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 investigation resulted in a 2006 consensus agreement that the NECC agreed to comply with. The NECC would avoid detrimental sanctions if they agreed to more stringent record-keeping and other procedures. Eight months before the outbreak in January 2012, through their wn monitoring, the NECC discovered pathogens in rooms designed to supply sterile vials. Neither the FDA or the state board could determine if the NECC had been able to rectify that particular problem. Both government agencies have said that they lacked the authority to enforce any type of effective action against the specialty pharmacy.4
In the wake of the NECC scandal, lawmakers attempted to extend the regulating power of the FDA over compounding pharmacies. Previously, compounding pharmacies straddled a line over being labelled drug manufacturers or simple mortar and pestle pharmaceutics. Since compounding pharmacies are not regarded as industrial manufacturers, their governing jurisdiction fell under the state.5 On November 27, 2013, President Obama ratified the Drug Quality and Security Act (DQSA), a body of laws that contains important provisions designed to grant greater oversight to the compounding of human drugs.6
The DQSA allows a compounding pharmacy to register with the FDA as an outsourcing facility. This facility would have to compound in compliance with Current Good Manufacturing Practice (CGMP) guidelines or under supervision of a licensed pharmacist in a registered facility. The facility would also be...