FDA Scrutiny of GLP-1 Compounding Is Just Getting Started, Expert Says

In an interview with Pharmacy Times, Annie Lambert, PharmD, BCSCP, clinical program manager for compliance solutions at Wolters Kluwer, discussed how pharmacists should reassess the appropriateness and risk of compounded glucagon-like peptide-1 (GLP-1) therapies as drug shortages ease, along with what to expect from FDA and state-level enforcement going forward.

Lambert acknowledged that shortages of semaglutide (Ozempic, Wegovy; Novo Nordisk) and tirzepatide (Mounjaro, Zepbound; Eli Lilly and Company) were real and that compounding played a meaningful role in helping patients access therapy when supply was constrained. However, she stressed that the underlying risk profile of compounding has not changed; what changed was the scale of demand, which surged alongside limited supply and drove a sustained increase in compounding activity. That scale, she noted, brings greater potential for variability in areas like ingredient sourcing, process controls, labeling, and patient instructions. As the supply chain stabilizes, Lambert said the conversation should shift from broad access toward individualized appropriateness, with compounding reserved for legitimate clinical scenarios, such as a need for a different dosage form, strength, or formulation, that are not met by an approved product.

On enforcement, Lambert said the visibility GLP-1 compounding has gained means pharmacies should expect more frequent reviews from the FDA and state boards of pharmacy. Her advice is to operate as though an inspection is always imminent: maintain robust operational processes and documentation, source active pharmaceutical ingredients from reputable suppliers, ensure staff are trained and competent, and conduct regular self-audits. This, she said, is not a time to cut corners on compliance.

Closing the interview, Lambert reiterated that pharmacists must remain vigilant as the regulatory landscape continues to evolve, balancing patient access with safety and rigorous documentation. She noted that adherence to US Pharmacopeia 797 standards represents best, and sometimes minimum, practice, and that these principles extend well beyond GLP-1 compounding to all compounded medications, underscoring pharmacists' ongoing role in ensuring safe, effective patient care.