FDA Form 5025 is the official Annual Report for Designated Medical Gas required under 21 CFR 230.80. Applicants who hold granted certifications for designated medical gases must submit this form within 60 calendar days of the new calendar year to maintain compliance with the Food and Drug Administration’s regulatory requirements.
Under 21 CFR Part 230, failure to submit annual reports can trigger enforcement actions that range from warning letters to potential revocation of a certification—meaning your designated medical gas could lose its “deemed approved” NDA or NADA status. According to FDA enforcement data, approximately 30% of regulated entities face compliance issues related to late or incomplete reporting requirements.
Here’s what you’ll learn:
- 📋 The exact sections of Form 5025 and what information goes in each field
- ⚠️ Critical mistakes that cause FDA rejections or delays
- 🏭 How to report facility updates when production locations change
- 💊 The seven designated medical gases covered by this form and their compendial standards
- 📅 Deadlines, submission methods, and what happens if you file late
What Is FDA Form 5025?
Form FDA 5025 serves as the standardized document for submitting annual reports for designated medical gases to the FDA’s Center for Drug Evaluation and Research (CDER). The form captures critical information about your medical gas operations during the previous reporting period, including distribution volumes, facility changes, and any significant new safety information.
The form exists because of the Food and Drug Administration Safety and Innovation Act (FDASIA), which created sections 575 and 576 of the FD&C Act. These sections established a streamlined certification process for certain medical gases with well-established uses. Once a company receives certification, the gas is “deemed to have in effect” an approved New Drug Application (NDA) for human use and/or a New Animal Drug Application (NADA) for animal use.
The annual report requirement ensures the FDA maintains current oversight of these products without requiring the extensive periodic safety reporting that applies to most other approved drugs. This reflects the FDA’s recognition that designated medical gases have long safety histories and rarely present new safety concerns.
Who Must File Form 5025?
Any entity holding a granted certification for a designated medical gas must submit Form 5025 annually. This includes:
| Entity Type | Filing Requirement | Notes |
|---|---|---|
| Original Manufacturers | Required | Companies that initially produce and certify designated medical gases |
| Certified Distributors | Required | Distributors who hold their own NDA/NADA certification |
| Foreign Applicants | Required | Must have a U.S. agent countersign the form |
| Subsequent Manufacturers | Not Required | Use supplier’s NDA/NADA number instead of obtaining separate certification |
The FDA distinguishes between original certification holders and companies that use a supplier’s NDA/NADA number. If you purchase bulk medical gas from a certified supplier and redistribute it, you do not need your own certification—you reference your primary supplier’s application number in your drug listing. However, if you hold your own granted certification, you must file Form 5025 annually.
The Seven Designated Medical Gases
Under section 575 of the FD&C Act, only seven medical gases qualify for the streamlined certification process:
| Gas | Compendial Standard | Primary Medical Use |
|---|---|---|
| Oxygen | USP (≥99.0% purity) | Respiratory therapy, anesthesia, hyperbaric treatment |
| Nitrogen | NF (≥99.0% purity) | Cryotherapy, dermatological procedures, hypoxic challenge testing |
| Nitrous Oxide | USP (≥99.0% purity) | Anesthesia, analgesic (pain relief) |
| Carbon Dioxide | USP (≥99.0% purity) | Respiratory stimulation, insufflation during surgery |
| Helium | USP (≥99.0% purity) | Airway obstruction treatment, pulmonary function testing |
| Medical Air | USP (19.5%-23.5% O₂) | Respiratory therapy, pneumatic medical equipment |
| Carbon Monoxide | USP | Specialized therapeutic applications |
Each gas must meet the standards set forth in an official compendium—typically the United States Pharmacopeia (USP) or the National Formulary (NF). This means your gas must be tested and verified to meet purity requirements before sale or distribution.
Section-by-Section Guide to Form 5025
Section 1: Applicant Information
This section captures the legal identity of the entity submitting the annual report. The FDA’s official instructions require precision here because this information links your report to your granted certification.
