The OTC drug approval process. The ACG Committee on FDA-Related Matters. American College of Gastroenterology.

The OTC drug monograph process and the NDA route of OTC drug approval are two different methods that reach the same result, the approval of safe and effective drugs. Both routes to OTC marketing require substantial evidence that the drugs are safe and effective for OTC use, including evidence that the drug would be safe for self-use without the supervision of a practitioner.