SB 671: Pharmacy: biological product.

The Pharmacy Law governs the practice of pharmacy in this state, including the permissible duties of licensed pharmacists. The Pharmacy Law authorizes a pharmacist filling a prescription order for a drug product prescribed by its trade or brand name to select another drug product with the same active chemical ingredients of the same strength, quantity, and dosage form, and of the same generic drug name as determined, as specified, of those drug products having the same active chemical ingredients. A knowing violation of the Pharmacy Law is a misdemeanor.

This bill, except as specified, would authorize a pharmacist to select an alternative biological product when filling a prescription order for a prescribed biological product if the alternative biological product is interchangeable, as defined, and the prescriber does not personally indicate in a prescribed manner that a substitution is not to be made. The bill would require a pharmacist or a designee, within a specified period following the dispensing of a biological product, to make an electronically accessible entry in a described entry system of the specific biological product provided to the patient. The bill would provide an alternate means of communicating the name of the biological product dispensed to the prescriber if the pharmacy does not have access to one or more of the described entry systems. The bill would also require that the substitution of a biological product be communicated to the patient. The bill would prohibit a pharmacist from selecting an alternative biological product that meets the requirements of these provisions unless the cost to the patient of the alternative biological product selected is the same or less than the cost of the prescribed biological product. Because a knowing violation of these requirements would be a misdemeanor, the bill would create new crimes, thereby imposing a state-mandated local program.

The bill would also require the California State Board of Pharmacy to maintain on its public Internet Web site a link to the current list, if available, of biological products determined by the federal Food and Drug Administration to be interchangeable.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.