Required Fields:
| Field | What to Enter | Common Errors |
|---|---|---|
| Applicant Name | Legal business name exactly as it appears on your certification | Using trade names or abbreviations instead of legal entity name |
| Address 1 | Primary business address | Missing suite or unit numbers |
| City/State/ZIP | Complete location information | Incorrect postal codes |
| Country | “United States” for domestic applicants | Foreign applicants must also complete Contact Information section |
Scenario: Sarah’s Medical Gas Supply, LLC
Sarah operates a medical gas manufacturing facility in Texas. She received NDA 212XXX for Oxygen, USP in 2024. On her Form 5025, she enters:
- Applicant Name: Sarah’s Medical Gas Supply, LLC (not “Sarah’s MG” or the DBA name)
- Address: 1234 Industrial Boulevard, Suite 500, Houston, TX 77001
For non-U.S. applicants, the Contact Information section becomes mandatory. You must provide the name, address, telephone number, and email address of your authorized U.S. agent—the person who resides or maintains a business within the United States and is authorized to represent your company.
Section 2: Product Information
This section identifies which designated medical gas your report covers. You must select only one gas per form. If you hold certifications for multiple gases, you must submit separate Form 5025 submissions for each.
Gas Selection Checklist:
The form presents seven options:
- ☐ Oxygen, USP
- ☐ Medical air, USP
- ☐ Nitrogen, NF
- ☐ Helium, USP
- ☐ Nitrous oxide, USP
- ☐ Carbon monoxide
- ☐ Carbon dioxide, USP
After selecting your gas, you must provide your application number(s). The FDA issues separate numbers depending on intended use:
| Use Type | Application Format | Example |
|---|---|---|
| Human Use Only | NDA number | NDA 212539 |
| Animal Use Only | NADA number | NADA 141-507 |
| Both Human and Animal | Both NDA and NADA numbers | NDA 220634 / NADA N-141-611 |
Critical Point: The application numbers were assigned when your certification request was granted. The FDA sends an acknowledgment letter with these numbers—keep this letter in your records.
Section 3: Annual Report Information
This is the substantive core of Form 5025. The FDA requires four categories of information for the reporting period:
3a. Summary of Significant New Information
Report any new information that might affect the safety, effectiveness, or labeling of your designated medical gas. This includes:
- New adverse events or safety signals you’ve identified
- Actions taken in response to safety concerns
- Labeling changes you’ve made or intend to make
- Results from any post-market studies
If no significant new information exists for the reporting period, state this explicitly. The FDA prefers clear affirmative statements such as: “No significant new information affecting the safety, effectiveness, or labeling of [Gas Name], USP was identified during the reporting period.”
3b. Distribution Data
This section requires quantitative information about how much medical gas you distributed during the reporting year. You must provide:
| Data Element | Description | Format |
|---|---|---|
| NDC Numbers | National Drug Code(s) for your product | 10-digit format (XXXXX-XXXX-XX) |
| Domestic Quantities | Volume distributed within the United States | Appropriate units (cubic feet, liters, etc.) |
| Foreign Quantities | Volume distributed outside the United States | Same units as domestic |
Alternative Reporting Option: If you already submit distribution data under section 510(j)(3) of the FD&C Act, you may reference that report instead of duplicating the data. Simply state: “Distribution data submitted under section 510(j)(3) report dated [MM/DD/YYYY].”
3c. Administrative Changes
Report any changes to your applicant information that occurred during the reporting year, including:
- Legal name changes (mergers, acquisitions, rebranding)
- Address changes for your principal place of business
- Changes in ownership structure
- Updated contact information
If no administrative changes occurred, state: “No administrative changes during the reporting period.”
3d. Facility Update
This section tracks your manufacturing locations. List all facilities where your designated medical gas was initially produced during the reporting year.
Facility Information Required:
| Field | Description |
|---|---|
| Name of Facility | Manufacturing site name |
| Complete Address | Street address, city, state/province, country, postal code |
| Unique Facility Identifier (UFI) | DUNS number (9-digit identifier) |
| FEI Number | FDA Establishment Identifier, if one exists |
| Status Change | Check if facility was added or removed during the year |
The Unique Facility Identifier (UFI) is typically a DUNS number—currently the only FDA-recognized UFI for drug establishments. You can obtain a DUNS number free of charge from Dun & Bradstreet at 866-705-5711 or via https://fdadunslookup.com.
