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 →
FDA DRUG REGISTRATION · LISTING · U.S. AGENT
FDA Drug Registration &
Compliance Services
FDA drug compliance involves more than one filing. Covered establishments must register under 21 CFR Part 207, foreign establishments must designate a single U.S. Agent, companies that need to list drugs must have the appropriate labeler code, and drug products must be listed and maintained in SPL. Registration and NDC listing do not mean FDA has approved the establishment or product.
FDA Drug Registration & Listing — Quick Facts
- 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
- $449/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.
$449/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.
$449/year
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.
ManufacturersFacilities manufacturing or processing drugs for U.S. distribution can be subject to registration/listing.
Repackers & RelabelersSites that repack or relabel drug products are specifically included in Part 207 registration requirements.
SalvagersDrug salvaging operations can trigger establishment-registration responsibilities under Part 207.
Foreign EstablishmentsCovered foreign sites register before their drugs are offered for import and designate one compliant U.S. Agent.
Private-label distributor ≠ manufacturing establishment automatically. A company can have labeler-code or drug-listing responsibilities without operating a registrable manufacturing/repacking/relabeling site. The establishment role should be determined from the actual operations.
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.
01
Establishment Registration
Register each covered establishment based on the operations performed at that physical location. Domestic and foreign timing rules differ.
02
Facility-Specific DUNS
Use the DUNS associated with the actual establishment location rather than a corporate-headquarters DUNS when FDA requires the establishment identifier.
03
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.
04
Official Contact
Every registrant designates an official contact responsible for accuracy of registration/listing information and FDA communications.
05
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.
06
Drug Listing / NDC
Registered establishments list the drugs they produce for U.S. commercial distribution and maintain current SPL product information.
07
Annual Renewal
Establishment registration is reviewed/renewed every year between October 1 and December 31; certain changes require updates within 30 calendar days.
08
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.
Establishment Registration SPL Labeler Code SPL Drug Listing SPL NDC Product / Package Data Annual Registration Renewal Annual Listing Certification FDA Direct / CDER Direct ESG NextGen
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.
1
Facility & Role Review
Confirm legal entity, physical establishment, operations performed, domestic/foreign status, DUNS, FEI status, products, and existing registrations/listings.
2
Submission Sequence
Determine which establishment registration, U.S. Agent, labeler-code, NDC, and drug-listing submissions are needed and in what order.
3
SPL Preparation & Filing
Prepare the applicable SPL data and submit through the current FDA electronic workflow, then address validation issues within scope.
4
Maintenance & Renewal
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.
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
Drug Establishment Registration
FDA registration of a covered physical establishment engaged in operations such as manufacturing, repacking, relabeling, or salvaging drugs for U.S. distribution.
FEI
Facility Establishment Identifier — an FDA identifier used to identify establishments. FDA's validated registration information includes the FEI when processing is complete.
DUNS
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.
SPL
Structured Product Labeling — FDA's XML-based format for electronic drug establishment registration, labeler code, and drug listing submissions.
FDA Direct / CDER Direct
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.
ESG NextGen
FDA's modernized Electronic Submissions Gateway platform used to receive and route regulatory submissions.
Labeler Code
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.
NDC
National Drug Code — currently FDA assigns 10-digit NDCs; FDA's uniform 12-digit native NDC format takes effect March 7, 2033.
Drug Listing
Electronic SPL submission of a drug's marketing, formulation, labeling, establishment, and NDC-related information.
Official Contact
The contact designated for each registered establishment who is responsible for accuracy and routing/responding to FDA communications.
U.S. Agent
The single U.S.-located representative required for a covered foreign drug establishment under 21 CFR 207.69.
DECRS
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?
With certain exemptions, establishments engaged in manufacturing, repacking, relabeling, or salvaging drugs for U.S. distribution are required to register under 21 CFR Part 207. The requirement is establishment- and activity-based, so a company that only owns a brand or distributes a drug should not automatically be treated as a manufacturing establishment.
+When must a domestic drug establishment first register?
FDA states that a domestic establishment must register no later than five calendar days after beginning to manufacture, repack, relabel, or salvage a drug at that establishment.
+When must a foreign drug establishment register?
A foreign establishment subject to Part 207 must register before a drug manufactured, repacked, relabeled, or salvaged there is imported or offered for import into the United States.
