Dive Brief:
- The FDA is urging healthcare providers to buy compounded drugs only from facilities registered with the federal government, which are subject to inspections.
- The request follows on a new law which gives the agency more authority over large compounding pharmacies; those that register as "outsourcers" must provide product information, submit to federal inspections and comply with quality standards similar to those followed by drug manufacturers.
- The new legislation governing compounding pharmacies responded to the death of 64 people who were given drugs from one such pharmacy in Framingham, Mass.
Dive Insight:
Compounding pharmacies have been a sore spot for the FDA for some time, as they have proven difficult to regulate adequately. With its new powers over these pharmacies, one should hope that incidents like the one in Massachusetts will be averted. However, the FDA is understandably concerned that large compounding pharmacies aren't required to register, but rather, have the choice to do so. It's possible that further regulation requiring that these pharmacies register may be in order.