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DRUGS


U.S. FDA Over the Counter (OTC) Drug Establishment Registration & Listing Requirements

An Over-the-Counter Drug is a human drug that is safe and effective for use without prescription by a licensed medical practitioner.

MEDERA Consulting assists companies with the following OTC Drug requirements

  • U.S. FDA OTC Drug Establishment Registration
  • U.S. FDA OTC Drug Listing Submissions
  • Obtaining a DUNS Number
  • U.S. Agent Requirements
  • Registrant Contact Requirements
  • U.S. FDA OTC Drug Labeling and Ingredient Requirements