FDA Form 2252 is the required transmittal form for annual reports of drugs and biologics for human use. This form accompanies every annual report submission for New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Biologics License Applications (BLAs) under 21 CFR 314.81(b)(2), 21 CFR 601.70(b), and 21 CFR 601.12(d).
The critical deadline for submission is within 60 days of the U.S. anniversary date of your application’s approval. Failure to submit this form and the accompanying annual report can result in FDA withdrawing approval of your drug application—effectively prohibiting continued marketing of your product.
According to FDA data, approximately 400 annual reports containing authorized generic drug information are submitted annually, and the average time to complete Form 2252 is estimated at 5 hours. Here’s what you’ll learn in this guide:
- 📋 Field-by-field instructions for completing every section of Form 2252 correctly
- ⚠️ Common mistakes that trigger FDA rejection or delay your submission
- 📊 Real-world scenarios showing how different application types complete this form
- ✅ Do’s and Don’ts to ensure compliance with 21 CFR requirements
- 🔍 FAQs answering the most common questions about annual report submissions
What Is FDA Form 2252 and Who Needs It?
FDA Form 2252, officially titled “Transmittal of Annual Reports for Drugs and Biologics for Human Use,” functions as the cover sheet and compliance certification for annual report submissions. The form creates a standardized method for pharmaceutical companies, biologics license holders, and their authorized agents to communicate critical updates about marketed products.
Regulatory Foundation
The requirement for Form 2252 originates from Section 505(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This section mandates that applicants with approved drug applications submit periodic reports containing specific information about their products. The FDA’s electronic Common Technical Document (eCTD) requirements make electronic submission mandatory for all annual reports.
Who Must File Form 2252
Even if your product is not actively marketed, you remain obligated to submit annual reports with Form 2252 for as long as your application remains approved. The FDA does not provide exceptions based on sales volume or commercial inactivity.
Step-by-Step Instructions: How to Fill Out Each Field
The FDA organizes Form 2252 into 14 numbered fields. Each field requires specific information, and errors in any field can delay your submission or prompt FDA requests for clarification.
Field 1: Select Appropriate Center
Choose the FDA center responsible for your product:
The center selection determines where your submission is routed and which regulations govern your report. Selecting the wrong center creates routing delays because FDA staff must manually redirect your submission.
Field 2: Application Type
Identify whether your submission is for an NDA, ANDA, or BLA. This classification matters because each application type has different reporting requirements under the Code of Federal Regulations:
- NDA: Governed by 21 CFR 314.81
- ANDA: Governed by 21 CFR 314.98 (referencing 314.81)
- BLA: Governed by 21 CFR 601.70
Field 3: Application Number
Enter your application number exactly as it appears on your approval letter. For CBER BLAs, include the supplement number if applicable. The format matters—FDA databases match your submission against existing records, and discrepancies trigger verification delays.
Example formats:
- NDA: 012345
- ANDA: 076543
- BLA: STN 125001
Fields 4 and 5: Applicant Name and Phone Number
These fields identify who is submitting the report. The requirements differ based on your circumstances:
For U.S.-Based Applicants Submitting on Their Own Behalf:
Enter the applicant company name in Field 4 and the contact phone number in Field 5.
For Foreign Applicants:
Enter the U.S. Agent’s name and phone number. Under 21 CFR 314.50(a)(5), an authorized U.S. agent is required if the applicant does not reside or maintain a place of business within the United States.
For Biologics:
Field 4 must contain the name of the person or legal entity to whom the license has been issued.
Field 6: Type of Report
Specify the type of submission. Common entries include:
- Annual Report
- Postmarketing Study Commitment Status Report
- Combined Annual Report and PMC Status Report
This field helps FDA reviewers immediately understand the submission’s purpose and route it to the appropriate division.
Field 7: Product Names
Enter both the proprietary (brand) name and established (generic) name for your product. If your product is marketed under multiple brand names, include all of them. This information enables FDA to match your report to the correct product record.
