Drug Registration Renewal Period Now Open
The annual drug registration renewal period is now open through December 31, 2021. To keep drug registration status current in 2022, FDA must receive notification that a firm's drug registration and listing information 1) is certified as accurate and no changes have occurred since the previous update, 2) was updated, or 3) will be de-registered as firm will cease operations.
What establishments need to register and list?
- Establishments that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. shall register. Foreign establishments must identify a U.S. agent and importers at the time of registration. Exemptions exist.
What does registration include?
- Domestic and foreign establishments must, at the time of registration include:
- The name and Dun and Bradstreet verification, or Data Universal Numbering System (DUNS) number of the establishment (not one linked to the corporate headquarters)
- Contact information of individual responsible for receiving FDA communications related to that establishment
- All applicable business operations that establishment performs
- For foreign establishments, the name and DUNS of a U.S. agent and all importers
What does listing include?
- Firms must list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S.
How do I renew a registration with no changes or de-register?
How do I know if my registration notification was successful?
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