California continues to increase its oversight of sterile compounding in the State, proposing new regulations and inspecting 58% of the total pharmacy population licensed for sterile compounding (LSC) in a three month period (March 2014- June 2014). Inspection results will likely shape California’s ongoing development of regulations and enforcement strategy, and pharmacies doing business in the State should be guided accordingly.
According to a recent report published by ITL Consulting, results of the inspections revealed a disproportionate amount of violations occurring at community based pharmacies as compared to hospital based and non-resident pharmacies. While only 31% of hospital pharmacies and 64% of non-resident pharmacies were out of compliance with California law, 89% of community pharmacies with an LSC permit were out of compliance. The most prevalent violation among all three groups related to insufficient policies and procedures for sterile compounding. Infrequent cleaning or failure to document cleaning, lack of policies related to end product testing, failure to maintain written standards for quantitative analysis, and insufficient staff training and record keeping were also among the top five violations identified. Pharmacies can expect a focus on these identified trends and should assess the adequacy of current operating procedures to ensure preparedness for an inspection. Other states have joined California in its commitment to enforcing high quality standards for sterile compounding. Florida, Maryland, New Jersey, and Utah have all recently passed laws transforming the requirements for compounders doing business in those States.
Contact Frier Levitt for help ensuring your pharmacy’s practices comply with these changing regulations.
