Drugs

Drug Establishments Current Registration Site

IMPORTANT CHANGES TO THE TIMING OF ANNUAL REGISTRATION

The Drug Establishments Current Registration Site (DECRS) is a database of current information submitted by drug firms to register establishments (facilities) which manufacture, prepare, propagate, compound or process drugs that are commercially distributed in the U.S. or offered for import to the U.S.

Establishments must be registered within 5 days of beginning operations. (21 CFR 207.21(a) and 207.40 and FD&C Act sections 510(c), (d), & (i)). In addition, establishments must renew registration annually between October 1st and December 31st of each year. (FD&C Act sections 510(b) & (i)).

Firms that send their initial or annual registrations during October 1st to December 31st period are considered registered until the end of following year. If a firm submits its initial, updated or annual registration outside this time frame, it is considered registered until the end of the current year and shall renew before December 31. 

Example 1: a new, updated or annual establishment registration SPL is received on October 1, 2013. Registration is current through December 31, 2014. However, the renewal for the next period must be submitted on or before December 31, 2014.

Example 2: a new, updated or annual establishment registration SPL is received on September 30, 2013. Registration is current through December 31, 2013. The renewal for the next period must be submitted on or before December 31, 2013.  

Regarding the effective time field in the annual establishment registration SPL, it should contain a reference to the year that is the same as the year you are submitting your SPL file.
For example, if a firm sends in an Establishment Registration SPL for 2014 on November 1, 2013 then the effective time field should be "20131101". 

In addition, at the time of annual registration, firms must list any drugs not previously listed. 

The links below provide a list of establishments that have submitted registrations that are currently valid.

For questions on the electronic registration and listing requirements send an inquiry to eDRLS@fda.hhs.gov.

If you have submitted your electronic registration and have questions on the status of your submission, please contact the SPL Coordinator at SPL@fda.hhs.gov.

 
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Compliance

 

Page Last Updated: 09/29/2014
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