How to Fill Out FDA Form 3938 (w/Examples) + FAQs

FDA Form 3938 is the standardized electronic form required for all Drug Master File (DMF) submissions to the U.S. Food and Drug Administration. The form captures essential administrative and regulatory information about drug substances, packaging materials, excipients, and manufacturing facilities that support pharmaceutical applications.

Under 21 CFR 314.420, DMF holders must provide confidential information to the FDA while protecting proprietary data from applicants who reference their files. The consequence of submitting incomplete or incorrect Form 3938 data includes technical rejection, which delays review timelines by weeks or months and can disrupt pending drug application approvals.

In Q1 2025, a record 440 DMFs were submitted across all categories—a 24.65% increase from the previous year—demonstrating the growing importance of proper Form 3938 completion for pharmaceutical companies worldwide.

In this guide, you will learn:

📋 Every field of Form 3938 explained with step-by-step instructions and real examples

⚠️ The most common mistakes that trigger FDA rejection and how to avoid them

🔄 The differences between DMF Types II, III, IV, and V and their specific requirements

📝 How to submit amendments, annual reports, and letters of authorization correctly

✅ Do’s and don’ts from FDA guidance that prevent costly delays

What Is FDA Form 3938 and Who Must Use It?

FDA Form 3938 is the official administrative cover sheet for Drug Master File submissions. The FDA designed this form to standardize DMF information, allow automated data extraction, and improve the consistency of submissions received through the Electronic Submissions Gateway (ESG).

Three types of entities use Form 3938:

A third-party contractor can prepare the DMF submission, but only the DMF holder’s Responsible Official or the appointed U.S. Agent can sign Form 3938. This restriction exists because the signature certifies the accuracy and completeness of all information submitted.

The Four Types of Drug Master Files

Before completing Form 3938, you must understand which DMF type applies to your submission. The FDA categorizes DMFs into four active types (Type I was discontinued):

Type II DMFs represent the most frequently submitted category. In Q3 2025, 323 Type II DMFs were submitted, with India and China accounting for approximately 88.9% of all filings.

Type III DMFs received a significant exemption in the 2020 FDA guidance. Packaging material suppliers no longer need to submit in eCTD format, reducing their compliance burden considerably.

Type V DMFs require special treatment. You must contact the FDA before submitting a Type V DMF to discuss the proposed content and obtain approval for the submission type.

Step-by-Step Guide: How to Fill Out Every Field of Form 3938

The FDA’s official Form 3938 instructions outline 17 fields that must be completed sequentially. Each field serves a specific regulatory purpose.

Fields 1–4: Basic DMF Information

Field 1: DATE

Enter the date you submit the form using the format mm/dd/yyyy. For example, if submitting on January 31, 2026, enter “01/31/2026.”

Field 2: DMF NUMBER

Provide your six-digit DMF number. If your number has fewer than six digits, add leading zeros. For example, DMF 12345 becomes “012345.”

Important: You must request a pre-assigned DMF number through the CDER NextGen Portal before submitting an original DMF. The FDA will not accept submissions without this number.

Field 3: DMF SUBJECT

Enter the title of your DMF exactly as it appears on the FDA DMF List. This information becomes publicly available, so use a clear, descriptive title like “Metformin Hydrochloride Drug Substance” rather than internal project codes.

Field 4: DMF TYPE

Select one applicable type:

• Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
• Type III Packaging Material
• Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
• Type V FDA Accepted Reference Information, REMS

Field 5: DMF Holder Information

This field captures the company that owns the DMF. The holder is expected to be the manufacturer. If the holder is not the manufacturer, include a signed statement assuming responsibility for manufacturing.

DUNS Number Requirement: If you do not have a DUNS number, enter “999999999” (9 digits) to avoid a validation error. However, you should obtain a DUNS number from Dun & Bradstreet, which is free of charge.

Field 6: DMF Agent or Holder Representative

Complete this field if the DMF holder has appointed a U.S. Agent or if the contact person is located at a different address than the holder.

While no regulation requires foreign DMF holders to appoint an agent, the FDA strongly recommends this appointment for companies outside the United States. The agent serves as the primary point of contact for FDA communications.

If the Responsible Official who signs the form (Field 11) is the agent or is employed by the agent, this must be specified in the Agent Appointment Letter.

Agent Appointment Letter Requirements:

• Must be on the DMF holder’s letterhead
• Must include agent’s name, address, and contact information
• Must specify the scope of the agent’s authority
• Must be signed by the DMF holder

Field 7: Submission Type

Select all submission types that apply. A single submission can contain multiple types.

