Who Faces Federal Charges in the Peptide and GLP-1 Business? A Role-by-Role Guide for Florida

On October 28, HHS told compounding pharmacies and physicians it will not take enforcement action over six peptides, BPC-157 among them, when every condition in a new draft policy is met. Within a day, sellers and clinics were calling it legalization. It is not. The policy covers a narrow group, and the businesses it leaves out are the ones federal and Florida prosecutors have been charging all year.

Exposure follows the role you play in the supply chain, not the product alone. Here is where each role stands, what starts a case, and what to do before anyone asks.

Exposure follows the role you play in the supply chain, not the product alone.

Key Takeaways

• HHS's October 2026 peptide policy covers only 503A pharmacies, federal facilities and physicians. Online sellers, 503B facilities and med spa resale remain outside it.
• Selling an unapproved peptide for human use violates 21 U.S.C. §§ 331 and 355 whatever the label says; research use only is not a defense.
• Prison time comes from intent to defraud under 21 U.S.C. § 333(a)(2) and from stacked wire fraud, smuggling and money laundering counts.
• Florida can charge a knowing sale of a misbranded drug as a second-degree felony under § 499.0051, with no federal referral needed.
• For every role, the weeks after a warning letter, board inspection or agent contact decide whether a matter stays regulatory or turns criminal.

What Changed in October, and What Did Not

HHS filed its draft Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances on October 28 (Docket No. HHS-OASH-2026-0496). It covers BPC-157, TB-500, epitalon, KPV, MOTS-c and Semax, and only when a licensed pharmacy or physician compounds on a patient-specific prescription, using bulk substance from a registered manufacturer with a qualifying certificate of analysis, one active ingredient, an approved route, a "not for resale" label and adverse event reporting. Comments close in mid-November. We cover each condition in our analysis of the HHS peptide policy.

Where Each Role's Exposure Sits

Online and research use only peptide sellers

This is the most exposed model, and the HHS policy does nothing for it. Selling a research use only peptide that the record shows was meant for people is introduction of an unapproved new drug under 21 U.S.C. § 331(d) and § 355(a). FDA reads intended use from the totality of the evidence: website copy, dosing calculators, bacteriostatic water sold beside the vials, and social posts. Cases start with FDA's review of the public site, a customs detention or a processor flag. If you are still selling, archive the site and talk to a peptide attorney before you change a word.

FDA reads intended use from the totality of the evidence: website copy, dosing calculators, bacteriostatic water sold beside the vials, and social posts.

Compounding pharmacies and outsourcing facilities

A 503A pharmacy is protected only while it meets every condition of section 503A: a patient-specific prescription, an eligible bulk substance and no regular copying of an approved drug. Miss one and every vial becomes an unapproved new drug. A 503B outsourcing facility is not covered by the HHS policy at all, and the GLP-1 shortage argument is gone. Inspections, Form 483 observations and warning letters start these files. A compounding pharmacy attorney should write the 15-business-day response, because it is the first statement in a possible criminal case.

Telehealth platforms and management companies

Online intake, a contracted prescriber and a partner pharmacy is a lawful structure until the marketing says a compounded drug is the same as an approved one, or the platform pays for patients. In Florida, per-patient and percentage fees implicate the Patient Brokering Act, § 817.505, which is not limited to insurance-billed care. A telehealth fraud investigation usually starts with the marketing and the payment flow.

Prescribers: physicians, APRNs and PAs

A prescription does not cure a product-source problem. Prescribing an unapproved peptide is not off-label use. Prescribers face misbranding and conspiracy theories, parallel board discipline, and a mandatory consecutive two years under 18 U.S.C. § 1028A when a clinic orders under their name or NPI without authority. Where testosterone is involved, DEA registration defense and Ruan v. United States, 597 U.S. 450 (2022), come into play.

Med spas, IV and weight-loss clinics

Florida does not license med spas; the clinic runs on a practitioner's license. From Miami to Palm Beach County, the problems we see are office stock ordered without patient-specific prescriptions, research-grade product, take-home vials and supervision that exists only on paper. Receiving and delivering a misbranded drug is a federal crime, and the policy's "not for resale" condition excludes clinic retail. A med spa compliance attorney can fix the structure before a patient complaint or an inspection forces the issue.

