New Peptide Policy: Which Peptides Are Covered and What the Rules Require

Originally published October 20, 2026. Updated October 28, 2026.

After months of anticipation, FDA advisory committee meetings, and White House review, HHS has released its long-awaited peptide compounding policy. For telemedicine companies and compounding pharmacies, this is an exciting development: a concrete federal framework for providing six peptides through patient-specific prescriptions while FDA considers their permanent eligibility for compounding.

The announcement follows a promise Robert F. Kennedy Jr. publicly made nearly two years ago. On October 25, 2024, he declared that “FDA’s war on public health is about to end,” specifically identifying peptides among the products he believed the agency was suppressing. The new policy brings that promise substantially closer to becoming a practical prescription pathway. [13]

The details determine what companies can offer. The policy covers particular peptides, chemical forms, and routes of administration. It requires single-ingredient products, qualifying ingredient sourcing and testing, patient-specific prescriptions, labeling, and safety reporting. Oral formulations carry an additional requirement to document adequate bioavailability in humans.

This is an interim enforcement policy while FDA develops its permanent bulk drug substances list. It does not make the covered peptides FDA-approved or establish their safety or effectiveness. The practical questions are which products qualify, whether companies can begin now, how state law applies, and what companies can advertise. [1–2]

Which peptides are covered?

The policy addresses these six peptides in the following forms and routes:

• BPC-157 acetate: Subcutaneous or intramuscular injection, oral, and topical.
• TB-500 acetate: Subcutaneous or intramuscular injection.
• Epitalon acetate: Subcutaneous or intramuscular injection, dispensed in intermittent courses.
• KPV acetate: Oral and topical.
• MOTS-c acetate: Subcutaneous or intramuscular injection.
• Semax free base: Intranasal.

The actual ingredient must match the identity and route described in Appendix B. The policy does not cover injectable KPV, injectable Semax, nasal BPC-157, or intravenous administration of these peptides.

It also does not create a new pathway for peptides outside this list, such as CJC-1295, ipamorelin, AOD-9604, or retatrutide. Those substances require a separate analysis. [1, Appendices A–B]

Can companies start now?

In our view, qualifying compounders have a reasonable basis to begin compounding now in reliance on HHS’s announced enforcement policy, provided they satisfy its conditions and applicable state requirements.

HHS has already released the complete policy. Its operative language states that “HHS does not intend to take action” against qualifying compounders when the specified conditions are satisfied. That language describes a present enforcement position, and the policy does not expressly condition reliance on subsequent Federal Register publication or the close of the comment period. [1, pp. 2–4]

The October 30 publication is scheduled to publish the notice announcing the policy’s availability. The filing does not announce a separate, forthcoming policy document. Accordingly, we do not recommend delaying otherwise qualifying compounding solely to await that publication. [2]

There remains an interpretive uncertainty: the notice describes the policy as a draft, and HHS has not expressly confirmed an implementation date. Our conclusion reflects our reading of the present-tense enforcement language. Businesses proceeding now would be relying on an announced, nonbinding enforcement position; every proposed product must still satisfy the conditions discussed below.

How can companies advertise a product that is not FDA-approved?

Lack of FDA approval does not automatically prohibit all advertising of an otherwise permissible compounded prescription program. But the new policy supplies no independent substantiation for claims about a peptide’s benefits.

FDA states that prescription-drug promotion by or on behalf of compounders must be truthful, accurate, and nonmisleading. That includes promotional activity through telehealth companies. [4]

Describe the service and product accurately

Advertising can describe a genuinely available consultation service, the ingredient and route offered, pricing, and prescription requirements, provided the overall presentation is accurate.

For example:

Consultations are available to discuss compounded peptide options. Prescriptions are issued only when clinically appropriate following a medical evaluation. Compounded medications are not FDA-approved; FDA has not reviewed them for safety, effectiveness, or quality.

That wording must reflect the actual offering. It does not authorize unsupported claims elsewhere in the advertisement or website.

Substantiate claims about benefits

Claims about injury recovery, fat loss, longevity, or other benefits require evidence before publication. The FTC calls for “competent and reliable scientific evidence,” generally including randomized, controlled human clinical testing for health-benefit claims.

The evidence must be relevant to the advertised product, dose, route, patient population, and claimed result. Animal studies and anecdotes alone are insufficient. Claims that BPC-157 heals injuries, MOTS-c produces fat loss, or Epitalon slows aging require their own substantiation; inclusion in HHS’s policy does not supply it.

Disclaimers do not cure unsupported claims

Statements such as “not FDA-approved” or “results vary” do not cure an otherwise misleading advertisement. Words such as “may help” or “supports” can still communicate a benefit requiring proof.

The same principles apply to testimonials, influencers, before-and-after images, and promotional articles. Companies cannot make unsupported claims indirectly through those channels. [5]

Advertising also should not characterize the compounded drug as FDA-approved or FDA-cleared, or imply that HHS’s policy constitutes government endorsement of the product’s safety or effectiveness.

