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HHS allows compounding pharmacies to make six specific unapproved peptides temporarily

The Department of Health and Human Services announced a temporary policy change permitting licensed pharmacies to compound six specific peptide products.

STAT+: HHS moves to allow compounding of some unapproved peptides
File photo STAT+: HHS moves to allow compounding of some unapproved peptides Photo: STAT

Enforcement discretion for state facilities

HHS will use enforcement discretion to avoid taking action against state-licensed pharmacies, federal facilities, or licensed physicians. This approach applies specifically to the six peptides previously backed by an FDA advisory committee. The policy aims to increase access to these experimental wellness therapies while the agency reviews further options.

FDA advisory panel recommendations

An FDA advisory panel voted in July to recommend that pharmacies be cleared to manufacture these substances. The Department of Health and Human Services released this new policy as the Food and Drug Administration continues weighing its own stance. This move follows the committee's suggestion regarding the safety and utility of the six specific peptide products.

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