An Overview of FDA Requirements for OTC Drugs (Over the Counter Products ) and understanding FDA regulation for OTC drugs

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

FDA regulations for OTC drugs - FDA requirements for OTC drugs

FDA  requirements for OTC drugs   (OTC monograph product)-

  1. Compliance with OTC monograph – Ingredients, concentration, and purpose should be in accordance with the OTC monograph.
  2. OTC drug labeling  – The content and format of the labeling should be in accordance with FDA OTC drug labeling requirements.
  3. Establishment  Registration – Manufacturing facilities involved in manufacturing, packing, and processing the drug must be registered with the FDA.
  4.   NDC drug listing – Drug listing is a mandatory requirement for all the drug products marketed in the USA.
  5. GMP (Good Manufacturing Practice ) – Manufacturing of the product should be in accordance with Good Manufacturing  Practice as defined in the 21 CFR 210 and 211.
  6.  US Agent Appointment  – Foreign facilities must appoint US Agent for FDA communication purposes.

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.

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