FDA Regulations for OTC Drugs

Loren Gelber

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Description of the topic:

The three ways that the FDA regulates OTC (Over-the-Counter) drugs: Monographs, Rx to OTC switches and NDA/ANDA submissions, will be discussed in detail.  Labeling and advertising of OTC drugs will be covered.  Other requirements, including Registration, Drug Listing and Current Good Manufacturing Practice, will be reviewed.  Examples from recent Warning Letters and FDA Inspectional Observations (483s) will be used to show what not to do.


There are three ways that the FDA regulates OTC (Over-the-Counter) drugs: Monographs, Rx to OTC switches and NDA/ANDA submissions.


Why should you attend?

Both new and experiences OTC manufacturers will benefit from a review of the various FDA rules for OTC drugs.  Knowledge of these rules and regulations is important for staying out of trouble with the FDA, which should be one of the main objectives of every drug manufacturer

Areas Covered in the Session :

  • Rx versus OTC Drugs – Deciding which classification
  • How are OTC drugs regulated?
  • Labeling Rules
  •  CGMPs
  • Avoiding FDA Warning Letters

Who will benefit: 

  • Regulatory Affairs,
  • Labeling,
  • Quality
  • Advertising of OTC Drugs

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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Loren Gelber, Regulatory Compliance Consultant (Ex-FDA Official)

Dr. Loren Gelber has more than 40 years of experience in pharmaceutical industry regulatory compliance. She worked for about 10 years at the FDA, including as a reviewer in the Division of Generic Drugs. She participated in the development of method validation requirements for HPLC analytical methods. She then transitions to industry, working for four different pharmaceutical companies. For the last 13 years she has been a regulatory compliance consultant, both for consulting companies and independently.

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