(1) In General. Each person who is engaged in wholesale distribution of prescription drugs, including repackagers, but excluding the original manufacturer of the finished form of the prescription drug, that leaves, or has ever left, the normal distribution channel shall, before each wholesale distribution of such drug, provide a pedigree to the person who receives such drug. (a) A retail pharmacy or chain pharmacy warehouse shall comply with the requirements of this section only if the pharmacy or chain pharmacy warehouse engages in wholesale distribution of prescription drugs. (b) The board shall determine by July 1, 2009, a targeted implementation date for electronic track and trace pedigree technology. Such a determination shall be based on consultation with manufacturers, distributors and pharmacies responsible for the sale and distribution of prescription drug products in this state. After consultation with interested stakeholders and prior to implementation of the electronic pedigree, the board shall deem that the technology is universally available across the entire prescription pharmaceutical supply chain. The implementation date for the mandated electronic track and trace pedigree technology will be no sooner than July 1, 2010, and may be extended by the board in one (1) year increments if it appears the technology is not universally available across the entire prescription pharmaceutical supply chain. (2) Authentication. Each person who is engaged in the wholesale distribution of a prescription drug, including repackagers, but excluding the original manufacturer of the finished form of the prescription drug, who is provided a pedigree for a prescription drug and attempts to further distribute that prescription drug, shall affirmatively verify before any wholesale distribution of a prescription drug occurs that each transaction listed on the pedigree has occurred. (3) Contents. The pedigree shall: (a) Include all necessary identifying information concerning each sale in the chain of distribution of the product from the manufacturer, or the manufacturer's third party logistics provider, colicensed product partner, manufacturer's exclusive distributor, or a repackager who is an authorized distributor of record for the manufacturer, whose facility is registered with the United States food and drug administration and who engages in the practice of repackaging the original dosage form of a prescription drug in accordance with applicable regulations and guidelines of the United States food and drug administration, through acquisition and sale by any wholesale distributor or repackager, until final sale to a pharmacy or other person dispensing or administering the drug. At minimum, the necessary pedigree information shall include: (i) Name, address, telephone number and, if available, the e-mail address, of each owner of the prescription drug, and each wholesale distributor of the prescription drug; (ii) Name and address of each location from which the product was shipped, if different from the owner's; (iii) Transaction dates; and (iv) Certification that each recipient has authenticated the pedigree. (b) At minimum, the pedigree shall also include the: (i) Name of the prescription drug; (ii) Dosage form and strength of the prescription drug; (iii) Size of the container; (iv) Number of containers; (v) Lot number and national drug code number of the prescription drug; and (vi) Name of the manufacturer of the finished dosage form. (4) Maintenance Provisions. Each pedigree or electronic file shall be: (a) Notwithstanding the provisions in section 54-1735 , Idaho Code, maintained by the purchaser and the wholesale distributor for not less than three (3) years from the date of sale or transfer; and (b) Available for inspection or use within five (5) business days upon a request of an authorized officer of the law. (5) Implementation. The board shall adopt rules and a form relating to the requirements of this section no later than ninety (90) days after the effective date of this act.
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