FDA DRUG REGISTRATION · LISTING · U.S. AGENT
FDA Drug Registration &
Compliance Services
- Who Registers
- Covered establishments that manufacture, repack, relabel, or salvage drugs for U.S. distribution, subject to Part 207 exemptions.
- Domestic Timing
- Generally no later than 5 calendar days after beginning covered operations at the establishment.
- Foreign Timing
- Before a covered drug from that establishment is imported or offered for import into the United States.
- Submission Format
- Structured Product Labeling (SPL) XML using FDA Direct/CDER Direct or another compatible SPL workflow; submissions can be transmitted through FDA's electronic gateway.
- Facility Identifier
- Use the DUNS associated with the actual establishment location, not merely the corporate headquarters.
- Foreign Establishments
- Must designate one U.S. Agent that meets 21 CFR 207.69.
- Annual Renewal
- Registration reviewed/renewed every October 1 through December 31; specified changes are updated within 30 calendar days.
- Drug Listing
- Initial listing is generally submitted within 3 days after initial registration; changes are maintained under FDA's June/December and annual certification rules.
- Professional Service Fee
- $849/year for the standard Drug Establishment Registration package, including U.S. Agent designation for a foreign establishment within scope.
Registration is an administrative FDA requirement—not product approval. We help determine the right establishment role, prepare SPL submissions, coordinate DUNS/FEI issues, manage foreign U.S. Agent requirements, list products, and maintain annual registration/listing status.
Drug & Pharmaceutical Services
FDA Drug Registration, Listing & Compliance Services
A focused drug-only service hub for establishment registration, NDC/listing, labeler codes, U.S. Agent representation, labeling, DUNS, DMFs, and import issues.
Drug Establishment Registration
Register a covered domestic or foreign drug establishment, maintain the annual registration, and coordinate the U.S. Agent for foreign facilities.
$849/year
Learn more →Labeler Code Registration
Request and confirm the FDA labeler code needed before a company can list drugs or reserve NDCs for the first time.
$349 one-time
Learn more →NDC / Drug Product Listing
Prepare NDC product/package information and the SPL drug listing using the current FDA listing requirements.
$199/product
Learn more →Drug Label & Ingredient Review
Review human drug labeling, active/inactive ingredients, required statements, monograph or application references, and SPL-label consistency.
$249/review
Learn more →Drug DUNS Assistance
Help verify or obtain the facility-specific DUNS information used in FDA drug establishment registration and listing workflows.
$399 one-time
Learn more →Drug U.S. Agent Services
Serve as the single U.S. Agent for a covered foreign drug establishment and handle the communication responsibilities in 21 CFR 207.69.
Foreign establishments
Learn more →Drug Listing Verification & Maintenance
Review current listing status, product data, annual no-change certification, and listing updates. Registration/listing does not mean FDA approval.
Annual maintenance
Learn more →Drug Master File (DMF) Support
Support DMF preparation and submission strategy for confidential manufacturing, chemistry, or ingredient information when a DMF is appropriate.
Custom quote
Learn more →Drug Import Alert Assistance
Review drug Import Alert/DWPE issues, corrective evidence, entry history, and the alert-specific FDA pathway for resolving import problems.
Custom quote
Learn more →Who Must Register?
Registration Is Based on the Establishment's Actual Drug Operations
The key question is what the physical site does—not simply whether the company owns a drug brand.
What We Manage
The Core Drug Registration & Listing Responsibilities
A compliant program keeps establishment, contact, U.S. Agent, labeler, NDC, listing, and annual-maintenance information aligned.
Establishment Registration
Register each covered establishment based on the operations performed at that physical location. Domestic and foreign timing rules differ.
Facility-Specific DUNS
Use the DUNS associated with the actual establishment location rather than a corporate-headquarters DUNS when FDA requires the establishment identifier.
Foreign U.S. Agent
A covered foreign establishment must designate one U.S. Agent that resides or maintains a place of business in the United States and is physically present there.
Official Contact
Every registrant designates an official contact responsible for accuracy of registration/listing information and FDA communications.
Labeler Code
A company needs a labeler code before listing a drug or reserving an NDC for the first time. The labeler code identifies the company marketing the drug.
Drug Listing / NDC
Registered establishments list the drugs they produce for U.S. commercial distribution and maintain current SPL product information.
Annual Renewal
Establishment registration is reviewed/renewed every year between October 1 and December 31; certain changes require updates within 30 calendar days.
Listing Maintenance
Drug listings are updated when changes occur, no later than the following June or December; unchanged listings require annual certification when applicable.
