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 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

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 OTC monograph.
  2. OTC drug labeling  –  Content and format of the labeling should  be in accordance with FDA OTC drug labelling requirements.
  3. Establishment  Registration – Manufacturing   facilities involved in the manufacturing, packing, processing or the drug must be registered with FDA.
  4.   NDC drug listing – Drug listing is mandatory requirements 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 purpose.

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.

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