Is BPC-157 Legal Now? What the HHS Peptide Enforcement Discretion Policy Covers, and Who It Leaves Exposed in Florida

On October 28, HHS posted the peptide policy the market has been waiting for since July. Within hours, headlines said the federal government would allow the temporary sale of unapproved peptides. That is not what the document says. Secretary Robert F. Kennedy Jr.'s policy tells state-licensed pharmacies, federal facilities and licensed physicians that HHS does not intend to act against them for compounding six peptides, BPC-157 and TB-500 among them, when ten conditions are met. Hold those conditions up against what is sold in Florida today and most of it falls outside, including the BPC-157 and TB-500 blend marketed as the "Wolverine stack."

HHS created a lawful channel for six peptides. Most of what is sold in Florida today sits outside it.

Key Takeaways

• HHS's peptide policy is enforcement discretion under 21 U.S.C. § 353a, not approval; it binds no one and creates no rights for any person.
• Only six peptides qualify, each limited to specific routes, single-ingredient products and FDA-registered sources; combination vials like the Wolverine stack fall outside.
• Research use only sellers, 503B outsourcing facilities and med spa resellers are not covered, and 21 U.S.C. §§ 331 and 333 still apply to them.
• The policy forgives nothing; peptide sales made before October 2026 remain chargeable, and wire fraud under 18 U.S.C. § 1343 sits outside it entirely.
• Florida regulators are not bound by HHS; the Florida Drug and Cosmetic Act, Fla. Stat. § 499.005, still governs peptide sales across South Florida.

What HHS Published on October 28

The Associated Press, citing six people familiar with its development, reported that FDA drug staff had little input and opposed it. The notice calls the policy a draft and accepts comments for two weeks after publication. It does not state an effective date, and the compounding industry's trade association has said that point needs clarification.

Six Peptides and Ten Conditions

The policy itself lists six bulk drug substances in Appendix A: BPC-157, TB-500, epitalon, KPV, MOTS-c and Semax. They are the six peptides FDA's Pharmacy Compounding Advisory Committee voted to recommend in July, after FDA's own reviewers recommended against them. For those six, HHS says it does not intend to take enforcement action against compounding under section 503A of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 353a, when every one of ten conditions is present. The ones that matter most:

• The bulk peptide comes from an FDA-registered facility with a valid certificate of analysis that meets a detailed testing standard, and the original manufacturer, not a repacker, is registered, CGMP-compliant and named on the certificate.
• Each compounded product contains a single active ingredient from Appendix A.
• Each peptide is used only by the routes HHS specified for it: BPC-157 by injection, orally or topically; TB-500 and MOTS-c by injection; epitalon by injection in intermittent courses; Semax intranasally; KPV topically or orally.
• The label reads: "This is a compounded drug product. Not for resale."
• The only delivery device packaged with the product is an FDA 510(k)-cleared syringe.
• Serious adverse events and product quality problems go to FDA's MedWatch program and to every state where the drug is compounded or shipped, along with product information that names the original manufacturer's facility.
• Every product is compounded against a valid patient-specific prescription, under sanitary conditions.

"does not establish any rights for any person and is not binding on HHS or the public."— HHS peptide enforcement discretion policy, Docket No. HHS-OASH-2026-0496

The document also states what it is not. It "does not establish any rights for any person and is not binding on HHS or the public," and HHS may revisit it if a safety signal or product quality problem appears. When the notice was still under White House review, we wrote that the conditions would be the whole game. They are, and they are tighter than the market expected.

Who the Policy Leaves Outside

Start with the group HHS was aiming at. The Secretary's stated reason for the policy is to discourage the widespread use of research use only peptides supplied by foreign manufacturers. Read that as a statement of enforcement priorities. The federal health department has created a lawful channel for six peptides and said in writing that the RUO peptide market is the safety problem. That takes away the argument that patients had no other way to get these products, and it tells FDA investigators and federal prosecutors where to look. FDA warning letters to research use only peptide sellers have not stopped.

