FDA, HHS, and Six Compounded Peptides: What Changed in October 2026, and What Did Not

In late October 2026, the U.S. Department of Health and Human Services (HHS) announced that it does not intend to take enforcement action against certain licensed compounders using six peptides, as long as specific conditions are met. The notice was filed on October 28 and published in the Federal Register on October 30. This is not FDA approval. The peptides were not added to the federal list of substances allowed in this type of compounding, and HHS says it may revisit the policy.

You may have seen this described as the FDA restoring access to peptides. Here is what the policy does, and what it means if you are considering peptide therapy.

What HHS actually did

The notice, titled "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances," came from the HHS Office of the Secretary and was signed by Secretary Robert F. Kennedy Jr. It applies to state-licensed pharmacies, federal facilities, and licensed physicians. HHS describes it as an interim measure while the list of allowed substances is developed through rulemaking.

According to Holland & Knight, AJMC, and Scientific American, the six peptides are:

• BPC-157
• Epitalon
• KPV
• MOTS-c
• Semax
• TB-500

Three terms worth knowing

• FDA approved: FDA has reviewed a drug's safety, effectiveness, and quality before it is marketed. None of that happens here. The notice itself says compounded drugs are not FDA approved and that FDA does not review them that way before marketing.
• 503A bulks list: a list that sets out which bulk ingredients may be used in this type of compounding. The notice says future FDA rulemaking may propose adding some or all of these peptides. It has not happened yet.
• Enforcement discretion: an agency's statement that it does not plan to act in a defined situation. The notice says the policy creates no rights and is not binding, so it is much less durable than an approval or a final rule.

How we got here

• 2023: the peptides were placed in FDA's Category 2, a group of nominated substances that FDA said may present significant safety risks in compounding.
• April 22, 2026: they were removed from Category 2 after the nominations were withdrawn. Legal analysts stressed that removal did not by itself make them eligible for compounding.
• July 23 and 24, 2026: FDA's Pharmacy Compounding Advisory Committee met on seven peptides. Law firm summaries report that it voted to recommend six and narrowly declined the seventh, emideltide. Those votes are advice, not a final decision.
• October 28, 2026: the HHS notice was filed. Law firm summaries put the public comment deadline at November 13, 2026.

The conditions attached

Holland & Knight reports that all ten conditions must be met. For patients, these are the most relevant:

• a prescription for an individual patient
• only peptides and routes named in the policy's appendices
• ingredients from an FDA-registered facility, with a valid certificate of analysis
• one covered peptide per product, not a blend
• serious adverse events and quality problems reported through FDA's MedWatch program
• a label stating that it is a compounded drug and not for resale

The same summary says the policy does not cover research-use-only material or peptides outside its list, and that state rules still apply. A different peptide is not covered simply because it appears next to these six in an online article or a social media post.

Safety and your care at Harmony

HHS said the policy is meant to move patients away from unregulated gray-market products and toward patient-specific prescriptions from licensed pharmacies, with traceable ingredients and safety reporting. Because these are compounded medications rather than FDA-approved drugs, the research behind them is still developing. That is why peptide therapy at Harmony Med Spa always begins with a provider consultation.

A change in policy does not mean a peptide is right for everyone. Our providers review your health history and goals, explain the expected benefits and possible side effects, and monitor you throughout treatment, so you can make an informed decision.

Where the EVEXIAS news fits

You may have seen this news through a press release from EVEXIAS Health Solutions and its pharmacy network, FarmaKeio, dated October 28, 2026. Harmony Med Spa works with EVEXIAS, and their announcement welcomes the decision as restoring access to these peptides through licensed compounding pharmacies.

Questions to ask a provider

• What is the exact name of the peptide, and is it FDA approved for what I want it to do?
• Is it covered by this policy, or by something else?
• Which pharmacy would prepare it, and how is that pharmacy licensed?
• What human evidence exists, and how strong is it?
• What are the known risks, and what is unknown?
• How does it interact with my medications and health conditions?
• What will we monitor, and what would make us stop?

When to get medical care

Do not buy peptides sold as research use only or not for human use, and do not start, combine, or adjust any peptide on your own. If you are using a peptide and develop hives, facial swelling, trouble breathing, chest pain, fainting, or a severe headache, seek emergency care. Contact a clinician promptly about spreading redness, pus, or fever, or about any new symptom that concerns you.

Peptide conversations at Harmony Med Spa

Harmony Med Spa offers virtual peptide therapy consultations, where a provider reviews your health history and goals and may decide a peptide is not the right choice. This article is general education. It is not a statement that Harmony offers any of the six peptides listed above, and availability can change as rules change. If this news raised questions for you, contact us to schedule a consultation.

Sources and further reading

Federal Register, 91 FR 68526 (Oct. 30, 2026), HHS notice via govinfo: https://www.govinfo.gov/content/pkg/FR-2026-10-30/html/2026-22192.htm

FDA: Certain bulk drug substances for use in compounding that may present significant safety risks: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

FDA: July 23-24, 2026 Pharmacy Compounding Advisory Committee meeting: https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026

Holland & Knight: HHS issues interim enforcement discretion policy: https://www.hklaw.com/en/insights/publications/2026/11/hhs-issues-interim-enforcement-discretion-policy-for-compounding

AJMC: 5 things to know about HHS's interim peptide compounding policy: https://www.ajmc.com/view/5-things-to-know-about-hhs-s-interim-peptide-compounding-policy

Scientific American: coverage of the HHS peptide policy: https://www.scientificamerican.com/article/rfk-jr-loosens-restrictions-for-six-popular-peptides-bypassing-the-fda/

EVEXIAS and FarmaKeio press release, Oct. 28, 2026 (company statement): https://natlawreview.com/press-releases/us-food-and-drug-administration-restores-access-six-peptides

FDA Law Blog: FDA's Pep(tide) Rally: https://www.thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-1-of-2/