Electronic Filing
SPL · FDA Direct / CDER Direct · ESG NextGen
FDA uses Structured Product Labeling XML for establishment registration, labeler-code, and drug-listing submissions. FDA Direct includes the CDER Direct drug workflow, while FDA's electronic gateway provides the secure submission route for compatible electronic regulatory submissions.
How It Works
FDA Drug Compliance in 4 Steps
We identify the establishment role first, then build the filing sequence around the registration, labeler-code, listing, and foreign-agent requirements that actually apply.
Confirm legal entity, physical establishment, operations performed, domestic/foreign status, DUNS, FEI status, products, and existing registrations/listings.
Determine which establishment registration, U.S. Agent, labeler-code, NDC, and drug-listing submissions are needed and in what order.
Prepare the applicable SPL data and submit through the current FDA electronic workflow, then address validation issues within scope.
Track annual establishment renewal, listing updates/certification, contact/U.S. Agent changes, and product-maintenance requirements.
Legal Authority
The FDA Rules Behind Drug Registration & Listing
Registration/listing is one part of the drug regulatory framework. It should not be confused with product approval or cGMP compliance.
21 CFR Part 207
Part 207 governs establishment registration, the NDC framework, drug listing, electronic format, official contacts, and U.S. Agents for covered human and animal drugs.
Read Part 207 →FD&C Act §510
Section 510 provides the statutory foundation for establishment registration and drug listing and ties noncompliance to the Act's misbranding provisions.
FD&C Act Resources →21 CFR Parts 210 & 211
Current good manufacturing practice requirements are separate from registration/listing. A registered establishment can still be noncompliant if its manufacturing systems fail applicable cGMP requirements.
FDA cGMP Resources →Comparison 1
Drug Establishment Registration vs Labeler Code vs Drug Listing / NDC
| Factor | Establishment Registration | Labeler Code | Drug Listing / NDC |
|---|---|---|---|
| Identifies | Physical establishment performing covered drug operations | Company marketing the drug | Specific drug product and package configurations |
| Primary FDA Rule | 21 CFR Part 207 — Registration | 21 CFR Part 207 — NDC / labeler code | 21 CFR Part 207 — Listing |
| When Needed | When the physical site performs registrable operations, subject to exemptions | Before first drug listing or NDC reservation when the company needs a labeler code | For drugs produced for U.S. commercial distribution |
| Key Identifier | FEI + facility-specific DUNS in the registration workflow | FDA-assigned labeler code | NDC product/package codes + SPL listing |
| Renewal / Maintenance | Annual registration review Oct 1–Dec 31; certain updates within 30 days | Update labeler-code information when required | Update after changes; no later than following June/December; annual certification when applicable |
| FDA Approval? | No | No | No |
Comparison 2
Domestic vs Foreign Drug Establishment
| Factor | Domestic Establishment | Foreign Establishment |
|---|---|---|
| Initial Registration Timing | No later than 5 calendar days after beginning covered operations | Before a covered drug is imported or offered for import into the U.S. |
| U.S. Agent | Not required solely because the establishment is domestic | One U.S. Agent required under 21 CFR 207.69 |
| Official Contact | Required | Required |
| DUNS | Facility-specific DUNS used in registration workflow | Facility-specific DUNS used in registration workflow |
| Annual Renewal | October 1–December 31 | October 1–December 31 |
| Import Information | Not applicable as a foreign-site requirement | Foreign registration/listing information supports FDA import review |
Comparison 3
Registration & Listing vs FDA Drug Approval
| Factor | Registration / Listing | NDA / ANDA Approval or Applicable OTC Pathway |
|---|---|---|
| Purpose | Identifies establishments and drugs in commercial distribution | Establishes lawful product marketing status under the applicable drug pathway |
| Core Rule | 21 CFR Part 207 / FD&C Act §510 | Application or OTC-monograph statutes/regulations, depending on the drug |
| Evaluates Safety / Effectiveness? | Registration/listing itself does not constitute product approval | NDA/ANDA review evaluates application-specific evidence; monograph products must meet applicable monograph conditions |
| NDC Means Approval? | No | No — NDC remains an identifier, not approval evidence |
| Can You Market Solely Because You Registered? | No | Marketing status must independently comply with the applicable approval or monograph framework |
Glossary
FDA Drug Registration & Listing Terms
FDA registration of a covered physical establishment engaged in operations such as manufacturing, repacking, relabeling, or salvaging drugs for U.S. distribution.
Facility Establishment Identifier — an FDA identifier used to identify establishments. FDA's validated registration information includes the FEI when processing is complete.
Data Universal Numbering System identifier used in FDA drug registration/listing workflows. FDA instructs registrants to use the number for the actual establishment, not a corporate headquarters.
