Two ways this practice helps you
Most firms in this space do one thing. They defend after the raid, or they write compliance memos. The problem is that the two are the same case. Every compliance decision made today becomes evidence in a prosecution eighteen months from now, and every statement made to a regulator in a licensing posture is available to a grand jury without any of the protections a criminal defendant has.
AMC Defense Law works both sides of that line, and works them from a criminal defense posture.
If nothing has happened yet. Business model review, product and SKU risk mapping, intended-use and marketing audit, sourcing and supply chain review, contract and end-use certification work, state licensing analysis, and a written privileged assessment of where the criminal exposure actually sits. This is the cheapest work you will ever buy in this industry. This is the firm's federal investigations and white collar consulting practice applied to this industry.
If something has already happened. Form 483 and warning letter response, state board cease and desist response, FDA Office of Criminal Investigations and DOJ interface, grand jury subpoena response, search warrant management, internal investigation, parallel proceedings coordination, and pre-indictment declination advocacy. If charges come, federal trial defense.
The difference matters most in the first thirty days. What a company does immediately after a warning letter or a cease and desist order determines whether the matter stays regulatory or becomes a federal criminal case.
Why this industry is under enforcement pressure right now
The peptide and GLP-1 market grew up in a decade of regulatory ambiguity. That period is over, and the enforcement is coming from more directions than most operators realize.
FDA. Warning letters, Form 483 observations, unannounced inspections of 503A and 503B facilities, product seizures, and import alerts. In September 2025 the FDA issued more than fifty warning letters to GLP-1 compounders and to vendors selling peptides labeled research use only where the advertising indicated human use. Import Alert 66-80 now targets GLP-1 active pharmaceutical ingredients at the border.
DOJ. In November 2025 the Department of Justice created a Health and Safety Unit inside the Fraud Section specifically to prosecute criminal Food, Drug, and Cosmetic Act violations. Peptide and compounding cases now sit with prosecutors whose entire job is this statute.
Bulk drug substance classification. The FDA has moved BPC-157, TB-500, and more than fifteen other peptides to Category 2 on the 503A bulk drug substance list, meaning identified safety concerns and no compounding for human use. On April 30, 2026 the FDA proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B Bulks List, which would close compounding from bulk API at outsourcing facilities as well. Retatrutide, cagrilintide, mazdutide, and survodutide are investigational and have no lawful human pathway at all.
State boards of pharmacy. Boards issue cease and desist orders to unlicensed operators shipping into their states, and those orders are published. A board order is not a private letter. It is a public document that every other regulator, every plaintiff's lawyer, and every payment processor can find, and it establishes the knowledge element that turns a one-year federal misdemeanor into a three-year felony.
State attorneys general. Connecticut sued a company over research grade GLP-1 sold directly to consumers. Alabama obtained a temporary restraining order against GLP-1 distributors. More than forty attorneys general have petitioned the FDA about counterfeit peptides entering from China, Turkey, and India. State consumer protection and unfair trade practice statutes reach conduct federal drug law may not, and they move faster.
Manufacturers and the ITC. Eli Lilly obtained a General Exclusion Order at the International Trade Commission barring importation of infringing tirzepatide products, which binds every importer and not only named respondents. Novo Nordisk has pursued parallel litigation against compounders and telehealth platforms. These proceedings generate findings and documents that federal prosecutors then use.
Banks and payment processors. A published warning letter or board order routinely triggers account termination, processor offboarding, and reserve holds. That commercial consequence often arrives before any legal one.
Who we represent
Research peptide and RUO vendors
Online and business-to-business sellers operating on a research use only model. Exposure arises when the government can show the products were actually intended for human use, which it proves through website copy, social advertising, dosing tables, injection routes, reconstitution instructions, bundled diluent and syringes, customer base, and influencer content. We analyze the whole record, identify what creates exposure, and build the defense around actual intended use.
503A compounding pharmacies and 503B outsourcing facilities
Facilities investigated for compounding from bulk substances not on the FDA list, compounding Category 2 substances, compounding copies of commercially available drugs outside a valid shortage, using research grade or non-pharmaceutical-grade API, or marketing compounded product as equivalent to an approved drug. These are technical fights and they are winnable on the merits when the facts support it.
Unlicensed operators and out-of-state shippers
Companies that ship prescription drugs, compounded preparations, or dangerous devices into states where they hold no pharmacy, outsourcing facility, wholesaler, or third-party logistics license. This is the fastest-growing category of state enforcement, and most operators do not learn they needed a license until the cease and desist order arrives.
Telehealth and direct-to-consumer platforms
Platforms and their executives investigated over prescribing workflow, clinical evaluation adequacy, comparative marketing against approved products, and social advertising practices.
Prescribers, med spas, and wellness clinics
Physicians, nurse practitioners, and clinic owners who prescribe or administer peptides and GLP-1 products in weight loss, anti-aging, regenerative, and hormone practices. Prescribing an unapproved peptide is not off-label use, because the substance was never approved for any use. See Med Spa Defense.
