(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert Name:
Reason for Alert:
***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 II provides reauthorization of industry user fees through September 30, 2022.
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 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 (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 II 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 (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. ***
Divisions may detain, without physical examination, the indicated products from the facilities identified on the Red List of this Import Alert.
***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:***
For guidance on removal from DWPE, refer to FDA's Regulatory Procedures Manual, Chapter 9, "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 forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or, 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 should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
Questions involving fee payment requirements should be addressed to CDERCollections@fda.hhs.gov or to email@example.com, and questions involving self-identification requirements should be addressed to firstname.lastname@example.org.
Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at email@example.com.
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 ***
OASIS charge code: GDUFA FEE
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
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)