Structured Product Labeling — FDA's XML-based format for electronic drug establishment registration, labeler code, and drug listing submissions.
FDA's web-based SPL authoring environment for drug registration/listing and related submissions. FDA Direct is the broader platform that includes CDER Direct functionality.
FDA's modernized Electronic Submissions Gateway platform used to receive and route regulatory submissions.
FDA-assigned segment used to construct or reserve NDCs and identify the company marketing the drug. It is not a separate code for each manufacturing establishment.
National Drug Code — currently FDA assigns 10-digit NDCs; FDA's uniform 12-digit native NDC format takes effect March 7, 2033.
Electronic SPL submission of a drug's marketing, formulation, labeling, establishment, and NDC-related information.
The contact designated for each registered establishment who is responsible for accuracy and routing/responding to FDA communications.
The single U.S.-located representative required for a covered foreign drug establishment under 21 CFR 207.69.
Drug Establishments Current Registration Site — FDA's public database of currently registered drug establishments, updated each business day.
Common Problems
Drug Registration & Listing Problems to Avoid
Most serious filing problems come from role errors, identifier mismatches, missed maintenance, or treating administrative registration as product approval.
Wrong Establishment Role
Registering an entity that is only a brand owner/distributor as though it performs manufacturing operations, or failing to register the actual manufacturing/repacking/relabeling site.
Corporate DUNS Instead of Facility DUNS
Using a DUNS tied to headquarters rather than the physical establishment can create validation problems.
Missing or Inactive U.S. Agent
A foreign establishment must maintain one compliant U.S. Agent and keep the agent's contact information current.
Missed Annual Registration Renewal
Drug establishments must review/renew registration between October 1 and December 31 each year.
Expired Drug Listing Certification
Human drug listings that are not updated or certified as required can be inactivated and removed from FDA listing publications.
Labeler Code / Listing Mismatch
A labeler code, NDC, labeler name, product listing, and actual marketed labeling must remain consistent.
Treating NDC as FDA Approval
FDA expressly states that assignment of an NDC or inclusion in the NDC Directory does not denote FDA approval of the product.
Ignoring Program-Specific Requirements
Part 207 registration/listing does not replace approval/monograph status, cGMP, DSCSA, GDUFA, labeling, adverse-event, or other applicable requirements.
Frequently Asked Questions
FDA Drug Registration & Compliance FAQs
Direct answers about establishment registration, DUNS, FEI, U.S. Agents, labeler codes, NDCs, SPL drug listings, annual renewals, FDA Direct, and product approval.
+Who is required to register a drug establishment with FDA?
+When must a domestic drug establishment first register?
+When must a foreign drug establishment register?
+How often is drug establishment registration renewed?
+What changes must be reported within 30 days?
+Do foreign drug establishments need a U.S. Agent?
+What are the responsibilities of a drug U.S. Agent?
+Can the U.S. Agent be only a mailbox or answering service?
+Does every registered establishment also need an official contact?
+What DUNS number should I use for drug establishment registration?
+What is an FEI number?
+Does registration itself approve my drug?
+Does having an NDC mean FDA approved my drug?
+What are the three major electronic submissions in FDA drug registration/listing?
+What electronic format does FDA use for drug registration and listing?
+What is FDA Direct?
+Can SPL files be submitted through ESG NextGen?
+Do I need a labeler code before listing a drug?
+Does every manufacturing establishment need a separate labeler code?
+Who generally needs a labeler code?
+What information is needed to list a drug?
+When should the initial drug listing be submitted?
+When are drug listing updates due?
+What is annual drug listing certification?
+Does a private-label brand automatically need its own drug establishment registration?
+Do API manufacturers register and list?
+Do animal drug establishments use Part 207 too?
+Does standard Part 207 registration have the same FDA fees as medical-device registration?
+Can generic-drug establishments have additional FDA user fees?
+What does the $849/year service include?
+Is the $849 an FDA government fee?
+Can I file drug establishment registration myself?
+How quickly can registration be completed?
+Does FDA issue a Drug Establishment Registration certificate?
+What is DECRS?
+Does registration replace cGMP compliance?
+Does registration replace an NDA or ANDA?
+What about OTC drugs that do not have an approved NDA/ANDA?
+Is FDA changing NDCs to 12 digits?
+Should companies start preparing for the 12-digit NDC transition now?
+Can FDA Registration Assistance manage multiple drug establishments and products?
Drug Compliance Consultation
Tell Us What You Manufacture or Market
We will help determine whether you need establishment registration, a U.S. Agent, labeler code, NDC/drug listing, annual renewal, or another drug compliance service.
Request Drug Compliance Assistance
Complete the form and our compliance team will review the request.