Specifically, SB 294 requires both in-state and out-of-state pharmacies that compound sterile drug products for California patients that will be inhaled, injected, or administered into the eye to apply for a special, additional license from the California State Board of Pharmacy. Under this new law, the board is required to inspect these facilities annually to provide consistent oversight and ensure compliance with pharmacy law.
"Recent events have made it clear that it's necessary to increase oversight of sterile compounding pharmacies to ensure patient safety," Senator Emmerson said. "I'm pleased that the Governor signed SB 294 into law because we must do everything we can to prevent another patient injury or death."
In June 2012, a sterile injectable pharmacy located in Florida shipped contaminated medications into California which resulted in significant patient harm, including blindness in some cases. Then in October 2012, the New England Compounding Center based in Massachusetts shipped tainted steroid injections throughout the country, including California, causing fungal meningitis and other infections in 700 patients and resulting in the death of more than 60 people.
"The California State Board of Pharmacy is a consumer protection agency charged with patient safety with respect to prescription medications," Board President Stanley Weisser said. "California has strong laws to ensure patients receive sterile compounded medication that has been accurately and safely prepared. Board inspectors are all licensed pharmacists who will perform these annual, but unannounced inspections of these specialty pharmacies."
In addition to the licensure requirement, SB 294 requires the pharmacy to report to the board within 10 days any disciplinary action taken by another state or suspension of any accreditation held by the pharmacy. Also, this legislation requires any recall notice issued by the pharmacy for sterile drug products it has compounded to be provided to the board with 12 hours. By doing so, the board can assure that patients and their prescribers have been appropriately notified about the rare instance of a recall.
SB 294 will go into effect in July of 2014.