Launching a Peptide Program Under the HHS Policy: A Checklist

On October 30, 2026, HHS published an enforcement discretion policy for 503A compounding of six peptides: BPC-157, TB-500, KPV, MOTS-c, epitalon and Semax. HHS says it does not intend to take enforcement action against state-licensed pharmacies, federal facilities and licensed physicians that compound them, but only when every condition in the policy is met.

The policy is about the compounder. But almost every condition depends on decisions the brand, clinic and prescriber make upstream. If those decisions are wrong, the pharmacy cannot meet the policy, and the program sits outside it.

This checklist walks through what to put in place. For the full text of the policy, the covered forms and routes, and what is unsettled, read our policy explainer.

1. A prescriber licensed in the patient's state

Section 503A compounding runs on a valid patient-specific prescription, and the policy keeps that requirement in condition 10. A prescription is only valid if the prescriber is licensed where the patient is located and acting within that state's rules.

• Confirm active licensure in every state where you will see patients.
• Confirm the prescriber's scope of practice covers these products in that state. Nurse practitioner and physician assistant authority varies by state.
• Keep a current roster of licenses and expiry dates, and stop scheduling patients in any state where coverage lapses.

2. A real clinical evaluation before any prescription

Every patient needs an individual evaluation by a licensed clinician: history, medications, contraindications and goals, documented in the medical record. For a med spa or clinic administering products on site, that usually means a good faith exam before treatment.

• The clinician decides. A prescription follows only when it is clinically appropriate and permitted.
• Build the workflow so a "no" is a normal outcome, and make sure nothing in scripts or pricing pushes the clinician toward "yes."
• Many states set specific rules for telehealth evaluations, including when a synchronous visit is needed. Check them state by state in our state compliance guides.

3. Patient-specific prescriptions only

The policy does not stretch section 503A. Each product should be compounded for a named patient on a valid prescription.

• Do not order these products as clinic or office stock for later use.
• Do not plan programs around a pharmacy preparing large batches ahead of prescriptions. The policy does not separately address anticipatory compounding.
• Keep the prescription, the evaluation and the dispensing record linked in the chart.

4. One peptide per product, in a covered form and route

Condition 7 limits each compounded product to one active ingredient from the list. Condition 2 limits each peptide to the salt form and routes in Appendix B.

• Retire any protocol or product that combines two or more peptides in one preparation.
• Remove any form or route not in the table from your formulary for these six peptides.
• For oral BPC-157 or oral KPV, ask the pharmacy for the documentation of adequate oral bioavailability in humans that condition 8 expects it to keep.
• The only device that may come with or contain the product is an FDA 510(k)-cleared syringe (condition 9).

5. A vetted 503A pharmacy with traceable ingredients

This is where most of the policy's weight sits. Conditions 3 and 4 require the bulk peptide to come from an FDA-registered (section 510) original manufacturer that complies with CGMP, with a valid certificate of analysis for each lot.

Ask each pharmacy, in writing:

• Its state licenses, including nonresident licenses for every state you serve.
• The original manufacturer of each peptide, its FDA Establishment Identifier, and the facility location shown on the COA.
• A sample lot COA showing the tests Appendix B describes: identity by orthogonal methods, assay, impurities, residual solvents, elemental impurities, bioburden and bacterial endotoxins.
• If it buys through a repacker or reseller, evidence that the intermediary validated the manufacturer and its COA.
• Its process for MedWatch reporting and state reporting (see step 6).

A pharmacy that cannot answer these is not a pharmacy that can meet the policy. Our compounding pharmacy map is a starting point for finding licensed pharmacies by state; vetting still has to be done one by one.

6. Labeling and MedWatch reporting

Condition 5 requires the compounder to report products compounded, serious adverse events and product quality issues to FDA's MedWatch program and to the relevant states. Condition 6 requires a label statement: "This is a compounded drug product. Not for resale."

On your side:

• Confirm the patient labeling explains how to report adverse events and quality problems.
• Give patients a clear way to reach a clinician about side effects, and route every report to both the prescriber and the pharmacy.
• Record adverse events in the chart and keep a log you can produce on request.

7. State board rules

The HHS policy addresses federal enforcement only. It does not change what a state board of pharmacy or medical board permits.

• Before launching in a state, check its pharmacy, medical and telehealth rules for these products.
• Watch for state actions after October 30. States may respond differently to the federal policy.
• Keep a state-by-state launch list, and do not treat the federal policy as a nationwide green light.

8. Corporate practice of medicine structure

Many states restrict who may own a medical practice or control clinical decisions. A brand or med spa owned by non-physicians usually needs a compliant structure, such as a professional entity owned by licensed clinicians and a management services agreement, in which clinical judgment stays with the clinicians.

• Check each launch state's rules before contracting. Our state compliance guides summarize corporate practice and medical director rules by state.
• Make sure prescribing decisions, protocols and patient selection sit with the medical group, not the business.

9. Marketing claims

The policy is enforcement discretion. Your marketing should say no more than that.

• Do not describe the peptides as "approved," "FDA-cleared," "legal" or "safe."
• Do not make treatment or outcome claims the evidence does not support.
• Do not market multi-peptide "stacks"; they are outside the policy.
• Do not promise a prescription. Say that a licensed clinician will decide whether treatment is clinically appropriate.
• Review all copy, ads and patient scripts before launch, and again if HHS revises the policy.

10. Plan for change

The notice describes the document as a draft, invites comments through November 13, 2026, and says HHS may revisit the policy, in whole or in part, after a safety signal or quality issue. Build the program so that you can stop offering a peptide quickly: know which patients are on which products, how you will contact them, and what clinical alternatives exist.

Where TrueEval fits

TrueEval is a licensed medical group. We supply the clinicians, medical directors and good faith exams for telehealth brands, med spas and longevity clinics in all 50 states plus DC, and we keep the state-by-state compliance work current. For a peptide program, that means licensed prescribers in each state, documented evaluations, and prescribing decisions that stay with clinicians.

If you are launching or adjusting a peptide program, tell us what you are building. You can also read more about our work with longevity programs.

*This article is general information, not legal or medical advice.*