Can prescribers and/or pharmacies combine the peptides?

The policy addresses single-API products so adding a second active ingredient is not allowed. A compounded BPC-157 and TB-500 blend falls outside that condition, even though each ingredient appears separately on the covered list.

Adding a second active ingredient does not become permissible merely because the principal peptide is covered. The finished preparation must satisfy the single-ingredient condition. [1, condition 7]

What is required for oral formulations?

The policy addresses oral BPC-157 acetate and KPV acetate, but oral eligibility comes with an additional requirement: the compounder is expected to maintain documentation confirming adequate oral bioavailability in humans for the specific formulation supplied to the patient.

An ingredient purity certificate does not establish absorption. Animal studies, injection data, or research on a materially different oral formulation do not, by themselves, establish that the dispensed formulation satisfies this condition.

The documentation may come from an appropriate external source; the policy does not expressly require each pharmacy to conduct its own human study. The obligation is to maintain evidence supporting the particular formulation being provided. [1, condition 8]

Where must the ingredients come from?

The original bulk ingredient manufacturer must be FDA-registered, comply with current good manufacturing practice and other applicable federal drug requirements, and have its physical manufacturing location identified on the certificate of analysis.

Registration of a reseller alone is insufficient. When an FDA-registered repacker, relabeler, or reseller supplies the ingredient, the policy calls for that intermediary’s documented validation of the original manufacturer and the manufacturer’s COA.

Appendix B also calls for information identifying the manufacturer, processing firms, applicable repackers and testing laboratory, batch, manufacturing and release dates, expiration or retest date, storage conditions, and intended human compounding use. FDA registration should not be represented as FDA approval of the ingredient or finished medication. [1, conditions 3–4 and Appendix B]

Does testing occur at the manufacturer or pharmacy level?

The policy addresses two different stages: qualification of the bulk ingredient and quality of the finished medication.

Bulk ingredient testing

The Appendix B testing framework concerns the peptide API before it is compounded. It addresses identity and sequence, potency and peptide content, impurities, residual solvents, elemental impurities, and microbiological and endotoxin attributes appropriate to the intended dosage form. Additional structural and biological characterization applies where specified.

This testing can be performed by the manufacturer or an appropriate contract laboratory. The results must be supported by a valid, lot-specific COA with the information and analytical-method documentation described in Appendix B. FDA’s Q7 guidance also recognizes contract laboratories within the API manufacturing quality system. [1, Appendix B; 12]

Appendix B does not expressly require every receiving pharmacy to repeat the entire API testing panel. It does require qualifying material and documentation. A COA reporting only a purity percentage does not establish compliance with the broader testing framework.

Pharmacy responsibility for the finished medication

The pharmacy remains responsible for using suitable ingredients and meeting the standards applicable to the finished preparation. A manufacturer’s API COA does not establish that the compounded injection, capsule, cream, or other preparation has the correct strength, appropriate quality, or required sterility and endotoxin characteristics.

Finished-preparation testing obligations depend on the applicable compounding standards, formulation, and state requirements. The absence of an express requirement to repeat the entire API panel does not eliminate any incoming-material or finished-preparation testing otherwise required.

For example, California requires injectable compounded sterile preparations made from nonsterile components to undergo endotoxin testing regardless of USP category. Its regulation states:

“Results shall be reviewed and documented in the compounding record prior to furnishing.”

The API manufacturer’s testing therefore does not replace this pharmacy-level obligation. [6–7]

Can pens or autoinjectors qualify?

The policy limits a drug-delivery device co-packaged with, or containing, the compounded drug to an “FDA 510(k)-cleared syringe.” It also identifies additional risks associated with more complex delivery devices. [1, condition 9]

A pen is not automatically excluded simply because it is called a pen. FDA’s piston-syringe guidance expressly includes “cartridge or pen syringes not including the cartridge itself.” A pen that is itself cleared as a syringe therefore has a substantial argument for fitting the policy’s device condition. [10]

The actual clearance and configuration matter. Clearance of an empty device or syringe component does not automatically establish the regulatory status of every cartridge, filled preparation, or assembled delivery system. FDA also distinguishes syringes, pen injectors, and autoinjectors in its combination-product constituent reporting framework; the presence of a cleared syringe inside a larger system does not by itself answer the question for the complete device. [11]

The policy does not expressly resolve every pen, cartridge, or prefilled configuration. Device clearance also does not confer FDA approval on the compounded peptide.

What labeling and reporting are required?

The policy specifies this statement on product labeling:

“This is a compounded drug product. Not for resale.”

Patient labeling should also explain how to report adverse events and problems involving the product’s identity, strength, purity, or quality. [1, conditions 5–6]

Compounders are expected to report compounded products, serious adverse events, and product-quality issues to FDA and the states where the products are compounded and sent, if different.

Serious adverse events are reportable regardless of whether they are considered drug-related. The policy directs serious-adverse-event and product-quality reporting to FDA’s MedWatch program. Quality issues include contamination, significant changes in the distributed product, and failures to meet applicable specifications.

