California Bill Would Implement Stricter Requirements for Pharmacies Compounding Sterile Drugs

Pharmacies compounding sterile drug products for dispensing to patients in California would be required to obtain a license to engage in that practice under a bill (SB 294) introduced to the state’s senate on February 19, 2013. Under the bill, both resident and nonresident pharmacies that compound sterile products for dispensing or shipment into the state must apply to the California State Board of Pharmacy for licensure. An on-site inspection by the Board would be required prior to licensure. Nonresident pharmacies would be responsible for payment of travel expenses of the Board in connection with an inspection. In addition, a list of all sterile drug products compounded by the pharmacy must be provided to the Board, as well as notification of any disciplinary action taken by another state or suspension of any accreditation held by the pharmacy.