Drugs or Active Pharmaceutical Ingredients From Facilities That Have Not Submitted Self-Identifying Information or Paid Facility or Program Fees Required Under GDUFA

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 03/26/2025 updates the reason for alert, guidance section including agency contacts, and PAC. Changes to the import alert are bracketed by asterisks (***). This Import Alert identifies facilities that are not in compliance with the fee payment and self-identification requirements of the Generic Drug User Fee Amendments (GDUFA). A facility is a specific business or other entity whose owner is subject to self-identification or fee payment. Any drug manufactured by a facility that is not subject to this Import Alert, such as facilities that solely produce positron emission tomography drugs (21 U.S.C. Section 379j-42(l)), will be identified as exempted. Congress enacted GDUFA to ensure patients have access to safe, high-quality, and affordable generic drugs. GDUFA enables FDA to assess industry user fees to bring greater predictability and t

Quoted from the “Reason for Alert” section of the FDA page for 66-76, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.