Chapter Phar 7

Phar 7.53(2) (2) In the absence of a pharmacist, drugs shall be stored in a manner in which only authorized personnel may obtain access and is sufficiently secure to deny access to unauthorized persons.

Phar 7.53(3) (3) The managing pharmacist shall develop policies and procedures in place to mitigate and prevent theft and diversion.

Phar 7.53 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

Phar 7.54 Phar 7.54 Return or exchange of health items.

Phar 7.54(1) (1) In this section:

Phar 7.54(1)(a) (a) “Health item” means drugs, devices, hypodermic syringes, needles or other objects for injecting a drug product, or items of personal hygiene.

Phar 7.54(1)(b) (b) “Original container” means the container in which a health item was sold, distributed, or dispensed.

Phar 7.54(1)(c) (c) “Tamper-evident package” means a package that has one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence that tampering has occurred.

Phar 7.54(2) (2) A health item which has been sold, distributed or dispensed, may be returned to the institutional pharmacy under s. Phar 7.10 (2) or if the health item has not left the control of the health care facility staff authorized to have access to prescription drug products.

Phar 7.54(3) (3) A health item returned to an institutional pharmacy may be sold, distributed, or dispensed to the institutional facility if all of the following apply:

Phar 7.54(3)(a) (a) The health item was never in the possession and control of the patient.

Phar 7.54(3)(b) (b) The health item was sold, distributed or dispensed in a tamper-evident package and, for a drug product, includes the beyond use date or expiration date and manufacturer’s lot number.

Phar 7.54(3)(c) (c) The health item is in its original container and the pharmacist determines the contents are not adulterated or misbranded.

Phar 7.54 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction in (2), (3) (intro.) made under s. 35.17, Stats., Register December 2020 No. 780.

Phar 7.55 Phar 7.55 Automated technology product verification.

Phar 7.55(1) (1) Definitions. In this section:

Phar 7.55(1)(a) (a) “Product verification” means doing a check of the accuracy and correctness of a product, including drug, strength, formulation, and expiration or beyond use date, as part of the final check.

Phar 7.55(1)(b) (b) “Supervising pharmacist” means the pharmacist licensed in this state who is responsible for the operations and outcomes of the product verification done by an automated technology.

Phar 7.55(2) (2) Automated technology product verification qualifications. Product verification may be done only by an automated technology which meets all of the following:

Phar 7.55(2)(a) (a) Located within a licensed pharmacy.

Phar 7.55(2)(b) (b) Utilizing barcodes or another machine-readable technology to complete the product verification.

Phar 7.55(2)(c) (c) Validated by the following process:

Phar 7.55(2)(c)1. 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%.

Phar 7.55(2)(c)2. 2. A pharmacist shall audit 100% of the product verifications made by the automated technology during the validation process.

Phar 7.55(2)(d) (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.

Phar 7.55(3) (3) Eligible product. The automated technology may do the product verification if the product meets all of the following:

Phar 7.55(3)(a) (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.

Phar 7.55(3)(b) (b) Has a drug utilization review performed by a pharmacist prior to delivery.

Phar 7.55(3)(c) (c) Will be administered by an individual authorized to administer medications at the institution where the medication is administered.

Phar 7.55(4) (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.

Phar 7.55(5) (5) Records.

Phar 7.55(5)(a) (a) Each pharmacy shall maintain for 5 years the following records:

Phar 7.55(5)(a)1. 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.

Phar 7.55(5)(a)2. 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.

Phar 7.55(5)(a)3. 3. Documentation of the completion of the manufacturer’s recommended maintenance and quality assurance measures.

Phar 7.55(5)(a)4. 4. Documentation of the dates of all software upgrades.

Phar 7.55(5)(a)5. 5. Documentation of all service performed outside of the manufacturer’s standard maintenance recommendations.

Phar 7.55(5)(b) (b) Records shall be made available to the board upon request.

Phar 7.55 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

subch. V of ch. Phar 7 Subchapter V — Uncredentialed Pharmacy Staff

Phar 7.60 Phar 7.60 Definition. In this subchapter, “uncredentialed pharmacy staff” means any staff practicing in the pharmacy who are not otherwise licensed or registered under s. 450.03 (1) (f), (g), or (gm), Stats.

Phar 7.60 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; EmR2303: emerg. cr. (intro.), (3), eff. 2-3-23; CR 23-072: r. and recr. Register August 2024 No. 824, eff. 9-1-24.

Phar 7.62 Phar 7.62 Uncredentialed pharmacy staff.

Phar 7.62(1) (1) This section does not apply to a person practicing pharmacy under s. 450.03 (1) (f) or (g), Stats., or a pharmacy graduate as defined in s. Phar 1.02 (10m).

Phar 7.62(2) (2) A pharmacist shall provide direct supervision of uncredentialed pharmacy staff. A pharmacist shall be available to the uncredentialed pharmacy staff person for consultation either in person or contact by telecommunication means.

Phar 7.62(3) (3) An uncredentialed pharmacy staff person may not engage in the practice of pharmacy as defined in s. 450.01 (16), Stats., or the practice of a pharmacy technician as defined in s. Phar 19.02.

Phar 7.62(4) (4) The prohibitions in sub. (3), do not apply to a person completing an internship for purposes of meeting the internship requirement under s. 450.03 (2) (b), Stats.

Phar 7.62(5) (5) A managing pharmacist shall provide training to or verify competency of an uncredentialed pharmacy staff person prior to the uncredentialed pharmacy staff person performing a delegated act.

Phar 7.62(6) (6) The managing pharmacist shall determine which acts may be delegated in a pharmacy. The managing pharmacist has a duty to notify all pharmacists practicing in that pharmacy which acts may be delegated to specific uncredentialed pharmacy staff. This record shall be provided to the board upon request.

Phar 7.62(7) (7) A pharmacist may delegate to an uncredentialed pharmacy staff person any delegated act approved by the managing pharmacist outside of the restrictions in sub. (3).

Phar 7.62 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction in (3) (b), (4), (5) made under s. 35.17, Stats., Register December 2020 No. 780; CR 23-054: am. (1) Register August 2024 No. 824, eff. 9-1-24; EmR2303: emerg. am. (title), (1), (2), renum. (3) (intro.) to (3) and am., r. (3) (a) to (d), am. (5) to (7), eff. 2-3-23; CR 23-072: r. and recr. (title), am. (2), renum. (3) (intro.) to (3) and am., r. (3) (a) to (d), am. (5) to (7) Register August 2024 No. 824, eff. 9-1-24.