The Generic Drug User Fee Amendments (GDUFA) of 2012 give the U.S. Food and Drug Administration (FDA) authority to collect annual user fees from active pharmaceutical ingredient (API) and finished dosage form (FDF) facilities. The fees are due on October 1 of each year. FDA must receive the full payment within 20 days of the due date.
The FY 2015 facility fees are:
- Domestic FDF facility: $247,717
- Foreign FDF facility: $262,717
- Domestic API facility: $41,926
- Foreign API facility: $56,926
What happens if FDA does not receive the payment on time?
The facility will be placed on a publicly available arrears list and no new drug submission referencing the facility will be received until the fee is paid. Along with this, all FDFs and/or APIs manufactured in the facility will be deemed misbranded, making it illegal to ship the products into interstate commerce or import them into the U.S.
Can FDA require a company to pay multiple facility fees?
Yes. If a facility manufactures both FDFs and APIs, both fees must be paid for that facility. A company will also have to pay separate fees if it owns multiple facilities in different geographic locations. A company may be able to pay only one facility fee if it owns two facilities that are considered to be in the same geographic location. For facilities to qualify as being in the same geographic location:
- The activities in the separate buildings must be closely related to the same business enterprise
- The two facilities must be under the supervision of the same local management
- FDA must be able to cover both facilities in a single inspection
FDA requires facilities to submit a GDUFA cover sheet along with user fees.
The cover sheet allows FDA to track the payment and ensure the correct fee was paid by a facility. Cover sheets are submitted to the User Fee System, which is now open for FY 2015 submissions. Facility fee cover sheets must include:
- The facility’s name and address
- The facility’s FDA establishment identification (FEI) number and data universal numbering system (DUNS) number
- Confirmation of whether the facility manufactures human drugs that are not human generic drugs
Registrar Corp offers a variety of services for drug facilities, including proper FDA registration renewal, product listing, label reviews for FDA compliance, detention assistance, and more.
If you have any questions about generic drug facility fees or any other FDA drug regulations, contact us at +1-757-224-0177 or receive online Live Help from Regulatory Specialists: https://www.registrarcorp.com/livehelp.