Pharmacy Compounding of Sterile Products (Resolution 109-1-13)

Resolution No: 109-1-13
Title: Pharmacy Compounding of Sterile Products
Action: Pass

WHEREAS, the patient need for compounded medications has increased and pharmacists compounding safe and effective medications of the required quality for their patients is necessary; and

WHEREAS, shortages of critical, lifesaving prescription medication have resulted in the increased demand for compounded medications by pharmacists; and

WHEREAS, in many states, pharmacies engaging in sterile compounding must meet or exceed the applicable quality standards contained in the most current edition of the United States Pharmacopeia (USP), including but not limited to Chapter <797>; and

WHEREAS, pharmacies engaging in high risk sterile compounding require additional oversight; and

WHEREAS, protecting the public health is the primary mission of the state boards of pharmacy and the National Association of Boards of Pharmacy (NABP);

THEREFORE BE IT RESOLVED that NABP encourage boards of pharmacy to reference sterile compounding quality standards, including but not limited to those contained in USP Chapter <797> , as the standard for sterile compounding in their state; and

BE IT FURTHER RESOLVED that NABP encourage that all boards of pharmacy conduct qualified surveys or inspections of pharmacies engaged in sterile compounding, or use and recognize qualified surveys or inspections conducted by a nationally recognized body; and

BE IT FURTHER RESOLVED that NABP review and, if necessary, propose amendments to the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy to address appropriate regulation and require inspection of pharmacies engaged in sterile compounding.

(Resolution passed at the NABP 109^th Annual Meeting in St Louis, MO)