Saturday, October 19, 2013

California Governor nixes biotech drug bill, approves compounding pharmacy oversight

California Governor Jerry Brown (D) has vetoed a bill (S.B. 598) that would have imposed certain requirements on pharmacists substituting a biosimilar product for a branded reference drug. In his veto statement, Brown expressed his concern that because the U.S. Food and Drug Administration has not yet established the “interchangeability” standards for biosimilars, it would be “premature” to require pharmacists to notify prescribing physicians that they have dispensed a biosimilar to fill a prescription. He referred to the controversy that this requirement had engendered among stakeholders, stating “[d]octors with whom I have spoken would welcome this information,” but “other large purchasers warn that the requirement itself would cast doubt on the safety and desirability of more cost-effective alternatives to biologics.” 

Meanwhile, Brown has approved a bill (S.B. 294) that 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. The law requires the board to adopt “standards for compounding injectable sterile drug products in a pharmacy.” The law will take effect in July 2014.

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