HHS said in writing that the RUO peptide market is the safety problem. That tells FDA investigators and federal prosecutors where to look.

Then compare the conditions with what dominates the Florida market:

• Blends. The single-ingredient condition puts every multi-peptide vial outside the policy, including the BPC-157 and TB-500 combination. Two separately compounded products may fit. One blended vial does not.
• Unlisted routes. Injectable KPV, injectable Semax and oral TB-500 are outside.
• Pens and auto-injectors. Only a 510(k)-cleared syringe qualifies.
• 503B outsourcing facilities. The policy addresses 503A compounding only. An outsourcing facility shipping peptide products for office use gets nothing from it.
• Office stock and resale. The patient-specific prescription requirement and the "Not for resale" label exclude med spas and wellness clinics that buy peptide inventory and sell vials to clients.
• Unregistered sources. Ingredient from a manufacturer that is not registered with FDA, or a certificate of analysis that does not identify the original facility, puts the product outside.
• Every other peptide. Anything not on Appendix A, which is most of a typical peptide catalog, receives nothing.

The paperwork conditions point the same way. A compounder working inside the policy sends FDA and the states product information naming the active ingredient, its strength and the original manufacturer's facility. Over time, that builds a record of who is compounding these peptides inside the policy, and it makes the sellers who are not on that record easier to see.

The Charges That Still Apply: Florida Law First, Then Federal

Nothing HHS says binds Florida. The Florida Drug and Cosmetic Act makes it unlawful to sell, deliver or hold for sale a misbranded or adulterated drug, or to disseminate a false or misleading drug advertisement, under Fla. Stat. § 499.005. The baseline criminal grade is a second-degree misdemeanor under Fla. Stat. § 499.0051(11), and the same section carries felony grades for unauthorized prescription drug distribution. The Florida Board of Pharmacy regulates compounding through Rule 64B16-27.700 and disciplines licensees on its own authority. As of this writing, we have seen no statement from Florida regulators on whether they will follow HHS, and state board positions on peptides can become evidence of what a seller knew.

Federally, the statutes are unchanged. 21 U.S.C. § 331(a) prohibits introducing a misbranded or adulterated drug into interstate commerce, and § 331(d) prohibits introducing an unapproved new drug under 21 U.S.C. § 355.

A compounded product that misses a section 503A condition loses the statute's exemptions from new drug approval, adequate directions for use and current good manufacturing practice. That is how a compounding problem becomes an introduction of unapproved new drug case.

Wire fraud, conspiracy and smuggling each carry up to 20 years. None of them is FDA's to waive.

The heavier charges are not FDA's to waive. Wire fraud under 18 U.S.C. § 1343 and conspiracy under 18 U.S.C. § 1349 each carry up to 20 years, and prosecutors use them when peptide marketing makes health claims while disclaiming human use. Knowingly bringing foreign peptide ingredients into the country contrary to law can add smuggling under 18 U.S.C. § 545, another 20-year statute. At sentencing, the FDCA guideline, USSG § 2N2.1, sends fraud cases to the loss table in § 2B1.1, where the dollar figure drives the range.

Mistakes Florida Operators Will Make in the Next 90 Days

• Calling it legal. Website copy saying BPC-157 is now legal or FDA-approved is a fresh misbranding problem under 21 U.S.C. § 352 and a false advertising problem under Florida law. FDA reads websites, and intended use is proven with marketing.
• Relabeling RUO inventory. A research use only vial does not become a 503A product because a clinician writes a prescription for it. The ingredient source, the certificate and the compounding pharmacy all have to qualify.
• Splitting the stack on paper. Documenting two products while shipping one blended vial is the kind of workaround investigators look for, and it turns a regulatory problem into a false records problem.
• Assuming past sales are covered. They are not. The policy looks forward, and the general federal statute of limitations under 18 U.S.C. § 3282 is five years.
• Talking first. In FDCA cases, intent separates a misdemeanor from a felony, and intent is usually proven with the defendant's own words to an inspector or agent.

