A Pharmacist’s Look Into the Rise, Challenges of GLP-1 Compounding

With glucagon-like peptide-1(GLP-1) receptor agonists dominating headlines and clinical demand, the regulatory landscape surrounding their compounding is evolving at a breakneck pace. As telehealth and compounding entities are reprimanded and warned respectively, pharmacists are left to facilitate patients’ questions and concerns surrounding these uniquely formulated medications.

“While we cannot claim that there is similarity to a reference product, we can speak to the safety of the compounding process, the training of our personnel, and really the reliance on evidence-based literature to support our formulations and quality management processes,” Annie Lambert, PharmD, BCSCP, clinical program manager for compliance solutions at Wolters Kluwer and board-certified compounding expert, told Drug Topics. “Focus on your team’s abilities and your processes and go from there.”

In this episode of Over the Counter, Lambert dissects the FDA’s recent crackdown on marketing compounded GLP-1s and the critical role pharmacists play in ensuring patient safety.

The booming popularity of these medications has created a complex intersection of drug shortages, regulatory burdens, and clinical necessity. Lambert clarifies the essential distinctions between 503A patient-specific compounding and 503B outsourcing facilities—particularly how pharmacies must justify anticipatory batch quantities to avoid the impression of mass production.

The conversation also explores how pharmacists can serve as essential navigators for patients facing high out-of-pocket costs and confusing narratives in the media. For pharmacists looking to balance medication access with strict quality oversight, Lambert taps into her expertise to provide the nuance and understanding necessary to manage this growing industry challenge.

Stay tuned for weekly podcast episodes of Over the Counter powered by Drug Topics. Check out our most recent episode with Lani Bertrand, senior director of clinical marketing and thought leadership at Omnicell. She joined us to discuss ongoing issues surrounding drug shortages and the emerging technologies being used to address them.

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