Gloved hand placing a compounded medication vial on a stainless tray, featured image for the HHS peptide compounding policy covering BPC-157 and TB-500, Cosmetiq Medicine Portland and Vancouver

HHS Opens a Path to Compound BPC-157, TB-500 and Four Other Peptides: What the Policy Allows and What It Doesn’t

Wellness & Regulation News

Portland, OR · October 29, 2026

By Cosmetiq Medicine · 7 min read

Six peptides sold online for healing, skin and longevity just got a temporary path into licensed pharmacies. On October 28, 2026, the U.S. Department of Health and Human Services filed a notice saying it will not take enforcement action against state-licensed pharmacies and other licensed compounders that make BPC-157, TB-500, epitalon, MOTS-c, semax and KPV, provided they meet a list of sourcing, testing and reporting conditions. None of the six is FDA approved. Here is what the policy actually allows, what it does not, and the questions worth asking before anyone injects a peptide.

The short version

  • HHS is using enforcement discretion, not approval: the six peptides remain unapproved while FDA works through formal rulemaking.
  • Each peptide is limited to specific routes. Semax is covered for intranasal use only, and KPV for topical and oral use only.
  • Compounders must use an active ingredient from an FDA-registered facility with a certificate of analysis, make single-ingredient products, label them as compounded and report serious adverse events.
  • HHS says it may revisit the policy if a safety signal or product quality issue arises.

What HHS announced

The notice was filed for public inspection at the Federal Register on October 28 at 11:15 a.m., with formal publication scheduled for October 30, 2026. The HHS policy document says the department does not intend to take enforcement action against a state-licensed pharmacy, federal facility or licensed prescriber compounding with the six listed peptides, as long as every condition in the policy is met, until each substance is resolved through a final rule.

NBC News reported that in practice this lets compounding pharmacies begin offering the six peptides now, even though they are not yet on FDA’s list of ingredients those pharmacies are allowed to use. RAPS Regulatory Focus also covered the policy.

6

Peptides covered by the interim policy

0

Of the six that are FDA approved

1

Active ingredient allowed per compounded product

Oct 30

Scheduled Federal Register publication, 2026

Source: HHS enforcement discretion policy; Federal Register document 2026-22192.

The six peptides and the routes HHS allows

This is the detail most coverage left out. The policy does not cover every form of each peptide. It sets a specific identity and route of administration for each one, and a product outside those limits is outside the policy.

Routes covered by the HHS interim policy

Peptide
Routes covered
Not covered
BPC-157
Subcutaneous, intramuscular, oral, topical
Other routes, such as intranasal
TB-500
Subcutaneous, intramuscular
Oral, topical, intranasal
Epitalon
Subcutaneous, intramuscular, in intermittent courses
Continuous dosing; other routes
MOTS-c
Subcutaneous, intramuscular
Oral, topical, intranasal
Semax
Intranasal only
Any injectable form
KPV
Topical, oral
Any injectable form

Source: HHS Appendix B, October 2026. Oral forms also require documentation that the formulation achieves adequate absorption in humans.

Why HHS made the move, and why critics object

HHS says the policy is meant to discourage the continued, widespread use of research-use-only peptides supplied by foreign manufacturers, which it describes as a safety risk to U.S. patients. An HHS spokesperson told NBC News the goal is to confront the risks of black-market peptides by moving demand toward tested, compounded products.

Critics see it differently. NBC reported that FDA’s own scientists had concluded there was insufficient data to show these peptides are safe and effective. Peter Lurie of the Center for Science in the Public Interest said FDA was effectively turning a blind eye, and the Partnership for Safe Medicines warned the move would expose Americans to untested substances. Both views are on the record in NBC News coverage.

Glass ampoules and vials on a stainless clinic tray, illustrating compounded peptide and wellness injection sourcing questions for Portland, OR and Vancouver, WA patients
The new policy turns on sourcing: where the active ingredient comes from and whether it was tested.

The angle most coverage missed

The policy is really a checklist, and patients can use it

Read past the headlines and the HHS document is a set of conditions any legitimate compounded peptide should meet. The active ingredient must come from an FDA-registered facility, with a certificate of analysis showing identity, purity, potency and testing for contaminants such as endotoxins, heavy metals and microbes. The original manufacturer, not just a repackager, must be registered with FDA.

The finished product must contain a single active ingredient, carry the statement “This is a compounded drug product. Not for resale.” and, if it comes with a delivery device, use only an FDA 510(k)-cleared syringe. Serious adverse events and quality problems must be reported to FDA and the relevant states.

That gives you five fair questions for anyone offering a peptide: Which pharmacy compounded it? Can I see the certificate of analysis? Is it a single ingredient? Is the route one HHS covers? Who reports a reaction if I have one? A vague answer to any of them is a reason to pause.

What this means in Portland and Vancouver

Expect to see more local advertising for peptide therapy in the months ahead. In Washington, the Department of Health is clear that anyone who administers medication to another person, including in a med spa, must have legal authority to do so. None of the six peptides in this policy is on Cosmetiq Medicine’s treatment menu.

For patients interested in wellness injections today, Cosmetiq Medicine offers IV and IM vitamin therapy in Portland and Vancouver, NAD+ therapy and the Tri-Immune Boost injection at both clinics, each started after a health review. Rates are listed on our Portland med spa price list.

Curious about wellness injections?

Book a wellness consultation in Portland or Vancouver. We will review your health history, explain what is in each formula and help you decide what fits your goals.

Frequently asked questions

Which peptides does the new HHS compounding policy cover?

The policy covers six peptides: BPC-157, TB-500, epitalon, MOTS-c, semax and KPV. None of them is FDA approved.

Does the HHS policy mean these peptides are FDA approved?

No. HHS is exercising enforcement discretion, meaning it does not intend to take enforcement action against licensed compounders who meet the policy’s conditions while FDA works through formal rulemaking. The peptides remain unapproved.

When was the HHS peptide policy announced?

HHS filed the notice for public inspection at the Federal Register on October 28, 2026, with formal publication scheduled for October 30, 2026.

Can BPC-157 be compounded as an injection under the policy?

Yes. HHS covers BPC-157 for subcutaneous, intramuscular, oral and topical dosage forms. Semax is covered for intranasal use only, and KPV for topical and oral use only.

Does Cosmetiq Medicine offer peptide injections?

None of the six peptides in the HHS policy is on Cosmetiq Medicine’s treatment menu. Cosmetiq Medicine offers IV and IM vitamin therapy, NAD+ therapy and the Tri-Immune Boost injection at both its Portland and Vancouver clinics.

This article is for general education and is not medical advice. Compounded drugs are not FDA approved. Treatment eligibility is determined at an in-person consultation. Results vary.

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