Note: The major revision of this Import Alert (IA) is in response to CDER ICB's request supporting CDER Office of Compliance, Office of Manufacturing Quality (OMQ), Division of Drug Quality I�s memo of March 19, 2026 recommending revision of Import Alert (IA)#66-80. This revision updates the guidance section including examples of information a manufacturer should submit to FDA to be considered for addition to the Green List, the list of firm and drugs that have met the criteria for exclusion from recommendation for DWPE under this Import Alert (a.k.a. Green List) and addition of new FDA Product Codes. � Add Orforglipron API to three manufacturers on the Green List. � Add Orforglipron SDD, a drug product intermediate, to one manufacturer on the Green List. � Add the new FDA Product Code for Orforglipron, 61P[][]77 (Anti-Diabetic).2 � Add the FDA Product Code for Hormone N.E.C o 64R[]S99 (Hormone N.E.C., Active Pharm Ingred/Chems for Further Manuf) o 64R[]T99 (Hormone N.E.C., Active Pharm Ingred/Chems for Rx Compounding) o 64R[]R99 (Hormone N.E.C., NonSterile Powder) o 64R[]Z99 (Hormone N.E.C., Sterile Powder) Changes to the import alert are bracketed by asterisks (***). FDA has approved several Glucagon-Like Peptide-1 Receptor Agonist (GLP-1) drug products for treatment of patients with type 2 diabetes mellitus and chronic weight management for obese and certain overweight patients, along with other indications. FDA is aware that some patients and health care professionals may seek unapproved GLP-1 drug products, such as those containing the active ingredients semaglutide and tirzepatide. Shortages of approved GLP-1 drug products led to increased compounding of such products using active pharmaceutical ingredients (APIs) from foreign sources. During the shortages, APIs used to compound GLP-1 drug products were supplied by various API manufacturers located around the world, including China, India, and Europe. GLP-1 APIs are drugs as defined by section 201(g)(1)(D) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for use as a component of a drug product and, thus, are subject to current good manufacturing practice (CGMP) requirements pursuant to section 501(a)(2)(B) of the FD&C Act. Under section 501(a)(2)(B), a drug is deemed to be adulterated when the methods used in, or the facilities, or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformance with CGMP. Moreover, drugs are deemed to be adulterated under section 501(j) if they are manufactured by a firm that delays, denies, or limits an inspection of a facility in which a drug is manufactured, processed, packed, or held, or that fails to provide requested records in advance of or in lieu of an inspection pursuant to section 704(a)(4) of the FD&C Act. Similarly, records provided pursuant to a request under section 704(a)(4) may provide evidence of adulteration under section 501(a)(2)(B). The Agency has identified specific areas of concern for drugs compounded from GLP-1 APIs that appear to be adulterated. Although API manufacturers are subject to CGMP requirements pursuant to section 501(a)(2)(B) of the FD&C Act, compounders whose drugs meet the conditions of section 503A of the FD&C Act are exempt from CGMP requirements, including the requirement to ensure API used in manufacturing meets specifications for impurities or potency, among other things. Therefore, there is a heightened risk that any quality concerns associated with the bulk drug substance would not be adequately controlled for or monitored during the compounding of finished dosage forms. Given its concern that GLP-1 APIs used in compounding may be adulterated, FDA has conducted both onsite inspections and remote regulatory assessments of 48 GLP-1 API sites via requests for records or other information under section 704(a)(4) of the FD&C Act to evaluate registered GLP-1 API manufacturers in the U.S. supply chain. Of the 48 GLP-1 API sites FDA evaluated, it found that 21% were noncompliant under section 501 of the FD&C Act, either because their responses to FDA records requests provided evidence of noncompliance with CGMP requirements or because firms did not respond to an FDA records request under section 704(a)(4) in a timely manner. In addition, FDA has encountered a pattern of sites that register as GLP-1 API manufacturers, offer GLP-1 APIs for import, refuse to answer FDA�s requests for records, and then deregister, all within a short period of time. Based on the information available to FDA described above, foreign-sourced GLP-1 APIs should be considered for detention without physical examination (DWPE) based on the appearance of adulteration. Adulteration puts the safety of the American public at risk.
Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist Bulk Drug Substances (or Active Pharmaceutical Ingredients [APIs]).
