If your medical practice or pharmacy compounds, prescribes, or dispenses semaglutide or tirzepatide, you may already be in the crosshairs of pharmaceutical giants Novo Nordisk and Eli Lilly.
Drug manufacturers have escalated their enforcement efforts with cease-and-desist letters targeting the entire supply chain – from compounding pharmacies to weight loss clinics to prescribing physicians. Pharmacies and medical practices are receiving such letters demanding immediate cessation of all compounding, distribution, and dispensing activities related to GLP-1 medications.
Recipients are given only days to respond and certify compliance. Failure to comply, says the drugmakers, will result in civil litigation and referral to regulatory authorities.
The message is clear: Compounding and dispensing “essentially a copy” of commercially available semaglutide or tirzepatide without medical necessity violates the Food, Drug, and Cosmetic Act (FD&C Act) and can result in legal action.
Why Enforcement Against Compounded GLP-1 Has Escalated
The legal landscape has changed dramatically since early 2025:
FDA removed semaglutide from the drug shortage list in February 2025. When the U.S. Food and Drug Administration declared that Ozempic® and Wegovy® supplies now meet or exceed nationwide demand, it triggered strict legal prohibitions under federal compounding laws.
Courts upheld FDA's decision. In April and June 2025, the U.S. District Court for the Northern District of Texas denied attempts to reverse FDA's shortage determination and dismissed the case with prejudice.
Federal law prohibits making “essentially a copy” of commercially available drugs. Under Sections 503A and 503B of the FD&C Act, compounding pharmacies cannot regularly or routinely compound drugs that are essentially copies of FDA-approved products when those products are available.
You may still prescribe compounded GLP-1 drugs in certain circumstances, but your prescription must clearly articulate a medically necessary and significant difference from the commercially available drug product.
When Is a Compounded Drug “Essentially a Copy”?
FDA applies four factors to determine whether a compounded drug is essentially a copy of a commercially available product:
- Same active ingredient – semaglutide or tirzepatide
- Same route of administration – subcutaneous injection
- Same dosage form – injectable solution
- Same strength – matching FDA-approved doses (0.25mg, 0.5mg, 1mg, 1.7mg, 2.4mg, etc.)
If your compounded product meets these four criteria, it is essentially a copy of Ozempic®, Wegovy®, Mounjaro®, or Zepbound® – and it is illegal to compound, prescribe, or dispense.
Common Misconceptions About Compounded GLP-1 Drugs
MYTH #1: “We add vitamin B6, so it's not a copy.”
REALITY: If two approved drug products are combined in a way that offers both active ingredients in the same dosage strengths, the compounded drug would be essentially a copy.
MYTH #2: “We use different concentrations, so we're allowed.”
REALITY: Minor concentration variations do not constitute legitimate individualization under FDA guidance.
MYTH #3: “Patients can't afford FDA-approved versions, so we have medical necessity.”
REALITY: Cost alone is not recognized as a medical necessity under federal compounding laws. Patient affordability does not justify compounding when FDA-approved alternatives exist.
MYTH: “We only fill individual prescriptions, not bulk orders.”
REALITY: The FDA has stated that it does not intend to take action against a compounder for compounding a drug product that is essentially a copy of a commercially available drug product regularly or in inordinate amounts if the compounder fills four or fewer prescriptions for the relevant compounded drug product in a calendar month. Filling individual prescriptions for essential copies of commercially available drugs in excess of this threshold would subject the compounding pharmacy to enforcement action.
When Is Compounded Semaglutide Permissible?
The only circumstances where compounding semaglutide or tirzepatide may be permissible are:
- True allergy to a specific inactive ingredient in the FDA-approved version, documented with allergy testing and medical records
- Documented medical need for a different concentration not commercially available, with clear clinical justification
- Specific patient population requiring dosage form modification, such as pediatric use, with proper medical justification
Healthcare providers must document medical necessity with extensive clinical evidence. “Patient preference” or “cost savings” are insufficient justifications.
If you cannot meet this burden of proof with clear, documented medical necessity, you cannot legally compound these medications.
What Drug Manufacturers Are Demanding
Novo Nordisk and Eli Lilly have sent cease-and-desist letters to compounding pharmacies, weight loss clinics, medical spas, and other entities involved in the compounding of GLP-1 medicines.
The letters allege:
- Unlawful participation in the distribution and sale of compounded semaglutide or tirzepatide products
- Violation of FDA compounding regulations under Sections 503A and 503B
- Creation of public health risks through unapproved, untested products
- Trademark infringement and false advertising
- Unfair competition
Recipients are typically given 10-14 days to respond in writing, certifying that they have ceased these activities. Failure to respond or continued non-compliance risks litigation and referral to the appropriate authorities for investigation.
What to Do If You Receive a Cease-and-Desist Letter over Semaglutide Compounding
If you've received a cease-and-desist letter from Novo Nordisk, Eli Lilly, or their legal counsel, take these steps immediately:
- Do Not Ignore the Letter. Cease-and-desist letters demand a response within a specific timeframe (typically 10-14 days). While missing this deadline does not create immediate legal consequences, ignoring the letter signals non-compliance, making litigation more likely.
- Do Not Respond Without Legal Counsel. Never draft a response yourself. Even well-intentioned responses can inadvertently admit liability or waive important defenses.
