Drug Establishment FDA Registration
Domestic and foreign drug manufacturers, repackers, and re-labelers must register with FDA and list all commercially marketed drug products. LMG handles the complete process — fast, accurate, and fully compliant.
21 CFR Part 207
Foreign Facilities Welcome
Electronic Submission
Since 2009
Regulatory Reference
21 CFR Part 207 — At a Glance
Legal Authority
Federal Food, Drug, and Cosmetic Act §510; 21 CFR Part 207
Submission System
Electronic Submissions Gateway Next Generation (ESG NextGen)
Renewal Window
October 1 – December 31 (annually)
Change Reporting
Within 30 days of any facility or ownership change
Drug Listing Update
Every June and December for all marketed products
Foreign Facilities
Must designate a U.S. Agent located in the United States
FDA Government Fee
$0 for standard registration (OMUFA fee may apply to OTC monograph drug manufacturers)
Oct 1
Renewal Opens
Dec 31
Renewal Deadline
30 days
To Report Changes
$0
FDA Govt Fee
Who Must Register for FDA Drug Establishment Registration?
Registration is required under 21 CFR Part 207 for any facility involved in manufacturing, repacking, or re-labeling drug products for U.S. commerce.
Registration Required
- Domestic drug manufacturers, repackers, and re-labelers
- Foreign drug manufacturers exporting to the U.S.
- API (Active Pharmaceutical Ingredient) manufacturers
- OTC drug product manufacturers
- Compounding outsourcing facilities
- Contract manufacturers producing drugs for the U.S. market
- Analytical testing labs performing testing of finished drugs
Generally Exempt
- Retail pharmacies dispensing prescriptions
- Practitioners licensed by a state to prescribe drugs
- Hospitals preparing drugs for in-house use only
- Research labs not manufacturing commercial products
- Excipients Manufacturer and Storage facilities
FDA Drug Registration Requirements & Timeline
FDA drug establishment registration follows specific deadlines and must be maintained annually to stay compliant.
Initial Registration
Drug establishments must register with FDA before beginning commercial manufacturing. Registration is submitted electronically through FDA's electronic submissions gateway next generation. Foreign establishments must designate a U.S. Agent as part of the registration process.
Annual Renewal — October 1 to December 31
All registered drug establishments must renew their registration annually between October 1 and December 31. Failure to renew results in the registration lapsing — products from lapsed registrations are considered misbranded and may be detained at U.S. ports of entry.
Drug Listing — Updated Every June & December
All commercially marketed drug products must be listed with FDA at registration and updated every June and December to reflect new products, discontinuations, or labeling changes. Unlisted products are considered misbranded.
NDC Labeler Code Assignment
Each labeler receives an NDC Labeler Code — The NDC Number (National Drug Code) is a unique 3 segment 10 digit number which identifies the drug. FDA assigns the first segment of the labeler code which represents the establishment. The second and third segments of NDC Labeler code are assigned by the labeler. The NDC Number for each drug will be different.
Amendments — Within 30 Days of Any Change
Any changes to registration information — address, ownership, or facility details — must be updated with FDA within 30 days of the change.
FDA Drug Registration Services — How LMG Can Help
LMG handles every step of your FDA drug establishment registration — from initial submission through annual renewals and drug listing maintenance.
Drug Establishment Registration
Complete preparation and electronic submission of your FDA drug establishment registration — domestic and foreign facilities.
U.S. Agent Service
LMG serves as your designated U.S. Agent — mandatory for all foreign drug establishments registering with FDA.
NDC Labeler Code
We manage the NDC labeler code assignment — the unique identifier required on all drug product listings in the U.S.
Drug Listing
Complete drug product listing submission and annual updates ensuring all products remain properly listed.
Annual Renewal Management
We track your renewal window and manage the annual process — so you never miss a deadline or risk product detention.
FDA Registration Certificate
LMG issues a certificate of FDA registration at no extra cost — verifiable by your customers at fdahelp.us.
Transparent, Competitive Fees
LMG's service fees for drug establishment registration are published on our Fees page. Price-locked since 2009 — no hidden charges.
FDA Drug Establishment Registration — Frequently Asked Questions
Common questions about FDA drug establishment registration.
Does FDA drug registration mean my drug is FDA approved?
No. FDA drug establishment registration does not constitute FDA approval or certification of your facility or drug products. Registration simply means your facility is listed in FDA’s database as a drug manufacturer. Any labeling that implies FDA approval based on registration number is misleading and constitutes misbranding.
What happens if I miss the annual renewal window?
If your registration lapses by missing the October 1 – December 31 renewal window, your drug products may be considered misbranded. FDA may detain shipments at U.S. ports of entry and issue Warning Letters. LMG tracks renewal deadlines for all clients to prevent this.
Is a U.S. Agent mandatory for foreign drug establishments?
Yes. All foreign drug establishments that manufacture, repack, or re-label drugs for import into the United States must designate a U.S. Agent as part of their FDA registration. The U.S. Agent must be located in the United States and available 24/7 for FDA communications.
What is an NDC Labeler Code and do I need one?
An NDC Labeler Code is a unique 4 or 5-digit number assigned by FDA to identify your company as a drug labeler. It is a mandatory requirement for all drug product listings sold in the United States and is assigned after a NDC Labeler code request submission to the FDA.
How long does the registration process take?
With LMG’s assistance, the registration process typically takes 3 to 7 business days from the time we receive your completed information. FDA processes electronic submissions quickly — in most cases the registration is active within 1 to 2 business days of submission.
Ready to Register Your Drug Establishment?
LMG handles the entire FDA registration process — from submission to annual renewal. Get started today.
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