28/29 October 2020
In a Federal Register Notice dated October 2, 2012 the FDA is notifying companies who manufacture Generic Drug Products and Active Pharmaceutical Ingredients as well as certain other sites and organisations that support the manufacture or approval of these products to identify themselves with FDA.
For fiscal year 2013 the indentification must be submitted by December 3, 2012. For each subsequent year, identification information must be submitted, updated, or reconfirmed until June 1 of the preceding fiscal year. To assist industry the FDA has published a draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and Organizations.
Self-identification is necessary to determine the number of facilities required to pay a fee. The new fee has been etablished with the Generic Drug User Fee Amendments of 2012 (GDUFA). The self-identification is also a central component to improve the transparency of the global supply chain. This will help FDA to plan GMP inspections. If companies fail to register facilities with FDA all products will be deemed misbranded.
FDA estimates that approx. 2,650 facilites will submit self-identification to FDA. The requested information will include:
- Registrant D-U-N-S Number
- Registrant Contact Information
- Establishment (Facility) Information
- Establishment Facility D-U-N-S Number
- FDA Establishment Identifier (FEI)
- Physical address
- Type of Business Operations
- Establishment (Facility) Contact Information
Conference Tip: The 15th European API Conference in Budapest from 7 - 9 November will inform about the latest development with regard to Active Pharmaceutical Ingredients and will also discuss the consequences from GDUFA.