New Sterile Compounding Requirements - SB 294

 Governor Brown signed a bill into law this month which will impact the practice of sterile compounding. The board of pharmacy supported SB 294 Sterile Drug Products authored by Senator Bill Emmerson (R-23) in an effort to maintain the safety of California’s supply of compounded sterile medications. 

This new law will preempt Joint Commission accreditation provisions for all hospitals, home health care and other facilities providing sterile compounding. These facilities will now be required to apply for a California LSC license, exclusively for compounding sterile medications. In addition to the initial application process, the facilities must comply with all state regulations pertaining to sterile compounding and undergo an inspection prior to receiving a license. 

Hospitals and other facilities will likely be charging their compliance officers and ad hoc committees with this task. Internal resources will need to be reallocated and changes to the workflow implemented. Preparing for an inspection can be a grueling process, as policies and procedures, facilities, documentation and training must all be up to par to obtain this license. Consulting with professionals to fill in these gaps and verify the accuracy of a pharmacy’s practice can prove time, resource and sanity saving. 

The board of pharmacy has spent more than half of its $14 million dollar expenditures on personnel alone, many being new inspectors. Additionally, they plan to hire more inspectors with the expectation of inspecting these new pharmacies applying for the LSC. California has been a national leader in patient safety for pharmacy compounding and continues to demonstrate this commitment through their legislative efforts and enforcement of sterile compounding. Let’s be sure our hospitals, home health care, and other facilities continue to uphold an exceptional level of quality as we move through the wake of the NECC calamity.