HOUSTON
Volume 16 | Issue 3
Inside This Issue
Texas A&M University Names Dr. Timothy B. Boone as Dean of the School of Engineering Medicine (EnMed) See pg. 10
INDEX Oncology Research......... pg.3 Healthy Heart....................... pg.7 Framework............................. pg.8 Hospital News ..................... pg.9 Financial Forecast............ pg.12
SHSU-COM’s Thomas J. Mohr, DO, Addresses Congress on the Future of Healthcare See pg. 11
March Edition 2026
FDA Threats Escalate, Signaling Heightened Enforcement Risk for GLP-1 Compounding
By Joshua D. McCann, J.D., Pharm.D. Suzanne E. Bassett, J.D. Polsinelli, PC
G
lucagon-like peptide-1 (“GLP-1”) receptor agonists, including semaglutide and tirzepatide, remain in high demand for diabetes management and chronic weight loss. FDA-approved GLP-1 products have faced supply constraints in recent years, and compounded alternatives expanded during periods when certain products appeared on FDA’s drug shortage list. FDA and other federal officials are now signaling a more aggressive posture toward non- FDA- approved compounded GLP-1 products, particularly where products are manufactured or distributed at scale or marketed directly to consumers as “copycats” or “generic” equivalents of approved drugs. Recently, FDA publicly announced it intends to take “decisive steps,” including restricting access to GLP-1 ingredients used in certain compounded products and using its enforcement tools against companies that manufacture, distribute, or market illegal “copycat” drugs. On the same day of the FDA’s public announcement, the HHS General Counsel stated on social media that his office referred Hims & Hers to the Department of Justice for investigation of potential federal law violations. These developments followed a rapid series of events tied to Hims & Hers’ announcement of a compounded oral semaglutide product, Novo Nordisk’s public response, and Hims &
Hers’ subsequent announcement that it would stop offering the compounded semaglutide pill. Key Enforcement Signals 1. Restricting access to GLP-1 active pharmaceutical ingredients (APIs). FDA indicated it intends to restrict access to GLP-1 ingredients used in certain non-FDA-approved compounded drugs, a step that could constrain supply for some compounding arrangements. 2. Broader use of compliance and enforcement tools. FDA stated it will use available enforcement tools— potentially including warning letters, injunctions, and seizures— against companies involved in manufacturing, distributing, or mass-marketing illegal GLP-1 copycats. 3. Increased scrutiny of advertising and marketing claims. FDA specifically pointed to “misleading direct-to-consumer advertising and marketing,” including claims that compounded products contain the “same active ingredient” as approved drugs or are “generic” versions. 4. Unclear line- drawing between 503A and 503B approaches. FDA’s announcement did not clearly
distinguish between compounded products that are direct copies and those involving formulation changes (e.g., dosage form changes, additional active ingredients, etc.). It also did not clearly delineate how the agency will apply its posture across Section 503A traditional pharmacy compounding and Section 503B outsourcing facilities, creating uncertainty for operators in both spaces. Regulatory Background Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act establish distinct compounding pathways. In general, both pathways restrict compounding drugs that are “essentially a copy” of an FDA-approved, commercially available drug, but shortages can change the analysis when a drug appears on FDA’s shortage list. FDA’s removal of certain GLP-1 products from the shortage list beginning in late 2024 narrowed the scope of permissible “copy” compounding and increased focus on how FDA applies the “essentially a copy” concept going forward. Under Section 503A, certain see GLP-1 ...page 14
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