Chapter Phar 7

Phar 7.14(2)(c)6.c. c. Wrong formulation.

Phar 7.14(2)(c)6.d. d. Omitted medication, if utilizing unit dose or compliance packaging.

Phar 7.14(2)(d) (d) Completed the following validation process:

Phar 7.14(2)(d)1. 1. The pharmacy technician being validated shall make a product verification on the work of a pharmacist or another pharmacy technician for accuracy and correctness of a minimum of 500 product verifications over a minimum of 5 separate days and achieve an accuracy rate of at least 99.8%.

Phar 7.14(2)(d)2. 2. A pharmacist shall audit 100% of the product verifications made by the pharmacy technician during the validation process.

Phar 7.14(2)(e) (e) Notwithstanding pars. (b) to (d), an individual who completed the board’s pilot program validation process between October 1, 2016 and September 30, 2019, meets the pharmacy product verification technician qualifications unless the individual fails to meet the quality assurance standards under sub. (4).

Phar 7.14(3) (3) Eligible product.

Phar 7.14(3)(a) (a) Institutional pharmacies. The pharmacy product verification technician may do the product verification in an institutional pharmacy if all of the following requirements are met:

Phar 7.14(3)(a)1. 1. The source drug product or device is in an original package from a manufacturer or a licensed pharmacist has ensured that the source package is labeled with the correct name, strength, form, control or lot number, and beyond use or expiration date.

Phar 7.14(3)(a)2. 2. A drug utilization review performed by a pharmacist prior to dispensing.

Phar 7.14(3)(a)3. 3. The drug product will be administered by an individual authorized to administer medications at the institution where the medication is administered.

Phar 7.14(3)(b) (b) Community pharmacies. The pharmacy product verification technician may do the product verification in a community pharmacy if all of the following requirements are met:

Phar 7.14(3)(b)1. 1. The source drug product or device is in an original package from a manufacturer or a licensed pharmacist has ensured that the source package is labeled with the correct name, strength, form, control or lot number, and beyond use or expiration date.

Phar 7.14(3)(b)2. 2. A drug utilization review performed by a pharmacist prior to dispensing.

Phar 7.14(3)(b)3. 3. A non-pharmacist shall be able to check the accuracy of the medication by one of the following:

Phar 7.14(3)(b)3.a. a. The drug product or device is in the original packaging from a manufacturer.

Phar 7.14(3)(b)3.b. b. The drug product or device includes a description of the drug product or device on the prescription label.

Phar 7.14(3)(b)3.c. c. The pharmacist shows the patient or patient’s agent the drug product or device and provides a monograph that includes a description of the drug product or device.

Phar 7.14(4) (4) Quality assurance.

Phar 7.14(4)(a) (a) A minimum of 5% of each pharmacy product verification technician’s verifications shall be audited by a licensed pharmacist. The accuracy of each pharmacy product verification technician shall be tracked individually.

Phar 7.14(4)(b) (b) A record of each pharmacy product verification technician-check-pharmacy technician audit shall include all of the following:

Phar 7.14(4)(b)1. 1. Name of the pharmacy product verification technician.

Phar 7.14(4)(b)2. 2. Total number of product verifications performed.

Phar 7.14(4)(b)3. 3. Number of product verifications audited by the pharmacist.

Phar 7.14(4)(b)4. 4. Percentage of product verifications audited by pharmacist.

Phar 7.14(4)(b)5. 5. Percentage of accuracy.

Phar 7.14(4)(b)6. 6. Number of product verification errors identified.

Phar 7.14(4)(b)7. 7. Type of error under sub. (2) (c) 2. a. to c. and e.

Phar 7.14(4)(c) (c) On a quarterly basis, the supervising pharmacist shall perform an assessment of each pharmacy product verification technician’s previous 12 months accuracy and correctness of pharmacy product verifications including a review of the quality assurance log.

Phar 7.14(4)(d) (d) A pharmacy product verification technician shall be revalidated if the individual fails to maintain a product verification accuracy rate of 99.8% based on the quarterly assessment of the previous 12 months or has not performed verifications within the last 6 months.

Phar 7.14(5) (5) Policies and procedures. Each pharmacy shall maintain policies, procedures, and training materials for the pharmacy product verification by technicians which shall be made available to the board upon request.

Phar 7.14(6) (6) Records.

Phar 7.14(6)(a) (a) Each pharmacy shall maintain for 5 years the following records:

Phar 7.14(6)(a)1. 1. All validation records of each pharmacy product verification technician 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 7.14(6)(a)2. 2. Documentation indicating accepting 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 the dates the supervision responsibilities begin and end.

Phar 7.14(6)(a)3. 3. Quality assurance audits and quarterly assessments.

Phar 7.14(6)(b) (b) Records shall be made available to the board upon request.

