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. Registration is current through December 31, of the following year.
Example 2: a new, updated or annual establishment registration SPL is received on September 30, 2013. Registration is current through December 31, that same year. The renewal for the next period must be submitted between October 1 and December 31.
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 and should make any updates to existing listing information.
The links below provide a list of establishments that have submitted registrations that are currently valid.
- This database does not contain establishments registered as Human Drug Compounding Outsourcing Facilities under 503B. the list of current 503B registrants can be found at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm393571.htm. A 503B registered facility may also appear in the DECRS database if it also registered under other business operations.
- This database does not contain prescription drug wholesale distributors and third-party logistics providers (3PLs) that report licensure annually to the FDA as required by the Drug Supply Chain Security Act. More information about Wholesale Distributors and 3PLs can be found at: http://www.fda.gov/drugs/drugsafety/drugintegrityandsupplychainsecurity/drugsupplychainsecurityact/ucm423749.htm
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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.
- Electronic Drug Registration and Listing Instruction
- Points of Contact for Drug Registration and Listing
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Compliance