Note: The revision of this Import Alert (IA) dated 08/31/2022 updates the guidance section and agency contacts. Changes to the import alert are bracketed by asterisks (***). Unapproved new animal drugs may present serious safety and effectiveness concerns. When evidence exists that finished new animal drugs offered for import into the United States for commercial distribution are unapproved, such products would appear to be adulterated. Accordingly, the products should be considered for detention without physical examination. Evidence of marketing or promotion may consist of information contained in: unapproved product being offered for import and distribution; solicitations for mail orders; press releases; internet websites; advertising materials; labeling indications of US patents or patent applications; or other public announcements directed to persons residing in the U.S. New animal drugs may not be legally marketed in the United States in the absence of an approved new animal drug application (NADA), abbreviated new animal drug application (ANADA), conditional approval, or an index listing, under sections 512, 571, and 572 of the FD&C Act. Detention without physical examination of bulk active pharmaceutical ingredients [APIs] is covered under Import Alert #68-09, "Detention Without Physical Examination of New Bulk Animal Drug Substances."
Unapproved New Animal Drugs, Misbranded Animal Drugs
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies. [Adulteration, Section 501(a)(5)]. OASIS Charge Cod e: NEW VET DR When unaccompanied by labeling which makes drug claims but other evidence attributable to the manufacturer, owner or consignee, importer of record, or end-user exists which establishes the product's intended use as a drug, charge: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use. [Misbranded, Section 502(f)(1)] OASIS Charge Code: DIRSEXMPT For any drugs being imported for fish, contact CVM, Division of Compliance Office Animal Drug Program Team (HFV-233). If prior notification (or statement from a scientific institution) has not been given and CVM cannot make an immediate determination that the import is to a legitimate sponsor, detain the entry and charge: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is Unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies. [Adulteration, Section 501(a)(5)] OASIS CHARGE CODE: NEW VET DR
Divisions may detain, without physical examination, the specified products from the firms listed in the Red List of this Import Alert. "*** The evidence to support recommendations for addition to the Red List of this Import Alert will be evaluated by Center for Veterinary Medicine (CVM) on a case-by-case basis. Final recommendations for DWPE additions to the Red List will be reviewed by the Division of Import Operations (DIO). ***" ***Release of Articles Subject to Detention without Physical Examination Under this Import Alert:*** In order to secure release of an individual entry ***shipment subject to DWPE under this import alert***, that has been detained, the importer should provide documentation which verifies the product has a valid New Animal Drug Application (NADA) or abbreviated NADA (ANADA), conditionally approved NADA (CNADA), index listing, or Investigational New Animal Drug exemption (INAD) and Generic Investigational New Animal Drug exemption. ***Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration, per the notice of detention.*** ***Removal from Detention without Physical Examination (REMOVE FROM RED LIST):*** To remove a firm's product 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 FD&C Act). For information on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention without Physical Examination (DWPE)." In addition to the information indicated by the RPM, and in order to fully evaluate whether the conditions that rendered such products non-compliant has been resolved, FDA recommends that firms provide the following information: a. Documentation which verifies the product has a valid NADA, ANADA, CNADA, index listing or INAD. b. Documentation showing firm's product has appropriate and valid registration and listings. 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 ***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 or issues on policy, sample collection recommendations, or any other additional questions, should be addressed to Center for Veterinary Medicine (CVM), Division of Compliance, Office Animal Drug Program Team (HFV-233) at CVMImportRequests@fda.hhs.gov
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: Note: The revision of this Import Alert (IA) dated 08/31/2022 updates the guidance section and agency contacts. Changes to the import alert are bracketed by asterisks (***). Unapproved new animal drugs may present serious safety and effectiveness concerns. When evidence exists that finished new animal drugs offered for import into the United States for commercial distribution are unapproved, such products would appear to be adulterated. Accordingly, the products should be considered for detention without physical examination. Evidence of marketing or promotion may consist of information contained in: unapproved product being offered for import and distribution; solicitations for mail orders; press releases; internet websites; advertising materials; labeling indications of US patents or patent applications; or other public announcements directed to persons residing in the U.S. New animal drugs may not be legally marketed in the United States in the absence of an approved new animal drug application (NADA), abbreviated new animal drug application (ANADA), conditional approval, or an index listing, under sections 512, 571, and 572 of the FD&C Act. Detention without physical examination of bulk active pharmaceutical ingredients [APIs] is covered under Import Alert #68-09, "Detention Without Physical Examination of New Bulk Animal Drug Substances."
Country-specific information is available in the full alert detail on the FDA website.
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