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315.408 Electronic track and trace system.
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(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requirements relating to a pedigree in KRS 315.406 shall be superseded by the FDA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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