the manufacturer must submit an NDA supplement and FDA must approve that supplement.
- OTC drug monograph. Legal marketing is in compliance with an OTC drug monograph. Unlike NDAs which are based on drug products, monographs specify the active ingredients that can be contained within OTC drug products. An OTC drug product containing ingredients that comply with standards established in an applicable monograph is considered to be “generally recognized as safe and effective” (GRASE) and does not require specific FDA approval before marketing. For example, OTC sunscreen drug products can be legally marketed if they contain ingredients which comply with the standards established in the OTC sunscreen monograph for formulation, labeling, and testing.