HHS announced an “enforcement discretion” approach that loosens restrictions around six unapproved “gray market” peptide injectables, allowing compounding pharmacies to prescribe and sell them from licensed US facilities despite earlier FDA guidance. The policy follows an FDA advisory committee vote recommending certain peptides for the 503A Bulks List while FDA experts had advised against loosening restrictions for some. The HHS announcement said the policy is intended to expand access while discouraging widespread use of research-use-only peptides from foreign manufacturers considered higher safety risk. The list includes BPC-157 and TB-500. Biotech and medical stakeholders will watch how enforcement discretion interacts with FDA review processes—particularly around chemical characterization, safety data, and contamination risk during formulation.