API suppliers, importers, and logistics providers
Importers facing FDA detention under Import Alert 66-80, CBP holds, refusals of admission, and criminal referral for importing unapproved drug substances or filing customs declarations that describe drugs as laboratory chemicals.
Owners, officers, and executives individually
The responsible corporate officer doctrine allows conviction of a corporate officer in a position of responsibility without proof of intent or personal participation. In closely held companies the owner is the target whether or not the company is. Individual representation is a separate engagement and often a separate lawyer, and we structure it correctly from day one.
What the government charges
| Statute | Conduct | Exposure |
|---|
| 21 U.S.C. 331, 355 | Introducing an unapproved new drug into interstate commerce | Misdemeanor under 333(a)(1), up to 1 year, no intent required |
| 21 U.S.C. 333(a)(2) | Same conduct with intent to defraud or mislead, or a second offense | Felony, up to 3 years per count |
| 21 U.S.C. 351, 352 | Adulteration and misbranding | Charged alongside 331 |
| 21 U.S.C. 353a, 353b | 503A and 503B compounding conditions | Loss of the exemption is the predicate for everything above |
| 18 U.S.C. 1343 | Wire fraud, each order and payment a separate count | Up to 20 years per count |
| 18 U.S.C. 1347 | Health care fraud where a payor was billed | Up to 10 years per count |
| 18 U.S.C. 371 | Conspiracy, sweeping in marketers, fulfillment, and medical directors | Up to 5 years |
| 18 U.S.C. 1956, 1957 | Money laundering on the proceeds | Up to 20 years per count |
| 18 U.S.C. 542, 545 | False customs declarations and smuggling on imported API | Up to 20 years |
| 18 U.S.C. 1960 | Unlicensed money transmitting where the business aggregates and routes customer funds | Up to 5 years |
| 18 U.S.C. 1519 | Obstruction, destroying or altering records after notice | Up to 20 years |
| 42 U.S.C. 1320a-7b(b) | Anti-Kickback Statute where value moves for referrals | Up to 10 years |
| State pharmacy acts and consumer protection statutes | Unlicensed practice, unapproved drug sale, deceptive trade practices | Varies, often per-day civil penalties |
Forfeiture runs alongside all of it. Tailor Made Compounding forfeited approximately $1.79 million on a guilty plea for distributing unapproved peptide drugs including BPC-157.
How these cases actually develop
The pathway is consistent, and knowing it is the whole advantage.
Stage one, regulatory. An inspection produces a Form 483. A complaint or a competitor referral produces a warning letter. A state board investigation produces a cease and desist order. None of these are criminal charges. All of them are published, and all of them establish notice.
Stage two, referral. The FDA refers when violations are willful, repeated, or involve patient safety risk, and above all when conduct continues after notice. Referrals go to the FDA Office of Criminal Investigations, which loops in HHS-OIG and now the DOJ Health and Safety Unit. This is the point at which target letter and pre-indictment defense becomes the whole case.
Stage three, investigation. By the time a grand jury convenes, the government has shipping records, payment processor data, years of advertising history, customer correspondence, and often cooperating former employees. It is building intent, and the marketing file is where it finds it.
Stage four, charging. FDCA counts anchor the indictment. Wire fraud, conspiracy, money laundering, and forfeiture are stacked on top to raise the guideline range and compel a plea.
The window that matters is between stage one and stage two. That is where documented cessation, a preserved record, a real remediation plan, and a declination presentation change outcomes. It closes fast. Where a case does reach sentencing, federal sentencing mitigation is where the loss and forfeiture calculations are fought.
Our approach
We assume parallel proceedings from day one. Administrative, civil, and criminal tracks run at the same time. Companies lose these cases in the administrative track, by answering a regulator in a licensing frame of mind and handing the government a statement it could never have compelled. Every outbound communication in a matter we handle gets cleared for criminal exposure before it goes.
We preserve before we remediate. Website changes, deleted marketing, purged order systems, and cleaned inboxes after notice are how a regulatory problem becomes an obstruction case, and the obstruction case is worse than the underlying offense. Archive first, then decide.
We litigate the statute, not the rhetoric. Whether the API was on the bulk list, whether a USP monograph existed, whether the shortage exception applied on the relevant date, whether compounding was patient-specific, whether the product was a copy of a commercially available drug. Most indictments in this space contain at least one count that fails statutory analysis.
We build the intent record early. FDCA felony counts and wire fraud counts both require intent. Reliance on counsel, the state of the regulatory guidance at the time, documented good-faith efforts, and prompt cessation on notice are all defenses, and they are far more persuasive when they were created contemporaneously rather than reconstructed after indictment.
We keep entity and individual counsel straight. When the owner and the company both have exposure, joint representation can work, but only with a written conflict waiver that actually explains what happens when the company is offered cooperation credit. We handle that structure correctly rather than discovering it at the worst moment.
The cheapest moment in this case is right now.
Nothing has been charged. No grand jury has convened. Whatever your position is today, it will be worse in six months if the record is not built correctly starting now. Call (561) 542-5494, any hour.
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