FDA Issues New Draft Guidances For Compounding Pharmacies

Just days after President Obama signed into law a bill that was designed to bolster FDA oversight of compounding pharmacies (back story with a link to the bill), the agency has issued no fewer than three new draft guidances that cover reporting procedures, registration requirements, conditions under the law that would determine when a compounded drug is exempt from certain other provisions and enforcement actions the FDA may take. The guidances appear after the FDA has spent the past year scrambling to recover from a scandal involving a fungal meningitis outbreak that was traced to the New England Compounding Center. So far, there are 751 reported cases, including 64 deaths, and the episode has been called the worst public health crisis in the US in decades (see this). The outbreak cast a harsh spotlight on the FDA and state regulators, and the extent to which they properly exercise their available authority. At a Congressional hearing held after the outbreak emerged, FDA officials were harshly criticized for not moving faster to prevent NECC from shipping medicines in large quantities across state lines. The FDA, however, maintained that additional Congressional authority is needed to more effectively oversee compounders because its resources were limited and court rulings compromised its ability to pursue suspect compounders, although the agency has previously declared a willingness to pursue compounders that engage in the equivalent of drug manufacturing (back story). The ...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs