HHS moved to allow compounding pharmacies to dispense certain unapproved wellness peptides under enforcement discretion, while FDA continues rulemaking. The policy expands access for six peptide substances previously reviewed by an FDA advisory panel, with conditions including device restrictions and specified routes of administration. The move is likely to accelerate market availability for compounded peptide combinations among licensed providers, raising additional scrutiny for quality systems, sourcing controls, and patient-risk management. It also underscores that regulatory timelines are diverging: enforcement discretion now, potential rule placement later.
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