(c) Validated by the following process:
1. The automated technology shall make a product verification for accuracy and correctness of a minimum of 2500 product verifications and achieve an accuracy rate of at least 99.8%.
2. A pharmacist shall audit 100% of the product verifications made by the automated technology during the validation process.
(d) Revalidated if the software is upgraded or any component of the automated technology responsible for the accuracy and correctness of the product verification is replaced or serviced outside of the manufacturer’s standard maintenance recommendations.
(3) Eligible product. The automated technology may do the product verification if the product meets all of the following:
(a) Is dispensed in the original package from a manufacturer or if a licensed pharmacist has ensured that any repackaging results in a package that is labeled with the correct drug name, strength, formulation, control or lot number, and expiration or beyond use date.
(b) Has a drug utilization review performed by a pharmacist prior to delivery.
(c) Will be administered by an individual authorized to administer medications at the institution where the medication is administered.
(4) Policies and procedures. Each pharmacy shall maintain policies, procedures, and training materials for the automated technology product verification which shall be made available to the board upon request.
(5) Records. (a) Each pharmacy shall maintain for 5 years the following records:
1. All validation records of each automated technology that include the dates that the validation occurred, the number of product verifications performed, the number of product verification errors, and overall accuracy rate.
2. Documentation indicating acceptance of responsibility for compliance with this section, signed and dated by both the managing pharmacist and supervising pharmacist, indicating the name of the supervising pharmacist and start and end dates of supervision.
3. Documentation of the completion of the manufacturer’s recommended maintenance and quality assurance measures.
4. Documentation of the dates of all software upgrades.
5. Documentation of all service performed outside of the manufacturer’s standard maintenance recommendations.
(b) Records shall be made available to the board upon request.
Section 2. EFFECTIVE DATE. The rules adopted in this order shall take effect on the first day of the month following publication in the Wisconsin Administrative Register, pursuant to s. 227.22 (2) (intro.), Stats. ---------------------------------------------------------------------------------------------------------------------
(END OF TEXT OF RULE)
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Dated October 23, 2019 Agency 
Chair of the Pharmacy Examining Board
