32-1984
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32-1984. Pedigrees; electronic files A. Each full service wholesale permittee must establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription-only drugs, including pedigrees for all prescription-only drugs that leave the normal distribution channel. B. A retail pharmacy or chain pharmacy warehouse must comply with this section if the pharmacy or chain pharmacy warehouse engages in the wholesale distribution of prescription-only drugs. C. Subsection A does not apply to: 1. The original manufacturer of the finished form of the prescription-only drug. 2. The sale, trade or transfer of a prescription-only drug between pharmacies with a common ownership or as required by an emergency. 3. cIntracompany transactions. 4. The sale, trade or transfer of a prescription-only drug by a full service wholesale permittee to an entity that assists in the administration of pharmacy benefits under contracts with insurers or to a company under common ownership with that entity. 5. The sale, trade or transfer of a prescription-only drug to a pharmacy or practitioner by an entity that assists in the administration of pharmacy benefits under contracts with insurers or by a company under common ownership with that entity. D. Each person who is engaged in the wholesale distribution of a prescription-only drug, who is in the possession of a pedigree and who attempts to further distribute that prescription-only drug must verify before any distribution of that drug occurs that each transaction listed on the pedigree has occurred. E. The pedigree must include: 1. The name of the prescription-only drug. 2. The dosage form and strength of the prescription-only drug. 3. The size of the container. 4. The number of containers. 5. The lot number of the prescription-only drug. 6. The name of the manufacturer of the finished dosage form. 7. All necessary identifying information concerning each sale in the chain of distribution of the product from the manufacturer through acquisition and sale by any full service wholesale permittee and until final sale to a pharmacy or other person dispensing or administering the drug. At a minimum this information must include: (a) The name, address, telephone number and, if available, the e-mail address of each owner of the prescription-only drug and each full service wholesale permittee that does not take title to the prescription-only drug. (b) The name and address of each location from which the product was shipped, if different from the owner's. (c) Transaction dates. (d) Certification that each recipient has authenticated the pedigree. 8. Any other information required by the board. F. Except as provided in subsection B, the purchaser and full service wholesale permittee must keep the information prescribed by this section for at least three years. G. The information prescribed by this section shall be available to the board of pharmacy on request. |