Moving fast to bolster its authority over compounding pharmacies that operate as manufacturers of prescription drugs, FDA is urging “outsourcers” to register, seeking state support, and moving to issue more rules and guidance. The agency is pleased that 14 outsourcers registered through mid-January. The number is small, considering that an estimated 3000 compounding pharmacies make sterile injectible drugs, but this initial activity reflects FDA’s fast action in implementing the Drug Quality and Security Act (DQSA), which was enacted less than three months ago.
One strategy to spur registration is to urge hospitals to exert their purchasing power to compel compounders to embrace the new regulatory system. FDA commissioner Margaret Hamburg sent letters in early January to hundreds of hospitals urging them to pressure the compounding pharmacies they buy from to sign up as outsourcing facilities. Support for this approach was recently voiced by executives at the Premier hospital system, which purchases drugs for hundreds of hospitals.
continue to read here
One strategy to spur registration is to urge hospitals to exert their purchasing power to compel compounders to embrace the new regulatory system. FDA commissioner Margaret Hamburg sent letters in early January to hundreds of hospitals urging them to pressure the compounding pharmacies they buy from to sign up as outsourcing facilities. Support for this approach was recently voiced by executives at the Premier hospital system, which purchases drugs for hundreds of hospitals.
continue to read here