The shortage that once let pharmacies compound semaglutide and tirzepatide with little federal friction is over, and the FDA has spent the time since treating the gap between marketing claims and compounding law as its own enforcement target. The agency determined the tirzepatide shortage was resolved on December 19, 2024 and the semaglutide shortage was resolved on February 21, 2025, closing the exception that let a pharmacy compound an essentially-copy GLP-1 formulation because the approved drug was hard to find. Since then, three rounds of FDA warning letters, most recently a September 18, 2026 letter to a Houston compounding pharmacy, have tested the marketing and prescribing files of businesses still selling compounded GLP-1 products.
The Shortage Determinations That Ended the Exception
Section 503A/503B of the Food, Drug and Cosmetic Act lets a pharmacy compound a drug that is essentially a copy of a commercially available product only while that product sits on FDA's drug shortage list. Tirzepatide's wind-down deadlines fell first: 503A pharmacies had until March 5, 2025 (postponed from FDA's original February 18 date by a federal court ruling) and 503B facilities until March 19, 2025, under FDA's December 2024 declaratory order. Semaglutide followed on a longer clock, with an April 24, 2025 deadline for 503A pharmacies (pushed back by a parallel court challenge) and May 22, 2025 for 503B facilities, under FDA's February 2025 order. After those dates, compounding either drug as an essentially-copy formulation falls outside the shortage exception.
Three Rounds of FDA Warning Letters to Telehealth Marketers
The FDA's enforcement response has targeted marketing claims as much as compounding practice. On March 3, 2026, the FDA announced 30 warning letters to telehealth companies selling compounded GLP-1 products, after an initial round in September 2025. The letters cited two recurring problems: advertising language implying a compounded product was the same as its FDA-approved counterpart, and branding that carried the telehealth company's own name or trademark without disclosing which pharmacy actually compounded the drug. A third wave followed on June 8, 2026, when the FDA sent more warning letters to telehealth sellers of compounded semaglutide and tirzepatide for the same claims. A separate telehealth warning letter in February 2026 cited the same sameness and branding problems over compounded liraglutide.
What an FDA Warning Letter to a Pharmacy Looks Like
On September 18, 2026, the FDA sent a warning letter to a Houston compounding pharmacy that reached past marketing language into the prescribing file itself. The agency found production volumes suggesting the differences the pharmacy documented between its compounded semaglutide and tirzepatide and the FDA-approved versions were pretextual, and it found significant-difference determinations that were missing altogether or repeated in identical language across many records, boilerplate that undercuts an individualized prescribing judgment. The letter also cited sterile compounding failures, including inadequate smoke studies and media fill records rewritten without a clear audit trail, all tied to the cGMP rules that, together with beyond-use date tracking and USP 797/800, set the sterile-compounding documentation standard, covered in Ampules, Single-Dose Vials and Multiple-Dose Containers Under USP 797.
What Pharmacies Can Still Lawfully Compound
A 503A pharmacy can still compound semaglutide or tirzepatide for an individual patient when the prescriber documents a clinically significant difference from the commercially available drug, and the FDA has said it will not pursue a pharmacy that fills four or fewer prescriptions of a formulation in a calendar month, a different ceiling than the Anticipatory Compounding Limits governing how far ahead a pharmacy can prepare compounded doses before a prescription arrives. A 503B outsourcing facility cannot compound either drug from bulk substances unless the drug reappears on FDA's shortage list or the 503B bulks list, and on April 30, 2026 the FDA proposed excluding semaglutide, tirzepatide, and liraglutide from that list. Correct active-ingredient sourcing, covered in API Sourcing Documentation: Certificates of Analysis, supports either exception, the discipline behind a compounding pharmacy defense matter.
The marketing letters and the pharmacy inspection letter are testing whether the compounded drug was ever lawfully different from the product it replaced.
Why Early Legal Counsel Is Critical
It is critical that compounding pharmacies and telehealth-affiliated prescribers promptly retain experienced healthcare defense counsel upon receiving an FDA warning letter, a state board of pharmacy inquiry, or any other government inquiry tied to compounded GLP-1 products. Early legal intervention can protect the pharmacy's rights, ensure an accurate and complete response to FDA's findings, avoid inadvertent admissions in a corrective action plan, and preserve the documentation showing which prescriptions met the significant-difference standard. Delaying legal representation can significantly affect the outcome of a matter and expose the pharmacy to unnecessary risk.
How Health Law Alliance Can Help
Health Law Alliance's attorneys have overseen 2,000+ audits and handled 5,000+ matters, with 25+ years of experience.
The firm represents compounding pharmacies and telehealth-affiliated prescribers responding to FDA warning letters, state board of pharmacy inquiries, and the underlying question of whether a compounded GLP-1 formulation was ever lawful to fill. If your pharmacy or telehealth practice has received an FDA warning letter or a state board notice over compounded GLP-1 marketing or production, contact Health Law Alliance's GLP-1 compounding defense attorneys for a free, confidential consultation.
