FDA Drug Establishment
Registration & Drug Listing
FDA Drug Establishment Registration is the mandatory federal filing that identifies every foreign and domestic facility that manufactures, repacks, or relabels finished drug products or active pharmaceutical ingredients intended for U.S. commercial distribution. The requirement is established by Section 510 of the Federal Food, Drug, and Cosmetic Act and operationalized through 21 CFR Part 207, administered by the U.S. Food and Drug Administration. Registration assigns each facility a unique FEI number, enables FDA inspection and post-market surveillance, and is paired with a separate drug listing submission that identifies every product the establishment commercially distributes. Without an active registration and current drug listings, your products are considered misbranded under Section 502(o) of the FD&C Act and are subject to FDA import refusal, detention, warning letters, and removal from regulated marketplaces such as Amazon, Shopify, and Walmart.
Foreign and domestic facilities that manufacture, repack, or relabel drug products for U.S. distribution must register with the FDA and list all drug products. FDA Registration Assistance handles your registration, drug listing, and annual renewal — accurately and in full compliance.
What Is FDA Drug Establishment Registration & Why Does It Matter?
FDA Drug Establishment Registration is a mandatory requirement for any foreign or domestic facility that manufactures, repacks, or relabels drug products intended for commercial distribution or use in the United States. Regulated under 21 CFR Part 207, all covered establishments must register with the FDA and submit drug listings for every product they plan to market in the U.S.
FDA Registration Assistance manages the complete drug establishment registration and drug listing process on your behalf — from initial registration through annual renewal. Failure to register and list properly may result in FDA enforcement action, import refusal, or market access restrictions.
- Required for foreign & domestic drug manufacturers, repackers, relabelers & API producers
- Governed by 21 CFR Part 207 under Section 510 of the Federal Food, Drug, and Cosmetic Act
- Each registered facility receives an FEI number; each product receives an NDC code
- Foreign establishments must designate a U.S. Agent with a verifiable U.S. street address
- Annual renewal required every October 1 – December 31; listing updates every June & December
Drug Establishment Registration & Listing Services
Everything drug manufacturers, repackers, and relabelers need to stay fully FDA-compliant.
Drug Establishment Registration
FDA Registration Assistance completes and submits your FDA Drug Establishment Registration accurately and efficiently — for both foreign and domestic facilities manufacturing, repacking, or relabeling drug products.
Drug Listing Submissions
Every registered drug establishment must submit a drug listing for each product it intends to commercially distribute in the U.S. FDA Registration Assistance prepares and submits accurate, complete drug listings on your behalf.
Annual Registration Renewal
Drug Establishment Registration must be renewed every year between October 1 and December 31. FDA Registration Assistance manages your annual renewal to ensure your registration never lapses.
Regulatory Guidance & Compliance Support
FDA Registration Assistance provides ongoing regulatory guidance to help drug establishments maintain compliance, respond to FDA inquiries, and understand their registration and listing obligations.
Trusted FDA Drug Registration Compliance Partner
Helping foreign and domestic drug establishments register, list, and renew with the FDA — accurately, on time, and in full compliance.
How Our Drug Establishment Registration Service Works
A simple four-step process to get your drug establishment registered, products listed, and registration renewed every year.
Submit Facility & Product Information
Provide your facility name, address, drug product details, and any existing FDA registration information to begin your Drug Establishment Registration.
Registration & Drug Listing Filed
FDA Registration Assistance submits your Drug Establishment Registration and drug listings to the FDA — ensuring all details are accurate and complete.
FDA Confirmation & Verification
We confirm receipt of your registration and drug listing by the FDA, verify all information is correctly recorded, and provide you with your registration details.
Annual Renewal & Ongoing Compliance
FDA Registration Assistance manages your annual Drug Establishment Registration renewal each year between October 1 and December 31 — keeping your registration active and compliant.
What Every Registered Drug Establishment Must Do
Under 21 CFR Part 207 and §510 of the FD&C Act, registered drug establishments — and the U.S. Agents who represent foreign facilities — must meet seven concrete compliance duties at all times.