Scenario: Adding a New Production Facility
MedGas Corp. added a second production facility in Nevada in July of the reporting year. On Form 5025, they:
- List both the original facility (California) and the new facility (Nevada)
- Check “This facility was added since the last annual report” for the Nevada location
- Provide DUNS numbers for both facilities
- Include FEI numbers if facilities have been inspected by FDA
Section 4: Signature(s)
Form 5025 must be signed and dated to be valid. The signature requirements differ based on your location:
Domestic Applicants
| Signer | Title | Date |
|---|---|---|
| Applicant (or attorney, agent, or other authorized official) | Regulatory Affairs Director, Quality Manager, Owner, etc. | MM/DD/YYYY |
One signature is sufficient for U.S.-based applicants.
Non-U.S. Applicants
Foreign applicants require two signatures:
| Signer | Role | Requirement |
|---|---|---|
| Applicant | Primary applicant outside U.S. | Must sign and date |
| U.S. Agent | Attorney, agent, or authorized official | Must countersign to validate the form |
The U.S. agent’s countersignature confirms that the foreign applicant has an authorized representative within the United States who can facilitate FDA communications and coordinate with the agency.
Warning Statement: The form includes a certification that the data is true and accurate. Under 18 U.S.C. 1001, a willfully false statement is a criminal offense punishable by fines and imprisonment.
How to Submit Form 5025
The FDA offers two submission methods, though electronic submission is strongly encouraged:
Electronic Submission (Preferred)
Submit via the CDER NextGen Portal:
- Create an account if you don’t have one (registration process takes 2-3 business days)
- Log in and select “Medical Gas” under Alternate Submission types
- Upload your completed, signed Form 5025
- Receive a confirmation number upon successful submission
The CDER NextGen Portal provides real-time submission status tracking and direct communication channels with FDA reviewers.
Paper Submission (Alternative)
If electronic submission is not feasible:
| Requirement | Details |
|---|---|
| Number of Copies | Two (2) copies of the completed, signed form |
| Mailing Address | Central Document Room, 5901B Ammendale Road, Beltsville, MD 20705 |
| Timing | Allow 5-10 business days for processing |
Paper submissions take longer to process and do not provide electronic confirmation.
Deadline and Timing
Under 21 CFR 230.80(a), applicants must submit Form 5025 within 60 calendar days of the new calendar year. For a December 31, 2025 reporting year end:
| Milestone | Date |
|---|---|
| Reporting Period End | December 31, 2025 |
| Submission Deadline | March 1, 2026 (60 days from January 1) |
| Recommended Filing | By February 15 to allow for corrections |
The annual report covers the calendar year (January 1 through December 31), not your fiscal year or the anniversary of your certification grant.
Mistakes to Avoid
Based on FDA warning letters and enforcement patterns, these errors cause the most problems:
| Mistake | Consequence | Prevention |
|---|---|---|
| Using wrong application number | Form processed under incorrect certification; potential “ghost” filings | Verify NDA/NADA against your original grant letter |
| Missing DUNS number for facilities | Incomplete facility identification; follow-up requests from FDA | Obtain DUNS numbers before filing |
| Selecting multiple gases on one form | Invalid submission; must resubmit | Submit separate Form 5025 for each gas |
| Filing after 60-day deadline | Triggers compliance review; potential enforcement action | Set calendar reminders for early February |
| Omitting U.S. agent countersignature | Invalid submission for foreign applicants | Coordinate with U.S. agent well before deadline |
| Referencing 510(j)(3) report without date | FDA cannot locate referenced data | Include complete report identification |
Do’s and Don’ts
Do’s
✅ Keep copies of your grant letter – The NDA/NADA numbers you received when your certification was granted are essential for all subsequent filings.
✅ Maintain current DUNS numbers – Verify that your facility DUNS numbers are active and correctly linked to your physical addresses.
✅ Submit electronically when possible – The CDER NextGen Portal provides confirmation, tracking, and faster processing.
