KRS 315.408: Electronic track and trace system.

(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.

sec. 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requirements relating to a pedigree in KRS 315.406 shall be superseded by the FDA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 opera tional feasibility, and reliability for manufacturers, wholesale

distributors, and pharmacies.