Assessing whether a compounded GLP-1 can lawfully be made and dispensed
Reviewing websites, ads and social media against FDA warning letters
Structuring telehealth, prescriber and pharmacy agreements
Responding to FDA, state boards and manufacturer cease-and-desist letters
Legal Counsel on Compounded Semaglutide and Tirzepatide
Compounded GLP-1s grew quickly while the branded drugs were in shortage. FDA has since declared the tirzepatide and semaglutide shortages resolved, and the agency is now focused on how compounded versions are made, sold and advertised. Since September 2025 it has issued several rounds of warning letters to telehealth companies, including 30 letters announced in March 2026 and 25 more in June 2026. In May 2026 FDA also proposed not to add semaglutide, tirzepatide or liraglutide to the 503B bulks list.
MDRXLaw draws on its pharmacy, telehealth and med spa practices to help clients understand what they can still do and how to do it lawfully.
What FDA's Warning Letters Target
Claims or impressions that a compounded drug is the same as, or as effective as, an FDA-approved product.
Statements that the product, or the pharmacy that made it, is "FDA-approved" or "FDA-licensed."
Branding that hides which pharmacy actually compounds the drug.
Formulation claims, such as added vitamins, presented as if clinically proven.
How We Help
Compounding analysis for 503A pharmacies and 503B outsourcing facilities, including the limits on copies of approved drugs and documentation of patient-specific clinical need.
Website and advertising review for telehealth platforms, med spas and weight-loss clinics, under FDA misbranding rules and FTC advertising standards.
Business structure: management services, prescriber and pharmacy agreements, and state corporate practice and fee-splitting rules.
Supply chain: API sourcing, supplier qualification and the risks of research-use-only peptides.
Enforcement and disputes: warning letter responses, state board investigations, and manufacturer trademark or false advertising claims.
Related Practices
See our drug and pharmacy regulatory, medical spa and digital health pages.
Talk to Us
If you compound, prescribe or sell GLP-1 products, or have received a warning letter or demand letter, contact us for a confidential review. Rules in this area are changing quickly.