✅ Report “no changes” explicitly – When nothing significant occurred, state this clearly rather than leaving sections blank.
✅ Coordinate with your U.S. agent early – Foreign applicants should give their U.S. agent at least two weeks to review and countersign the form.
Don’ts
❌ Don’t use trade names instead of legal names – The Applicant Name must match your certification exactly.
❌ Don’t combine multiple gases on one form – Each designated medical gas requires its own Form 5025 submission.
❌ Don’t wait until the deadline – Submit by mid-February to allow time for corrections if FDA identifies issues.
❌ Don’t ignore facility changes – Added or removed production locations must be reported, with appropriate status boxes checked.
❌ Don’t omit distribution data – Either provide quantities or reference your 510(j)(3) report—never leave this section incomplete.
Consequences of Non-Compliance
The FDA takes annual reporting obligations seriously because these reports support the agency’s post-market surveillance mission. Failure to file or filing incorrectly can trigger:
Enforcement Hierarchy
| Action Level | Description | Typical Timeline |
|---|---|---|
| Informal Communication | FDA contacts you requesting submission | Within 90 days of missed deadline |
| Warning Letter | Formal notice of violation requiring response within 15 working days | 3-6 months after missed deadline |
| Compliance Review | FDA evaluates whether certification should remain in effect | Ongoing |
| Certification Revocation | Withdrawal of “deemed approved” status | After sustained non-compliance |
The FDA’s Staff Manual Guide authorizes revocation of a granted certification if the request contained any material omission or falsification. This means your designated medical gas could lose its approved NDA/NADA status—requiring you to either cease distribution or pursue a full NDA application.
Civil monetary penalties for drug application violations can reach $10,000-$20,000 per violation under certain circumstances. While the FDA has historically emphasized voluntary compliance for designated medical gases, the establishment of 21 CFR Part 230 effective December 18, 2025, signals increased regulatory attention to this sector.
Real-World Scenarios
Scenario 1: First Annual Report After Certification
Situation: ABC Gas Corp. received certification for Nitrogen, NF (NDA 221XXX) on June 16, 2025.
Filing Requirement: ABC must file Form 5025 by March 1, 2026, covering the period from June 16, 2025 (certification grant date) through December 31, 2025.
| Section | Entry |
|---|---|
| Applicant Information | ABC Gas Corp., legal address |
| Product Information | Nitrogen, NF; NDA 221XXX |
| Distribution Data | Quantities for June-December 2025 |
| Facility Update | All facilities producing Nitrogen, NF during this period |
Scenario 2: Foreign Manufacturer with New U.S. Agent
Situation: EuroMed GmbH (Germany) changed U.S. agents in October 2025.
Filing Requirement: Form 5025 must reflect the current U.S. agent in the Contact Information section. The Administrative Changes section should note when the U.S. agent changed.
| Section | Entry |
|---|---|
| Contact Information | New U.S. agent: Jones Regulatory Services, LLC, Chicago, IL |
| Administrative Changes | “U.S. agent changed from Smith Consulting to Jones Regulatory Services, LLC effective October 15, 2025” |
| Signature | Primary applicant (EuroMed GmbH) AND U.S. agent countersignature required |
Scenario 3: Referencing 510(j)(3) Distribution Report
Situation: National Medical Gases Inc. already submits annual drug amount reports under section 510(j)(3).
Filing Requirement: Instead of duplicating distribution data on Form 5025, the company may reference its 510(j)(3) submission.
