Note: The revision of this Import Alert (IA) dated 4/4/2023 updates the guidance section including agency contacts. Changes to the import alert are bracketed by asterisks (***). FDA has observed foreign unapproved prescription drugs offered for sale in the United States by unsafe online pharmacies which poses a significant public health concern. Unapproved prescription drugs present serious safety and effectiveness concerns. Moreover, FDA-approved versions of these drugs are often available in the United States. Therefore, this import alert is intended to identify known distributors, including online pharmacies, of unapproved prescription drugs to U.S. consumers. There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, contain varying amounts of active ingredients, or contain different ingredients altogether. In examining imported drugs sent through the mail, FDA has identified unapproved drugs, counterfeit drugs, improperly labeled drugs, drugs that failed to meet special storage conditions, and drugs that require supervision of a practitioner licensed by law to administer them.
Foreign manufactured unapproved prescription drugs
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved new drug, Section 505(a)] OASIS charge code: UNAPPROVED
Divisions may detain without physical examination all dosage forms and shipments, commercial and personal, of foreign manufactured unapproved prescription drugs from distributors, including online pharmacies, identified on the Red List of this alert. Divisions should utilize affirmations of compliance to verify that the drugs are subjects of an approved new drug application (NDA), abbreviated NDA (ANDA), Biologics License Application (BLA), or investigational new drug application (IND). Also verify manufacturer registration and drug listing for drugs that are subjects of an NDA, ANDA, or BLA. Imported drugs with verified affirmations of compliance are not subject to 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. Please contact CDER/OC/ODSIR/DGDDP/ICB at CDERImports@fda.hhs.gov with questions on Personal Importation of drug products subject to this import alert. Recommendations for addition to DWPE for unapproved prescription drugs and/ or distributors, including online pharmacies, should be forwarded to the Division of Import Operations (DIO) for review. Recommendations should include background information, analytical worksheets if the product was analyzed, product labeling, and entry documents. DIO will coordinate the review of the DWPE recommendation with CDER/OC/ODSIR/DGDDP/ICB for consideration. Release of Articles Subject to Detention Without Physical Examination Under this Import Alert: In order to secure release of an individual shipment subject to DWPE under this Import Alert, the importer and/or another responsible party to the shipment should provide evidence that the shipment does not contain prescription drugs that appear to be unapproved. CDER/OC/ODSIR/DGDDP/ICB will evaluate on a case-by-case basis. Removal from Detention Without Physical Examination (REMOVE FROM RED LIST): ***In order 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 condition that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future entries will be in compliance with the FD&C Act. For guidance on removal from detention without physical examination, 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 Questions or issues involving import operations should be addressed to ORA/DIO at (301)796-0356 or FDAImportsInquiry@fda.hhs.gov. Questions or issues involving compliance of imported prescription drugs should be addressed to CDER/OC/ODSIR/DGDDP/ICB at CDERImports@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 4/4/2023 updates the guidance section including agency contacts. Changes to the import alert are bracketed by asterisks (***). FDA has observed foreign unapproved prescription drugs offered for sale in the United States by unsafe online pharmacies which poses a significant public health concern. Unapproved prescription drugs present serious safety and effectiveness concerns. Moreover, FDA-approved versions of these drugs are often available in the United States. Therefore, this import alert is intended to identify known distributors, including online pharmacies, of unapproved prescription drugs to U.S. consumers. There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, contain varying amounts of active ingredients, or contain different ingredients altogether. In examining imported drugs sent through the mail, FDA has identified unapproved drugs, counterfeit drugs, improperly labeled drugs, drugs that failed to meet special storage conditions, and drugs that require supervision of a practitioner licensed by law to administer them.
Country-specific information is available in the full alert detail on the FDA website.
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