Initial Registration of the Physical Facility
Submit complete registration before the establishment begins manufacturing, repacking, or relabeling drugs for U.S. distribution — including legal name, physical street address, DUNS number, and all activity types performed at the site.
Drug Listing for Every Marketed Product
File a separate SPL drug listing for each product under 21 CFR 207.49, including active ingredients, dosage form, route of administration, NDC, labeling, marketing category (Rx, OTC Monograph, ANDA, NDA), and packaging configuration.
Designation of a U.S. Agent (Foreign Establishments)
Foreign establishments must designate one U.S. Agent with a verifiable U.S. street address under 21 CFR 207.69. The agent serves as FDA's primary point of contact, accepts inspection-related communications, and helps schedule on-site FDA inspections.
Annual Registration Renewal
Renew the establishment registration every year between October 1 and December 31 (21 CFR 207.29). Failure to renew during this window automatically expires the registration on January 1 — exposing imports to refusal at U.S. ports.
Semi-Annual Drug Listing Updates
Update drug listings every June and December under 21 CFR 207.57, even when no changes have occurred (a "no-change certification" is required). Listings must also be updated within 3 business days when products are introduced or discontinued.
Reporting Changes Within Required Timeframes
Notify the FDA within statutory deadlines of any change to ownership, business name, U.S. Agent, facility location, contact information, or operations performed — using SPL submissions through CDER Direct or the FDA Electronic Submissions Gateway.
FDA Inspection Readiness & Records
Maintain registration records, batch records, and quality system documentation available for FDA inspection at any time. Foreign establishments must accept FDA Office of Pharmaceutical Quality inspections under §704 of the FD&C Act.
Truthful Representation of Registration Status
Never represent that FDA registration implies approval, endorsement, or evaluation of the drug — explicitly prohibited under 21 CFR 207.77. Misuse of the registration as a marketing claim is a separate violation that triggers FDA warning letters.
Drug Establishment Registration vs. FDA Drug Approval
These two FDA processes are constantly confused — but they are entirely separate regulatory tracks. Registration identifies your facility; approval clears your product.
| Attribute | Drug Establishment Registration | FDA Drug Approval (NDA / ANDA) |
|---|---|---|
| Who Designates It | The drug establishment itself (self-registration with the FDA) | The FDA Center for Drug Evaluation and Research (CDER), after a multi-year scientific review |
| What It Represents | Identifies the physical facility manufacturing, repacking, or relabeling a drug — and the products it makes | FDA's formal determination that a specific drug is safe and effective for its intended use |
| Required By | FD&C Act §510 — for any establishment producing drugs for U.S. distribution | FD&C Act §505 — for any new drug before it can be commercially marketed in the U.S. |
| Governing Regulation | 21 CFR Part 207 | 21 CFR Part 314 (NDA / ANDA submissions) |
| Primary Function | Enables FDA inspection, import monitoring, recalls, and supply-chain transparency | Grants legal market access by demonstrating safety, efficacy, and labeling adequacy |
| Required For | All drug manufacturers, repackers, relabelers, and API producers — including OTC monograph drugs | New prescription drugs, generic equivalents, biosimilars, and certain Rx-to-OTC switches |
Drug Establishment Registration and FDA Drug Approval address completely different regulatory questions and apply to different entities. Registration says "this facility exists, this is who runs it, and these are the products it makes" — it is a transparency and identification mechanism, not a quality verdict. Approval, by contrast, is FDA's scientific endorsement that a specific drug product is safe and effective for its intended use after years of clinical trials and review. OTC monograph drugs (sunscreens, hand sanitizers, basic acetaminophen) require registration but not individual approval. Branded prescription drugs require both. Most businesses operating in the U.S. drug market need to satisfy both pathways — registration is the entry ticket, approval is the green light to sell a specific product.
