(1) The board shall not require the use of an electronic track and trace system to initiate, provide, receive, or maintain a pedigree by a person or entity licensed to possess, distribute, dispense, or administer prescription drugs for use by an end user until the FDA develops and implements standards for identification, validation, authentication, and tracking and tracing of prescription drugs pursuant to 21 U.S.C. § 355e. The electronic track and trace system requirements by the board shall meet the FDA’s standards for all prescription drugs covered by the FDA standards.
(2) Upon implementation of FDA standards for an electronic track and trace system, the requirements relating to a pedigree in KRS § 315.406 shall be superseded by the FDA standards and shall not apply to any prescription drugs specified in the FDA standards.
(3) Prior to promulgation of any administrative regulation under KRS Chapter 13A that requires the use of an electronic track and trace system, the board shall consult with manufacturers, wholesale distributors, and pharmacies regarding implementation of the electronic track and trace system requirements and publish a report on its Web site about implementation issues, including but not limited to universal availability, technical and operational feasibility, and reliability for manufacturers, wholesale distributors, and pharmacies.
Effective: July 15, 2008
History: Created 2008 Ky. Acts ch. 124, sec. 7, effective July 15, 2008.