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Home U.S. FDA Drug Regulations U.S. FDA Drug Registration and Listings › Prescription Drugs

U.S. FDA Prescription Drug Establishment Registration & Listing Requirements

A Prescription Drug is a human drug that is not safe for use except under the supervision of licensed medical practitioner.

Registrar Corp assists companies with the following Prescription Drug requirements:
Drug Certificates Issued By Registrar Corp
  • U.S. FDA Prescription Drug Establishment Registration
  • U.S. FDA Prescription Drug Listings and Label Submissions
  • Obtaining a DUNS Number
  • U.S. Agent Requirements
  • Registrant Contact Requirements
  • U.S. FDA Prescription Drug Labeling and Ingredient Requirements


If you are not registered with FDA and have use of an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) number from U.S. FDA

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

If you are already registered with U.S. FDA and use an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) number

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

Order Your Prescription 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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