Example:
- Proprietary Name: Lipitor®
- Established Name: Atorvastatin calcium tablets
Field 8: Additional Application Numbers
If any portion of your annual report applies to multiple application numbers, list them here. Use the continuation page if you need additional space. This field is particularly relevant when:
- A single manufacturing change affects multiple strengths with separate ANDAs
- Distribution data covers multiple formulations under different applications
- CMC changes apply to both an NDA and subsequently approved ANDAs
Field 9: Reporting Period
Enter the beginning and end dates that define your annual reporting interval. Per 21 CFR 314.81(b)(2), the reporting period ends on your U.S. anniversary approval date.
Example:
If your NDA was approved on June 15, 2020, your annual report due within 60 days of June 15, 2026, would cover the period from June 16, 2025, through June 15, 2026.
Field 10: NDA/ANDA Report Information Required
This is the most substantive section of Form 2252. You must address each category of required information using the IDENTIFICATION column. The table structure requires you to indicate the electronic file name (for eCTD submissions), volume numbers (for paper submissions), and page references.
If you have nothing to report for a particular category, you must explicitly enter “None” under IDENTIFICATION. Leaving fields blank creates ambiguity and may prompt FDA requests for clarification.
Field 11: BLA Report Information Required
For BLA holders only, this section addresses status reports of postmarketing study commitments under 21 CFR 601.70. Check the box if your submission includes a Status Report of Postmarketing Study Commitment(s).
BLA holders report on studies concerning clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology that are either required by FDA or agreed upon in writing.
Fields 12-13: Responsible Official Information
Enter the name, title, and complete street address of the applicant’s Responsible Official or Authorized U.S. Agent. This is the person who:
- Certifies compliance with annual reporting requirements
- Receives correspondence from FDA regarding the annual report
- Bears responsibility for the accuracy of submitted information
The Authorized U.S. Agent named in Field 4 may also serve as the Responsible Official.
Field 14: Signature
The form requires a signature from the applicant, or the applicant’s attorney, agent, or other authorized official. Per 21 CFR 601.2(a), the signature certifies the accuracy of the submitted information.
Critical requirement: If the person named in Field 4 does not reside or maintain a place of business within the United States, the form must be signed by an attorney, agent, or authorized official who does reside or maintain a U.S. business presence.
Three Real-World Scenarios: Filing Form 2252
Understanding how different situations affect your Form 2252 submission helps prevent common errors.
Scenario 1: Generic Drug Manufacturer Filing Annual Report
Situation: A generic pharmaceutical company holds an ANDA for a cardiovascular medication. They made minor CMC changes during the reporting period and have an open postmarketing commitment.
Scenario 2: Foreign Biologics Company Submitting via U.S. Agent
Situation: A European biologics manufacturer with a BLA needs to submit their annual report but has no U.S. business location.
Scenario 3: NDA Holder With Authorized Generic Drug
Situation: An NDA holder began marketing an authorized generic version of their branded product during the reporting period.
Mistakes to Avoid When Filing Form 2252
Errors on Form 2252 delay annual report processing and can trigger FDA requests for additional information. Based on common FDA entry submission errors, the following mistakes occur frequently.
Mistake 1: Missing or Incorrect Application Numbers
Entering the wrong application number, or omitting digits, causes FDA systems to reject the match against existing records. The consequence is a delay while FDA staff manually verify the correct application.
How to avoid it: Copy your application number directly from your FDA approval letter. Verify all digits before submission.
Mistake 2: Failing to Enter “None” for Empty Categories
Leaving Field 10 categories blank creates ambiguity about whether you reviewed that category or simply forgot to address it.
How to avoid it: Explicitly enter “None” under IDENTIFICATION for any category where you have nothing to report.
Mistake 3: Using Incorrect PMC/PMR Status Terminology
The FDA requires specific status terms: Pending, Ongoing, Delayed, Submitted, or Terminated for open studies. Using non-standard language (such as “In Progress” or “Continuing”) prevents accurate categorization.
How to avoid it: Use only the defined status terms from 21 CFR 314.81(b)(2)(vii)(a)(8).
Mistake 4: Missing the 60-Day Submission Window
Annual reports must be submitted within 60 days of your U.S. approval anniversary date. Missing this deadline constitutes a regulatory violation that can result in withdrawal of approval.
How to avoid it: Calendar your submission deadline at least 90 days in advance. Build in time for internal review and eCTD publishing.
