The U.S. Food and Drug Administration today announced it is proposing to exclude semaglutide, tirzepatide, and liraglutide on the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances.
The 503B bulks list identifies bulk drug substances that outsourcing facilities may use in compounding under the conditions of section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In most cases, outsourcing facilities cannot compound drugs using bulk drug substances unless the substance appears on the 503B bulks list, or the compounded drug is on the FDA’s drug shortage list at the time of compounding, distribution, and dispensing.
After evaluating the nominations for these three substances, the FDA did not identify a clinical need for outsourcing facilities to compound semaglutide, tirzepatide, and liraglutide from bulk drug substances.
“When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This action reflects our responsibility to protect patients and preserve the integrity of the drug approval process while continuing to provide a transparent, science-based pathway for public input.”
The FDA carefully reviewed the nominations it received and did not identify sufficient evidence to include semaglutide, tirzepatide and liraglutide on the 503B bulks list. A determination of clinical need is based on patient safety and medical necessity under the law.
The FDA is now inviting interested parties to submit comments electronically through the docket by June 29, 2026. The agency will consider submitted comments before making a final determination.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
An unofficial translation of this announcement is provided below.
翻译参考：
FDA拟将司美格鲁肽、替尔泊肽和利拉鲁肽从503B原料药清单中排除
2026年4月30日，美国食品药品管理局（FDA）宣布，拟将司美格鲁肽、替尔泊肽和利拉鲁肽从503B原料药清单中排除，认定503B复方配制机构使用原料药复方配制上述药物并无临床必要性。
503B原料药清单列明了503B复方配制机构可在《联邦食品、药品和化妆品法》（FD&C Act）第503B条规定的条件下用于复方配制的原料药物质。在大多数情况下，503B复方配制机构不得使用原料药进行复方配制，除非该原料药已列入503B原料药清单，或所配制的药物在配制、分发和调配时已列入FDA的药品短缺清单。
在对上述三种物质的提名进行评估后，FDA未发现503B复方配制机构使用原料药复方配制司美格鲁肽、替尔泊肽和利拉鲁肽存在临床必要性。
"当FDA批准的药物已上市时，503B复方配制机构不得在没有明确临床需求的情况下合法地使用原料药进行复方配制，"FDA局长马蒂·马卡里博士表示，"此举体现了我们保护患者安全、维护药品审批程序完整性的责任，同时继续为公众参与提供透明、以科学为基础的渠道。"
FDA对收到的提名进行了审慎审查，未发现足够证据支持将司美格鲁肽、替尔泊肽和利拉鲁肽列入503B原料药清单。临床需求的认定依据法律规定，以患者安全和医疗必要性为基础。
FDA现诚邀相关方于2026年6月29日前通过电子案卷系统提交意见。FDA将在作出最终决定前充分考虑所提交的意见。
Sincerely,
Sarah McMullen
Country Director
FDA China Office
Office of Global Operations
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