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Home U.S. FDA Drug Regulations U.S. FDA Drug Registration and Listings › Over the Counter Drugs (OTC)

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.

Registrar Corp assists companies with the following OTC Drug requirements:
Drug Certificates Issued By Registrar Corp
  • 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


If you do not have an Establishment Registration Number and a Listing for your OTC Drug with U.S. FDA

New U.S. FDA OTC Drug Registration and Listings  ››

If you already have an Establishment Registration Number and a Listing for your OTC Drug with U.S. FDA

  
Option 1:   Update your existing OTC Drug Registration and Listing information
Click the Update button below for any of the following:
  • Update your OTC Drug Establishment Registration
  • Update an existing OTC Drug Listing with U.S. FDA
  • List another OTC Drug with the U.S. FDA
  • Change U.S. Agent or Registrant Contact
Update OTC Drug Registration and Listing Information  ››

  
Option 2:   Order a Certificate of Registration issued by Registrar Corp
Companies registered with FDA often are asked by their customers and suppliers to verify their registration and listings. A Certificate of Registration issued by Registrar Corp serves to verify your compliance with OTC Drug Registration and Listing requirements.

Order Your OTC Drug Certificate ››





 
U.S. FDA Regulations:

U.S. FDA Regulation: 21 C.F.R. Part 207


















Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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