+How often is drug establishment registration renewed?
Registration is reviewed and renewed annually. FDA requires the annual review/update between October 1 and December 31 of each calendar year.
+What changes must be reported within 30 days?
Under 21 CFR 207.29, specified changes such as closing or selling an establishment, changing its name or physical address, or changing official-contact or U.S.-Agent contact information must be updated no later than 30 calendar days after the change.
+Do foreign drug establishments need a U.S. Agent?
Yes. Registrants of covered foreign establishments must designate a single United States agent under 21 CFR 207.69.
+What are the responsibilities of a drug U.S. Agent?
The U.S. Agent reviews, routes, and responds to FDA communications including emergency communications; responds to questions concerning imported drugs; assists FDA in scheduling inspections; and can receive information/documents from FDA when FDA cannot contact the foreign registrant directly or expeditiously.
+Can the U.S. Agent be only a mailbox or answering service?
No. Under 21 CFR 207.69, the U.S. Agent must reside or maintain a place of business in the United States and may not be merely a mailbox, answering machine/service, or other place where a person acting as the agent is not physically present.
+Does every registered establishment also need an official contact?
Yes. Part 207 requires an official contact for each establishment. The official contact is responsible for ensuring registration/listing accuracy and reviewing, disseminating, routing, and responding to FDA communications.
+What DUNS number should I use for drug establishment registration?
FDA's current registration instructions tell establishments to use the DUNS for the actual establishment and specifically warn against using a DUNS linked only to the corporate headquarters.
+What is an FEI number?
FEI means Facility Establishment Identifier. FDA uses FEIs to identify establishments. FDA states that after registration is processed it sends the reporting official validated information that includes the FEI.
+Does registration itself approve my drug?
No. 21 CFR 207.77 provides that registration and listing do not denote approval of the establishment or any drug. Product approval/marketing status must be evaluated separately.
+Does having an NDC mean FDA approved my drug?
No. FDA expressly states that assignment of an NDC does not denote FDA approval and that implying approval based on an NDC can be misleading and constitute misbranding.
+What are the three major electronic submissions in FDA drug registration/listing?
FDA's current instructions describe three steps: establishment registration, labeler code, and drug product listing. Each requires initial submission and periodic maintenance as applicable.
+What electronic format does FDA use for drug registration and listing?
FDA uses XML files in Structured Product Labeling (SPL) format for drug establishment registration, labeler-code, and drug-listing submissions.
+What is FDA Direct?
FDA Direct is FDA's web-based SPL authoring platform. It includes the CDER Direct drug-submission functionality and can be used to create drug registration/listing submissions.
+Can SPL files be submitted through ESG NextGen?
FDA's drug registration/listing instructions permit SPL-formatted submissions through the FDA Electronic Submissions Gateway. ESG NextGen is FDA's modernized gateway platform for electronic regulatory submissions.
+Do I need a labeler code before listing a drug?
Yes. FDA states that a labeler code must be assigned before a drug can be listed or an NDC can be reserved for the first time.
+Does every manufacturing establishment need a separate labeler code?
No. FDA explains that the labeler code identifies the company marketing the product, not each separate manufacturing establishment. A company with multiple establishments can generally use one labeler code.
+Who generally needs a labeler code?
FDA says generally drug manufacturers and distributors need a labeler code when they must list drugs or reserve NDCs. A company that does not manufacture or distribute drugs in the United States should not apply for one.
+What information is needed to list a drug?
Current FDA listing instructions require information such as the proposed NDC, proprietary/nonproprietary name, dosage form, route, active ingredients and strengths, inactive ingredients, current labeling images/content, and the name and DUNS of establishments involved in manufacturing.
+When should the initial drug listing be submitted?
FDA currently states that initial drug listings should be submitted within three days after the initial registration of the establishment.
+When are drug listing updates due?
Listing information should be updated as soon as possible after changes occur, and required updates must be made no later than the following June or December.
+What is annual drug listing certification?
For drugs that were not listed or updated during the current calendar year, FDA permits a blanket no-change certification during the October 1 through December 31 renewal period. FDA states that human drug listings not appropriately certified can be inactivated each January.
+Does a private-label brand automatically need its own drug establishment registration?
