California BoP Modifies First Proposed E-Pedigree Regs in Response to Public Comment

During its public board meeting on December 13, the California State Board of Pharmacy discussed written and oral comments provided in response to the first proposed regulations needed to implement the state’s electronic drug pedigree provisions. These regulations establish requirements for the serialized numeric identifier; how manufacturers are to report how they calculate the 50 percent of their product on January 1, 2015, that must be serialized for sale in California; and “grandfathering” requirements for products that may remain in the supply chain after the staggered implementation. The public hearing, mandated under the state’s Administrative Procedure Act, was requested by commenters on the regulations.

Nancy Noe from J&J, for instance, spoke before the CA BoP on December 13, urging it to clarify the smallest level of packaging that would be required to carry serialization. She explained that industry needs clarification, so that the regulation “reads the smallest unit of sale,” rather than “the smallest package or immediate container.” Otherwise, it could apply to individual blisters, she said.

The board agreed that some clarification was needed. Counsel to the board pointed out that the statute does define the smallest unit as the “saleable unit,” so the following statement pertaining could be added to the e-pedigree regulation: “the smallest unit as defined in subdivision (d) in 4034.” The board agreed to update the regulation accordingly.

Steve Gray, president of the California Society of Health-System Pharmacists (CHSP) later spoke, asking the board to clarify whether hospitals or pharmacies splitting saleable units to support different treatment locations constituted a pedigree issue. The board said it was “a good question” but needed to be put in written form for consideration.

The board also took action thanks to a written comment from Dirk Rodgers. He asked the board to clarify different dates provided for reporting deadlines for existing drug stock, such as the following: Under the provisions, drug manufacturers “shall submit to the board, by December 1, 2014, but no later than December 31, 2014,” a list of drugs by name and SKU “representing at least 50% of the manufacturer’s total that are ready for initial implementation of the serialized electronic pedigree requirements as of January 1, 2015.” They will have to outline how they calculated the percentage. And “by December 1, 2015, but no later than December 31, 2015,” manufacturers will need to list the remaining percentage of drugs by name and SKU “that are ready for implementation of the serialized electronic pedigree requirements as of January 1, 2016.”

The board agreed to strike by December 1 in both instances, establishing the deadline as December 31.

The board did not discuss fining or extending deadlines for companies that cannot meet the January 2015 deadline, as had been speculated by others as of late. “We have no plans nor any vehicle to extend the dates in California,” Virginia Herold, CA BoP’s executive officer, told PMP News. “Any extension in CA’s dates would have to be done with California legislation.”

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