2026年5月26日 22:24 UTC / 路透社
5月26日（路透社）——阿拉巴马州医疗监管机构周二警告医疗从业者，切勿开具或使用所谓的“研究级肽类物质”，称此类物质未获得美国食品药品监督管理局（FDA）批准，可能存在安全风险。
以下是详细信息：
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- 阿拉巴马州医疗委员会表示，此类肽类物质未经过美国食品药品监督管理局的测试或审查，也不受安全性、有效性或生产标准的监管，因此难以验证其成分或评估潜在风险。
- 肽类物质是由氨基酸组成的短链结构，是蛋白质的组成部分，在人体中发挥着重要的生理功能。
- 该委员会在一份官方公告中表示，医生只能开具和调配从合法渠道获取、符合处方级标准的药物，在任何情况下都不得使用或供应未获FDA批准的肽类物质。
- 这项限制同样适用于认证助产士、执业护士和医师助理，他们只能开具经批准处方集内的药物。
- 该委员会称，医疗从业者不能通过将产品标注为“研究级”或依赖患者同意书来规避责任，并补充道，任何推荐、开具或使用此类物质的行为都将违反职业和法律义务。
- 此外，美国FDA将于7月召开咨询小组会议，讨论是否允许获得许可的配药药房生产特定肽类物质。
路透社班加罗尔 Siddhi Mahatole 报道；Shilpi Majumdar 编辑
Alabama warns healthcare providers against use of non-FDA-approved peptides
May 26, 2026 10:24 PM UTC / Reuters
May 26 (Reuters) – Alabama’s medical regulator on Tuesday warned healthcare providers against prescribing or using so-called research-grade peptides, saying the substances are not approved by the U.S. FDA and may pose safety risks.
Here are a few details:
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- The Alabama Board of Medical Examiners said the peptides have not been tested or reviewed by the U.S. Food and Drug Administration and are not subject to oversight on safety, effectiveness or manufacturing standards, making it difficult to verify their contents or assess potential risks.
- Peptides are short chains of amino acids that act as building blocks of proteins and perform essential biological functions in the body.
- In an official notice, the board said physicians must only prescribe and dispense drugs obtained from licensed sources and meeting prescription-grade standards, and cannot use or supply non-FDA-approved peptides under any circumstances.
- The restriction also applies to certified nurse midwives, nurse practitioners and physician assistants, who are limited to prescribing drugs on approved formularies.
- Healthcare providers cannot avoid liability by labeling products as “research-grade” or relying on patient consent forms, the board said, adding that any involvement in recommending, prescribing or administering such substances would violate professional and legal obligations.
- Separately, the FDA is set to convene an advisory panel in July to consider whether licensed compounding pharmacies should be allowed to manufacture certain peptides.
Reporting by Siddhi Mahatole in Bengaluru; Editing by Shilpi Majumdar
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