Self-Filing vs. FDA Registration Assistance
CDER Direct is open to the public — but doing it yourself means learning SPL XML, FEI assignment workflow, U.S. Agent rules, and 21 CFR Part 207 from scratch. Here is what the trade-off looks like.
| Factor | Self-Filing (DIY) | Recommended FDA Registration Assistance |
|---|---|---|
| Cost | $0 government fee + cost of internal staff time, SPL software, training, and rework | $449 USD / year — flat fee, includes U.S. Agent and SPL listing |
| Availability | You handle every FDA email, deadline, and inspection notification yourself, on your own time | Dedicated regulatory team responds to FDA communications during U.S. business hours, 365 days/year |
| Drug-Specific Expertise | Requires self-study of 21 CFR Part 207, SPL standards (HL7), CDER Direct workflow, and FEI lookup | 15+ years of drug registration experience — Rx, OTC monograph, API, and contract manufacturing |
| Risk of Filing Failure | High — XML validation errors, missing NDC structure, incorrect marketing category, or DUNS mismatch are common | Pre-submission audit catches errors before filing; rejected submissions are reworked at no extra charge |
| Confirmation & Handling | You must monitor FDA acknowledgments, parse XML responses, and verify FEI assignment yourself | FEI verification, listing confirmation, and clean PDF documentation delivered to your inbox |
| Renewal & Update Tracking | Easy to miss the Oct 1 – Dec 31 renewal window or the June / December listing update cycle | Automatic calendar tracking, advance reminders, and managed renewal — 100% on-time record |
Drug Establishment Registration is not difficult because the form is hard — it is difficult because the SPL submission format, FEI workflow, U.S. Agent requirements, and update cadence are unforgiving. Most foreign manufacturers who attempt self-filing succeed on the initial registration but fail on the semi-annual listing updates, the annual renewal window, or the U.S. Agent designation rules — and a single missed deadline can flip a compliant establishment into Import Alert status. FDA Registration Assistance manages all of it for a flat $449/year so you never miss a window.
Free / Friend U.S. Agent vs. FDA Registration Assistance
Foreign drug establishments can technically name any U.S. resident as their U.S. Agent — but "free" comes with very real liabilities under 21 CFR 207.69.
| Factor | Free / Friend U.S. Agent | Recommended FDA Registration Assistance |
|---|---|---|
| Government Fee | $0 — the FDA does not charge for U.S. Agent designation or for Drug Establishment Registration itself | $0 government fee + $449/year service (includes U.S. Agent, registration & listing) |
| Pros | No out-of-pocket cost; the friend already has a U.S. address you can use on the registration | Trained regulatory professional, monitored FDA inbox, documented inspection-readiness, no personal-relationship risk |
| Cons | Friend may not understand FDA Form 483, Import Alerts, or 21 CFR Part 207; missed FDA emails void the registration; address changes (e.g., your friend moves) trigger compliance breaks | Predictable annual cost; bundled with registration so renewals stay in sync |
| Best For | No legitimate business case — the FDA explicitly requires an agent who can act on inspection and regulatory communications | Every foreign manufacturer, repacker, relabeler, and API producer selling drugs into the U.S. |
A "free" U.S. Agent is one of the most common reasons foreign drug establishments end up on Import Alert. Friends and unrelated parties typically do not recognize FDA inspection scheduling requests, Form 483 observations, or recall notifications — and any missed response invalidates the registration under 21 CFR 207.69. Professional U.S. Agent service ensures every FDA communication is logged, triaged, and answered within FDA's expected timeframes.
Drug Registration Terms You Will Encounter
A quick reference of the technical acronyms, codes, and submission systems used throughout the FDA Drug Establishment Registration process.
FDA Establishment Identifier — a unique 7- to 10-digit number the FDA assigns to each physical facility that registers under 21 CFR Part 207. The FEI follows the facility, not the owner.
A 10- or 11-digit product code segmented into labeler, product, and package-size identifiers. Every commercially distributed drug product in the U.S. must have an NDC assigned through drug listing.
The XML-based HL7 standard the FDA requires for electronic submission of drug establishment registrations and drug listings. All filings must validate against current SPL schemas before acceptance.
The FDA's online portal operated by the Center for Drug Evaluation and Research used to create, submit, and manage Drug Establishment Registrations and SPL drug listings.
