- 1). Compare the ingredients in the new product to the OTC drug monographs established by the FDA. The active ingredients, classified under therapeutic classes of drug products are Generally Recognized as Safe and Effective (GRASE) in the doses, formulations, labeling and testing conditions listed. The final monographs for OTC products are available in the Code of Federal Regulations 21CFR331 to 358.
- 2). Confirm that the formulation and dose of active ingredients in the proposed OTC product conforms to an OTC monograph. If it does, further review by the FDA is not required. If it does not, then you must fill out a new drug application (NDA) or an abbreviated new drug application (ANDA).
- 3). Follow the standard format for labeling OTC products as described in 21CFR201.60. Clearly display the drug facts of the product on the label. Include the active ingredients, purpose, uses, warnings, directions, other information, and inactive ingredients present in the product.
- 4). Manufacture the new OTC drug product according to current good manufacturing practices (cGMP) 21CFR211. GMP facilities follow standard operating procedures for all aspects of manufacturing. This ensures the safety, efficacy, strength, purity, and quality of each lot of the manufactured OTC product.