Frier Levitt attorneys are featured in a Pharmacy Practice News article titled, “FDA and State Boards Eye GLP-1s Amid Larger Compounding Scrutiny,” written by Bruce Buckley. The article centers on the evolving regulatory environment of pharmacy compounding and the increasing challenges faced by the industry.
They emphasize the growing focus on compounding, remarking, “If you think this buzz about compounding is going to go quiet in the near future, you really couldn’t be more wrong.” The article further highlights the intensified scrutiny and how high demand for certain medications is contributing to drug shortages. “It’s almost as if boards of pharmacy have opened the floodgates for inspections, especially in the GLP-1 compounding space.” These inspections are critical, and compliance is crucial. “Pharmacies should also be aware that state boards of pharmacy cooperate with the FDA and often accompany the FDA during inspections…So whether you’re a 503A or 503B, you have to make sure you comply with federal as well as state regulations.”
The article also covers the importance of written agreements for distribution between 503B facilities and 503A pharmacies, and the need for robust policies and procedures. Additionally, it touches on the varying regulations from state to state. They advise, “Engage with your board…If you have a question, get an answer. In my experience, boards are very responsive when you reach out.”
Read the full article for more insights from our experienced attorneys: https://www.pharmacypracticenews.com/Policy/Endocrinology/Article/10-24/FDA-and-State-Boards-Eye-GLP-1s-Amid-Larger-Compounding-Scrutiny/75026
