FDA UPDATE: Now is the Time for the Annual FDA Drug Registration Renewal

It is that time of year, the annual drug registration renewal period opened through December 31, 2021.

If you’re a DRUG company and want to keep your 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.
• Please review all drug listing information and labeling.
• If there are no changes to report, the Blanket No-Changes Listing Certification Structured Product Labeling (SPL)document can be used.
• Any current drug listing file that has not been submitted or updated during the 2021 calendar year, must be certified either through the Blanket No-Changes Listing Certification SPL or submission of a higher drug listing version.
• How do I renew a registration with no changes? 
  • FDA is sharing technical submission information, training, and additional resources below to assist in submission questions.
• To submit No Change Notification using CDER Direct:
  • Open the previously submitted and accepted Establishment Registration
  • Click Create New Version
  • Change the document type to No Change Notification
  • Submit SPL.
• To submit No Change Notification using other applications:
  • Create a No Changes Notification Structured Product Labeling (SPL)
  • Fill in the SetID with the value from your previous or most recent submission
  • Enter the appropriate effective date and version number (generally, one number higher than the previous submission)
• How do I change establishment information in registration?
• FDA is sharing technical submission information, training, and additional resources below to assist in submission questions.
• Please review all drug listing information and labeling.
  • To submit a change using CDER Direct:
    • Open the previously submitted and accepted Establishment Registration
    • Click Create New Version
    • Enter the new address/DUNS or contact information that needs to be updated
    • SubmitStructured Product Labeling (SPL).
  • To submit a change using other applications:
    • Create a copy/new version of the most recent submission
    • Do not change the SetID. Retain the original SetID from the previous version
    • Generate a new DocumentID/RootID
    • Enter an appropriate effective date and version number (generally, one number higher than the previous submission)
    • Modify all establishment and contact information as appropriate and submit.
  • How do I de-register?
  • FDA is sharing technical submission information, training, and additional resources below to assist in submission questions.
    • To de-register using CDER Direct:
      • Open the previously submitted and accepted Establishment Registration
      • Click Create New Version
      • Change the document type to Establishment De-Registration and Submit SPL.
    • To de-register using another application:
      • Create an establishment deregistration SPL document.
      • Fill in the SetID  with the SetID from your previous submission
      • Enter the appropriate effective date and version number (generally, one number higher than the previous submission)
    • How do I know if my registration notification was successful?
    • Check the status of your registration at the Drug Establishment Current Registration Site (DECRS).Once your submission is successful, your firm’s name and information will appear with the expiration date of 12/31/2022 within 24 business hours.

IF you have any questions on drug registration and listings contact mdi at: [email protected]  We arebeen assisting companies with their drug registrations and drug listings. We are also recognized as an US Agent for foreign companies.