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315.408 Electronic track and trace system.
(1)
(2)
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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.
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superseded by the FDA standards and shall not apply to any prescription drugs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.
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.
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