Office stock ordered without patient-specific prescriptions, research-grade product, take-home vials and supervision that exists only on paper. The policy's not for resale condition excludes clinic retail.

Unlicensed injectors and wellness operators

Here the first charge is usually state, not federal. Practicing or offering to practice without a license is a third-degree felony with a one-year mandatory minimum under § 456.065, and a second-degree felony when a patient suffers serious bodily injury. A website or a social media reel can be the offer. These cases turn federal when investigators trace where the product came from.

Owners, officers and employees

Under the responsible corporate officer doctrine, an owner with authority to prevent a violation can be convicted of the FDCA misdemeanor without proof of knowledge. Employees are charged too; in the Indiana case above, the person who packed and shipped orders received 16 months. Dissolving the company does not end personal exposure, and owners often need counsel separate from the company.

The Charges That Carry the Prison Time

Florida does not wait for a federal referral. Under § 499.0051, a knowing sale of a misbranded drug is a second-degree felony, and trafficking $25,000 or more in contraband prescription drugs is a first-degree felony with mandatory fines.

The federal FDCA count is a strict-liability misdemeanor under 21 U.S.C. § 333, up to one year with no intent required, and a three-year felony with intent to defraud or mislead. The heavier exposure is what prosecutors stack on top: wire fraud under 18 U.S.C. § 1343 and smuggling under 18 U.S.C. § 545, each up to 20 years; money laundering under 18 U.S.C. § 1956; and obstruction under 18 U.S.C. § 1519 when records disappear after notice. Sentencing runs through the fraud loss table, and the government opens at gross receipts.

Mistakes We See in the First Weeks

• Answering FDA inspectors, agents in an FDA OCI investigation or board investigators without counsel. A false statement is its own felony under 18 U.S.C. § 1001.
• Editing the website or deleting messages before preserving them. That is how a regulatory problem becomes an obstruction case.
• Selling after a warning letter. The letter supplies the notice that turns the next sale into a felony.
• Restocking or remarketing on the HHS headline. Calling BPC-157 "now legal" or "FDA approved" is a fresh misbranding and wire fraud problem.
• Treating a warning letter or Form 483 response as paperwork.

What a Confidential Exposure Review Covers

Most people who call after an agency contact could have learned where they stood months earlier. A confidential exposure review is that earlier look, done through counsel so it stays privileged:

• Each product, its approval and compounding status on the dates you sold or used it, and whether it falls inside the HHS policy.
• The lane your business relies on (approved product, 503A, 503B or research supply), with sourcing, certificates of analysis and import records.
• Your website, social accounts and marketing measured against what FDA cites in its warning letters, archived before anything changes.
• Florida licensing, supervision and referral arrangements, and whether owners need counsel separate from the company.

Most people who call after an agency contact could have learned where they stood months earlier.

You receive a written, privileged assessment of what to stop, preserve and document. It is federal investigation defense work done before there is an investigation. If you are already under federal investigation, the same work is the foundation for responding to a grand jury subpoena or target letter before charging decisions are made.

Why the Next Ninety Days Matter

The HHS comment period closes in mid-November, and the final conditions will define who is inside the policy. FDA's compounding advisory committee takes up more peptides before the end of February. Florida's U.S. Attorneys and Attorney General now share data through a joint anti-fraud task force, and most of these offenses carry a five-year statute of limitations.

Common Questions

Facing a Peptide, GLP-1 or Med Spa Investigation in Florida?

AMC Defense Law represents online sellers, compounding pharmacies, telehealth platforms, prescribers, med spas and their owners in FDA, DOJ and Florida board matters, from Boca Raton and in federal courts nationwide, including the Southern District of Florida. If you want to know where your business stands before an agency asks, request a confidential exposure review. If you have received a warning letter, a grand jury subpoena or a letter from the U.S. Attorney's Office, or agents have contacted you or your staff, call (561) 542-5494 and speak with a white collar defense attorney before you respond.

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, GLP-1 or med spa 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 reading 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 a draft open for public comment when this article was written, and its final terms may differ. If you are facing an investigation or charges, consult a qualified attorney about your specific situation.