HHS announced a limited interim policy granting enforcement discretion for compounding with specific peptide bulk drug substances while FDA rulemaking continues. The policy is framed as conditional and not a final placement on FDA’s 503A bulk substance list. The coverage includes six peptides listed on an interim access list (including BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500), with restrictions described for peptide identity and limited routes of administration. HHS also specified constraints on drug delivery devices, citing patient safety risk from more complex systems. For compounding pharmacies and clinical prescribers, the main operational shift is what actions are deprioritized by regulators if all stated requirements are met—while the longer-term regulatory pathway remains under development.