Field 8: Amendment Type

When submitting an amendment, select all applicable categories. This field provides granular detail about what changed in your DMF:

Administrative Amendment Types:

• Change of agent/address/contact person (requires new Agent Appointment Letter)
• Change of holder/address/contact person
• Change of DMF Subject (title)
• Change of DMF Type
• Meeting Package or Meeting Request
• Agent Appointment

Technical/Quality Amendment Types:

• Controls Information
• Facility Information
• Formulation Information
• Manufacture Information
• Microbiology Information
• New Item (primarily for Type III and IV DMFs)
• Packaging Information
• Stability Information

REMS-Related Amendment Types:

• REMS Final
• REMS Assessment
• REMS Assessment Methodology
• REMS Revision
• REMS Modification (Due to Safety Labeling Changes, Major, or Minor)
• REMS Proposal-Standard
• REMS Correspondence

Field 9: Establishment Information

This critical field captures facility data for manufacturing, testing, and packaging sites described in the DMF.

Complete this field for:

• Type II DMFs (APIs, intermediates, drug products)
• Type III DMFs (sterile processing facilities only)
• Type V DMFs (sterile processing or biotech facilities only)

Do NOT include establishment information for:

• Manufacturers of packaging materials (non-sterile)
• Excipient manufacturers

FEI Number: The FDA Establishment Identifier (FEI) is a 10-digit number assigned by FDA to track facilities. Request an FEI by emailing [email protected].

Use the “Add Establishment” button to include multiple sites. If you accidentally add an extra establishment, click “Delete Page” at the bottom right.

Important: When removing a facility from your DMF, do not include it in Field 9. Instead, note the removal in your cover letter, Summary of Changes, and eCTD section 3.2.S.2.1.

Field 10: Referenced DMF(s)

List all DMFs that your current DMF references. Include:

• DMF number
• Subject (title) of the referenced DMF
• DMF holder name

This field creates a traceable chain of references that FDA reviewers use to evaluate complete manufacturing processes.

Fields 11–17: Certification

These fields require the Responsible Official’s information and signature, which certifies the accuracy of all submitted data.

Field 11: Responsible Official Name and Title

Enter the name and title of the person authorized to sign company documents. This must be either:

• The DMF holder’s contact person (named in Field 5), OR
• The appointed agent’s contact person or holder representative (named in Field 6)

Field 12: Date of Signature

Enter the date the form is being signed, using mm/dd/yyyy format.

Fields 13–15: Contact Information

Enter the Responsible Official’s telephone, fax, and email. If no fax is available, enter “not available” to avoid validation errors.

Field 16: Address

Enter the Responsible Official’s address (may differ from Field 5 or 6).

Field 17: Signature

The Responsible Official must sign the form. The FDA accepts digital signatures. If another employee signs on behalf of the Responsible Official using a digital signature, the Responsible Official’s name must still appear in Field 11.

Three Common Scenarios: Examples of Completed Form 3938

Scenario 1: Original Type II DMF Submission

Company Profile: ABC Pharmaceutical Co., an Indian manufacturer submitting a new DMF for Semaglutide API.

Cover Letter Action: Include statement of commitment signed by the DMF holder stating that the DMF is current and the holder will notify FDA of any changes.

Scenario 2: Annual Report Submission

Company Profile: XYZ Excipients Inc., maintaining an active Type IV DMF.

Annual Report Requirements:

• List of all amendments submitted in the past 12 months (with dates)
• List of all parties whose authorization remains in force
• List of parties whose authorization has been withdrawn
• Signed statement of commitment from the DMF holder
• If no amendments were submitted, include a statement confirming this

Consequence of Missing Annual Reports: If the FDA does not receive an annual report for three years, it sends an Overdue Notice Letter (ONL). Failure to respond within 90 days results in DMF closure.

Scenario 3: Letter of Authorization Submission

Company Profile: DEF Packaging Corp., authorizing a generic drug company to reference its Type III DMF.

Letter of Authorization Must Include:

• DMF holder name authorizing the specific party
• Name of the authorized party (one party per LOA)
• Specific products, items, or processes being authorized
• Statement granting FDA permission to review the DMF
• Signed statement of commitment

Mistakes to Avoid When Filing Form 3938

Based on FDA guidance and industry experience, these common errors cause technical rejections and review delays:

Do’s and Don’ts for Form 3938 Submission

Do’s ✅

1. Do request a pre-assigned DMF number before preparing your original submission. Submit requests through the CDER NextGen Portal or via secure email to [email protected].
2. Do submit Form 3938 with every DMF submission, including amendments and annual reports. The form must accompany all eCTD-format DMFs.
3. Do notify authorized parties of any changes to your DMF before submitting amendments. Provide sufficient advance notice to allow them to update their applications.
4. Do maintain your DMF annually by submitting an annual report on the anniversary date. Include the list of amendments, authorized parties, and signed statement of commitment.
5. Do use FDA templates for cover letters, letters of authorization, and other documents. Templates are available on the FDA DMF Templates page.

