HHS moves to allow compounding of some unapproved peptides
A draft enforcement-discretion policy covers 6 peptides while FDA rulemaking continues.
TL;DR
- HHS outlined an interim enforcement-discretion policy for qualifying compounding of 6 peptides.
- The policy is not FDA approval and does not establish clinical safety or effectiveness.
- A Federal Register notice is scheduled for publication on 2026-10-30.
The U.S. health department, HHS announced a draft policy describing when it does not intend to take enforcement action over compounding certain peptides. The interim approach applies while the FDA develops its list of bulk substances for compounding under section 503A. [1] [2]
STAT reported that the policy covers 6 peptides backed by an FDA advisory committee. ABC News identified the substances as BPC-157, TB-500, epitalon, MOTS-c, KPV and semax. [1] [3]
HHS said compounded drugs are not FDA-approved and are not reviewed by the FDA for safety, effectiveness or quality before marketing. An HHS statement reported by ABC News said the policy requires patient-specific prescriptions, traceable ingredients, quality testing and safety reporting. [2] [3]
The public-inspection notice calls the policy a nonbinding draft and says HHS may revisit it if safety or quality issues arise. It is scheduled for Federal Register publication on 2026-10-30, with comments accepted until 2 weeks after publication. [2]
Why it matters
The interim approach changes the federal enforcement position for part of the compounding industry while the formal list remains under development; it does not resolve the evidence questions behind FDA review.
Editor's note
The regulatory notice was filed for public inspection on 2026-10-28; formal publication was scheduled for 2026-10-30. The FDA has not approved the compounded products, and the policy itself is nonbinding.