Earlier this month, House Representatives Gene Green, Morgan Griffith and Diana DeGette introduced the Compounding Clarity Act (CCA), a bipartisan bill aimed at preventing future tragedies such as the one caused by the New England Compounding Center.
The CCA sets out to define the roles that the FDA and individual states should take to ensure the quality and safety of all compounded drugs in the country.
The core of the CCA aims to distinguish between small-scale and larger-scale compounders by clarifying the roles that individual states and the FDA have in regulating such facilities. Additionally, the CCA seeks to preserve the current physician-patient-pharmacist relationship and maintain access to compounded medications.
How will the Compounding Clarity Act prevent another public health crisis? (1)
Expecting frequent or routine examinations from state pharmacy boards and the FDA, compounding operations are evaluating their equipment, engineering controls, facility design, and the standard operating procedures for compounding. This article highlights the results from one such audit that was performed recently: Design and Certification of Compounding Pharmacies.
Sterile compounding facilities are now required to be certified on a semi-annual basis to reasonable ensure compliance with regulatory expectations. To help, one non-profit organization – The Eagleson Institute is offering a one-day class on the design elements required for a compounding facility to pass certification and operate properly. Included is instruction on primary engineering controls that may often be utilized within a compounding facility (biological safety cabinets).