HHS Draft Policy Shields Six Peptides in Compounding Pending FDA Rule
HHS says it does not intend to enforce against pharmacies, federal facilities and physicians compounding six named peptides when ten conditions are met, while FDA rulemaking on compounding stays pending.
HHS announced on October 28, 2026 a draft policy under which it does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians that compound a drug using six peptide bulk drug substances — BPC-157, epitalon, KPV, MOTS-c, semax and TB-500 — provided 10 conditions are met, while FDA rulemaking on compounding remains pending.
The step matters because it places an enforcement-discretion backstop between a still-unfinished FDA rulemaking record and businesses compounding peptides, a category frequently sold direct-to-consumer through telehealth and wellness channels. Because the discretion is expressly tied to pending rulemaking, the agency's position could shift once that rule is finalized; the available advisory does not describe the 10 conditions themselves, so the actual scope of protection cannot be assessed from this source alone and should be read in the draft text.
Practical actions for clients: check the draft and any comment deadline once published, test whether existing compounding arrangements can satisfy the 10 conditions, and assess whether product lines and distribution channels sit inside or outside the six named substances. Counsel should also track the pending FDA rulemaking closely, since the protection is temporary by design.