HHS announced an enforcement-discretion policy that will loosen restrictions on six unapproved peptide injectables, enabling compounding and sale through licensed U.S. facilities despite FDA guidance and earlier FDA advisory committee controversy, according to BioXconomy. The policy follows an advisory committee vote recommending to place six of seven peptides on the 503A Bulks List, while CDER’s recommendation reportedly opposed loosening restrictions across the full set. HHS framed the shift as aimed at improving access while discouraging supply from foreign “research-use-only” markets. The announcement reopens debate on safety characterization, contamination risk, and how enforcement discretion interacts with FDA and advisory committee critiques.