The Compounded GLP-1 Crisis: What Pharmacies, Telehealth Companies, and Prescribers Need to Know About Federal Exposure

On September 15, the Partnership for Safe Medicines launched a national campaign calling compounded GLP-1 drugs a patient safety crisis and pressing Washington to enforce existing law. The campaign is aimed at patients and policymakers. The people who should read it closely are the pharmacists, telehealth operators, med spa owners, and prescribers still selling compounded semaglutide and tirzepatide.

Campaigns like this give regulators cover to escalate, and the semaglutide enforcement record is already long. That record is where prosecutors start when compounded drug enforcement becomes a criminal case.

The shortages that made compounded semaglutide and tirzepatide lawful ended in 2025. The prescriptions did not.

Key Takeaways

• With the shortages resolved, most copies of semaglutide and tirzepatide no longer qualify for compounding exemptions under 21 U.S.C. §§ 353a and 353b.
• Since September 2025, FDA has issued more than 130 warning letters over compounded GLP-1 marketing and now threatens seizure and injunction without further notice.
• Misbranding is a felony under 21 U.S.C. § 333(a)(2) with proof of intent to defraud; wire fraud under 18 U.S.C. § 1343 carries 20 years.
• Florida operators face a state track under Chapter 499, Florida Statutes running alongside federal prosecutors in the Southern District of Florida.
• A company's advertising copy and its prescribers' patient-specific documentation are the first records investigators review in a compounded GLP-1 case.

The Shortages Ended in 2025. The Sales Kept Going.

FDA placed semaglutide and tirzepatide on its drug shortage list in 2022. That listing is what allowed 503A pharmacies and 503B outsourcing facilities to compound copies of the brand drugs. FDA resolved the tirzepatide shortage in December 2024 and the semaglutide shortage in February 2025, and the grace periods it gave compounders to wind down expired later that year.

The market did not wind down with them. The Partnership for Safe Medicines, citing IQVIA data, reports that compounded products still make up nearly one in five weight loss injection prescriptions nationwide. FDA has received more than 1,700 adverse event reports tied to compounded GLP-1 products.

Enforcement in this space arrived in stages, not all at once. Each stage narrowed the ground a compounder or telehealth platform could stand on, and each one is now dated proof of what the industry was told.

The federal response came in stages. FDA sent roughly 80 warning letters over compounded GLP-1 marketing in September 2025. On February 6, 2026, the FDA Commissioner announced restrictions on GLP-1 active ingredients used in mass-marketed compounded drugs and warned of seizure and injunction without further notice. The HHS General Counsel disclosed a Justice Department referral of a national telehealth company the same day. Thirty more warning letters followed in March and 25 in June. On April 1, FDA restated its essentially a copy policy. On April 30, it proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list, which would bar bulk compounding by outsourcing facilities even if a shortage returns (Federal Register notice).

What the Government Is Building

The warning letters show where FDA starts: the company's website. The agency has said sellers cannot call compounded GLP-1s generic, claim they contain the same active ingredient as an approved drug, or describe them as clinically proven. In a telehealth fraud investigation or a med spa FDA investigation, every landing page and patient email making those claims is a potential exhibit. Our analysis of GLP-1 and peptide advertising covers the rules in detail.

The intake form is the document that decides whether a personalized formulation is a lawful prescription or a marketing label. Investigators pull it for thousands of patients at once and look for the checkbox that never changes.

The second target is the personalized workaround. After the shortages ended, many compounders added vitamin B12 and called the result a different drug. FDA's April 1 statement used semaglutide with B12 as an example of a product it may still treat as essentially a copy. Under section 353a, the prescriber must document a change that makes a significant difference for that specific patient. Templated intake forms checking the same box for thousands of patients will not carry that weight, and volume far above FDA's four-prescriptions-a-month tolerance looks like commercial substitution.

The third target is supply. In an FDA OCI investigation, import entries, wire transfers to overseas ingredient vendors, and shipping records let agents build a case before anyone gets a phone call. Relabeling does not help: a research use only label is no defense when the seller is telling buyers how to dose for weight loss.

Exposure and Charges: Florida Law First, Then Federal

In Florida, a state track often runs alongside the federal one. The Florida Drug and Cosmetic Act bars distributing misbranded drugs under section 499.005, Florida Statutes, and section 499.0051 makes many violations crimes. Pharmacists face discipline under section 465.016, out-of-state pharmacies shipping here need a permit under section 465.0156, and prescribers face license action under section 456.072. See our post on unlicensed GLP-1 prescribing in Florida.

