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Frequently Asked Questions on
Drug Firm Annual Registration Status
- What is the list?
- How often is the re-registration current status updated?
- My site information is incorrect or I need to re-register. How do I do it?
- I submitted my annual re-registration form within the last 30 days, but it is not on the list. Why?
- When will I receive my validated 2656?
- What is the Data Universal Numbering System Number?
1. What is the list?
Firms manufacturing drug products must register the site where the product was made within
5 days of commercial distribution. Annually, firms must re-register, updating and
validating current site information as required by Section 510 of the Federal Food, Drug,
and Cosmetic Act and the Code of Federal Regulations 21 CFR part 207. Refer to Draft
Guidance for Industry Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial
Distribution for additional background information.
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2. How often is the re-registration current status updated?
Monthly.
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3. My site information is incorrect or I need to re-register. How do I do it?
Submit FDA Form 2656 to update or
correct your site registration information. Refer to the Draft Guidance for Industry Forms
for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution. The form can be downloaded from the HHS Program Support Center (PSC)
Forms Download website.
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4. I submitted my annual re-registration form within the last 30 days, but it is not on the list. Why?
The forms are processed within 60-90 days. You may not see your site Current Registration
annual year updated for several weeks.
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5. When will I receive my validated 2656?
Firms submitting Form FDA 2656 to
satisfy their annual re-registration requirement will not receive immediate written
confirmation of the submission. The validated copy of the submission will be mailed to the
firm within 30 to 90 days after receipt of form by FDA.
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6. What is the Data Universal Numbering System Number?
The Data Universal Numbering System or the D-U-N-S® Number is a product of the Dun and Bradstreet Company. Dun and Bradstreet provide finacial information on business entities including hierarchies lnking owners and subsidiaries. Each business entity in the Dun and Bradstreet system is assigned a 9 digit D-U-N-S® Number that is unique to each business entity.
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Last updated: December 30, 2008 |
