HHS 以执法裁量临时允许配制部分未获批肽类产品
STAT+: HHS moves to allow compounding of some unapproved peptides
美国卫生与公众服务部（HHS）发布政策，临时允许配制药房生产部分肽类产品，以扩大这类实验性健康疗法的可及性。政策称 HHS 将行使“执法裁量”，不对州许可药房、联邦机构和持照医生配制 FDA 顾问委员会此前支持的六种肽类产品采取行动。此事发生在 FDA 仍在权衡是否允许配制药房生产肽类产品之际，今年 7 月 FDA 顾问小组已投票建议放行其中六种物质。
WASHINGTON — The Department of Health and Human Services released a policy that will temporarily allow compounding pharmacies to manufacture some peptide products, increasing access to the experimental wellness therapies embraced by many in the MAHA movement.
The policy states that HHS will use “enforcement discretion” to not take action against state-licensed pharmacies, federal facilities, or licensed physicians compounding the six peptides previously backed by a Food and Drug Administration advisory committee.
The proposal comes as the FDA continues to weigh whether to allow compounding pharmacies to manufacture peptides. In July, an FDA advisory panel voted to recommend that these pharmacies be cleared to manufacture six of these substances.
STAT+ Exclusive Story
Already have an account? Log in
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.
Already have an account? Log in
To read the rest of this story subscribe to STAT+.
来源：STAT News · statnews.com