26-4-202. Pedigrees for prescription drugs.

1. (a)

   1. (1)

      Each person who is engaged in wholesale distribution of prescription drugs shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of the prescription drugs. These records shall include pedigrees for all prescription drugs that leave or have ever left the normal distribution channel in accordance with rules and regulations adopted by the board.#

   2. (2)

      A retail pharmacy or chain pharmacy warehouse shall comply with the requirements of this Code section only if the retail pharmacy or chain pharmacy warehouse engages in wholesale distribution of prescription drugs.#

   3. (3)

      The board shall conduct a study to be completed no later than July 1, 2009, which shall include consultation with manufacturers, distributors, and pharmacies responsible for the sale and distribution of prescription drug products in this state. Based on the results of the study, the board shall establish a mandated implementation date for electronic pedigrees which shall be no sooner than December 31, 2011, and may be extended by the board in one year increments if it appears the technology is not universally available across the entire prescription pharmaceutical supply; provided, however, that no provision of this article shall be effective until such time as the General Assembly appropriates reasonable funds for administration of this subsection. Effective at a date established by the board, pedigrees may be implemented through an approved and readily available system based on electronic track and trace pedigree technology. This electronic tracking system will be deemed to be readily available for use on a wide scale across the entire pharmaceutical supply chain which includes manufacturers, wholesale distributors, and pharmacies. Consideration must be given to the large-scale implementation of this technology across the supply chain and the technology must be proven to have no negative impact on the safety and efficacy of the pharmaceutical product.#

2. (b)

   Each person in possession of a pedigree for a prescription drug 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 and any entity engaged in the activities listed in paragraph (9) of Code Section 26-4-201, and who attempts to further distribute that prescription drug shall affirmatively verify before any distribution of a prescription drug occurs that each transaction listed on the pedigree has occurred.#

3. (c)

   The pedigree shall include all necessary identifying information concerning each sale in the chain of distribution of the product from the manufacturer, to acquisition and sale by any wholesale distributor or repackager, and to final sale to a pharmacy or other person dispensing or administering the prescription drug. At a minimum, the pedigree shall include:#

   1. (1)

      The name, address, telephone number, and, if available, email address of each owner of the prescription drug and each wholesale distributor of the prescription drug;#

   2. (2)

      The name and address of each location from which the prescription drug was shipped, if different from the owner’s;#

   3. (3)

      Transaction dates;#

   4. (4)

      Certification that each recipient, excluding retail or hospital pharmacies, has authenticated the pedigree;#

   5. (5)

      The name of the prescription drug;#

   6. (6)

      Dosage form and strength of the prescription drug;#

   7. (7)

      Size of the container;#

   8. (8)

      Number of containers;#

   9. (9)

      Lot number of the prescription drug; and#

   10. (10)

       The name of the manufacturer of the finished dosage form.#

4. (d)

   Each pedigree shall be:#

   1. (1)

      Maintained by the wholesale distributor at its licensed location, unless given written authorization from the board to do otherwise, for three years from the date of sale or transfer; and#

   2. (2)

      Available for inspection, copying, or use at the licensed location upon a verbal request by the board or its designee.#

5. (e)

   The board shall adopt rules and regulations, including a standard form, relating to the requirements of this article no later than 90 days after the effective date of this article.#

6. (f)

   Pharmacies licensed pursuant to this chapter shall not be required to possess or maintain any pedigree issued pursuant to this Code section.#

Reading note: a word broken across two lines in the printed volume was joined by rule and could not be checked against the volume's own vocabulary. The official page linked below settles any doubt.