FDA Drug Establishment
Registration & Drug Listing
FDA Drug Establishment Registration is the federal registration requirement for covered foreign and domestic establishments that manufacture, repack, relabel, or salvage drug products for U.S. commercial distribution, including many facilities that manufacture active pharmaceutical ingredients. 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. FDA uses establishment identifiers such as the FEI to track facilities for regulatory and inspection purposes, while a separate drug listing identifies drugs manufactured, repacked, relabeled, or salvaged for commercial distribution. Failure to meet applicable registration or listing requirements can cause a drug to be misbranded under Section 502(o) of the FD&C Act and may lead to import delays, detention or refusal, warning letters, or other FDA enforcement action.
Covered foreign and domestic establishments that manufacture, repack, relabel, or salvage drug products for U.S. commercial distribution must register with FDA and meet the drug listing requirements that apply to their operations. FDA Registration Assistance handles your establishment registration and annual renewal, provides U.S. Agent support for foreign facilities, and can prepare drug listing and NDC submissions when needed.
What Is FDA Drug Establishment Registration & Why Does It Matter?
FDA Drug Establishment Registration applies to covered foreign and domestic establishments that manufacture, repack, relabel, or salvage drugs for U.S. commercial distribution. Under 21 CFR Part 207, registrants must register each covered establishment and meet the drug listing requirements that apply to the drugs manufactured, repacked, relabeled, or salvaged there.
FDA Registration Assistance manages establishment registration and annual renewal, provides U.S. Agent representation for foreign facilities, and can prepare drug listing and NDC submissions based on your product scope. Incomplete or outdated registration and listing information can create FDA compliance and import problems.
- Required for covered foreign & domestic manufacturers, repackers, relabelers, salvagers and certain API facilities
- Governed by 21 CFR Part 207 under Section 510 of the Federal Food, Drug, and Cosmetic Act
- FDA uses an FEI to identify facilities; listed drugs use NDCs to identify labeler, product and package configurations
- Foreign establishments must designate one U.S. Agent that resides or maintains a place of business in the United States and is physically present there
- Annual renewal required every October 1 – December 31; listing updates every June & December
Drug Establishment Registration & Listing Services
Registration, U.S. Agent, renewal, and drug listing support built around the requirements that apply to your specific establishment and products.
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
Registrants must list drugs they manufacture, repack, relabel, or salvage for commercial distribution as required by 21 CFR Part 207. FDA Registration Assistance prepares SPL drug listing and NDC submissions as a separately scoped service based on your product portfolio.
Annual Registration Renewal
Drug Establishment Registration must be reviewed and updated annually during the October 1 through December 31 renewal period. FDA Registration Assistance manages the annual filing and tracks required registration updates.
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 manage registration, listing support, and annual renewal with clear, current FDA filing records.
How Our Drug Establishment Registration Service Works
A simple four-step process for establishment registration, U.S. Agent coordination when required, product-specific listing support, and annual renewal.
Submit Facility & Product Scope
Provide the facility identity, physical address, ownership/contact information, UFI details, operations performed, existing FDA identifiers, and the drug products that may require separate listing or NDC support.
Registration Prepared & Filed
We prepare and submit the Drug Establishment Registration electronically and coordinate U.S. Agent information for foreign establishments. Drug listing work is handled according to your separately scoped product needs.
FDA Status Verified
We review FDA acknowledgments and verify the establishment registration status in FDA records. When drug listing or NDC services are included, we also track the applicable submission status.
Annual Renewal & Updates
We manage the annual October 1–December 31 registration review and renewal and help coordinate required establishment updates. Drug listing updates are supported according to your selected service scope.
Core Drug Establishment Registration & Listing Responsibilities
Under 21 CFR Part 207 and §510 of the FD&C Act, registrants have ongoing registration and listing duties. Foreign establishments must also maintain a single U.S. Agent who performs the communication and inspection-scheduling functions described in 21 CFR 207.69.
Initial Registration of the Physical Facility
Domestic establishments generally register no later than 5 calendar days after beginning covered operations. A foreign establishment must be registered before a drug manufactured, repacked, relabeled, or salvaged there is imported or offered for import into the United States.
