# HHS interim policy covers 6 peptides for compounding

> On Oct 28, 2026 HHS said it will not act against 503A compounding of BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500 under conditions. Not FDA approval.

- Canonical URL: https://livingpluspeptides.com/news/hhs-interim-peptide-compounding-policy/
- Last updated: October 28, 2026
- Publisher: Living+

Published October 28, 2026.

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](/peptides/bpc-157/) acetate: injection under the skin or into muscle, oral and topical forms [1].
- [Epitalon](/peptides/epitalon/) acetate: injection under the skin or into muscle, given in intermittent courses [1].
- [KPV](/peptides/kpv/) acetate: topical and oral forms [1].
- [MOTS-c](/peptides/mots-c/) acetate: injection under the skin or into muscle [1].
- [Semax](/peptides/semax/) free base: nasal use [1].
- [TB-500](/peptides/tb-500-thymosin-beta-4/) 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](/news/pcac-july-2026-peptides/)) [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](/regulation/tracker/) [1].

## Sources

1. [HHS: Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, with Appendix A and B (Oct 28, 2026)](https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf)
2. [Federal Register: HHS notice of availability, FR Doc. 2026-22192, Docket HHS-OASH-2026-0496 (publishes Oct 30, 2026)](https://public-inspection.federalregister.gov/2026-22192.pdf)
3. [FDA: July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee](https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026)
4. [FDA: PCAC briefing document introduction, July 23-24, 2026](https://www.fda.gov/media/193342/download)

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