On the federal side, the backbone is the Food, Drug, and Cosmetic Act. 21 U.S.C. § 331 prohibits introducing a misbranded drug or an unapproved new drug into interstate commerce. A compounded product outside sections 353a and 353b loses its exemption from the approval requirement in 21 U.S.C. § 355, and misleading labeling is misbranding under 21 U.S.C. § 352. Under section 333(a)(1), a first violation is a misdemeanor carrying up to one year, and a company's responsible officers can be convicted without proof they knew of the violation. Add intent to defraud or mislead, and section 333(a)(2) makes it a felony with up to three years per count.

"Under section 333(a)(1), a first violation is a misdemeanor carrying up to one year, and a company's responsible officers can be convicted without proof they knew of the violation."— Aaron M. Cohen, AMC Defense Law

Prosecutors rarely stop there. Marketing a compounded drug as the same as the brand supports wire fraud under section 1343 and conspiracy under 18 U.S.C. § 1349. Importing ingredients contrary to law supports smuggling under 18 U.S.C. § 545. If insurers or a federal program paid, health care fraud under 18 U.S.C. § 1347 and False Claims Act liability under 31 U.S.C. § 3729 follow. Unauthorized brand marks can draw counterfeit drug charges under 18 U.S.C. § 2320.

At sentencing, the misbranding guideline, USSG §2N2.1, starts at a base offense level of 6, but its cross-reference sends fraud cases to §2B1.1, where loss controls. For a telehealth subscription business, the government will push to treat gross revenue as loss. Add an enhancement for conscious or reckless risk of serious bodily injury, and a marketing dispute carries a guideline range measured in years.

Mistakes That Make These Cases Worse

• Treating the warning letter as a marketing problem. A response drafted by the marketing team, conceding the claims, can become the government's proof of knowledge.
• Rewriting or deleting web content without a litigation hold. Once an investigation is foreseeable, destroying prior versions invites an obstruction charge under 18 U.S.C. § 1519.
• Talking to agents without counsel. Agents who visit a pharmacy or clinic are there to collect admissions, and a false statement is its own felony under 18 U.S.C. § 1001.
• Assuming a move to 503A pharmacies solved the problem. It changes which statute applies, not the essentially-a-copy analysis or the advertising.

A Strategic Defense Approach

Pre-indictment defense in a compounded GLP-1 matter starts with a privileged review, directed by counsel, of the marketing history, the prescriber documentation, and the supply chain. That review shows whether the company has a defensible 503A position, a marketing problem it can correct, or criminal exposure it has to confront directly.

Where the exposure is regulatory, a disciplined FDA warning letter response and documented corrective action can keep the matter civil. Where a referral is likely, counsel can reach the prosecutor before charging decisions harden. For an owner who is already the subject of a federal investigation, the choice between cooperation and litigation depends on the documents, and that analysis comes before any proffer.

A sound GLP-1 compounding defense also accounts for the state track, where board proceedings can generate sworn testimony prosecutors later use. Our peptide and compounded drug defense practice coordinates both.

Why Timing Matters Now

FDA told the industry in February that legal action could come without further notice. The comment period on the 503B bulks list proposal closed June 29, and a final decision can issue at any time. The general federal limitations period under 18 U.S.C. § 3282 is five years, so marketing and sales from 2025 remain chargeable into 2030.

A target letter attorney can do far more before an indictment than after. If you have received a warning letter, a subpoena, or a call from an agent, the window to shape the outcome is open now, and it narrows with every month of continued sales.

Common Questions

Facing a Compounded GLP-1 Investigation in Florida?

If your pharmacy, telehealth platform, or med spa has received a warning letter, a subpoena, or a visit from federal agents, speak with counsel before you respond. AMC Defense Law handles federal investigation defense involving compounded drugs and healthcare fraud, in Southern District of Florida federal defense matters and nationwide.

Aaron M. Cohen is a federal criminal defense attorney and white collar defense attorney based in Boca Raton. Consultations are confidential. Call 561.542.5494.

If you or your loved ones have been arrested or contacted by federal agents over compounded GLP-1 sales, call Aaron M. Cohen for a confidential consultation, 24 hours a day to get help.

This article is for general informational purposes only and is not legal advice. Reading it does not create an attorney-client relationship. Every matter turns on its own facts. The hiring of a lawyer is an important decision that should not be based solely upon advertisements. Prior results do not guarantee a similar outcome.

About the author: Aaron M. Cohen is the founder of AMC Defense Law, a federal criminal defense firm in Boca Raton, Florida. He is admitted to practice in Florida (Florida Bar No. 541427) and New York, and before the United States District Courts for the Southern District of Florida and the Southern District of New York. 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.