How to Register a Drug Establishment

Establishments, with certain exemptions, engaged in manufacturing, repacking, relabeling or salvaging drugs for U.S. distribution are required to register with FDA. Only establishments required to register with FDA should do so.

When to register

Establishments in the U.S. are required to register within five days of introducing drugs into commercial distribution. Establishments outside of the U.S. must complete registration prior to the drug being offered for import.

Establishments must renew their registration between October 1 and December 31 each year.

Registration process

Create and submit an establishment registration structured product labeling (SPL) document to register with FDA. The agency recommends establishments save a copy of their submission. Remember to 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 someone 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

Visit instructions for registering an establishment using FDA Direct (page three) for more information.

Renew or update with no changes

• To submit no change notification using FDA Direct:
  • Open the previously submitted and accepted establishment registration
  • Click create new version
  • Change the document type to no change notification
  • Submit SPL

Visit step-by-step instructions on submitting a no change notification submission using FDA Direct.

• To submit a no change notification using other applications:
  • Create a no changes notification SPL document
  • Fill in the set ID with the value from the previous or most recent submission 
  • Enter the appropriate effective date and version number (generally, one number higher than the previous submission)
  • Submit SPL

Update establishment registration information

• To submit a change using FDA 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
  • Submit SPL

Visit instructions to update establishment registration using FDA Direct (page 13) for more information.

• To submit a change using other applications: 
  • Create a copy/new version of the most recent submission 
  • Do not change the set ID. Retain the original set ID from the previous version
  • Generate a new document ID/root ID
  • Enter an appropriate effective date and version number (generally, one number higher than the previous submission) 
  • Modify all establishment and contact information as appropriate
  • Submit SPL

De-register or submit an out of business notification

• To de-register using FDA Direct: 
  • Open the previously submitted and accepted Establishment Registration SPL
  • Click create new version
  • Change the document type to establishment de-registration or out of business notification as appropriate and submit SPL

Visit Instructions to de-register an establishment and submit an out of business notification using FDA Direct (page 23) for more information.

• To de-register using another application: 
  • Create an establishment deregistration SPL document 
  • Fill in the set ID with the set ID from the previous submission 
  • Enter the appropriate effective date and version number (generally, one number higher than the previous submission)
  • Submit SPL

Check registration status

Find registration status at drug establishment current registration site (DECRS). After successfully submitting the registration, the company’s name and information will appear on the site by the end of next business day. The listing will show an expiration date of December 31 of the following year.

Visit Drug Registration and Listing Instructions for instructions on how to list drugs with FDA.