ASBM: With GLP-1 Shortage Over, Increased Focus on Safe Compounding is Needed

ARLINGTON, VIRGINIA / ACCESS Newswire / March 3, 2025 /Following the Food and Drug Administration 's (FDA 's) recent announcement marking the end of the shortage for popular GLP-1 weight loss drugs Ozempic and Wegovy, the Alliance for Safe Biologic Medicines (ASBM) urges a closer look at compounding pharmacies as their practices don 't always adhere to the FDA 's safety standards or other rules.

Ensuring the safety of compounded drugs has never been more important, following numerous serious safety incidents traced to compounding pharmacies including a 2012 meningitis outbreak that killed more than 100 people and sickened nearly 800. The outbreak was traced to products made by the New England Compounding Center, which as a compounding pharmacy was exempt from the FDA 's Current Good Manufacturing Practices (CGMP) to which drug manufacturers must adhere. Although the Drug Quality and Security Act (DQSA) was subsequently passed to give the FDA more authority to regulate the manufacturing and distribution of drugs, including those prepared by compounding pharmacies, significant gaps persist that put Americans taking compounded drugs at risk.

"Compounding pharmacies provide an important public service by increasing supply of medicines that are in shortage," says Philip Schneider, Chair of ASBM 's Advisory Board and past president of the American Society of Health-system Pharmacists (ASHP). "But some compounding pharmacies are now trying to continue this practice after a drug shortage ends-skirting FDA safety regulations and oversight, and potentially jeopardizing patient health." Compounding pharmacies ' lower regulatory compliance costs can contribute to a lower price point, which is frequently emphasized in direct-to-consumer advertising such as a recent Super Bowl ad for compounded GLP-1s watched by 123 million people.

Ronald Jordan, former president of the American Pharmacists Association (APhA) and a member of ASBM 's Advisory Board, highlights the need for more education on the risks of pharmacy compounding: "The U.S. drug supply is probably the safest in the world because of the FDA 's standards for drug manufacturing-but the public should know that these standards don 't apply to compounders, and those that do are not consistently enforced. On a continuum of risk, U.S. drug manufacturers would be on the low end for risk and pharmacy compounders would be on the high end."

ASBM Executive Director Michael Reilly, who assisted in overseeing FDA operations during his tenure as Associate Deputy Secretary at the U.S. Department of Health and Human Services, expressed concerns about the risks associated with reduced regulatory enforcement: "The resolution of the GLP-1 shortage presents an opportunity to reassess compounding practices and ensure that these pharmacies are only making compounded versions of GLP-1 drugs in rare circumstances where the FDA-approved versions do not meet a patient 's unique needs, and that they are doing so with the appropriate regulatory and safety compliance. Patients need to know their medicines are manufactured to the same quality and safety standards, wherever they are dispensed."

Founded in 2010, ASBM is a coalition of patients, physicians, pharmacists and manufacturers that has partnered with regulators worldwide to promote patient-centered policies that promote and preserve patient access to innovative medicines without sacrificing safety. ASBM is committed to collaborating with federal and state regulators, pharmacy societies, and Boards of Pharmacy to uphold high safety standards in compounding practices, ensuring that compounded medications remain as safe and effective for patients as their manufactured counterparts.

SOURCE: Alliance for Safe Biologic Medcines

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