Required Drug Listing Information
Submit required SPL drug listing information for drugs manufactured, repacked, relabeled, or salvaged for commercial distribution, including the applicable NDCs, ingredients, dosage form, route, establishment information, labeling, and marketing information required by Part 207.
Designation of a U.S. Agent (Foreign Establishments)
Foreign establishments must designate one U.S. Agent under 21 CFR 207.69. The agent must reside or maintain a place of business in the United States, may not be only a mailbox or answering service, and is responsible for FDA communications, import-related questions, and inspection scheduling assistance.
Annual Registration Renewal
Review and update establishment registration every year during October 1 through December 31 under 21 CFR 207.29. If no changes have occurred, the registrant must certify that no changes have occurred. A registration that is not renewed does not remain current for the following calendar year.
Semi-Annual Drug Listing Updates
Review drug listing information each June and December under 21 CFR 207.57 and submit required information for new listings, discontinued or resumed drugs, and material changes. Drugs being manufactured at the time of an initial establishment registration generally must be listed no later than 3 calendar days after that initial registration.
Reporting Changes Within Required Timeframes
Submit required registration updates on time. Certain changes — such as closing or selling an establishment, changing the establishment name or physical address, or changing official-contact or U.S.-Agent information — must be updated no later than 30 calendar days after the change.
FDA Inspection Readiness & Records
Maintain accurate registration and listing information and be prepared for applicable FDA inspection and records obligations under the FD&C Act and current good manufacturing practice requirements. Registration is only one part of overall drug compliance.
Truthful Representation of Registration Status
Do not represent registration, listing, database inclusion, or an NDC as FDA approval or proof that a drug may be legally marketed. 21 CFR 207.77 expressly states that registration and listing do not confer FDA approval.
Drug Establishment Registration vs. FDA Drug Approval
These two FDA processes are constantly confused — but they are entirely separate regulatory tracks. Registration identifies covered establishments and listed drugs; FDA approval or another lawful marketing pathway addresses whether a particular drug may be marketed.
| 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 covered establishment and its regulated operations; drug listing separately identifies the applicable drug products | FDA's approval of a specific application after review of the evidence required for that application pathway |
| Required By | FD&C Act §510 — for covered establishments subject to registration and listing requirements | FD&C Act §505 — for drug products that require an approved NDA or ANDA before U.S. marketing |
| 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 | For drugs requiring an approved application, authorizes marketing under the terms of the approved application |
| Required For | All drug manufacturers, repackers, relabelers, and API producers — including OTC monograph drugs | Drug products that require an approved application, such as many new and generic drugs; other pathways can apply to other products |
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, applies to drug products that require an approved application and reflects FDA review under that pathway. Some nonprescription drugs may be marketed under the OTC monograph system rather than an individual NDA. Registration and listing never substitute for whatever marketing authorization or legal pathway applies to the drug.
Self-Filing vs. FDA Registration Assistance
FDA Direct / CDER Direct provides electronic tools for registration and listing, but self-filing still requires a correct understanding of Part 207, SPL data, establishment identifiers, U.S. Agent requirements, and update deadlines.
