10/29/2026
Regulatory Update | HHS Announces New Peptide Compounding Policy
On October 28, 2026, the U.S. Department of Health and Human Services (HHS) announced an interim enforcement discretion policy allowing qualifying 503A compounding pharmacies to prepare certain peptides under specific regulatory conditions.
What does this mean?
Under the new policy, HHS generally does not intend to take enforcement action against qualifying 503A compounders for preparing six specified peptides:
BPC-157 | KPV | TB-500 | MOTS-c | Epitalon | Semax
The policy establishes specific requirements, including:
• Valid patient-specific prescriptions
• Sourcing from qualifying FDA-registered manufacturers
• Ingredient identity, purity, potency, and contaminant testing
• Compliance with applicable compounding and safety requirements
• Single-active-ingredient formulations
Importantly, this is not FDA approval. The policy provides temporary enforcement discretion while the FDA continues its rulemaking process regarding these substances.
Healthcare providers are encouraged to review the official HHS notice for complete details and applicable conditions.
Read the Official Decision Notice:
https://public-inspection.federalregister.gov/2026-22192.pdf
For healthcare professional education only. Compounded drugs are not FDA-approved. Applicable federal and state requirements remain in effect.