(d) Necessary for the administration and enforcement of this chapter and ch. 961. (e) Establishing minimum standards for the practice of pharmacy.
450.071 (4) The board may set, by rule, continuing education requirements for designated representatives under this section.
450.073 (3) The board shall promulgate rules implementing an electronic track and trace pedigree system. Not later than July 1, 2010, the board shall determine the date on which the system will be implemented. The system may not be implemented before July 1, 2011, and the board may delay the implementation date in increments if the board determines that the technology to implement the system is not yet universally available across the prescription drug supply chain or is not capable of adequately protecting patient safety.
5. Estimate of amount of time that state employees will spend developing the rule and of other resources necessary to develop the rule:
300 hours
6. List with description of all entities that may be affected by the proposed rule:
Pharmacies, pharmacists, manufacturers, distributors, and consumers.
7. Summary and preliminary comparison with any existing or proposed federal regulation that is intended to address the activities to be regulated by the proposed rule:
The Drug Quality and Security Act (DQSA) was enacted in 2013 and the Title II of that Act, the Drug Supply Chain Security Act (DSCSA), outlines requirements for an electronic, interoperable system to identify and trace prescription drugs as they move through the supply chain in the United States. The system is to enhance the Food and Drug Administration’s ability to protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful, and to improve detection and removal of potentially dangerous drugs from the drug supply chain to protect consumers. DSCSA requires the establishment of national licensure standards for wholesale distributors and third-party logistics providers.
8. Anticipated economic impact of implementing the rule (note if the rule is likely to have a significant economic impact on small businesses):
This rule is anticipated to have a moderate economic impact and may have a significant economic impact on small businesses.
Contact Person: Sharon Henes, Administrative Rules Coordinator, (608) 261-2377
Authorized Signature
July 23, 2020
Date Submitted
