Last updated October 29, 2026. This is a fast-moving story and we'll keep this page current.

The short version

On October 28, 2026, HHS announced it does not intend to take enforcement action against state-licensed compounding pharmacies that compound six peptides:

BPC-157, TB-500, KPV, MOTS-c, Semax and Epitalon.

This applies while FDA goes through formal rulemaking to decide whether to add them to its official 503A compounding list.

This is not FDA approval. None of these six are FDA-approved drugs.

Timeline

  • 2023: FDA placed BPC-157 and other peptides in a category of substances that raised safety concerns for compounding.
  • April 2026: FDA moved 12 peptides out of that category and scheduled them for advisory committee review.
  • July 23–24, 2026: FDA's Pharmacy Compounding Advisory Committee voted in favor of all six. The votes were close, and FDA's own staff had recommended against them, citing limited human data.
  • October 28, 2026: HHS released its interim enforcement policy.
  • October 30, 2026: The notice is scheduled to be published in the Federal Register, followed by a two-week public comment period (Docket HHS-OASH-2026-0496).
  • Next 12 to 24 months: FDA rulemaking on whether to add some or all of these peptides to the 503A list.

Why HHS says it's allowing them

  • Patient interest and access. HHS cited significant interest in these peptides given the lack of approved products.
  • Moving people away from the gray market. Many people buy "research use only" peptides online, often from overseas sellers. Compounding through a licensed pharmacy with a prescription is a safer path.
  • Advisory committee recommendation. The July 2026 committee votes favored all six.
  • New evidence and safeguards. HHS pointed to usage data and better ingredient testing, and added testing and side-effect reporting requirements.

The conditions

  • One peptide per product. Blends, such as the Wolverine Blend, are not covered by this policy.
  • Specific forms and routes only:
    • BPC-157: subcutaneous, intramuscular, oral, topical
    • TB-500: subcutaneous, intramuscular
    • KPV: topical, oral
    • MOTS-c: subcutaneous, intramuscular
    • Semax: intranasal
    • Epitalon: subcutaneous, intramuscular, intermittent courses
  • Patient-specific prescriptions from a licensed prescriber.
  • Quality requirements, including ingredients from FDA-registered manufacturers with lot-specific testing.
  • Side-effect reporting to FDA's MedWatch program.

What could change

This is an interim, non-binding policy. HHS says it may revisit it, in whole or in part, if a safety or quality issue comes up.

The final outcome depends on FDA's rulemaking, and future policy changes are possible.

We'll update this page as things develop.

What about sermorelin and tesamorelin?

Neither is part of the October 28 policy.

  • Sermorelin was once FDA-approved as Geref. Its approval was withdrawn in 2009 at the manufacturer's request, and FDA later determined that was not for safety or effectiveness reasons. Compounded sermorelin is not FDA-approved.
  • Tesamorelin is the active ingredient in Egrifta, a brand-name drug approved for one specific use. Compounded tesamorelin is not Egrifta, is not a generic, and is not FDA-approved.

Sources

  • HHS, Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (Federal Register doc 2026-22192): View source
  • FDA, Compounding and the FDA: Questions and Answers: View source
  • FDA, Determination regarding Geref (sermorelin acetate), 2013: View source

Explore each peptide

Talk with our provider

Optimize Hormone offers these prescription peptides from an FDA-inspected 503(a) pharmacy in the US, with full testing reports, delivered directly to your home.

Our provider reviews your health history and goals and determines whether any peptide is appropriate for you.

Book your free consultation

Start your intake

Educational information only, not medical advice. Compounded medications are not FDA-approved, which means FDA does not review their safety, effectiveness or quality before they are dispensed. Our provider determines whether any medication is appropriate for you. Regulatory information is current as of October 29, 2026 and may change. Prescriptions are filled by a state-licensed 503(a) compounding pharmacy in the US.