The FDA Electronic Submissions Gateway — the secure transport layer that delivers SPL files (and other regulated submissions) from filers to FDA review queues.
A nine-digit unique identifier issued by Dun & Bradstreet that the FDA uses to verify the legal identity and physical address of every registered drug establishment.
An individual or business with a U.S. street address designated by a foreign drug establishment to act as the FDA's primary point of contact under 21 CFR 207.69.
The first segment of the NDC, assigned by the FDA to identify the company responsible for placing a drug into U.S. commerce — the manufacturer, repacker, relabeler, or distributor under whose name the product is sold.
The regulatory pathway under which a drug is marketed — NDA, ANDA, BLA, OTC monograph, unapproved drug, or compounded — declared in every SPL drug listing.
A non-prescription drug marketed under an FDA OTC monograph (e.g., sunscreens, hand sanitizers, antiperspirants). Subject to registration and listing without requiring an individual NDA.
Legacy paper forms for Drug Establishment Registration and Drug Product Listing. Replaced for routine use by SPL electronic submissions but still referenced in 21 CFR Part 207.
A public FDA mechanism that authorizes Detention Without Physical Examination of products from establishments with known compliance failures. Often triggered by lapsed registration or missing listings.
Why Drug Establishment Registrations Get Cancelled or Rejected
After 15+ years of filings, these are the most frequent root causes of registration cancellation, import refusal, and FDA enforcement action against drug establishments.
Missing the Oct 1 – Dec 31 Renewal Window
Registrations not renewed during the annual fourth-quarter window automatically expire on January 1. Once expired, all listed drugs are treated as unregistered and refused at U.S. ports until reinstated.
Skipping the Semi-Annual Listing Update
Even when nothing changes, 21 CFR 207.57 requires every June and December a "no-change" certification per listed drug. Skipping this update causes the listing — and any related NDC — to fall out of FDA's active records.
Invalid or Unresponsive U.S. Agent
If the designated U.S. Agent's address is a P.O. Box, no longer valid, or the agent fails to respond to FDA communications, the registration is deemed not to have a U.S. Agent — and is therefore invalid under 21 CFR 207.69.
SPL Validation Errors
Incorrect XML structure, invalid HL7 codes, missing dosage form / route of administration, or malformed NDC segments cause CDER Direct to reject the submission. Many self-filers never realize their SPL never validated.
Wrong Address Type on the Registration
The FDA requires the physical street address where drug operations actually occur. Using a P.O. Box, virtual office, freight forwarder, or unrelated warehouse triggers automatic rejection — or worse, post-registration audit findings.
Claiming "FDA-Approved" Based on Registration
21 CFR 207.77 explicitly prohibits stating or implying that registration constitutes FDA approval, endorsement, or evaluation. Marketing copy that claims "FDA-approved" because the facility is registered is misbranding under §502(a) of the FD&C Act.
Not Registering Every Physical Site
Each distinct physical address performing drug operations needs its own FEI and registration under 21 CFR 207.17. Treating multiple sites as a single registration causes products manufactured at unregistered sites to be deemed unapproved drugs.
Mismatched DUNS, Legal Name, or Owner Information
The FDA cross-checks DUNS records against registration data. Discrepancies in legal name, physical address, or ownership trigger holds, RFIs, or rejection of the entire SPL submission until the records are reconciled.
Complete FDA Compliance Solutions
We offer a full range of FDA registration and compliance services to help your facility and shipments meet all U.S. regulatory requirements.
Drug Establishment Registration
Register your foreign or domestic drug manufacturing, repacking, or relabeling facility with the FDA — required for all drug products distributed in the U.S.
Labeler Code Registration
Obtain your FDA Labeler Code — required to identify your company on drug product labels and NDC numbers distributed in the United States.
NDC Code / Product Code
Register your National Drug Code (NDC) and product codes with the FDA — mandatory for all drug products commercially distributed in the U.S.
Drug Label & Ingredient Review
Ensure your drug product labels and ingredient declarations meet all FDA labeling requirements before entering the U.S. market.