| Factor | Self-Filing (DIY) | Recommended FDA Registration Assistance |
|---|---|---|
| Cost | No general Part 207 registration filing fee, but internal time, training, SPL preparation, and any separately applicable FDA user-fee programs still need to be considered | $849 USD / year for Drug Establishment Registration management; U.S. Agent representation is included for foreign facilities. Drug listing/NDC work is scoped separately. |
| Availability | You handle every FDA email, deadline, and inspection notification yourself, on your own time | Dedicated regulatory team monitors and routes FDA communications during U.S. business hours and supports inspection scheduling for foreign facilities |
| Drug-Specific Expertise | Requires self-study of 21 CFR Part 207, SPL standards (HL7), FDA Direct / CDER Direct workflows, and FDA establishment identifiers | FDA compliance support since 2013 across drug establishment, OTC, API, contract manufacturing, labeling and listing matters |
| Risk of Filing Failure | Errors can occur when establishment identifiers, SPL data, NDC structure, marketing category, labeling, or facility information do not match FDA requirements | Pre-submission review helps identify data and formatting issues before filing and supports correction of FDA validation errors |
| Confirmation & Handling | You monitor FDA acknowledgments, resolve validation messages, and verify current establishment status yourself | Registration-status verification and filing documentation are organized and delivered to you; listing/NDC confirmations are provided when those services are included |
| Renewal & Update Tracking | Easy to miss the Oct 1 – Dec 31 renewal window or the June / December listing update cycle | Annual renewal tracking and managed October–December registration updates, with listing-update support available based on your service scope |
The challenge is not simply completing a form. Registration and listing data must be accurate, electronic submissions must validate, foreign establishments must maintain an eligible U.S. Agent, registration must be reviewed annually, and listing information must be reviewed each June and December. FDA Registration Assistance manages the annual Drug Establishment Registration service for $849/year, while drug listing and NDC work is scoped to the products that actually need it.
Free / Friend U.S. Agent vs. FDA Registration Assistance
A foreign drug establishment may designate an eligible person or business as its U.S. Agent, but the agent must meet the physical-presence requirement and be able to perform the communication and inspection-scheduling duties in 21 CFR 207.69.
| Factor | Free / Friend U.S. Agent | Recommended FDA Registration Assistance |
|---|---|---|
| Government Fee | FDA does not impose a separate fee simply to designate a U.S. Agent or submit a standard Part 207 registration; separate user fees can apply to certain drug programs and facility types | $849/year service for Drug Establishment Registration management; U.S. Agent representation included for foreign facilities. Drug listing/NDC services are separate. |
| Pros | Potentially lower service cost if the person or business independently meets the U.S. Agent requirements and can reliably perform the required duties | Regulatory-focused point of contact, organized FDA communications, inspection-scheduling support, and continuity of representation |
| Cons | An inexperienced agent may not recognize urgent FDA communications, may be unavailable, or may cease to meet the U.S. physical-presence requirement; agent information changes also require timely registration updates | Predictable annual service with U.S. Agent representation coordinated with registration and annual renewal |
| Best For | A capable in-house affiliate or other eligible U.S. person/business that can reliably perform every duty in 21 CFR 207.69 | Foreign establishments that want a dedicated regulatory contact to manage FDA communications and registration continuity |
The regulation does not require the U.S. Agent to be a paid regulatory consultant, but it does require the agent to reside or maintain a place of business in the United States, be physically present there rather than function only as a mailbox or answering service, respond to FDA communications and import questions, and assist with inspection scheduling. A professional U.S. Agent can provide continuity when those responsibilities are difficult to manage internally.
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 — an FDA-issued identifier used to track regulated establishments and inspections. An FEI is not the same thing as FDA approval and should not be presented as proof that a product is approved.
A numeric code that identifies the labeler, product, and package size/type for a listed drug. Current NDC formatting and assignment requirements are governed by 21 CFR Part 207 and FDA's current implementation rules.
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.
FDA Direct is FDA's web-based SPL authoring tool. Its CDER Direct functions support drug establishment registration, drug listing, labeler code requests, NDC reservations, and related drug submissions.
FDA's electronic submission infrastructure used for many regulated submissions. Drug registration and listing data are submitted electronically in SPL format through FDA-supported submission tools and workflows.
The Data Universal Numbering System identifier issued by Dun & Bradstreet. FDA has specified DUNS as the UFI system for drug-establishment registration, and the facility information must align with the submitted registration data.
The single person or business designated by a foreign drug establishment under 21 CFR 207.69. The agent must reside or maintain a place of business in the United States, be physically present there, handle FDA communications and import questions, and assist with inspection scheduling.
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 category reported in drug listing data that describes the legal marketing basis or status applicable to the product. Registration or an NDC does not itself establish that the product may be legally marketed.
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.
An FDA import-compliance mechanism that can allow Detention Without Physical Examination when the criteria for a particular Import Alert are met. Import Alert placement is separate from ordinary registration status.