For drugs that appear to be adulterated due to Current Good Manufacturing Practice (CGMP) violations: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practice within the meaning of Section 501(a)(2)(B). [Adulteration, Section 501(a)(2)(B)] OASIS charge code: DRUG GMPS
Divisions may detain without physical examination (DWPE) shipments of GLP-1 APIs offered for entry, except for the products and firms identified on the Green List of this Alert. The Green List, as of the date of initial issuance of this import alert, lists GLP-1 APIs of registered foreign manufacturers whose facilities and associated products, based on FDA�s evaluation of recent evidence, appear to be in compliance with CGMP requirements. Release of Articles Subject to Detention Without Physical Examination Under This Import Alert: To facilitate review of the submissions, FDA recommends that evidence be submitted in English (original documents should be translated and both the translation and original should be provided). Documents not submitted in English will delay FDA reviews. ***Removal from Detention without Physical Examination (ADDITION TO THE GREEN LIST):*** Requests for removal from DWPE (added to the Green List of this import alert) should include information to adequately demonstrate that the requestor has in place appropriate measures to overcome the appearance of the violation, so that the agency will have confidence that future entries will be in compliance. Examples of such information may include: Records from the manufacturer providing information about all GLP-1 API physical manufacturing sites, and Information from the manufacturer demonstrating that the GLP-1 APIs at issue have been manufactured and distributed in compliance with CGMP requirements in section 501(a)(2)(B), and that their drugs are not otherwise adulterated under section 501 of the FD&C Act. This could include: � An example of the certificate of analysis (COA) that would accompany each lot of the API or drug substance of any GLP-1 receptor agonist-related drug products distributed to the U.S. market. Provide a copy of the COA for the last ten GLP-1 API lots manufactured or for all lots if less than ten have been manufactured. � An example of labels used on the containers of the GLP-1 APIs that would be distributed. � A list of your customers (such as the shipper, consignee, and/or importer), including the name, address, FEI number, and contact information, if known. � A list of release specifications and testing methods for the finished GLP-1 API. Include your scientific justification for the specifications listed, including but not limited to, impurities, potency, and microbial attributes for APIs intended for use in injectable drug products. � A copy of your stability testing protocol (including test methods, acceptance criteria, and testing intervals) and summary report of the testing results for each GLP-1 API drug manufactured. � A copy of the specification and testing report for the starting materials used in GLP-1 API manufacturing. � The test method validation report for each release test, or if a USP compendial test, the test method verification report. If a USP test exists for an attribute and you use an alternate method, provide supporting data to show the alternate method utilized is equivalent or superior to the USP method. � Names and addresses of any contract laboratories used to conduct release testing of the GLP-1 APIs. � Process validation protocol and associated validation report for the GLP-1 API manufacturing process. � A copy of the Master Batch Record and a copy of the most recent manufacturing batch record for a GLP-1 API lot. � A list of equipment used in the manufacture of the GLP-1 API. Include equipment description, where used, shared, or dedicated and the qualification date. � A list of all out-of-specification (OOS) test results, including phase 1 laboratory OOS results, for GLP-1 drugs manufactured for both the U.S. and non-U.S. markets. Include information on lot disposition and OOS investigation reports. � A list of standard operating procedures (SOPs) related to the manufacture of the GLP-1 API. Include the SOP title, revision number, and effective date. � Your organization chart. Include names, titles, and associated responsibilities for the quality unit. � Summaries of complaints, adverse events, recalls, and product returns received in the past five years, and