How These Matters Get Defended

For 503A pharmacies and physicians, the work is an audit against all ten conditions before a single product ships under the policy: ingredient source traced to the original manufacturer, certificates matched to lots, routes, single-ingredient formulations, labels, syringes, MedWatch and state submissions, and a patient-specific prescription behind every unit. A 503A compounding pharmacy attorney can run that review under privilege, so the gaps it finds get fixed instead of discovered.

For med spas and telehealth prescribers, the question is where each product comes from and who sells it to the patient. Office stock resold to clients has to stop, and marketing claims need review. A med spa attorney or peptide attorney should look at both before an FDA investigator does.

For RUO peptide sellers, the policy changes the calculation. Winding down, moving into a compliant 503A structure, disposing of inventory and changing a website all have consequences, and nothing should be deleted once an investigation is reasonably anticipated. Destroying records turns a regulatory problem into an obstruction case under 18 U.S.C. § 1519.

For anyone already facing an FDA OCI investigation or a federal grand jury, the policy is a new fact to use. Conduct that sits close to its conditions supports an argument that the matter belongs in a regulatory lane rather than a criminal one. Whether to engage the assigned prosecutor, whether to proffer, and how to answer a grand jury subpoena are decisions for a federal criminal defense attorney or white collar defense attorney, made before the government finishes its file. That is federal investigation defense at its most useful, and it is the same work a federal target letter attorney does when a letter arrives. In Southern District of Florida federal defense practice, that early window is where any chance to avoid indictment exists. Our peptide and compounding defense work starts there.

Why the Next Two Weeks Matter

Comments on the draft close two weeks after its October 30 publication. HHS can change the conditions, shorten the list or withdraw the policy, and a future Secretary can drop it. The effective date is unsettled. Nothing in the notice pauses FDA warning letters or pending federal cases against peptide sellers.

And if you have received an FDA warning letter, a grand jury subpoena or a letter from the U.S. Attorney's Office, the time to act is now, while charging decisions are still open.

Facing a Peptide or Compounding Investigation in Florida?

AMC Defense Law represents compounding pharmacies, prescribers, med spa operators, telehealth companies and peptide businesses in federal investigations and prosecutions, from its Boca Raton office and in federal districts nationwide. If you have received an FDA warning letter, a federal grand jury subpoena or a letter from the U.S. Attorney's Office, or if agents have contacted you or your staff, contact the firm for a confidential consultation before you respond to the government. Call 561-542-5494 or email amc@amcdefenselaw.com.

Aaron M. Cohen, AMC Defense Law, Boca Raton.

If you or your loved ones have been arrested or are under federal investigation in a peptide or compounding matter, call Aaron M. Cohen, 24 hours a day to get help.

About the author: Aaron M. Cohen is the founder and principal attorney of AMC Defense Law, a criminal defense firm in Boca Raton, Florida, with more than 30 years of experience in state and federal courts. He is admitted to practice in Florida, New York, New Jersey, and the District of Columbia, and before the United States District Courts for the Southern and Middle Districts of Florida, the Southern, Eastern, and Western Districts of New York, the District of New Jersey, and the Northern District of Texas. He appears pro hac vice in other federal districts nationwide. The firm represents clients in federal investigations and prosecutions involving healthcare fraud, Anti-Kickback Statute matters, DME and telemedicine fraud, peptide and compounded-drug enforcement, controlled-substance and drug conspiracy cases, financial crimes, and complex federal litigation, in Florida and nationwide.

This article is provided for general informational purposes only. It is not legal advice, and it does not create an attorney-client relationship. Every case is different, and outcomes depend on the specific facts and law involved. The HHS policy discussed here was published as a draft open for public comment, and its final terms may change. If you are facing an investigation or charges, consult a qualified attorney about your specific situation.