Why Drug Registration & Listing Filings Fail or Fall Out of Compliance
These are common registration and listing problems that can create validation errors, outdated FDA records, loss of current registration status, import delays, or broader compliance concerns.
Missing the Oct 1 – Dec 31 Renewal Window
If the annual registration review is not completed during the October 1 – December 31 period, the establishment will not remain current for the following calendar year. For foreign facilities, an outdated registration can create import delays or admissibility problems until the record is corrected.
Skipping the Semi-Annual Listing Update
21 CFR 207.57 requires registrants to review drug listing information each June and December and submit required new, discontinued, resumed, or materially changed listing information. Treating listing data as a one-time filing can leave FDA records inaccurate or incomplete.
Invalid or Unresponsive U.S. Agent
A U.S. Agent may not be only a mailbox, answering machine/service, or another location where a person acting as the agent is not physically present. An unavailable agent can also interfere with FDA communications and inspection scheduling, while changes to agent information must be reported on time.
SPL Validation Errors
Incorrect SPL structure, invalid terminology, missing required product data, or malformed identifiers can trigger FDA Direct / CDER Direct validation errors or prevent a submission from processing correctly. Validation messages should be reviewed and resolved before relying on the filing.
Wrong Address Type on the Registration
Registration must identify the actual establishment and its physical address. Using an address that does not correspond to the establishment can cause validation, identity-matching, inspection, or registration-status problems.
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 covered establishment must be registered as required by 21 CFR 207.17. When operations occur at more than one establishment, the registration data must accurately identify the establishments involved; an unregistered manufacturing site can create registration, listing, and import compliance problems.
Mismatched DUNS, Legal Name, or Owner Information
Mismatched facility identifiers, legal names, addresses, or ownership details can prevent FDA from reliably matching the establishment record and may lead to submission errors or requests to correct the information.
Complete FDA Compliance Solutions
We offer related FDA registration and compliance services to help address the requirements that apply to your facility, products, and U.S. market activities.
Drug Establishment Registration
Professional registration support for covered foreign and domestic drug manufacturing, repacking, relabeling, and related establishments serving the U.S. market.
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
Prepare NDC product/package code and drug listing submissions for products that must be listed for U.S. commercial distribution.
Drug Label & Ingredient Review
Review drug product labeling and ingredient information against applicable FDA requirements before U.S. distribution.
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 qualified U.S. Agent for a covered foreign drug establishment as required by 21 CFR 207.69.
FDA Drug Listing Certificate
Obtain documentation summarizing your drug product’s FDA listing status and the listing information available in FDA records.
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 support addressing FDA drug import alerts and detentions, including corrective-action documentation and regulatory response strategy.
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 the FDA registration process required for covered domestic and foreign establishments that manufacture, repack, relabel, or salvage drugs for U.S. commercial distribution, unless an exemption applies. FDA Registration Assistance can prepare and manage the establishment registration filing and annual renewal.
Who is required to register a drug establishment?
Owners or operators of covered domestic and foreign establishments engaged in manufacturing, repacking, relabeling, or salvaging drugs for U.S. commercial distribution must register as required by 21 CFR Part 207, unless an exemption applies. Foreign establishments must register before their drugs are imported or offered for import into the United States.
Is drug listing required in addition to establishment registration?
Covered registrants must list the drugs they manufacture, repack, relabel, or salvage for U.S. commercial distribution as required by 21 CFR Part 207. Establishment registration and drug listing are separate obligations. FDA Registration Assistance can prepare drug listing submissions when that service is included in your product scope.
How often must Drug Establishment Registration be renewed?
Drug Establishment Registration is reviewed and renewed annually during the October 1 through December 31 registration period. Drug listing information has its own review and update requirements, including June and December updates when applicable. FDA Registration Assistance can manage the annual registration renewal and separately scoped listing updates.
What happens if a facility fails to register or list drugs?
Failure to meet applicable establishment registration or drug listing requirements can cause a drug to be misbranded under the FD&C Act and may lead to FDA enforcement or import consequences, including warning letters, import delays, detention, refusal, seizure, or injunction depending on the circumstances.
