On October 28, 2026, the U.S. Department of Health and Human Services issued an interim enforcement-discretion policy. It lets 503A compounding pharmacies and licensed physicians compound six peptides, including BPC-157.
For wellness professionals in Florida, this is the biggest shift in peptide therapy regulations in years. It is also the moment when sloppy compliance becomes expensive. As a peptide compliance attorney in Florida, B&M Law Group explains what changed, what did not, and what your practice should do this week.
The short version
- Six peptides now have federal enforcement relief, and only on listed routes.
- Every condition must be met, or the relief does not apply.
- It is not FDA approval, and HHS can withdraw it at any time.
- Florida boards are not bound by it. State rules apply exactly as they did last week.
What the HHS peptide policy actually says
The policy covers six peptides only, each limited to specific routes:
| Peptide | Permitted route |
|---|---|
| BPC-157 | Injectable, oral or topical |
| TB-500 | Injectable only |
| KPV | Topical or oral only |
| MOTS-c | Injectable only |
| Semax | Intranasal only |
| Epitalon | Injectable only |
HHS says it does not intend to take enforcement action against state-licensed 503A pharmacies, federal facilities, or licensed physicians that compound these peptides. That holds only when every condition is met:
- A single active ingredient per product.
- Active ingredient from an FDA-registered original manufacturer, with a full certificate of analysis.
- A patient-specific prescription.
- A “Not for resale” label.
- Adverse-event reporting to FDA and the states.
The policy publishes in the Federal Register on October 30, 2026, with a two-week comment period. It is not FDA approval, it creates no legal rights, and HHS can withdraw it at any time.
What did not change
- 503B outsourcing facilities are not covered.
- Peptide blends, such as BPC-157 with TB-500, are not covered.
- DSIP, CJC-1295, ipamorelin, GHK-Cu, AOD-9604 and every other Category 2 peptide remain unauthorized.
- Approved peptides such as semaglutide, tirzepatide and tesamorelin are still prescribable off-label under ordinary rules.
Most important for Florida practices: the Florida Board of Pharmacy and Board of Medicine are not bound by this federal policy. State rules on supervision, delegation, telehealth prescribing and corporate ownership apply exactly as they did last week.
Five things your practice must do this week
- Audit your peptide menu. Compare it with the six covered peptides and their permitted routes. Pull anything else.
- Get your pharmacy’s confirmation in writing. Your 503A pharmacy should confirm it meets the HHS sourcing, testing, labeling and reporting conditions. Keep a copy.
- Individualize every prescription. Each one should follow a good-faith exam by your supervising physician or authorized prescriber. Templated or menu-style ordering is the first thing FDA and state boards look for.
- Rewrite your marketing. Remove “FDA-approved,” “cleared,” “legal now,” and any blend or route the policy does not cover from your website, social media and influencer content.
- Document each patient file. Include the exam note and clinical rationale, a signed consent stating the product is compounded and not FDA-approved, lot number, strength, route, pharmacy name, certificate of analysis, and an adverse-event log.
Frequently asked questions
Is BPC-157 legal in Florida in 2026?
HHS says it does not intend to take federal enforcement action against state-licensed 503A pharmacies or licensed physicians that compound BPC-157 under every stated condition. That is not FDA approval, and Florida’s boards are not bound by it, so state rules still apply.
Can we offer peptide blends?
No. The policy covers single-active-ingredient products only.
Does the policy cover 503B outsourcing facilities?
No. It applies to 503A pharmacies, federal facilities and licensed physicians.
Can the policy change?
Yes. It is interim, it has a two-week comment period, and HHS can withdraw it at any time. Check with counsel before changing a peptide program.
Why wellness professionals in Florida hire B&M Law Group
B&M Law Group, PLLC is a Miami business and commercial law firm that advises medspas, wellness clinics, telehealth platforms and compounding partners across Florida. We:
- Review peptide programs against the HHS policy and Florida board rules.
- Draft informed-consent and documentation protocols.
- Structure supervising-physician and management-services arrangements.
- Negotiate pharmacy supply agreements.
- Respond when a board or federal inquiry arrives.
The enforcement window has opened and closed before. Clients who built compliant programs early kept operating when it closed.
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This article is for general information and is not legal advice. Sources: HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (Oct. 28, 2026); Federal Register Doc. 2026-22192.