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.
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Here are a few details:
• 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.
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(Reporting by Siddhi Mahatole in Bengaluru; Editing by Shilpi Majumdar)
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