No. Establishment registration depends on whether the entity operates an establishment performing a registrable activity such as manufacturing, repacking, relabeling, or salvaging. A private-label distributor can have labeler/listing responsibilities without operating a registrable manufacturing establishment.
+Do API manufacturers register and list?
FDA's registration/listing instructions include active pharmaceutical ingredient and other bulk-drug manufacturers among establishments that may have registration and listing obligations when their drugs are for U.S. commercial distribution.
+Do animal drug establishments use Part 207 too?
Part 207 covers human drugs, drugs regulated under BLAs, animal drugs, and the NDC framework, subject to the applicable scope and exemptions. Animal-drug user-fee and approval requirements can be separate.
+Does standard Part 207 registration have the same FDA fees as medical-device registration?
No. Drug establishment registration is not the medical-device MDUFA establishment-fee program. Separate statutory drug user-fee programs can apply in particular situations, such as GDUFA facilities or application-related fees.
+Can generic-drug establishments have additional FDA user fees?
Yes. FDA's GDUFA program assesses separate facility and other user fees for covered generic-drug program participants. Those fees are distinct from the professional $449 drug-registration service shown on this page.
+What does the $449/year service include?
The current $449/year service package includes professional Drug Establishment Registration management, annual renewal support, DUNS verification, U.S. Agent designation for a covered foreign establishment, and one SPL drug-listing setup within the standard scope. Labeler Code, additional NDC/product listings, labeling review, DMF work, and other specialized services are separate unless included in a written quote.
+Is the $449 an FDA government fee?
No. The $449 is FDA Registration Assistance's professional service fee. It should not be represented as an FDA government registration fee. Separate FDA user fees can apply to particular drug programs or facilities.
+Can I file drug establishment registration myself?
Yes. FDA provides electronic submission tools and instructions. The reason to use a professional service is assistance with establishment-role analysis, SPL preparation, DUNS/FEI issues, U.S. Agent requirements, listing maintenance, and annual renewal—not because FDA requires a private registrar.
+How quickly can registration be completed?
Our standard service target is typically 24–48 hours after complete and accurate establishment information is available and the required identifiers are ready. FDA processing, validation, FEI-related issues, and corrections can extend that timeline, so no FDA processing time should be guaranteed.
+Does FDA issue a Drug Establishment Registration certificate?
FDA provides registration information/status and maintains the DECRS public registration database. A private consultant may provide copies of confirmations or a verification report, but those should not be presented as FDA product approval or an official FDA certificate of approval.
+What is DECRS?
DECRS is FDA's Drug Establishments Current Registration Site, a public database of currently registered drug establishments. FDA states that it is updated each business day.
+Does registration replace cGMP compliance?
No. Establishment registration and drug listing are administrative requirements. Applicable current good manufacturing practice requirements under the FD&C Act and FDA regulations remain separate.
+Does registration replace an NDA or ANDA?
No. An NDA or ANDA is a separate product-approval pathway. Drug establishment registration does not authorize marketing of a drug that otherwise requires an approved application.
+What about OTC drugs that do not have an approved NDA/ANDA?
OTC marketing status depends on the specific product. Some nonprescription drugs may be marketed under the applicable OTC monograph framework when all requirements are met; others may require an approved application. Registration/listing does not determine that status by itself.
+Is FDA changing NDCs to 12 digits?
Yes, but not yet. FDA's final rule adopts a uniform 12-digit native NDC format beginning March 7, 2033. During the transition period through March 6, 2033, FDA continues assigning 10-digit NDCs in the current formats.
+Should companies start preparing for the 12-digit NDC transition now?
FDA encourages manufacturers, distributors, repackagers, relabelers, pharmacies, payors, and other supply-chain partners to use the transition period to update systems and labeling so they can handle the 12-digit format when it takes effect in 2033.
+Can FDA Registration Assistance manage multiple drug establishments and products?
Yes. Multi-establishment and multi-product programs can be scoped based on the number of physical locations, registration roles, U.S. Agent needs, labeler codes, product listings, NDC/package configurations, and ongoing maintenance requirements.
Drug Compliance Consultation
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Foreign & domestic establishment review
SPL registration & listing support
Annual renewal & listing maintenance
Drug-only regulatory support
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