Mistake 5: Submitting Annual Reports in Incorrect Format
Since 2018, FDA requires eCTD format for all annual reports for NDAs, ANDAs, BLAs, and commercial INDs. Paper submissions without an approved waiver face rejection.
How to avoid it: Use FDA-validated eCTD publishing software. Submit through the Electronic Submissions Gateway (ESG).
Mistake 6: Combining BLA Annual Reports With Other Notifications
CBER instructs BLA holders not to include other notifications or submissions in their annual report package. Manufacturing change notifications under 21 CFR 601.12 must be submitted separately.
How to avoid it: Submit your Form 2252 and annual report as a standalone package. File 601.12 changes in separate submissions clearly labeled by change type.
Do’s and Don’ts for FDA Form 2252
Do’s
Don’ts
Consequences of Non-Compliance
The FDA treats annual reporting requirements as fundamental to post-approval oversight. Failure to comply carries serious regulatory consequences.
Approval Withdrawal
Under 21 CFR 314.81(d), if an applicant fails to make reports required by Section 314.81, FDA may withdraw approval of the application. This action prohibits continued marketing of the drug product. The FDA does not issue warnings before taking this action—the regulation itself provides notice of the consequence.
Public Disclosure of Non-Compliance
For postmarketing study commitments, FDA publicly discloses applicant names and study statuses on its website and in annual Federal Register reports. If a study is delayed or terminated, FDA publishes the reasons provided by the applicant—making compliance failures visible to competitors, investors, and the public.
Impact on Future Applications
A pattern of non-compliance with annual reporting can affect FDA’s assessment of an applicant’s reliability when reviewing subsequent submissions. Regulatory history factors into FDA’s evaluation of manufacturing quality systems and organizational trustworthiness.
Where to Submit Form 2252
Submission addresses depend on your application type and the FDA center responsible for review.
CDER Submissions (NDAs, ANDAs, Therapeutic BLAs)
Submit electronically via FDA’s Electronic Submissions Gateway. Physical media (DVD, USB) may be used as fallback for submissions over 10GB.
Central Document Room Address:
FDA/Center for Drug Evaluation and Research (CDER)
Central Document Room (CDR)
5901-B Ammendale Road
Beltsville, MD 20705-1266
CBER Submissions (Biological Products)
Submit to the CBER Document Control Center.
Document Control Center Address:
CBER Document Control Center, HFM-99
1401 Rockville Pike
Rockville, MD 20852-1448
Email submission (under 150MB):
[email protected]
FAQs
Is Form 2252 required for every annual report?
Yes. Each annual report must be accompanied by a completed transmittal Form FDA 2252 under 21 CFR 314.81(b)(2) for drugs and 21 CFR 601.70(b) for biologics.
What happens if I miss the 60-day deadline?
FDA may withdraw your application’s approval. Under 21 CFR 314.81(d), failure to submit required reports can result in approval withdrawal, prohibiting continued marketing.
Can I submit Form 2252 on paper?
No, unless you have an approved waiver. FDA mandated eCTD electronic format for NDAs, ANDAs, BLAs, and commercial INDs since 2017-2018.
Do I need Form 2252 if my product isn’t being marketed?
Yes. The regulations apply regardless of whether the product is actively marketed, as long as the application remains approved.
What’s the difference between Field 10 and Field 11?
Field 10 applies to NDAs/ANDAs; Field 11 applies specifically to BLAs for postmarketing study commitment status reports under 21 CFR 601.70.
Who can sign Form 2252 for a foreign company?
An authorized U.S. agent must sign if the applicant does not reside or maintain a U.S. business location. This requirement comes from 21 CFR 314.50(a)(5).
How do I report authorized generic drugs?
Include the entry date, exit date (if applicable), and brand name in the distribution data section (Field 10b). Send a copy to [email protected].
What status terms must I use for postmarketing commitments?
Pending, Ongoing, Delayed, Terminated, or Submitted. These are the only acceptable status terms under 21 CFR 314.81(b)(2)(vii)(a)(8).
Can I combine multiple applications on one Form 2252?
Yes, if information in your annual report applies to multiple applications. List additional application numbers in Field 8 and use continuation pages as needed.
Where can I download Form 2252?
From FDA’s official forms page at FDA Forms. The form is available as a fillable PDF.