Section 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, repackagers, 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 dangerous drug, the quantity of the dangerous drug, its dosage form and strength, the date of the transaction, the sales invoice number or, if not immediately available, a customer-specific shipping reference number linked to 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.

(5) The unique identification number described in subdivision (i).

(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. Dangerous drugs that are repackaged shall be serialized by the repackager and a pedigree shall be provided that references the pedigree of the original package or packages provided by the manufacturer.

(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 or repackager, and received by the pharmacy or another person furnishing, administering, or dispensing the dangerous drug. For purposes of this section, the "smallest package or immediate container" of a dangerous drug shall include any dangerous drug package or container made available to a repackager, wholesaler, pharmacy, or other entity for repackaging or redistribution, as well as the smallest unit made by the manufacturer for sale to the pharmacy or other person furnishing, administering, or dispensing the 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 exempt from the pedigree requirement created by this section:

(1) An intracompany sale or transfer of a dangerous drug. For purposes of this section, "intracompany sale or transfer" means any transaction for any valid business purpose between a division, subsidiary, parent, or affiliated or related company under the common ownership and control of the same corporate or legal entity.

(2) Dangerous drugs received by the state or a local government entity from a department or agency of the federal government or an agent of the federal government specifically authorized to deliver dangerous drugs to the state or local government entity.

(3) 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.

(4) (A) A sale, trade, or transfer of a radioactive drug, as defined in Section 1708.3 of Title 16 of the California Code of Regulations, between any two entities licensed by the Radiologic Health Branch of the State Department of Public Health, the federal Nuclear Regulatory Commission, or an Agreement state.

(B) The exemption in this paragraph shall remain in effect unless the board, no earlier than the date that is two years after the compliance date for manufacturers set forth in subdivision (k) of Section 4034 or Section 4163.5, determines after consultation with the Radiologic Health Branch of the State Department of Public Health that the risk of counterfeiting or diversion of a radioactive drug is sufficient to require a pedigree. Two years following the date of any such determination, this paragraph shall become inoperative.

(5) The sale, trade, or transfer of a dangerous drug that is labeled by the manufacturer as "for veterinary use only."

(6) The sale, trade, or transfer of compressed medical gas. For purposes of this section, "compressed medical gas" means any substance in its gaseous or cryogenic liquid form that meets medical purity standards and has application in a medical or homecare environment, including, but not limited to, oxygen and nitrous oxide.

(7) The sale, trade, or transfer of solutions. For purposes of this section, "solutions" means any of the following:

(A) Those intravenous products that, by their formulation, are intended for the replenishment of fluids and electrolytes, such as sodium, chloride, and potassium, calories, such as dextrose and amino acids, or both.

(B) Those intravenous products used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions.

(C) Products that are intended for irrigation or reconstitution, as well as sterile water, whether intended for those purposes or for injection.

(8) Dangerous drugs that are placed in a sealed package with a medical device or medical supplies at the point of first shipment into commerce by the manufacturer and the package remains sealed until the drug and device are used, provided that the package is only used for surgical purposes.

(9) A product that meets either of the following criteria:

(A) A product comprised of two or more regulated components, such as a drug/device, biologic/device, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity.

(B) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products or device and biological products.

(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 and supplemented by a linked unique identification number in the event that drug is repackaged, contained within a standardized nonproprietary data format and architecture, that is uniformly used by manufacturers, wholesalers, repackagers, and pharmacies for the pedigree of a dangerous drug. No particular data carrier or other technology is mandated to accomplish the attachment of the unique identification number described in this subdivision.

(j) The application of the pedigree requirement shall be subject to review during the board's evaluation pursuant to Section 473.4.

(k) This section shall become operative on January 1, 2015.

(Amended by Stats. 2008, Ch. 713, Sec. 2. Effective January 1, 2009. Section operative January 1, 2015, by its own provisions. Conditionally inoperative as prescribed in subd. (a) of Section 4034.1.)