Can FDA Registration Assistance manage the entire process?
Yes. FDA Registration Assistance can manage Drug Establishment Registration and annual renewal, provide U.S. Agent representation for foreign establishments, and prepare drug listing, labeler-code, and NDC submissions when those services are included in your scope.
What is included in the Drug Establishment Registration fee?
FDA Registration Assistance charges $849 USD per year for Drug Establishment Registration management and annual renewal support. U.S. Agent representation is included for foreign establishments. Drug listing, labeler code, and NDC services are quoted separately based on the product and submission scope. Contact FDA Registration Assistance to get started today.
What is the purpose of FDA drug establishment registration?
FDA uses establishment registration and drug listing information for regulatory programs including inspections, post-market surveillance, recalls, supply-chain oversight, and import review. FDA Registration Assistance helps prepare and maintain the filing records included in your service scope.
Does drug establishment registration apply to foreign facilities?
Yes. Covered foreign establishments whose drugs are imported or offered for import into the United States must register before the drug is imported or offered for import and must designate one U.S. Agent. FDA Registration Assistance supports foreign establishments worldwide.
What information is required for drug listing?
Drug listing submissions include required product, labeling, establishment, and marketing information in Structured Product Labeling (SPL) format. The exact data depends on the drug and listing type. FDA Registration Assistance can prepare and review the listing information included in your product scope.
When must drug listings be updated?
Registrants must review and update drug listing information in June and December as required by 21 CFR Part 207, including newly listed drugs and material changes that must be reported. Other listing submissions may also be needed when a drug is introduced, discontinued, or resumes marketing. FDA Registration Assistance can manage these updates when listing maintenance is included in your service scope.
What is the difference between Drug Establishment Registration and drug listing?
Drug Establishment Registration identifies the regulated establishment and its operations. Drug listing identifies the drugs manufactured, repacked, relabeled, or salvaged for commercial distribution and includes product-specific data. They are related but separate Part 207 obligations, and the exact listing responsibilities depend on the parties and operations involved.
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 includes U.S. Agent representation for foreign establishments as part of the $849/year Drug Establishment Registration service.
How does FDA Registration Assistance help with drug establishment compliance?
FDA Registration Assistance prepares and manages the registration filings included in your service scope, coordinates annual renewal, provides U.S. Agent support for foreign establishments, and assists with drug listing/NDC submissions when separately scoped. We help keep FDA registration and listing records accurate and current, while overall drug compliance remains the establishment’s responsibility.
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 and drug listing requirements are primarily governed by Section 510 of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 207. FDA Registration Assistance prepares filings to address the registration and listing requirements included in your service scope.
What does the $849 annual Drug Establishment Registration service include?
The $849 USD annual Drug Establishment Registration service covers registration management under 21 CFR Part 207 and annual renewal support. For foreign establishments, U.S. Agent representation is included. Drug listing, labeler code, and NDC services are scoped separately because the work varies by product count, labeler structure, and submission needs.
Can my U.S. Agent for drug establishment registration be a friend or unrelated party in the United States?
An eligible individual or business may serve as the U.S. Agent if it meets 21 CFR 207.69. The agent must reside or maintain a place of business in the United States and may not be only a mailbox, answering service, or location where the person acting as agent is not physically present. Regulatory experience is not expressly required by the rule, but the agent must be able to handle FDA communications, import questions, and inspection scheduling responsibilities reliably.
What happens if my U.S. Agent does not respond to the FDA?
The U.S. Agent is responsible for reviewing, routing, and responding to FDA communications, answering import-related questions, and assisting FDA with inspection scheduling. If the agent is unavailable or fails to perform those functions, FDA communications and inspection coordination can break down and the foreign establishment may face compliance or import complications. The registrant should keep U.S. Agent information current and designate a replacement when necessary.
How do I change the U.S. Agent on an existing FDA drug establishment registration?
The registrant must update the establishment registration to designate the new U.S. Agent and provide the required agent contact information. Under 21 CFR 207.29, changes to U.S. Agent information must be updated no later than 30 calendar days after the change, and only the registrant may designate a new U.S. Agent. FDA Registration Assistance can prepare and manage that update for you.
