Saturday, April 12, 2014

New California Sterile Compounding Laws to Take Effect July 1, 2014--Is your compounding pharmacy ready for these changes?

In October 2013 , California Governor Jerry Brown signed a new law (SB 294).  SB 294  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 California.  SB 294 also removes accreditation as an option for  obtaining a license for facilities providing sterile compounds  from the California State Board of Pharmacy.  SB 294 also mandates that all pharmacies that compound sterile drug products for use in California comply with the regulations in Title 16, California Code of Regulation (CCR), Sections 1735 and 1751, which address  sterile compounding record keeping, labeling requirements, training, quality assurance among other things related to sterile compounding.  This new law becomes effective July 1, 2014.

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