ASCRS supports the Food and Drug Administration’s (FDA) efforts to ensure the safety and sterility of compounded and repackaged drugs. Most recently, ASCRS advocated for revised policies that seek to improve physicians’ access to compounded drugs for office-use to treat patients that present with emergent conditions. Additionally, we have been successful in advocating for continued access to repackaged biologics, such as Avastin.Issue Brief
How it Impacts You
ASCRS is concerned with the FDA’s implementation of the compounding provisions of the Drug Quality and Security Act (DQSA) and its impact on the availability of compounded drug products. Specifically, we are concerned with the FDA’s final guidance to only include substances on the 503B Bulks List if there is no FDA-approved drug available and if there is a clinical need for the compounded drug, as this action may limit patient and physician access to compounded drugs.