Do online sellers need FDA Drug Establishment Registration for OTC or prescription drug products?
The FDA registration obligation depends on the activities you perform, not whether you sell through Amazon or another online marketplace. A seller that also manufactures, repacks, relabels, or salvages covered drugs may need to register the establishment. A business acting only as a distributor or private label distributor can have different Part 207 obligations. Marketplace documentation requirements are separate and can change, so registration should not be presented as automatic authorization to sell a drug online.
Does FDA Drug Establishment Registration mean my drug is FDA-approved?
No. Establishment registration, drug listing, an NDC, or inclusion in an FDA database does not mean FDA has approved the drug or verified the submitted information. 21 CFR 207.77 specifically prohibits representing registration or listing in a way that suggests FDA approval or legal marketability.
Do contract manufacturers and contract packagers need their own FDA drug establishment registration?
Covered contract manufacturers, packagers or repackers, relabelers, and testing laboratories that perform manufacturing operations can have their own registration obligations under 21 CFR Part 207. The registration and drug listing records must accurately identify the establishments performing regulated operations; a brand owner’s registration does not automatically cover an independent contractor.
Are OTC monograph drugs required to be registered and listed with the FDA?
Covered establishments that manufacture, repack, or relabel OTC monograph drugs are subject to Part 207 establishment registration and drug listing requirements. OTC monograph products in commercial distribution must be appropriately listed with the applicable NDC information. Separate OTC monograph drug user-fee obligations can also apply to certain facilities.
Is a P.O. Box acceptable as the facility address for FDA Drug Establishment Registration?
The establishment registration must identify the establishment’s actual physical address. A mailing-only address, P.O. Box, or unrelated location should not be used as the establishment address. For a foreign establishment’s U.S. Agent, 21 CFR 207.69 requires the agent to reside or maintain a place of business in the United States and prohibits an arrangement that is only a mailbox, answering service, or other location where the person acting as agent is not physically present.
How do I verify that an FDA Drug Establishment Registration is real?
Use FDA’s Drug Establishments Current Registration Site (DECRS) to check current establishment registration status. FDA states that DECRS is updated each business day. If a facility is not shown as current, verify the identifiers, spelling, timing, and registration status rather than assuming fraud. Drug listing information can also be checked through FDA’s NDC Directory where applicable.
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 an FDA-issued identifier used to track a regulated establishment or facility. An NDC (National Drug Code) is a numeric drug identifier that includes labeler, product, and package information under Part 207. One facility can be associated with many listed drug NDCs. Neither an FEI nor an NDC indicates FDA approval.
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)?
FDA Direct is FDA’s current web-based SPL authoring environment and includes CDER Direct functions for drug establishment registration, drug listing, labeler-code requests, and NDC reservations. FURLS is used for other FDA registration programs. Human drug establishment registration and listing data are submitted electronically in SPL format through FDA-supported drug registration and listing workflows, not through the food-facility FURLS module.
Do private label distributors need FDA Drug Establishment Registration?
A private label distributor that does not manufacture, repack, relabel, or salvage drugs is generally not required to register an establishment under 21 CFR 207.17. However, private label distributors are covered by certain Part 207 requirements, including labeler-code obligations, and drug listings may be submitted on their behalf by the manufacturer or by an authorized agent. The exact filing structure depends on who performs the regulated operations and whose labeler code is used.
Does FDA charge a government fee for Drug Establishment Registration?
FDA does not impose a general filing fee simply to submit a standard Drug Establishment Registration under 21 CFR Part 207. However, separate FDA user-fee programs can apply depending on the facility and drug program. For example, certain generic-drug facilities can incur GDUFA facility fees, and OTC monograph drug facilities can be subject to OMUFA fees. Our $849 annual service fee is a professional service fee, not an FDA government fee.
Register Your Drug Establishment & Keep FDA Records Current
Submit your facility details and FDA Registration Assistance will manage your Drug Establishment Registration and annual renewal. For foreign facilities, U.S. Agent representation is included; drug listing and NDC services are available based on product scope.
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