a copy of the associated investigation reports conducted by your firm. If a firm and/or a representative thereof would like to petition for removal of their GLP-1 API from DWPE under this import alert (i.e., Addition to the Green List), all relevant information supporting the request should be forwarded to the following: Food and Drug Administration Division of Import Operations (DIO) Email to: Importalerts2@fda.hhs.gov. FDA recommends firms interested in petitioning for removal from DWPE under this import alert provide relevant information prior to shipping drugs subject to this import alert into the U.S. This may help facilitate review and avoid delays at the time of import. Requests for removal from DWPE (Addition to the Green List) will be referred by DIO to CDER/OC/ODSIR/DGDDP/ICB for evaluation. For further guidance on removal from DWPE, refer to FDA�s Regulatory Procedures Manual (RPM), Chapter 9-8, �Detention Without Physical Examination (DWPE).� A firm may be removed from the Green List if FDA has information indicating that the products are no longer manufactured in compliance with the FD&C Act such that future shipments may appear violative. 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 involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@fda.hhs.gov Questions or issues involving compliance of imported drugs and drug products should be addressed to the CDER Imports Compliance Branch at CDERImports@fda.hhs.gov. List of firms and their drugs that have met the criteria for exclusion from recommendation for Detention Without Physical Examination (DWPE) under this Import Alert (a.k.a. Green List) , BELGIUM 61P[][]72 Semaglutide (Anti-Diabetic) 61P[][]75 Exenatide (Anti-Diabetic) , CANADA 61P[][]74 Tirzepatide (Anti-Diabetic) , CHINA 56F[][]99 Peptide N.E.C. (Antibiotics), and the importer description contains the word, Retatrutide 61P[][]77 Orforglipron (Anti-Diabetic) 61P[][]99 Anti-Diabetic N.E.C. (Anti-Diabetic) and the importer description contains the word, Retatrutide , CHINA 61P[][]76 Liraglutide (Anti-Diabetic) 61P[][]72 Semaglutide (Anti-Diabetic) 61P[][]74 Tirzepatide (Anti-Diabetic) , CHINA 56F[][]99 Peptide N.E.C. (Antibiotics) 61P[][]72 Semaglutide (Anti-Diabetic) 61P[][]99 Anti-Diabetic N.E.C. (Anti-Diabetic) , CHINA 56F[][]99 Peptide N.E.C. (Antibiotics), and the importer description contains the word, Retatrutide 61P[][]76 Liraglutide (Anti-Diabetic) 61P[][]72 Semaglutide (Anti-Diabetic) 61P[][]74 Tirzepatide (Anti-Diabetic) , CHINA 61P[][]74 Tirzepatide (Anti-Diabetic) , CHINA 56F[][]99 Peptide N.E.C. (Antibiotics), and the importer description contains the word, Retatrutide 61P[][]76 Liraglutide (Anti-Diabetic) 61P[][]72 Semaglutide (Anti-Diabetic) 61P[][]74 Tirzepatide (Anti-Diabetic) , CHINA 56F[][]99 Peptide N.E.C. (Antibiotics), and the importer description contains the word, Retatrutide 61P[][]76 Liraglutide (Anti-Diabetic) 61P[][]72 Semaglutide (Anti-Diabetic) 61P[][]74 Tirzepatide (Anti-Diabetic) , CHINA 61P[][]76 Liraglutide (Anti-Diabetic) 61P[][]72 Semaglutide (Anti-Diabetic) 61P[][]74 Tirzepatide (Anti-Diabetic) , CHINA 61P[][]76 Liraglutide (Anti-Diabetic) , CHINA 61P[][]76 Liraglutide (Anti-Diabetic) 61P[][]72 Semaglutide (Anti-Diabetic) 61P[][]74 Tirzepatide (Anti-Diabetic) , CHINA 61P[][]74 Tirzepatide (Anti-Diabetic) 61P[][]77 Orforglipron (Anti-Diabetic) , CHINA 61P[][]72 Semaglutide (Anti-Diabetic) 61P[][]74 Tirzepatide (Anti-Diabetic) , CHINA 61P[][]76 Liraglutide (Anti-Diabetic) 61P[][]72 Semaglutide (Anti-Diabetic) 61P[][]74 Tirzepatide (Anti-Diabetic) , DENMARK 61P[][]76 Liraglutide (Anti-Diabetic) 61P[][]72 Semaglutide (Anti-Diabetic) , INDIA 61P[][]76 Liraglutide (Anti-Diabetic) , INDIA 61P[][]75 Exenatide (Anti-Diabetic) , IRELAND 58H[][]06 Dulaglutide (Endocrine-Metabolic Agent) 61P[][]77 Orforglipron (Anti-Diabetic) , ITALY 61P[][]72 Semaglutide (Anti-Diabetic) , PORTUGAL 61P[][]72 Semaglutide (Anti-Diabetic) 61P[][]77 Orforglipron SDD (Anti-Diabetic) , TAIWAN 61P[][]72 Semaglutide (Anti-Diabetic)
