HHS Outlines Conditional Enforcement Discretion for 6 Compounded Peptides

The US Department of Health and Human Services (HHS) has outlined an interim enforcement policy for compounding 6 peptide bulk drug substances—BPC-157, epitalon, KPV, MOTS-c, Semax, and TB-500—while their inclusion on the section 503A bulks list is considered through rulemaking. For dermatology clinicians considering these products, the policy establishes conditions for enforcement discretion; it does not constitute US Food and Drug Administration (FDA) approval or establish safety or effectiveness.

Under specified conditions, HHS does not intend to take enforcement action against state-licensed pharmacies, federal facilities, or licensed physicians compounding drug products using these substances. The discretion applies until a final rule addresses whether a substance is included on the 503A bulks list.

HHS states that the approach is intended to improve patient access and discourage use of certain research-use-only peptides supplied by foreign manufacturers that pose safety risks. The agency cites interest in peptide compounding and the potential for public comments to provide additional evidence for rulemaking.

Understanding the 503A Bulks List

The 503A bulks list identifies bulk drug substances that may be used in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act when the substances lack an applicable US Pharmacopeia (USP) or National Formulary (NF) monograph and are not components of FDA-approved drugs. The list is established through rulemaking, with required consultation with the Pharmacy Compounding Advisory Committee and USP.

Section 503A provides exemptions from FDA premarket approval, labeling with adequate directions for use, and current good manufacturing practice requirements for compounded drug products that meet its conditions. Bulk substances must meet applicable USP or NF standards when a monograph exists; otherwise, they must be components of FDA-approved drugs or appear on the 503A bulks list. Additional conditions include manufacturer registration, valid certificates of analysis, and patient-specific prescriptions.

The interim policy addresses the 6 listed peptides while rulemaking proceeds. It does not itself add them to the 503A bulks list.

Manufacturing and Product Requirements

To fall within the policy, a compounded product must contain only 1 active pharmaceutical ingredient. Compounding must follow all other applicable requirements, including a valid patient-specific prescription and protection against insanitary conditions.

The original bulk substance manufacturer must be FDA registered and comply with current good manufacturing practice and other applicable requirements. A valid certificate of analysis must identify the manufacturing facility’s physical location and include testing for identity, purity, potency, and contaminants. Registered intermediaries supplying the substance must document appropriate manufacturer and certificate validation.

Peptides must also meet identity specifications and route restrictions. For oral formulations, compounders are expected to maintain documentation demonstrating adequate oral bioavailability in humans for the specific formulation provided. Any delivery device containing or co-packaged with the drug must be an FDA 510(k)-cleared syringe.

Reporting and Clinical Implications

The policy calls for compounders to report information on compounded products, serious adverse events, and product quality issues to the FDA and the states where products are compounded and, if different, sent. Product reporting includes the active ingredient and strength per unit, the original ingredient manufacturer and manufacturing facility’s unique identifier, and the dosage form and route of administration.

Compounders must report serious adverse events associated with human use to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program, regardless of whether the events are considered drug related. Reportable quality issues include bacteriological contamination, significant chemical or physical changes in distributed products, and failure to meet applicable specifications. These reports provide an opportunity for the FDA and states to respond to emerging risks.

Patient labeling must detail procedures for reporting adverse events and concerns about product identity, strength, purity, or quality. It must also state: “This is a compounded drug product. Not for resale.”

For dermatology practice, access remains conditional on sourcing, formulation, documentation, reporting, and patient-specific prescribing requirements. Compounded drugs undergo no FDA premarket review for safety, effectiveness, or quality. HHS may revisit the policy if safety signals or product quality concerns emerge.

Reference

HHS enforcement discretion policy regarding 503A compounding using certain peptide bulk drug substances. US Department of Health and Human Services. October 29, 2026. Accessed October 29, 2026. https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf