Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Tuesday, August 27, 2013
Proposed Law to Regulate Out-Of-State Compounding Pharmacies in California Introduced
August 27, 2013
A bill introduced in the California State Legislature is proposing that pharmacies that sell sterile compounded drugs in the state must meet stricter standards. This proposed legislation comes in the wake of a nationwide fungal meningitis outbreak in 2012 caused by tainted epidural steroid injections manufactured by a Massachusetts-based compounding pharmacy. Some 14,000 patients received injections of the drug, 700 became ill and 63 died.
In reaction to that and several other high-profile incidents concerning compounding pharmacies, the California State Board of Pharmacy threw its weight behind Senate Bill 294, which was introduced by State Sen. Bill Emmerson (R-Redlands). The bill would tighten oversight of compounding pharmacies to “ensure patient safety.” It passed the Senate in May and will now go before the Assembly Appropriations Committee.
The bill would require out-of-state pharmacies that sell or distribute sterile compounded drugs in California to meet the same standards as compounding facilities in California. The legislation would also require that out-of-state compounding pharmacies be subject to annual inspections and that they obtain a license to do business in the state. Those inspections would run about $780 per visit.
“I have introduced SB 294 to strengthen consumer protection and provide consistent oversight of pharmacies that ship or dispense sterile drug products in California so we can do everything we can to prevent another patient injury or death,” Emmerson said.
While some compounding pharmacy owners have lauded the proposed legislation, others have stated that stricter regulations would cause a shortage of sterile medications in California. This would ultimately make sterile compounded drugs more expensive.