FDA Reaffirms Strict Regulations Amid GLP-1 Compounding Concerns

Last week, the FDA announced that it is taking a more focused approach at regulating the marketing of glucagon-like peptide-1 (GLP-1) drugs as lawsuits and concerns over compounded formulations have swarmed pharmacy discourse as of late.¹

Dae Lee, PharmD, Esq, CPBS, and Lucas Morgan, Esq, are shareholders at Buchanan Ingersoll & Rooney and the hosts of the Pharmacy Law Lowdown podcast sponsored by Drug Topics. They recently joined us to provide much-needed legislative context to this ongoing development in the GLP-1 space as well as the ways in which pharmacies dispensing these drugs can stay safe from legal action.

“The lesson is simple and has been consistent, which is 503A pharmacies must remain patient-specific in both form and reality,” said Lee. “High-volume, standardized formulation, and national distribution are no longer being treated as aggressive compounding; they're being treated as manufacturing. If your GLP-1 business model depends on the scale rather than individualized prescription, you might be exposed.”

Whilst these medications continue to boom across the prescription drug marketplace, this phenomenon has drawn eyes from several stakeholders including US regulators, lawmakers, as well as patients and providers of various backgrounds.

As Morgan states, it’s important for pharmacies to “be very smart, cautious, and strict about marketing and advertising practices.” While these ongoing developments are expected to make a significant impact on the business of pharmacy, Lee and Morgan can help guide industry leaders toward where they need to be in order to maximize profits and avoid detrimental penalties.

Stay tuned for more updates from Lee and Morgan throughout the year. In the meantime, check out our most recent episode of the Pharmacy Law Lowdown to gain more insights from our hosts and learn about the hard-hitting legal developments that have been circulating at the start of 2026.

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REFERENCE

FDA intends to take action against non-FDA-approved GLP-1 drugs. News Release. FDA. February 6, 2026. February 11, 2026. https://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs