FDA Drug Establishment Registration and Listing Fee
The FDA drug establishment registration and listing fee has two parts: service fees for the registration, NDC labeler code and each drug listing, and, for facilities outside the USA, the annual US Agent fee. The FDA does not charge for the registration and listing submissions themselves, but manufacturers of OTC monograph drugs pay a separate annual FDA facility fee. The figures are below.
What Is the FDA Drug Establishment Registration and Listing Fee?
I3CGLOBAL charges $100 to complete the FDA establishment registration and request the NDC labeler code, $400 for each drug listing and $650 a year for the US Agent service that foreign establishments must appoint. These service fees apply to OTC, prescription, homeopathic and API manufacturers. They do not include FDA government fees such as the OMUFA facility fee, which are paid directly to the FDA.
| Service | Fee (USD) |
|---|---|
| FDA registration and NDC labeler code request | $100 |
| Annual US Agent service (mandatory for foreign manufacturers) | $650 |
| Drug listing (per product) | $400 |
What Are the FDA Government Fees for FY 2027?
The FDA does not charge for the registration and listing submissions themselves. Facilities that manufacture OTC monograph drugs pay an annual FDA facility fee under the Over-the-Counter Monograph Drug User Fee Program (OMUFA). The fiscal year 2027 rates are below (FDA OMUFA FY 2027 fee notice, Federal Register).
| Facility type | FY 2026 (USD) | FY 2027 (USD) |
|---|---|---|
| MDF facility (Monograph Drug Facility) | $19,188 | $47,891 |
| CMO facility (Contract Manufacturing Organization) | $12,792 | $31,927 |
Note: These government fees are paid directly to the FDA and are not part of our service fee. For fiscal year 2027 the FDA notice sets payment in two equal instalments, due 1 October 2026 and 1 February 2027. The FY 2027 facility fees are about 2.5 times the FY 2026 rates.
Companies that ask the FDA to add or change a monograph through an OTC Monograph Order Request (OMOR) pay a separate one-time fee when they submit it. For FY 2027 this is $614,608 for a Tier 1 OMOR and $122,921 for a Tier 2 OMOR. Most manufacturers that only register and list products do not pay it.
Example: total annual cost for a foreign OTC manufacturer
A monograph drug facility (MDF) outside the USA that lists three OTC monograph products would pay the following in FY 2027:
| Item | Amount (USD) |
|---|---|
| Registration and NDC labeler code (I3CGLOBAL) | $100 |
| US Agent service, one year (I3CGLOBAL) | $650 |
| Drug listing, 3 products × $400 (I3CGLOBAL) | $1,200 |
| OMUFA MDF facility fee (paid to the FDA) | $47,891 |
| Total | $49,841 |
Of this, $1,950 is the I3CGLOBAL service fee and $47,891 is paid directly to the FDA. A facility that does not manufacture OTC monograph drugs, such as a prescription-only site, does not pay the OMUFA fee. We confirm which FDA fees apply to your site in writing.
What Are the Drug Label Review and DMF Fees?
Drug label review and Drug Master File (DMF) submission are optional services. A label review costs $950 per product and takes 14 working days. We check the label against the FDA labeling requirements before you list the product. A DMF submission costs $650 per product and takes 30 working days.
| Service | Fee (USD) |
|---|---|
| Drug label review | $950 per product (14 working days) |
| DMF submission | $650 per product (30 working days) |
What Should You Know Before You Pay?
- Renewal. Registration is renewed and listings are certified every year between 1 October and 31 December. See FDA drug establishment registration for the full process.
- Late OMUFA payment. If a facility fee is not paid within 20 calendar days of the due date, the FDA puts the facility on a public arrears list and treats its OTC monograph products as misbranded until the fee is paid (FDA).
- Listing is per product. Each drug needs its own listing.
- Other FDA user fees. Generic drug and API facilities named in applications can be subject to separate FDA programme fees, such as GDUFA fees. We confirm what applies to your site.
Work with I3CGLOBAL
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- Registration, labeler code and listings prepared in SPL format
- US Agent based in the USA
- Annual renewal and certification reminders
Request a proposal
Send us your facility and product details and we will confirm the total fee in writing.
FAQs
Drug Registration Fee: Frequently Asked Questions
Does the FDA charge for drug establishment registration?
The FDA does not charge for the registration and listing submissions themselves. Separate FDA user fees apply to some facilities, such as the OMUFA facility fee for OTC monograph drug manufacturers.
Is the listing fee charged per drug?
Yes. Each drug product has its own listing and listing fee.
Is the US Agent fee annual?
Yes. It covers the US Agent service for one year and applies to establishments outside the USA.
Who pays the OMUFA facility fee?
The owner of a facility that manufactures OTC monograph drugs pays it directly to the FDA each fiscal year.
When is the FY 2027 OMUFA facility fee due?
The FDA has set payment in two equal instalments: half by 1 October 2026 and the other half by 1 February 2027.
What happens if the OMUFA fee is paid late?
If the fee is not paid within 20 calendar days of the due date, the FDA puts the facility on a public arrears list and treats its OTC monograph drug products as misbranded until the fee is paid.
What is the total cost for a foreign OTC drug manufacturer?
For a foreign monograph drug facility listing three products in FY 2027, the I3CGLOBAL service fee is $1,950 ($100 registration, $650 US Agent and $1,200 for three listings). The FDA OMUFA facility fee of $47,891 is paid separately, for a total of $49,841.