BILL NUMBER: SB 1270 INTRODUCED BILL TEXT INTRODUCED BY Senator Cedillo FEBRUARY 19, 2008 An act to amend Sections 4034, 4163, and 4163.5 of the Business and Professions Code, relating to pharmacy. LEGISLATIVE COUNSEL'S DIGEST SB 1270, as introduced, Cedillo. Pharmacy: dangerous drug and device pedigrees. Existing law, the Pharmacy Law, provides for the licensure and regulation of the practice of pharmacy and the sale of dangerous drugs or dangerous devices by the California State Board of Pharmacy, in the Department of Consumer Affairs. On and after January 1, 2009, existing law requires a pedigree, as defined, to accompany each distribution of a dangerous drug, and prohibits a wholesaler or pharmacy from selling, trading, transferring, or acquiring a dangerous drug without a pedigree. Existing law authorizes the board to extend the compliance date for these pedigree requirements to January 1, 2011, in specified circumstances. Existing law provides exceptions from the pedigree requirements for certain transactions. This bill would instead impose the pedigree requirement and the prohibition against selling, trading, transferring, or acquiring a dangerous drug without a pedigree on an unspecified date, authorize the board to extend the compliance date to an unspecified date in those specified circumstances, and make conforming changes. Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. Section 4034 of the Business and Professions Code is amended to read: 4034. (a) "Pedigree" means a record, in electronic form, containing information regarding each transaction resulting in a change of ownership of a given dangerous drug, from sale by a manufacturer, through acquisition and sale by one or more wholesalers, manufacturers, or pharmacies, until final sale to a pharmacy or other person furnishing, administering, or dispensing the dangerous drug. The pedigree shall be created and maintained in an interoperable electronic system, ensuring compatibility throughout all stages of distribution. (b) A pedigree shall include all of the following information: (1) The source of the dangerous drug, including the name, the federal manufacturer's registration number or a state license number as determined by the board, and principal address of the source. (2) The trade or generic name of the drug, the quantity of the dangerous drug, its dosage form and strength, the date of the transaction, the sales invoice number, the container size, the number of containers, the expiration dates, and the lot numbers. (3) The business name, address, and the federal manufacturer's registration number or a state license number as determined by the board, of each owner of the dangerous drug, and the dangerous drug shipping information, including the name and address of each person certifying delivery or receipt of the dangerous drug. (4) A certification under penalty of perjury from a responsible party of the source of the dangerous drug that the information contained in the pedigree is true and accurate. (c) A single pedigree shall include every change of ownership of a given dangerous drug from its initial manufacture through to its final transaction to a pharmacy or other person for furnishing, administering, or dispensing the drug, regardless of repackaging or assignment of another National Drug Code (NDC) Directory number. (d) A pedigree shall track each dangerous drug at the smallest package or immediate container distributed by the manufacturer, received and distributed by the wholesaler, and received by the pharmacy or another person furnishing, administering, or dispensing the dangerous drug. (e) Any return of a dangerous drug to a wholesaler or manufacturer shall be documented on the same pedigree as the transaction that resulted in the receipt of the drug by the party returning it. (f) If a licensed health care service plan, hospital organization, and one or more physician organizations have exclusive contractual relationships to provide health care services, drugs distributed between these persons shall be deemed not to have changed ownership. (g) The following transactions are not required to be recorded on a pedigree: (1) The provision of samples of dangerous drugs by a manufacturer' s employee to an authorized prescriber, provided the samples are dispensed to a patient of the prescriber without charge. (2) An injectable dangerous drug that is delivered by the manufacturer directly to an authorized prescriber or other entity directly responsible for administration of the injectable dangerous drug, only for an injectable dangerous drug that by law may only be administered under the professional supervision of the prescriber or other entity directly responsible for administration of the drug. Injectable dangerous drugs exempted from the pedigree requirement by this paragraph may not be dispensed to a patient or a patient's agent for self-administration, and shall only be administered to the patient, as defined in Section 4016, by the prescriber or other authorized entity that received the drug directly from the manufacturer. (3) The exemption in paragraph (2) shall expire and be inoperative on January 1,
2010____ , unless prior to that date the board receives, at a public hearing, evidence that entities involved in the distribution of the injectable dangerous drugs subject to that paragraph are not able to provide a pedigree in compliance with all of the provisions of California law, and the board votes to extend the expiration date for the exemption until January 1, 2011____ . The decision as to whether to extend the expiration date shall be within the sole discretion of the board, and shall not be subject to the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of the Government Code. (h) If a manufacturer, wholesaler, or pharmacy has reasonable cause to believe that a dangerous drug in, or having been in, its possession is counterfeit or the subject of a fraudulent transaction, the manufacturer, wholesaler, or pharmacy shall notify the board within 72 hours of obtaining that knowledge. This subdivision shall apply to any dangerous drug that has been sold or distributed in or through this state. (i) "Interoperable electronic system" as used in this chapter means an electronic track and trace system for dangerous drugs that uses a unique identification number, established at the point of manufacture, contained within a standardized nonproprietary data format and architecture, that is uniformly used by manufacturers, wholesalers, and pharmacies for the pedigree of a dangerous drug. (j) The application of the pedigree requirement in pharmacies shall be subject to review during the board's sunset review to be conducted as described in subdivision (f) of Section 4001. (k) This section shall become operative on January 1, 2009____ . However, the board may extend the date for compliance with this section and Section 4163 until January 1, 2011____ , in accordance with Section 4163.5. SEC. 2. Section 4163 of the Business and Professions Code is amended to read: 4163. (a) A manufacturer or wholesaler may not furnish a dangerous drug or dangerous device to an unauthorized person. (b) Dangerous drugs or dangerous devices shall be acquired from a person authorized by law to possess or furnish dangerous drugs or dangerous devices. When the person acquiring the dangerous drugs or dangerous devices is a wholesaler, the obligation of the wholesaler shall be limited to obtaining confirmation of licensure of those sources from whom it has not previously acquired dangerous drugs or dangerous devices. (c) Except as otherwise provided in Section 4163.5, commencing on January 1, 2009____ , a wholesaler or pharmacy may not sell, trade, or transfer a dangerous drug at wholesale without providing a pedigree. (d) Except as otherwise provided in Section 4163.5, commencing on January 1, 2009____ , a wholesaler or pharmacy may not acquire a dangerous drug without receiving a pedigree. SEC. 3. Section 4163.5 of the Business and Professions Code is amended to read: 4163.5. The board may extend the date for compliance with the requirement for a pedigree set forth in Sections 4034 and 4163 until January 1, 2011____ , if it determines that manufacturers or wholesalers require additional time to implement electronic technologies to track the distribution of dangerous drugs within the state. A determination by the board to extend the deadline for providing pedigrees shall not be subject to the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.