Import Alert 66-76

Import Alert # 66-76

Published Date: 03/26/2025

Type: DWPE

"Detention Without Physical Examination of Drugs or Active Pharmaceutical Ingredients From Facilities That Have Not Submitted Self-Identifying Information or Paid Facility or Program Fees Required Under GDUFA "

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 timeliness to the review of generic drug applications. ***GDUFA III provides reauthorization of industry user fees through September 30, 2027.***

Facility Fees:

GDUFA defines a facility in relevant part as "a business or other entity ... at one geographic location or address engaged in manufacturing or processing an active pharmaceutical ingredient or a finished dosage form" (21 U.S.C. Section 379j-41(6)(A)(i) ). The owner of a facility identified in a generic drug submission that is approved to produce at least one human finished dosage form generic drug, an active pharmaceutical ingredient (API), or a site or organization identified in a generic drug submission must submit, update, or reconfirm information concerning the facility to FDA (self-identify) on ***or before*** June 1st of the previous fiscal year (21 U.S.C. Section 379j-42(f)).

Facility fees are due annually on the first business day on or after October 1st of each fiscal year, or the first business day after the enactment of an appropriations Act providing for the collection of fees for such year,***whichever is later*** (21 U.S.C. Section 379(j)-42(a)(4)(D)). Failure to pay a facility fee causes, among other things, all finished dosage form generic drugs or APIs manufactured in the non-paying facility, and all finished dosage form generic drugs containing APIs manufactured in such a facility to be deemed misbranded.

Generic Drug Applicant Program Fees:

***GDUFA III*** enables FDA to assess a program fee to each generic drug applicant and its affiliates according to the number of abbreviated new drug applications (ANDAs) in their portfolio. Program fees are due annually on the first business day on or after October 1st of each fiscal year, or the first business day after the enactment of an appropriations Act providing for the collection of fees for such year, ***whichever is later*** (21 U.S.C. Section 379j-42(a)(5)(D)). Failure to pay a program fee causes, among other things, all drugs marketed pursuant to any ANDA held by the generic drug applicant and its affiliates to be deemed misbranded.

The Red List of this Import Alert identifies facilities whose owners are not in compliance with the fee payment or self-identification requirements of GDUFA and that have imported or offered for import drug products or APIs. The owners of the facilities identified on the Red List were notified individually and in writing, by warning letter and/or other means, that they are in violation of Section 502(aa) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. Section 352(aa), and their articles are subject to refusal of admission because they appear to be misbranded. FDA may also have placed the facilities on a publicly available arrears lists posted at https://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-lists. The owners of these facilities have not made significant efforts to correct the violations during the time allotted in the communication notifying them of the violation. CDER monitors the arrears lists and will add facilities to the Red List as appropriate.

Divisions may detain, without physical examination, the indicated products from the facilities identified on the Red List of this Import Alert.

***Divisions should follow the guidance in the Regulatory Procedures Manual (RPM) Chapter 9-2 for Personal Importation shipments. Commercial or promotional shipments and products subject to DWPE are generally not amenable to the use of enforcement discretion.***

Release of Articles Subject to Detention Without Physical Examination Under this Import Alert:

In order to secure release of an individual shipment subject to detention without physical examination (DWPE) under this Import Alert, the owner, consignee, and/or another responsible party to the shipment should provide evidence indicating the owner of the subject facility is in full compliance with the fee payment and self-identification requirements of GDUFA.

Requests for Removal from Detention Without Physical Examination Under this Import Alert:

***To request removal of a firm's drugs from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so the Agency will have confidence that future entries will be in compliance with the Federal Food, Drug, and Cosmetic Act.

For further guidance on removal from DWPE, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention Without Physical Examination (DWPE)."

If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be ***sent via email to: Importalerts2@fda.hhs.gov ***

Requests for removal from DWPE will be reviewed by the Division of Import Operations (DIO) and then referred to the Center for Drug Evaluation and Research (CDER) for additional evaluation.

***Questions or issues involving import operations or the submissions of petitions for removal from DWPE should be addressed to OII/DIO (301) 796-0356 or Imports@fda.hhs.gov***

Questions involving fee payment requirements should be addressed to CDERCollections@fda.hhs.gov or to askgdufa@fda.hhs.gov, and questions involving self-identification requirements should be addressed to askgdufa@fda.hhs.gov.


Questions or issues involving compliance of imported drugs or drug products should be addressed to the CDER Imports Compliance Branch at CDERImports@fda.hhs.gov

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Human Finished Dosage Form Generic Drug Products and Active Pharmaceutical Ingredients (APIs) Used to
Manufacture Human Finished Dosage Form Generic Drug Products

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to
be misbranded as defined in section 502(aa) of the Act. It appears the drug or active pharmaceutical
ingredient was manufactured, prepared, propagated, compounded, or processed in a facility for which fees
have not been paid as required in 21 U.S.C. Section 379j-42(a)(4), or it contains an active pharmaceutical
ingredient that was manufactured, prepared, propagated, compounded, or processed in such a
facility. [Misbranding, Section 502(aa)]

OASIS charge code: GDUFA FEE

And

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to
be misbranded as defined in section 502(aa) of the Act. It appears that the drug or active pharmaceutical
ingredient was manufactured, prepared, propagated, compounded, or processed in a facility for which
identifying information required by 21 U.S.C. Section 379j-42(f) has not been submitted, or it contains an
active pharmaceutical ingredient that was manufactured, prepared, propagated, compounded, or
processed in such a facility. [Misbranding, Section
502(aa)]

OASIS charge code: GDUFA SELF

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