California Passes Law Requiring Special Licenses for Sterile Compounding

Governor Jerry Brown of California signed a new law (SB 294) that requires sterile compounding pharmacies to obtain additional licensure from the California State Board of Pharmacy before compounding or dispensing sterile drug products, or before shipping these products into the state. Under the law, compounding pharmacies will also be subject to random, annual inspections by the Board. Pharmacies will also be required to report to the Board any disciplinary or regulatory action taken against the pharmacy by another state within 10 days, and any recall notice within 12 hours. According to a news release from the office of State Senator Bill Emmerson, the bill’s sponsor, two separate incidents in June and October 2012 in which contaminated compounded products shipped into the state caused “significant patient harm” were the impetuses for the legislation. SB 294 will go into effect on July 1, 2014.