Don’ts ❌

1. Don’t submit changes in an annual report. Changes must be submitted as amendments separately. Annual reports only summarize what was already submitted.
2. Don’t allow multiple entities to be the DMF holder. Only one person or entity can hold a DMF. If ownership transfers, submit an administrative amendment with a New Holder Acceptance Letter.
3. Don’t use placeholder data expecting to update later. Incorrect application numbers, holder names, or establishment information cause rejection.
4. Don’t skip the agent appointment if you’re a foreign company. While not legally required, FDA strongly recommends appointing a U.S. Agent to facilitate communication.
5. Don’t submit in paper format (with limited exceptions). Since May 5, 2018, all Type II and IV DMFs must be in eCTD format. Type III DMFs are exempt but can be submitted electronically through the NextGen Portal.

Pros and Cons of Drug Master File Submissions

Pros ✅

Cons ❌

Key Entities Involved in DMF Submissions

Understanding the roles of different parties helps ensure proper completion of Form 3938:

DMF Holder: The company or individual that owns the DMF and assumes responsibility for its accuracy. The holder signs the statement of commitment and must notify authorized parties of any changes.

Authorized Party: A company (such as an NDA or ANDA applicant) that receives permission to reference information in the DMF. Each authorized party requires a separate Letter of Authorization.

U.S. Agent: A person or company located in the United States that represents foreign DMF holders. The agent receives correspondence from FDA and can submit documents on behalf of the holder.

Responsible Official: An employee with signatory authority who certifies Form 3938. This can be an employee of the DMF holder or the appointed agent.

Office of Pharmaceutical Quality (OPQ): The FDA division that reviews DMF content for technical adequacy.

Division of Lifecycle API (DLAPI): Within OPQ, this division conducts assessments of Type II DMFs and issues adequacy letters.

Electronic Submission Process

Submitting Through the Electronic Submissions Gateway (ESG)

The FDA ESG is the mandatory portal for eCTD submissions 10 gigabytes or smaller. Follow these steps:

1. Request an ESG account at the ESG website. The account creation includes a testing phase to verify your systems work correctly.
2. Request a pre-assigned DMF number through the CDER NextGen Portal (https://edm.fda.gov).
3. Prepare your DMF in eCTD format with validated XML backbone files. Use commercial validation tools to check for errors before submission.
4. Include Form 3938 in Module 1 of your eCTD structure, typically in section 1.2.
5. Submit through ESG and wait for technical acknowledgment (usually within 2-4 hours for compliant submissions).

Using CDER NextGen Portal for Type III DMFs

Type III DMFs have an exemption from eCTD requirements. You can submit non-eCTD format submissions through:

1. Navigate to https://edm.fda.gov
2. Create an account or log in
3. Click on “FDA Alternate Submissions” tab
4. Follow the prompts to upload your submission

DMF Status Timeline: From Pending to Active

Understanding the DMF review timeline helps set appropriate expectations:

If the FDA finds deficiencies, it issues a Complete Response (CR) letter. DMF holders typically have 30-120 days to respond, depending on the severity.

FAQs

Can a contracted company sign FDA Form 3938?

No. A third-party contractor cannot sign Form 3938. Only the DMF holder’s Responsible Official or the appointed Agent can sign the certification.

Can a DMF agent sign Form 3938?

Yes. The appointed DMF Agent can sign Form 3938. The agent’s appointment letter must authorize this and specify signing authority.

Is a DUNS number required for Form 3938?

Yes. A DUNS number must be entered in Field 5. If unavailable, enter “999999999” to allow form finalization, then update later.

What happens if I miss my annual report deadline?

No. Missing one year does not close your DMF. After three years without an annual report, FDA issues an Overdue Notice Letter giving 90 days to respond.

Can multiple companies hold the same DMF?

No. Only one person or entity can be the holder of a DMF. Joint ownership is not permitted under FDA regulations.

Is Form 3938 required for Type III packaging DMFs?

Yes. Form 3938 should accompany all DMF submissions, but Type III DMFs are exempt from eCTD formatting requirements.

Do I need a pre-assigned number when converting paper DMF to eCTD?

No. Continue using your existing DMF number. Add leading zeros to make it six digits (e.g., 001234).

What if my facility lacks an FEI number?

Yes, you can submit. Enter “9999999999” (10 digits) in the FEI field and request an FEI by emailing [email protected].

Is a cover letter still needed with Form 3938?

Yes, for technical submissions. For simple administrative submissions like annual reports or LOAs, Form 3938 may replace the cover letter, but technical amendments need both.

Can I submit Form 3938 by email?

No. Form 3938 must be submitted through the FDA ESG for eCTD submissions or the CDER NextGen Portal for non-eCTD Type III DMFs.