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: Note: The major revision of this Import Alert (IA) is in response to CDER ICB's request supporting CDER Office of Compliance, Office of Manufacturing Quality (OMQ), Division of Drug Quality I�s memo of March 19, 2026 recommending revision of Import Alert (IA)#66-80. This revision updates the guidance section including examples of information a manufacturer should submit to FDA to be considered for addition to the Green List, the list of firm and drugs that have met the criteria for exclusion from recommendation for DWPE under this Import Alert (a.k.a. Green List) and addition of new FDA Product Codes. � Add Orforglipron API to three manufacturers on the Green List. � Add Orforglipron SDD, a drug product intermediate, to one manufacturer on the Green List. � Add the new FDA Product Code for Orforglipron, 61P[][]77 (Anti-Diabetic).2 � Add the FDA Product Code for Hormone N.E.C o 64R[]S99 (Hormone N.E.C., Active Pharm Ingred/Chems for Further Manuf) o 64R[]T99 (Hormone N.E.C., Active Pharm Ingred/Chems for Rx Compounding) o 64R[]R99 (Hormone N.E.C., NonSterile Powder) o 64R[]Z99 (Hormone N.E.C., Sterile Powder) Changes to the import alert are bracketed by asterisks (***). FDA has approved several Glucagon-Like Peptide-1 Receptor Agonist (GLP-1) drug products for treatment of patients with type 2 diabetes mellitus and chronic weight management for obese and certain overweight patients, along with other indications. FDA is aware that some patients and health care professionals may seek unapproved GLP-1 drug products, such as those containing the active ingredients semaglutide and tirzepatide. Shortages of approved GLP-1 drug products led to increased compounding of such products using active pharmaceutical ingredients (APIs) from foreign sources. During the shortages, APIs used to compound GLP-1 drug products were supplied by various API manufacturers located around the world, including China, India, and Europe. GLP-1 APIs are drugs as defined by section 201(g)(1)(D) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for use as a component of a drug product and, thus, are subject to current good manufacturing practice (CGMP) requirements pursuant to section 501(a)(2)(B) of the FD&C Act. Under section 501(a)(2)(B), a drug is deemed to be adulterated when the methods used in, or the facilities, or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformance with CGMP. Moreover, drugs are deemed to be adulterated under section 501(j) if they are manufactured by a firm that delays, denies, or limits an inspection of a facility in which a drug is manufactured, processed, packed, or held, or that fails to provide requested records in advance of or in lieu of an inspection pursuant to section 704(a)(4) of the FD&C Act. Similarly, records provided pursuant to a request under section 704(a)(4) may provide evidence of adulteration under section 501(a)(2)(B). The Agency has identified specific areas of concern for drugs compounded from GLP-1 APIs that appear to be adulterated. Although API manufacturers are subject to CGMP requirements pursuant to section 501(a)(2)(B) of the FD&C Act, compounders whose drugs meet the conditions of section 503A of the FD&C Act are exempt from CGMP requirements, including the requirement to ensure API used in manufacturing meets specifications for impurities or potency, among other things. Therefore, there is a heightened risk that any quality concerns associated with the bulk drug substance would not be adequately controlled for or monitored during the compounding of finished dosage forms. Given its concern that GLP-1 APIs used in compounding may be adulterated, FDA has conducted both onsite inspections and remote regulatory assessments of 48 GLP-1 API sites via requests for records or other information under section 704(a)(4) of the FD&C Act to evaluate registered GLP-1 API manufacturers in the U.S. supply chain. Of the 48 GLP-1 API sites FDA evaluated, it found that 21% were noncompliant under section 501 of the FD&C Act, either because their responses to FDA records requests provided evidence of noncompliance with CGMP requirements or because firms did not respond to an FDA records request under section 704(a)(4) in a timely manner. In addition, FDA has encountered a pattern of sites that register as GLP-1 API manufacturers, offer GLP-1 APIs for import, refuse to answer FDA�s requests for records, and then deregister, all within a short period of time. Based on the information available to FDA described above, foreign-sourced GLP-1 APIs should be considered for detention without physical examination (DWPE) based on the appearance of adulteration. Adulteration puts the safety of the American public at risk.
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