How to get a product approved by the FDA for OTC - The Food and Drug Administration (FDA) monitors all over-the-counter (OTC) drugs available in most grocery stores and department stores. The FDA defines OTC drugs as safe and effective for use by the general public without a doctor's prescription. Therefore, any new product sold as OTC FDA must ensure that it is safe and effective; has benefits that are greater than the associated risks; and has a low risk of diversion and abuse.
How to get a product approved by the FDA for OTC
• Compare the ingredients in the new product to the OTC drug monographs established by the FDA. The active ingredients, classified as therapeutic drug classes are generally recognized as safe and effective (GRASE) in doses, formulations, labeling and testing requirements listed. The final monograph for OTC products are available in the Code of Federal Regulations 21CFR331 358.
• Ensure that the formulation and dose of active ingredients in the proposed OTC product meets a willing monograph counter. If it does, further FDA review is not necessary. If this is not the case, you must complete a new New Drug Application (NDA) or abbreviated new drug application (ANDA).
• Follow the standard format for labeling of OTC products will be described in 21CFR201.60. clearly view product facts drugs on the label. Include active ingredients, purpose, uses, warnings, directions, other information, and inactive ingredients in the product.
• Manufacturing of the new product counter medication in accordance with current good manufacturing practices (cGMP) 21CFR211. GMP facilities follow standard operating procedures for all aspects of manufacturing. This ensures the safety, effectiveness, strength, purity and quality of each batch of product manufactured OTC.