DUNS Request Assistance
Obtain your DUNS Number required for FDA Drug Establishment Registration and federal compliance — filed accurately on your behalf.
Drug / OTC U.S. Agent Services
Designate a U.S. FDA Agent for your foreign drug establishment — legally required for all foreign drug facilities registered with the FDA.
FDA Drug Listing Certificate
Obtain your official FDA Drug Listing Certificate confirming your drug product is registered and listed with the U.S. Food and Drug Administration.
FDA Drug Master Files (DMF)
Submit an FDA Drug Master File (DMF) to protect confidential manufacturing information while supporting drug product applications and registrations.
Drug Import Alert Removal
Get expert help resolving FDA drug import alerts and detentions to restore your drug products' ability to enter the United States.
Frequently Asked Questions About FDA Drug Establishment Registration
Find answers to the most common questions about FDA Drug Establishment Registration, drug listing requirements, and how FDA Registration Assistance helps your facility stay compliant.
What is FDA Drug Establishment Registration?
FDA Drug Establishment Registration is a mandatory requirement for any foreign or domestic facility that manufactures, repacks, or relabels drug products for U.S. commercial distribution. FDA Registration Assistance manages the full registration process on your behalf.
Who is required to register a drug establishment?
Any foreign or domestic facility involved in drug manufacturing, repacking, or relabeling for U.S. commercial distribution must register with the FDA. FDA Registration Assistance handles registrations for facilities of all types and sizes worldwide.
Is drug listing required in addition to establishment registration?
Yes. All registered drug establishments must submit a drug listing for every drug product they intend to commercially distribute in the U.S. FDA Registration Assistance prepares and submits accurate drug listings alongside your establishment registration.
How often must Drug Establishment Registration be renewed?
Drug Establishment Registration must be renewed annually between October 1 and December 31. FDA Registration Assistance manages your annual renewal to ensure your registration never lapses and your drug listings remain current.
What happens if a facility fails to register or list drugs?
Failure to register or properly list drug products may result in FDA enforcement action, import refusal or detention, product recalls, and identification as an unapproved or illegally marketed drug. Contact FDA Registration Assistance to get compliant before issues arise.
Can FDA Registration Assistance manage the entire process?
Yes. FDA Registration Assistance handles your Drug Establishment Registration, drug listings, annual renewals, and ongoing compliance support — the entire process, managed professionally on your behalf.
What is included in the Drug Establishment Registration fee?
FDA Registration Assistance charges $449 USD per year for Drug Establishment Registration services, which includes the U.S. Agent fee, drug listing submission, and full registration management. Contact FDA Registration Assistance to get started today.
What is the purpose of FDA drug establishment registration?
The FDA uses drug establishment registration and drug listing information to support inspections, post-market surveillance, counterterrorism, drug recalls, adverse event monitoring, drug shortage monitoring, import/export oversight, and identification of unapproved drugs. FDA Registration Assistance ensures your records are accurate and up to date.
Does drug establishment registration apply to foreign facilities?
Yes. Foreign facilities that manufacture, repack, or relabel drug products for distribution in the United States are subject to the same FDA Drug Establishment Registration requirements as domestic facilities. FDA Registration Assistance works with facilities in over 135 countries.
What information is required for drug listing?
Drug listings must include accurate product information, labeling, and manufacturing details. They must be updated whenever product information, labeling, or status changes. FDA Registration Assistance ensures your drug listings are complete, accurate, and current.
When must drug listings be updated?
Drug listings must be updated as required by FDA regulations — including when product information, labeling, or marketing status changes. FDA Registration Assistance monitors your listings and manages all required updates to keep your records current.
What is the difference between Drug Establishment Registration and drug listing?
Drug Establishment Registration identifies the facility, while drug listing identifies the specific drug products the facility manufactures or distributes. Both are required and must be maintained separately. FDA Registration Assistance manages both for your facility.
Does my facility need a U.S. Agent for drug establishment registration?
