The following types of generic industry facilities, sites, and organizations are required to self-identify with FDA:
- Facilities that manufacture, or intend to manufacture, human generic drug APIs or FDFs, or both.
- Facilities that package the FDF of a human generic drug into the primary container/closure system and label the primary container/closure system.
- Sites that are identified in a generic drug submission and pursuant to a contract with the applicant remove the drug from a primary container/closure system and subdivide the contents into a different primary container/closure system.
- Bioequivalence (BE)/bioavailability (BA) sites that are identified in a generic drug submission and conduct clinical BE/BA testing, bioanalytical testing of samples collected from clinical BE/BA testing, and/or in vitro BE testing.
- Sites that are identified in a generic drug submission and perform testing of one or more attributes or characteristics of the FDF or the API pursuant to a contract with the applicant to satisfy a current good manufacturing practice (CGMP) testing requirement (excludes sites that are testing for research purposes only).
Keep in mind, a GDUFA Self-Identification submission does not necessarily equate to a GDUFA user fee. Only facilities that manufacture, or intend to manufacture, generic drug APIs or FDFs, or both, are required to pay facility fees. Sites and organizations that only perform testing, repackaging, or relabeling are not required to pay a user fee. If you have questions on whether your facility needs to Self-identify, or if a fee will be assessed, EAS is here to assist.
FDA announced the fiscal year 2025 OTC-Monograph Drug User Fee rates in the Federal Register Vol. 90, No. 54 published Friday 21 March 2025. These fees cover FDA’s FY2025 which runs from October 2024 through September 2025. The facility fees for FY 2025 are due on 2 June 2025.
Regarding fee specifics,
- Owners of manufacturing and processing facilities of finished OTC-drug dosage forms will pay a full facility fee: $37,556
- Owners of a contract manufacturing facility will pay 2/3 of the full fee: $25,037
- Submitters of OTC monograph order requests (OMOR) will pay tier-based user fees, (with the exception of those submitting certain safety-related changes). Tier 1 OMOR user fees are assessed at $559,777, Tier 2 OMOR user fees are assessed at $111,955
The facility fees are assessed on any facility that identified the business process of OTC monograph drug facility in their establishment registration during the fee-liable period of 1 January 2024 through 31 December 2024. The agency has proactively sent invoices for OMUFA user fees, a departure from previous years when invoices were only sent to those companies in arrears after the payment grace period.
If you have any questions on OMUFA user fees, please reach out to Victoria Pankovich for support.
For those not already aware, the FDA has launched an updated ESG system called the “Industry USP Log In”, which can be accessed via the FDA’s Electronic Submissions Gateway website. In addition to the resources on this webpage, the agency sent extensive details via email on the new program, how to access it, and how the system works. If you need assistance with this new process, please reach out.
EAS would like to inform our clients that the CDER Ombuds service is currently unavailable as of 3 April 2025. The response received when requesting support was as follows: “CDER Ombuds services are currently unavailable at the Food and Drug Administration.” We will keep you informed as this situation evolves.
For any questions regarding the status of a product in the NDC Directory, you may access downloadable NDC database files available at the bottom of the National Drug Code Directory page. Currently, the searchable site is not being updated, but the downloadable files are current.
For finished drug products you would download: ‘NDC Directory’
For unfinished drug products you would download: ‘NDC unfinished drugs database’
For compounded drug products you would download: ‘Product Reports’
If the NDC appears in the downloadable file, it is the equivalent of the NDC appearing in the NDC Directory searchable site. If you need support with this process contact Victoria Pankovich.
We have seen an uptick in Warning Letters issued to compounding facilities. If you have questions on your compliance status, EAS is here to help you assess your specific case.
EAS has learned of an unannounced FDA inspection at a drug site in Canada. Historically the agency has always reached out to international facilities prior to inspection in order to arrange a suitable time, travel requirements, etc. We do not currently have any further details on whether the FDA anticipates continuing this practice, or whether it will extend beyond Canada to other international sites. We will keep our clients informed of any further information we receive on this matter.
Federal Register Notices
FR Vol 90, No. 67 Electronic Study Data Submission; Data Standards; Clinical Data Interchange Standards Consortium Dataset-JavaScript Object Notation; Request for Comments
FR Vol 90, No. 72 Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients
FR Vol 90, No. 74 Executive Order 14273, Lowering Drug Prices by Once Again Putting Americans First
FR Vol 90, No. 77 Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program
FR Vol 90, No. 77 Exploration of Health Level Seven Fast Healthcare Interoperability Resources for Use in Study Data Created From Real-World Data Sources for Submission to the Food and Drug Administration; Establishment of a Public Docket; Request for Comments
All Guidance Documents can be searched on the FDA’s website.
Posted in Drug and Device Corner, Drugs, Medical Devices.