Comment from Eastwood Pharmacy
AnonymousSupportIndividual
Summary: Anna Pawelczyk, a pharmacist and small business owner, supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulk drug list. She argues that the mass compounding of these GLP-1 medications lacks the safety regulations and quality standards of FDA-approved manufacturers, posing significant risks to consumers.
I am writing to support the FDA’s proposed decision to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list.
As a pharmacist, I know first-hand the role that compounding pharmacies play, and in many cases they fill a critical gap for some patients who need specialized medications. While there are risks associated with compounding, for patients who have serious allergies or need an alternative form of a medication, the benefit outweighs the risk
However; the mass compounding of GLP-1s far exceeds anything I have seen in my profession. Unfortunately for too many patients, they don’t even realize the risks they are taking. Compounding pharmacies don’t have the same safety regulations and aren’t held to the same production and quality standards like FDA-approved medication manufacturers are. This means that ingredients, impurities, and labeling aren’t monitored the way that FDA-approved medications are.
I have dedicated my career to ensuring people have access to safe medications and know what they are taking. As a pharmacist and small business owner, I support the important step to protecting consumers that this proposed decision represents.
Anna Pawelczyk, Pharmacist & Pharmacy Owner