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. For assistance with U.S.
Registrar Corp assists companies with the following Prescription Drug requirements:
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- 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
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If you are already registered with U.S. FDA and use an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) number
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Option 1: Update your existing Prescription Drug Registration and Listing information
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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 ››
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Option 2:
Order a Certificate of Registration issued by Registrar Corp
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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 ››
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U.S. FDA Regulations:
U.S. FDA Regulation: 21 C.F.R. Part 207
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| 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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