- Cease Prohibited Activities Immediately. Regardless of whether you respond to the letter, you must stop all activities that violate federal compounding laws. Continuing these activities after receiving the letter significantly increases your legal exposure.
- Preserve All Records. Document destruction during an investigation constitutes obstruction and can result in separate federal charges.
- Consult a Healthcare Attorney Immediately. Contact an attorney who focuses on healthcare regulatory law and FDA compliance.
Drug manufacturers have filed hundreds of lawsuits already. Many defendants who received cease-and-desist letters and failed to respond or continued prohibited activities were sued within weeks.
The Broader Enforcement Campaign Against “Bootleg” GLP-1
Cease-and-desist letters are only one tool in an aggressive, nationwide movement to stop the illegal compounding of GLP-1s.
Federal Lawsuits
As of mid-2025, Novo Nordisk has filed more than 130 lawsuits across 40 states against telehealth companies and compounding pharmacies marketing and selling compounded semaglutide. The company has obtained permanent injunctions against numerous defendants, barring them from future violations.
On February 8, the drugmaker announced legal action against telehealth company Hims & Hers, asking the court to permanently ban the company from selling unapproved, compounded drugs.
Eli Lilly has filed similar lawsuits to protect its FDA-approved brand-name drugs, Mounjaro® and Zepbound®, suing dozens of compounding pharmacies, clinics, and medical spas.
These lawsuits assert legal theories, including:
- Trademark infringement
- Violating the corporate practice of medicine doctrine
- False advertising
- Unfair competition
- Violations of federal drug laws (misbranding, unapproved new drugs)
FDA Enforcement
On February 6, 2026, FDA announced its intent to use “all available compliance and enforcement tools within its authorities to address unsubstantiated claims and associated public health concerns.”
The FDA explicitly announced steps to combat compounding pharmacies making these marketing claims:
- Compounded products are “generic versions” of FDA-approved drugs
- Compounded products are “the same as” FDA-approved drugs
- Compounded products use “the same active ingredient” as FDA-approved drugs
- Compounded products are “clinically proven” to produce results
FDA has made clear that “failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.” This means the agency may bypass traditional warning letter procedures.
State Regulatory Actions
18 state boards of pharmacy and medicine have issued direct alerts to licensees about compounded GLP-1 medications, like this one from the Idaho Division of Occupational and Professional Licenses. Professional license investigations and disciplinary actions are underway in multiple states.
Some states have taken particularly aggressive stances:
- Louisiana's Board of Pharmacy imposed restrictions on semaglutide compounding
- Alabama's State Board of Medical Examiners issued declaratory rulings
- Multiple state Attorneys General have issued consumer warnings
State medical and pharmacy boards are coordinating with FDA to investigate complaints about compounded “semaglutide” and “tirzepatide” products.
What This Means for You: If You're a Compounding Pharmacy
You cannot legally compound semaglutide or tirzepatide except in rare, documented cases of true medical necessity. Consult a healthcare attorney about potential liability exposure from your operations.
The risk is real. Compounding pharmacies face:
- FDA warning letters and enforcement actions
- State pharmacy board investigations and license discipline
- Civil lawsuits from drug manufacturers seeking damages and permanent injunctions
What This Means for You: If You Operate a Weight Loss Clinic
You cannot order, distribute, or dispense compounded GLP-1 medications that are essential copies of commercially available drug products. Consult a healthcare attorney about potential liability exposure from your operations.
You face liability for ordering compounded copies of commercially available drugs. Essential copies of commercially available drug products, which are made in violation of 503A and 503B of the FD&C Act, may be considered to be adulterated or misbranded. Even if you are not the compounding pharmacy, you can be held responsible under federal law for ordering and purchasing adulterated or misbranded drugs.
What This Means for You: If You're a Prescribing Physician
You should not prescribe compounded semaglutide or tirzepatide except in rare circumstances where the individual patient medically requires a compounded alternative to the commercially available drug product. Consult a healthcare attorney about potential liability exposure from your operations.
Your professional license is at risk. State medical boards are scrutinizing GLP-1 prescribing practices. Prescribing compounded drugs when FDA-approved alternatives exist may trigger investigations, particularly if you are prescribing via telemedicine or without established patient relationships.
Professional liability insurance may not cover claims related to unapproved drugs.
The Stakes Are Too High to Delay
This is not a gray area anymore. The legal requirements are clear, enforcement is active and aggressive, and the consequences of non-compliance are severe.
Don't let short-term revenue concerns lead to long-term professional and financial disaster.
The window for claiming ignorance has closed. With FDA's shortage resolution, court decisions upholding that determination, and drug manufacturers' aggressive enforcement campaign, continued involvement with compounded semaglutide or tirzepatide is legally indefensible.
Contact Hendershot Cowart P.C. Today
Our healthcare law attorneys understand the complex regulatory landscape surrounding pharmaceutical compounding. We can help you:
- Assess your specific legal risk from past and current compounding activities
- Develop a compliance plan to transition your practice or pharmacy
- Respond to cease-and-desist letters from drug manufacturers or their counsel
- Defend against regulatory investigations from FDA or state boards
- Protect your professional license during board investigations or disciplinary proceedings
Call (713) 783-3110 or contact us online for a confidential consultation.