HHS interim policy covers 6 peptides for compounding

On October 28, 2026, the Department of Health and Human Services (HHS) released an enforcement discretion policy for six peptides used in compounding ^{[1, 2]}. HHS says it does not intend to take action against a state-licensed pharmacy, a federal facility or a licensed physician that compounds a drug with one of these peptides, as long as every condition in the policy is met ^[1]. The policy lasts until FDA decides, by final rule, whether each peptide goes on the 503A Bulks List ^[1].

The six peptides and the routes covered

Appendix A of the policy lists six peptides, and Appendix B limits the form and route for each ^[1]:

• BPC-157 acetate: injection under the skin or into muscle, oral and topical forms ^[1].
• Epitalon acetate: injection under the skin or into muscle, given in intermittent courses ^[1].
• KPV acetate: topical and oral forms ^[1].
• MOTS-c acetate: injection under the skin or into muscle ^[1].
• Semax free base: nasal use ^[1].
• TB-500 acetate: injection under the skin or into muscle ^[1].

The conditions

HHS lists ten conditions that must all be met ^[1]:

• The peptide matches the identity and route in Appendix B ^[1].
• The bulk ingredient comes from an FDA-registered manufacturer that follows current good manufacturing practice, with a certificate of analysis showing identity, purity, potency and tests for endotoxins, heavy metals, microbes and impurities ^[1].
• Each product has a single active ingredient ^[1].
• Compounders report the products they make, serious adverse events and quality problems to FDA's MedWatch program and to the states involved ^[1].
• The label says "This is a compounded drug product. Not for resale." ^[1]
• Oral forms need records showing adequate absorption in people, and the only device allowed is an FDA-cleared syringe ^[1].
• Every other legal requirement still applies, including a prescription for an individual patient ^[1].

What it does not do

The policy is not FDA approval, and it does not put any peptide on the 503A Bulks List ^{[1, 2]}. The Federal Register notice calls it a draft policy, says it is not binding on HHS or the public, and invites comments for two weeks after it is published on October 30, 2026 ^[2]. HHS says it may revisit the policy if a safety signal or product quality problem appears ^[1].

How it relates to the July advisory meeting

FDA's Pharmacy Compounding Advisory Committee reviewed these peptides in July 2026 (coverage) ^[3]. FDA staff had recommended against listing each of them, and HHS's policy states that the committee voted in favor ^{[1, 4]}. HHS gives three reasons for each peptide: newer quality testing data from FDA-registered sources, documented use, and conditions meant to manage the risks FDA staff raised ^[1]. Current status for each peptide is on the Status Tracker ^[1].

Peptides in this update

• BPC-157: FDA status, research and uses
• Epitalon: FDA status, research and uses
• KPV: FDA status, research and uses
• MOTS-c: FDA status, research and uses
• Semax: FDA status, research and uses
• TB-500 and Thymosin Beta-4: FDA status, research and uses

More news

• DEA telemedicine flexibilities run through 2026
• FDA advisers review seven peptides for compounding
• FDA proposes keeping GLP-1s off the 503B bulks list
• FDA warns 30 telehealth firms over compounded GLP-1 ads
• Most peptides leave FDA's Category 2 list
• WADA 2027 List names peptides as S0 examples

Status of every peptide

• FDA Peptide Status Tracker

Sources

1. HHS: Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, with Appendix A and B (Oct 28, 2026)
2. Federal Register: HHS notice of availability, FR Doc. 2026-22192, Docket HHS-OASH-2026-0496 (publishes Oct 30, 2026)
3. FDA: July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee
4. FDA: PCAC briefing document introduction, July 23-24, 2026

Updated October 28, 2026. Educational information, not medical advice.