FDA requirements for OTC drugs vary for OTC monograph products and new OTC drugs.
Drugs with active ingredients published in the OTC final monograph can be marketed without prior approval from FDA.
However, if you plan to market OTC drugs with active ingredients that are not part of the OTC monograph, you should obtain FDA approval through the new drug approval process.
The list of OTC monograph ingredients and 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 as per the FDA guidance for OTC sunscreen products marketed without FDA approval.
OTC drug manufacturers must also renew their drug establishment registration between 1st October to 31st December. Also, the NDC drug listing should be updated every year. If there are no changes to drug listing information, companies must submit no change notification. Contact us for more information about the registration renewal process.
While developing the OTC monograph drugs, you must consider the requirements mentioned in 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.
If you have any questions about FDA OTC registration, contact us.