Legislation, Regulation and Advocacy
Compounding Legislation Action Center - California
Senate Bill 294
California compounding legislation has been signed into law to regulate sterile compounding pharmacies resident to California and sterile compounding pharmacies that ship product into California.
The new California law creates a new type of licensure for sterile compounding pharmacies called a “sterile compounding pharmacy license.” This new licensure requirement becomes effective in July of 2014. The new licensure requirement is applicable to both California resident pharmacies and nonresident pharmacies. Specifically the new law would increase state oversight of compounding pharmacies by prohibiting any pharmacy, including those outside the state, from dispensing compounded pharmaceuticals to state residents without first obtaining a sterile compounding pharmacy license from the California State Board of Pharmacy. Without the sterile compounding pharmacy license it would be a crime to dispense sterile compounded product in California.
Under the new licensure requirement the state board of pharmacy will inspect the pharmacy, including nonresident pharmacies, to ensure the pharmacy is found in compliance with California state law and regulations adopted by the board. The pharmacy must also submit:
- the pharmacy’s policies and procedures for sterile compounding;
- self-assessment form (pursuant to state law);
- copies of all inspection reports conducted of the pharmacy’s premises;
- any reports from private accrediting agencies conducted in the prior 12 months documenting the pharmacy’s operations; and
- a list of all sterile medications compounded by the pharmacy since the last license renewal.
Any licensed pharmacy must also:
- provide to the board a copy of any disciplinary or other action taken by another state within 10 days of the action;
- notify the board within 10 days of the suspension of any accreditation held by the pharmacy;
- provide to the board, within 12 hours, any recall notice issued by the pharmacy for sterile drug products it has compounded; and
- report adverse effects reported or potentially attributable to a pharmacy’s sterile drug product to the board within 12 hours and immediately report to the MedWatch program of the federal Food and Drug Administration.
The legislation also sets for a fee schedule for the licensure. For resident pharmacies the fee for licensure remains the same as it was prior to the legislation being passed. For nonresident pharmacies the cost of the licensure is $780 and the cost of the inspection is born on the nonresident pharmacy. This payment is initiated by a deposit of funds deemed reasonable by the board of pharmacy and after the inspection overruns will be covered by the pharmacy and if the amount deposited is in excess of costs the difference would be remitted to the pharmacy.