Manufacturers, re-packers, re-labelers, and salvagers of human and animal drugs must register annually with the FDA’s Drug Registration and Listing System (DRLS). We manage the entire submission process from initial registration to annual renewal.
Initial Drug Establishment Registration
New drug establishments must register before manufacturing or distributing drugs for U.S. sale. We handle the full submission.
- OTC & prescription drug facilities
- Human & animal drug manufacturers
- DUNS number coordination
- Official correspondent designation
Annual Renewal
Drug establishment registrations must be renewed annually between October and December. We track your deadline and file on time, every time.
- Deadline tracking & advance reminders
- Updated establishment information
- Timely DRLS submission
- User fee payment guidance
Drug Product Listing (NDC)
All marketed drug products must be listed with the FDA with an assigned National Drug Code (NDC). We prepare and submit your drug listings accurately.
- NDC number assignment support
- Active & inactive ingredient listing
- Drug listing system
- OTC monograph products included
Registration Amendments
Changes to ownership, personnel, or operations require timely updates to your drug establishment registration. We file amendments promptly.
- Official correspondent updates
- Facility address amendments
- Drug activity type changes
- Ownership transfer support
Ready to Register Your Establishment?
Miss the October to December renewal window and your registration deactivates automatically. Let us track your deadline and file on time, every time.
Drug Establishment FAQs
Any manufacturer, re-packer, re-labeler, or salvager of human or animal drugs intended for the U.S. market must register, including OTC and prescription drug facilities, whether domestic or foreign.
Yes. The FDA requires a DUNS number as the unique facility identifier for drug establishment registration. We coordinate this as part of your registration if you don’t already have one.
Registration covers the facility itself. Listing is separate and per-product: each marketed drug needs its own National Drug Code (NDC) and listing record tied back to your registered establishment.
Registrations must be renewed every year between October 1 and December 31. Miss that window and the FDA automatically deactivates the registration on January 1, pulling the establishment’s products from the NDC directory until it’s reactivated.