The FDA’s designation for 503B outsourcing facilities has opened a fast-growing, high-demand segment in the compounding pharmacy market. There is tremendous potential to improve the purity and sterility of both human and veterinary drugs with the use of cGMP, or current Good Manufacturing Practices. While the FDA regulates adherence to the manufacturers’ quality, training, and control processes, pharmaceutical manufacturers must determine their own testing protocols and test equipment that make up cGMP.
