503b Outsourcing Facility, cGMP, & Sterile Cleanroom Supplies
Transitioning a compounding pharmacy to a compliant 503b outsourcing facility is challenging. Our cleanroom consultants specialize in conversion to and maintaining compliance for outsourcing facilities. Following the Drug Quality and Security Act made effective November 27, 2013, the 503b section in the FDCA applies. Under this 503B section a sterile compounding pharmacy must register as…