FDA Drug Establishment Registration Renewal

Domestic and foreign Drug Establishments registered with US FDA must renew their registration every year between October 1st and December 31st. Missing this window can result in misbranded products and port detentions.

Oct 1 – Dec 31Annual RequirementSPL FormatSince 2009

About FDA Drug Registration Renewal

Domestic and foreign Drug Establishments registered with US FDA must renew their registration every year between October 1st and December 31st. The renewal must be submitted in SPL format with the same set-id used in the original establishment registration SPL via FDA ESG.

The establishment registration is valid until December 31st of the following year. The FDA registration number and facility identifier remain the same after renewal.

The drug manufacturer must have at least one drug listing with FDA to keep their Establishment registration and NDC Labeler Code active. If the establishment does not renew its registration before December 31st, FDA may consider its drug products as misbranded and may take regulatory action. Foreign manufacturers' products may be detained at the port.

Cosmetic companies that manufacture OTC Drug products like acne cream, sunscreen, anti-bacterial hand sanitizer, etc. also need to renew their registration every year.

If your drug is no longer marketed in the USA and you wish to cancel the existing registration, you need to submit an Establishment De-Registration SPL to FDA. FDA will not issue any certificate after registration renewal, but you can verify your drug establishment registration status at the FDA website. LMG will issue a free registration renewal certificate as proof.

Drug listing update or blanket no-change certification must be submitted every year during October 1 – December 31
Any changes to drug listing must be submitted immediately — do not wait for the renewal period
Blanket no-change certification covers all drugs reviewed by the labeler
Any drug listing not updated between October 1 and December 31 will be considered inactive
LMG tracks renewal deadlines for all clients and issues renewal certificates

If you need assistance in FDA drug establishment registration renewal, please complete our online form. LMG will issue a free certificate of FDA registration renewal after successfully completing the process.

FDA Drug Renewal Services — How LMG Can Help

LMG manages the complete drug establishment registration renewal process — from SPL preparation to certificate issuance.

Drug Renewal Submission

Preparation and electronic submission of your annual drug establishment registration renewal in SPL format via FDA ESG.

Drug Listing Update

Annual drug listing update including new products, discontinuations, labeling changes, or blanket no-change certification.

Renewal Certificate

LMG issues a free FDA registration renewal certificate as proof of completed renewal for your records and customers.

Deadline Tracking

LMG tracks the October 1 – December 31 renewal window for all clients to ensure no registration lapses.

Frequently Asked Questions

Common questions about this FDA service.

When must drug establishment registration be renewed?

Drug establishment registration must be renewed annually between October 1st and December 31st. The renewal window is the same every year.

What happens if I miss the renewal deadline?

If the establishment does not renew its registration before December 31st, FDA may consider its drug products as misbranded and take regulatory action. Foreign manufacturers’ products may be detained at U.S. ports of entry.

Does LMG issue a certificate after drug renewal?

Yes. FDA does not issue a renewal certificate, but LMG issues a free FDA registration renewal certificate as proof of completed renewal.

Does drug listing also need to be renewed?

Yes. Drug listing update or blanket no-change certification must be submitted every year during the renewal period. Any drug listing not updated will be considered inactive.

Can I cancel my drug registration?

Yes. If your drug is no longer marketed in the USA, you can submit an Establishment De-Registration SPL to FDA to cancel the registration.