In October 2026, the U.S. Department of Health and Human Services (HHS) introduced an interim policy outlining limited enforcement discretion for 503A compounding of six peptides, including BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500, subject to specific sourcing, testing, and safety requirements.
HHS Introduces Interim Policy for Six Compounded Peptides
On October 28, 2026, the U.S. Department of Health and Human Services (HHS) announced an interim enforcement discretion policy covering six peptide bulk drug substances. The policy, formally published in the Federal Register on October 30, states that HHS does not intend to take enforcement action against qualifying Section 503A compounders who meet 10 specific conditions while the Food and Drug Administration (FDA) continues its formal review. Existing state and federal licensing, prescribing, and treatment requirements for Med Spa and wellness operators remain in effect.
Regulatory Background and Details of the Interim 503A Compounding Policy
In April 2026, the FDA removed 12 peptides from its Category 2 bulk substances list after nominations were withdrawn. In July, the agency published evaluations recommending against adding seven peptide substances to the 503A Bulks List. During its July 23–24, 2026 meeting, the Pharmacy Compounding Advisory Committee (PCAC) voted in favor of including six of these substances. The new HHS interim policy outlines conditions for limited enforcement discretion involving their compounding while the FDA continues its formal 503A Bulks List rulemaking process.
HHS identified the following peptide forms and administration routes in Appendix B of the policy:
- BPC-157: Subcutaneous, intramuscular, oral, and topical formulations
- Epitalon: Subcutaneous and intramuscular injections administered in intermittent courses
- KPV: Topical and oral formulations
- MOTS-c: Subcutaneous and intramuscular injections
- Semax (free base): Intranasal formulations
- TB-500: Subcutaneous and intramuscular injections
The policy text explains that HHS Secretary Robert F. Kennedy Jr. determined that permitting limited compounding under specified safeguards would discourage the use of certain research-use-only peptides supplied by foreign manufacturers that pose safety risks to U.S. patients.
Under the interim framework, qualifying 503A compounders must meet 10 conditions addressing product quality and patient safety. The policy does not grant FDA approval or add the six peptides to the permanent 503A Bulks List. HHS may revise it if new safety or product quality concerns arise.
Source: Federal Register Notice
According to the October 30, 2026 Federal Register notice, HHS issued the interim enforcement discretion policy while the FDA continues developing the 503A Bulks List through formal rulemaking.
DISCOVER YOUR MED SPA’S GROWTH POTENTIAL
How much time and revenue could you unlock by outsourcing your GFEs?
Use our GFE Calculator to find out in under 5 minutes. It’s quick, easy, and tailored to your Med Spa.
Compliance Requirements Under the Interim Peptide Policy
The HHS policy establishes 10 conditions for qualifying 503A compounders to fall within its interim enforcement discretion. These conditions address peptide eligibility, pharmaceutical sourcing, product preparation, and reporting obligations.
Peptide Eligibility and Administration
- Eligible substances: Compounding must involve one of the six peptides identified in Appendix A.
- Identity and administration: Each substance must match the specific identity and administration routes outlined in Appendix B.
Ingredient Sourcing and Quality Control
- Ingredient testing: Bulk substances must originate from FDA-registered facilities and have valid certificates of analysis (COAs) documenting identity, purity, potency, and relevant contaminant testing.
- Manufacturer verification: Original manufacturers must be FDA-registered and comply with applicable manufacturing requirements. Repackers, relabelers, and resellers must document appropriate supplier and COA verification.
The U.S. Department of Health and Human Services (HHS) has established an interim enforcement discretion policy for 503A compounding of six peptides while the Food and Drug Administration (FDA) continues its formal rulemaking process.
Product Formulation and Labeling
- Product labeling: Labels must include the statement “This is a compounded drug product. Not for resale.”
- Single-ingredient formulations: Compounded products must contain only one active pharmaceutical ingredient listed in Appendix A.
- Oral formulations: Compounders must maintain documentation demonstrating adequate oral bioavailability in humans.
- Drug delivery devices: Only FDA 510(k)-cleared syringes may be co-packaged with or contain the compounded medication.
Reporting and Federal Compliance
- Reporting obligations: Compounders must report specified product information, serious adverse events, and product quality issues to the FDA and applicable state authorities.
- Additional federal requirements: Compounding must comply with other applicable federal requirements, including patient-specific prescriptions and restrictions against compounding under insanitary conditions.
The 10 conditions apply to qualifying state-licensed pharmacies, federal facilities, and licensed physicians compounding under Section 503A. The interim policy does not independently authorize Med Spa, aesthetic, or wellness providers to prescribe or administer these substances outside applicable state and federal requirements.
Practical Implications for Med Spa and Wellness Operators
- Review the scope and limitations of the interim HHS policy for qualifying 503A compounders.
- Evaluate relationships with pharmacies and medication suppliers, including applicable licensing and regulatory compliance requirements.
- Assess state-specific prescribing, administration, scope-of-practice, and sourcing requirements applicable to services offered.
- Follow state regulatory guidance and enforcement announcements concerning peptides.
- Monitor the FDA rulemaking process concerning the six peptides and the 503A Bulks List.
What to Watch Next
HHS is accepting public comments on the interim policy through November 13, 2026, and may reconsider its application if new safety concerns or product quality issues arise. Further developments from federal and state agencies may provide additional details on peptide compounding requirements and regulatory status.
About Spakinect
Spakinect provides compliance infrastructure and telehealth-supported supervision solutions for medical aesthetic practices. For additional information, see our website.
Image Attribution: “United States Department of Health and Human Services – Humphrey Building” by ajay_suresh, via Wikimedia Commons, licensed under CC BY 2.0.