Yes. Foreign drug establishments registering with the FDA are required to designate a U.S. Agent. FDA Registration Assistance provides U.S. Agent services as part of the $449/year Drug Establishment Registration package.
How does FDA Registration Assistance help with drug establishment compliance?
FDA Registration Assistance prepares and submits all required registration and listing documents, manages annual renewals, and provides ongoing regulatory guidance to ensure your drug establishment remains fully compliant with FDA requirements at all times.
Can FDA Registration Assistance handle multiple drug products and facilities?
Yes. FDA Registration Assistance can manage Drug Establishment Registration and drug listings for multiple facilities and product lines, scaling our services to meet the needs of your organization. Contact FDA Registration Assistance for a customized compliance plan.
What regulatory framework governs Drug Establishment Registration?
Drug Establishment Registration is governed by 21 CFR Part 207 under the Federal Food, Drug, and Cosmetic Act. FDA Registration Assistance ensures your registration and drug listings fully comply with all applicable FDA regulations and requirements.
What does the $449 annual fee cover and what is the bundle math with U.S. Agent service?
The $449 USD annual fee covers everything: initial Drug Establishment Registration filing under 21 CFR Part 207, SPL drug listing submission for your products, designation of a U.S. Agent (a separate service typically billed at $299/year on its own), FEI number confirmation, and the mandatory annual renewal between October 1 and December 31. Purchased separately, Drug Establishment Registration management plus a standalone U.S. Agent designation would normally exceed $700/year. The $449 bundle is structured so foreign drug manufacturers receive one fixed price covering both regulatory obligations — registration + listing + U.S. Agent — under one renewal cycle.
Can my U.S. Agent for drug establishment registration be a friend or unrelated party in the United States?
Technically yes, but it is strongly discouraged. Under 21 CFR 207.69, the U.S. Agent must be a person or business with a U.S. street address (not a P.O. Box) who acts as the FDA's communication liaison for your foreign establishment. A friend without regulatory expertise will not understand FDA inquiries, Form 483 observations, or import detention notices — and any missed response can trigger registration cancellation, warning letters, or import refusal at U.S. ports. A professional U.S. Agent is trained to log, escalate, and respond to FDA communications within required timeframes.
What happens if my U.S. Agent does not respond to the FDA?
Your drug establishment registration can be deemed invalid and your products refused entry at U.S. ports. The FDA expects the U.S. Agent to respond promptly to communications, inspection requests, and emergency notifications on behalf of the foreign establishment. Non-response can result in the FDA treating the registration as if no U.S. Agent has been designated — which under 21 CFR 207.69 means the registration itself is not valid, exposing your shipments to detention, Import Alert listing, and Amazon / Shopify / Walmart delisting.
How do I change the U.S. Agent on an existing FDA drug establishment registration?
Update the registration record in CDER Direct (or via SPL submission through the FDA Electronic Submissions Gateway) to designate the new U.S. Agent. The change must include the new agent's name, U.S. street address, phone number, and email, and must be accepted by the new agent in writing. FDA Registration Assistance handles the full transition: we file the change in your CDER Direct account, confirm acceptance with the FDA, and update your registration record — typically completed within 1–3 business days, with no lapse in your active registration.
Do I need FDA Drug Establishment Registration if I only sell prescription drugs on Amazon?
Yes, if you are the manufacturer, repacker, or relabeler of those drugs. Amazon's Professional Beauty and OTC drug categories require sellers to provide a valid FDA Drug Establishment Registration number (FEI) and NDC code before listings go live. Pure distributors who do not manufacture, repack, or relabel are generally not required to register, but they must source from an FDA-registered establishment and may still need to provide proof of registration to Amazon during category gating.
Does FDA Drug Establishment Registration mean my drug is FDA-approved?
No. Registration is not approval. Drug Establishment Registration under 21 CFR Part 207 only identifies your facility and the products it makes — it does not constitute FDA approval, endorsement, or evaluation of safety and efficacy. The FDA explicitly prohibits any representation that registration implies approval (21 CFR 207.77). Claiming "FDA-approved" because your establishment is registered is misbranding under §502(a) of the FD&C Act and can trigger an FDA warning letter on its own.
Do contract manufacturers and contract packagers need their own FDA drug establishment registration?
Yes. Under 21 CFR 207.17, every establishment engaged in the manufacture, repackaging, or relabeling of a drug product must register independently — including contract manufacturing organizations (CMOs), contract packagers, and contract testing laboratories that perform manufacturing operations. The brand owner does not "cover" the contractor under their own registration; each physical site that handles the drug must hold its own FEI number and submit its own registration and listings.
Are OTC monograph drugs required to be registered and listed with the FDA?
Yes. OTC monograph drugs — including sunscreens, hand sanitizers, antiperspirants, acne products, dandruff shampoos, and topical pain relievers — are subject to the same Drug Establishment Registration and drug listing requirements as prescription drugs under 21 CFR Part 207. Each OTC product must have an NDC code and be listed under the manufacturer's registered establishment, even though OTC monograph drugs do not require an individual NDA approval.
Is a P.O. Box acceptable as the facility address for FDA Drug Establishment Registration?
No. The FDA requires the physical street address of the actual manufacturing, repacking, or relabeling site — not a mailing address, P.O. Box, virtual office, freight forwarder, or warehouse where no drug operations occur. Each unique physical address performing drug operations must be registered separately and receives its own FEI number. The U.S. Agent for foreign establishments is also required to have a physical U.S. street address — P.O. Boxes are not accepted under 21 CFR 207.69.
How do I verify that an FDA Drug Establishment Registration is real?
Use the FDA's public Drug Establishments Current Registration Site (DECRS) database on FDA.gov to search by FEI number, firm name, or address. Listed drug products can be cross-checked through the FDA's National Drug Code Directory (NDC Directory). If a registration is not searchable in DECRS, it is either inactive, never filed, or fraudulent. FDA Registration Assistance provides DECRS-verifiable confirmation for every registration we file on your behalf.
Do compounding pharmacies and outsourcing facilities need FDA Drug Establishment Registration?
Outsourcing facilities under Section 503B of the FD&C Act must register with the FDA annually and report compounded products every six months — a separate, stricter pathway from 21 CFR Part 207 that includes cGMP compliance. Traditional 503A compounding pharmacies are generally regulated by state boards of pharmacy and are not required to register as drug establishments under Part 207, unless their operations exceed the limits set by Section 503A.
What is an FEI number and how is it different from an NDC?
An FEI (FDA Establishment Identifier) is a unique 7- to 10-digit number assigned to each registered facility — it identifies the physical site. An NDC (National Drug Code) is a 10- or 11-digit number that identifies a specific drug product (labeler segment + product segment + package size). A single FEI can be associated with many NDCs because one facility can manufacture many drugs, but they serve different purposes: FEI for facility identification and inspection, NDC for product identification and commerce.
Do API (active pharmaceutical ingredient) manufacturers need to register with the FDA?
Yes. Manufacturers of bulk drug substances (APIs) intended for use in finished drug products distributed in the U.S. must register under 21 CFR Part 207 and submit drug listings for each API. API manufacturers supplying generic finished-dose manufacturers may also be subject to GDUFA (Generic Drug User Fee Amendments) facility fees separately. Both domestic and foreign API manufacturers fall under the same registration and listing requirements as finished-product manufacturers.
What is the difference between CDER Direct and the FDA Unified Registration and Listing System (FURLS)?
CDER Direct is the FDA portal used to manage Drug Establishment Registration and SPL drug listing submissions for human drug products under 21 CFR Part 207. FURLS is the broader FDA platform that houses registration systems for food facilities (FFRM), medical devices, tobacco products, and other product categories. Human drug establishment registration is not handled through FURLS — it is processed exclusively through CDER Direct via SPL XML submissions over the FDA Electronic Submissions Gateway.
Register Your Drug Establishment & Stay FDA-Compliant
Submit your facility and product details and FDA Registration Assistance will complete your Drug Establishment Registration, submit your drug listings, and manage your annual renewal — all handled professionally.
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