Pharmacy Compounding Regulations The Genesis of the Drug...

Compounding is an important facet of pharmaceutics that allows the formulation of specific drugs for individual patients. The work done at compounding pharmacies permits the development of medicinal products for patients that cannot tolerate certain components from mass production pharmaceutical companies. These individuals may require uniquely compounded agents to be flavorless, preservative-free, dye-free, liquid, solid, or more. These specialty production facilities are necessary for therapy and an acceptable quality of life for individuals with specific needs. Recently, the patient-driven role of designer therapeutics that compounding pharmacies occupy was overshadowed when a manmade epidemic was produced a medical catastrophe when supposedly sterile materials were contaminated with infectious agents.1 In September 2012, a now defunct Massachusetts compounding pharmacy, the New England Compounding Center (NECC) synthesized over 17,000 contaminated steroid pain injections that were shipped to 23 states.2 Up to this point, the methylprednisolone acetate (MPA) injections compounded by the NECC have caused the death of 64 people and resulted in 751 cases of fungal meningitis in 11 states. With over 750 cases and still counting, the NECC outbreak is one the largest of healthcare-associated infections ever reported in the United States.3 In 2006, the NECC was under investigation by the Massachusetts pharmacy board and the FDA for numerous complaints. The