Outside narrow, documented medical need, compounded versions of these drugs are no longer a lawful option, and FDA has logged hundreds of adverse event reports, some requiring hospitalization, tied to dosing errors from patients measuring their own doses out of compounded vials
For 503B outsourcing facilities, no equivalent safe harbor appears to apply, and enforcement grace periods that had been in place through early 2026 are expiring, leaving bulk compounders of GLP-1s in a substantially more precarious legal position
However, he added, It would be better if we figured out a national way to improve affordability across the broad set of patients.
Instead, integrated care models encompassing psychological support and medical management are recommended to improve treatment efficacy and patient adherence
What raises concerns are some of the recent reports of serious ADRs associated with GLP-1RAs: (i) Pfizers disclosure of elevated aminotransferases in users of lotiglipron (a novel oral GLP-1RA) is indicative of hepatocellular injury [11]