| Section | Entry |
|---|---|
| Distribution Data | “Distribution data, including domestic and foreign distribution amounts, was submitted under section 510(j)(3) of the FD&C Act. Reference: Report dated February 10, 2026, covering calendar year 2025.” |
Key Entities and Their Roles
Understanding the organizational relationships helps ensure proper compliance:
| Entity | Role | Contact |
|---|---|---|
| CDER (Center for Drug Evaluation and Research) | Reviews Form 5025, maintains certification records | 5901-B Ammendale Road, Beltsville, MD 20705 |
| Office of Pharmaceutical Quality | Technical oversight of designated medical gas manufacturing | Part of CDER |
| CVM (Center for Veterinary Medicine) | Reviews animal-use certifications (NADA applications) | For animal-only use questions |
| Dun & Bradstreet | Issues DUNS numbers (Unique Facility Identifiers) | 866-705-5711 or https://fdadunslookup.com |
| U.S. Agent | Required liaison for foreign applicants | Must be U.S.-resident or U.S.-based business |
Recent Regulatory Changes
The FDA issued a final rule on June 18, 2024, establishing comprehensive regulations for medical gases that took full effect December 18, 2025. Key changes affecting Form 5025 filers include:
New 21 CFR Part 213: Establishes medical gas-specific Current Good Manufacturing Practice (CGMP) requirements—previously, medical gas manufacturers followed general pharmaceutical CGMP under Parts 210 and 211.
New 21 CFR Part 230: Codifies the certification process and annual reporting requirements, replacing the previous reliance on draft guidance documents.
Field Alert Reports (FARs): Under 21 CFR 230.205, applicants must submit FARs within 3 days of identifying significant quality defects in distributed medical gases.
Adverse Event Reporting: Serious adverse events for human-use designated medical gases must be reported within 15 calendar days under 21 CFR 230.220.
Pros and Cons of the Annual Reporting System
Pros
✅ Streamlined Process: Form 5025 is simpler than the extensive annual reports required for most approved drugs—typically requiring 2 hours to complete.
✅ No Periodic Safety Reports: Designated medical gases are exempt from routine periodic safety reporting requirements that apply to other NDAs.
✅ Electronic Submission: The CDER NextGen Portal provides convenient, trackable submission.
✅ Calendar-Year Alignment: All applicants report on the same timeframe, simplifying compliance planning.
✅ No Filing Fee: Unlike many FDA submissions, Form 5025 carries no user fee.
Cons
❌ Strict Deadline: The 60-day window offers limited flexibility, especially over the year-end holiday period.
❌ Multiple Forms for Multiple Gases: Holding certifications for several gases requires separate filings.
❌ DUNS Number Requirement: Obtaining DUNS numbers can take up to 45 days for new facilities.
❌ Foreign Applicant Complexity: Non-U.S. companies face additional requirements including U.S. agent countersignature.
❌ Limited Guidance: While 21 CFR Part 230 is now final, specific implementation questions may require direct FDA consultation.
FAQs
Do I need to file Form 5025 if I only distribute (not manufacture) designated medical gases?
No. Form 5025 is required only for entities holding their own granted certification. If you distribute under a supplier’s NDA/NADA number, that supplier is responsible for the annual report.
Can I submit one Form 5025 covering multiple designated medical gases?
No. The form requires selecting only one gas. Submit separate forms for each gas for which you hold certification.
What happens if I miss the 60-day deadline?
The FDA will follow up. Late submission triggers compliance review and may result in warning letters or, in sustained cases, certification revocation.
Do I need both NDA and NADA numbers for human-use-only medical gases?
No. If your certification is only for human use, provide only the NDA number. The NADA applies only to animal drug use.
Can my U.S. agent submit Form 5025 on my behalf?
Yes. The U.S. agent may submit the form, but it must still be signed by both the applicant and countersigned by the U.S. agent.
Is there a fee to submit Form 5025?
No. The FDA does not charge a fee for annual report submissions for designated medical gases.
What if I have no significant new information to report?
State this explicitly. Enter “No significant new information identified during the reporting period” rather than leaving the section blank.
Can I reference my 510(j)(3) report instead of providing distribution data?
Yes. Include the date of your 510(j)(3) report and state that distribution data is included there.
What is a DUNS number and where do I get one?
A DUNS number is a 9-digit Unique Facility Identifier assigned by Dun & Bradstreet. Obtain one free at 866-705-5711 or https://fdadunslookup.com.
What compendial standard must my medical gas meet?
USP (United States Pharmacopeia) or NF (National Formulary). Oxygen, nitrous oxide, carbon dioxide, helium, medical air, and carbon monoxide must meet USP standards; nitrogen must meet NF standards.