FDA requirements for OTC drugs vary for OTC monograph products and new OTC drugs.
Drugs with active ingredients published in the OTC final monograph which can be marketed without prior approval from FDA.
However, if you are planing to market OTC drugs with active ingredients which are not part of the OTC monograph you should obtain the FDA approval through new drug approval process.
List of OTC monograph ingredients along with FDA regulation for OTC drugs can be found in the 21 CFR Part 330 .
Overview of FDA Requirements for OTC Drugs
OTC sunscreen products must meet the additional requirements which are defined in FDA guidance for OTC sunscreen products marketed without FDA approval .
OTC drug manufacturer are also required to renew their drug establishment registration annually between 1st October to 31st December. Also, NDC drug listing should be update every year, if there are no changes to drug listing information companies must submit no change notification. Contact us for more information about registration renewal process.
While developing the OTC monograph drugs, you must consider the requirements mentioned FDA regulation for OTC drugs which is 21 CFR Part 330.
FDA basics is an experience FDA consulting firm and assists companies to comply with FDA requirements for OTC monograph drugs.