Product reporting includes:

• Active ingredient and strength per unit.
• Original API manufacturer and the manufacturing facility’s unique identifier.
• Dosage form and route of administration.

The text does not provide a complete reporting calendar or every state submission mechanism. Its reporting condition should not be reduced to reporting only events a compounder believes the peptide caused. [1, condition 5]

How does state law affect the policy?

It is not yet clear how each state pharmacy board will apply this new federal policy.

As of October 28, 2026, we are not aware of a pharmacy board publicly rejecting the new HHS policy or announcing that compounding meeting its conditions is prohibited in that state. Earlier statements concerning research-use-only peptides or federally ineligible ingredients should be evaluated in their own context; they are not automatically responses to this newly released policy.

Without a state-specific statutory, regulatory, or board basis, we cannot conclude that compounding covered by the policy is prohibited under state law. Board silence, however, does not establish affirmative approval.

California illustrates the issue. Its existing regulations and board guidance recognize use of ingredients on FDA’s published 503A Category 1 list, subject to suitability and quality requirements. That supports an argument that California accommodates federal interim compounding policies, but it does not conclusively establish how the board will treat the separate HHS policy and its Appendix A. [6]

Could a contrary state restriction be preempted?

There is an argument for preemption where a state restriction would frustrate the federal compounding framework and HHS’s deliberate decision to permit interim access under specified safeguards. The argument is particularly relevant where a claim depends on enforcing the FD&C Act despite the federal government’s contrary enforcement position.

In Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc., the Ninth Circuit held that private state-law claims dependent on alleged violations of federal compounding requirements were preempted. The court explained:

“The statutory prohibition on private enforcement gives the FDA discretion to temper enforcement or not to enforce in circumstances it deems appropriate.”

That reasoning supports a preemption argument, but the decision concerned private litigation. It did not establish blanket immunity from state pharmacy-board enforcement or independent state licensing and quality requirements. [8]

The counterargument is that enforcement discretion does not amend federal law. In Iowans for Alternatives to Smoking & Tobacco, Inc. v. Mosiman, the Eighth Circuit rejected an argument that FDA’s discretionary enforcement approach to unauthorized vaping products displaced a state restriction. The court distinguished federal law from federal enforcement preferences. That case concerns a different statutory framework, but it cautions against assuming that a nonbinding enforcement policy automatically preempts state law. [9]

Preemption therefore remains an available, fact-dependent argument. The new policy supports neither a categorical conclusion that state law prohibits covered compounding nor an assumption that every contrary state requirement is displaced.

How can a telemedicine company offer these peptides?

The pathway is through an authorized prescribing practitioner and an eligible compounder, with a valid prescription for an identified patient.

Section 503A expressly recognizes prescriptions issued by a physician or “other licensed practitioner authorized by State law to prescribe drugs.” The policy does not expand anyone’s prescribing authority or replace applicable requirements for licensure, telehealth evaluations, supervision, or the practitioner-patient relationship. Nor does it establish approved indications, doses, or treatment protocols. [3]

The actual compounding must be performed by a licensed pharmacist in a state-licensed pharmacy or federal facility, or by a licensed physician within the policy’s scope. An unlicensed telemedicine platform cannot itself become a compounder by arranging the sale. This policy also does not establish an equivalent pathway for Section 503B outsourcing facilities. [1, 3]

The patient-specific prescription requirement remains. Section 503A permits limited anticipatory compounding based on an established history of prescriptions and the relationships specified in the statute. Anticipated demand for a new peptide program alone does not authorize unrestricted inventory production or blanket office stock for unidentified future patients. [3]

What other requirements remain?

The policy retains other applicable federal drug requirements, including the prohibition on insanitary compounding and Section 503A’s patient-specific prescription requirement. Applicable state requirements remain subject to the state-law analysis above. [1, condition 10]

The interim policy continues until a covered peptide is addressed in a final rule as included or excluded from the 503A bulks list. HHS also reserves the ability to revisit the policy, in whole or in part, including if safety signals or product-quality problems arise. [1–2]

Primary sources

1. HHS peptide compounding enforcement-discretion policy, including Appendices A and B.
2. HHS notice of availability filed October 28, 2026, scheduled for publication October 30.
3. 21 U.S.C. § 353a — Pharmacy compounding.
4. FDA — Compounding and the FDA: Questions and Answers.
5. FTC — Health Products Compliance Guidance.
6. California State Board of Pharmacy — Compounding FAQs.
7. 16 CCR § 1736.12 — Release Inspections and Testing.
8. Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc. — Ninth Circuit opinion.
9. Iowans for Alternatives to Smoking & Tobacco, Inc. v. Mosiman — Eighth Circuit opinion.
10. FDA — Guidance on 510(k) Submissions for Piston Syringes.
11. FDA — Device Product Codes for Combination-Product Constituents.
12. FDA — Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
13. Robert F. Kennedy Jr. — October 25, 2024 public statement.

This article provides general legal and regulatory information as of October 28, 2026 and does not constitute legal advice.