Phar 7.14 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; corrections in (2) (e) made under ss. 13.92 (4) (b) 12. and 35.17, Stats., and correction in (2) (c) 6. (intro.), (4) (b) 7. made under s. 35.17, Stats., Register December 2020 No. 780; EmR2303: emerg. am. (title), (1) (a), (b), (d), (2) (intro.), r. (2) (a), am. (2) (b), (c) 3., 6., (d) 1., 2., (e), (3) (a) (intro.), (b), (4) (a), (b) (intro.), 1., (c), (d), (5), (6) (a) 1., 2., eff. 2-3-23; CR 23-072: r. and recr. (title), am. (1) (a), (b), (d), (2) (intro.), r. (2) (a), am. (2) (b), (c) 3., 6., (d) 1., 2., (e), (3) (a) (intro.), (b) (intro.), 1., (c), (d), (5), (6) (a) 1., 2. Register August 2024 No. 824, eff. 9-1-24.

Phar 7.15 Phar 7.15 Consumer disclosures.

Phar 7.15(1) (1) Each pharmacy shall post in a prominent place and maintain the consumer disclosures required in ss. 450.13 (5m) and 450.135 (8m), Stats.

Phar 7.15(2) (2) A link to the 100 most commonly prescribed generic drug product equivalents as determined by the board, shall be maintained on the department’s website as required in s. 450.13 (5m) (b), Stats.

Phar 7.15 Note Note: Copies of the required consumer disclosures are located on the Department of Safety and Professional Service’s website: https://dsps.wi.gov.

Phar 7.15(3) (3) Pursuant to s. 450.13 (5m) (c), Stats., each pharmacy shall maintain and make available to the public a list of the drugs from the list in sub. (2) that are available for purchase at that pharmacy. The list shall be updated monthly, with all of the following information included:

Phar 7.15(3)(a) (a) Brand name.

Phar 7.15(3)(b) (b) Generic equivalent drugs and biological products.

Phar 7.15(3)(c) (c) Interchangeable biological products.

Phar 7.15(3)(d) (d) Retail price.

Phar 7.15(4) (4) The list required under sub. (3) may differ depending on whether the drugs on the list from sub. (2) are available for purchase at a specific pharmacy.

Phar 7.15 History History: CR 23-015: cr. Register April 2024 No. 820, eff. 5-1-24; correction in (2) made under s. 35.17, Stats., Register April 2024 No. 820.

subch. II of ch. Phar 7 Subchapter II — Central Shared Services

Phar 7.30 Phar 7.30 Definitions. In this subchapter:

Phar 7.30(1) (1) “Central shared services pharmacy” means a pharmacy licensed in this state acting as an agent of an originating pharmacy.

Phar 7.30(2) (2) “Labeling pharmacy” means the central shared services pharmacy or originating pharmacy which is responsible for product verification under s. Phar 7.07 (1) (a) and (b).

Phar 7.30(3) (3) “Originating pharmacy” means a pharmacy licensed in this state that uses a central shared services pharmacy.

Phar 7.30 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

Phar 7.31 Phar 7.31 Requirements. An originating pharmacy may use a central shared services pharmacy only pursuant to the following requirements:

Phar 7.31(1) (1) The central shared services pharmacy either has the same owner as the originating pharmacy or has a written contract with the originating pharmacy outlining the services to be provided and the responsibilities of each pharmacy in fulfilling the terms of the contract.

Phar 7.31(2) (2) The central shared services pharmacy shall maintain a record of all originating pharmacies, including name, address and DEA number that it provides services to.

Phar 7.31(3) (3) The central shared services pharmacy and originating pharmacy maintain a written protocol delineating each pharmacy’s assumption of responsibility for compliance with state and federal law.

Phar 7.31(4) (4) Unless the central shared services pharmacy shares a computer system with the originating pharmacy meeting the requirements of s. Phar 7.04 (4) and contains the medication profile record under s. Phar 7.11 (3), it may not perform drug utilization review under s. Phar 7.03 to satisfy the final check requirement under s. Phar 7.07 (1) (c).

Phar 7.31(5) (5) The prescription label attached to the container shall contain the name and address of the labeling or originating pharmacy. The date on which the prescription was dispensed for purposes of s. 450.11 (4) (a) 2., Stats., shall be the date on which the labeling pharmacy filled the prescription order.

Phar 7.31(6) (6) The originating pharmacy or central shared services pharmacy shall maintain the original of all prescription orders received for purposes of filing and recordkeeping as required by state and federal law.

Phar 7.31(7) (7) In addition to meeting the other recordkeeping requirements required by state and federal law, the central shared services pharmacy and originating pharmacy shall each maintain records to identify each of its pharmacists responsible for the final check under s. Phar 7.07 (1).

Phar 7.31 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

subch. III of ch. Phar 7 Subchapter III — Delivery Systems and Remote Dispensing

Phar 7.40 Phar 7.40 Definitions. In this subchapter:

Phar 7.40(1) (1) “Delivery system” means a structure, controlled by a pharmacy licensed in this state, that a prescription is placed in for patient pick-up.

Phar 7.40(2) (2) “Supervising pharmacy” means a licensed pharmacy that oversees the operations and administration of remote dispensing.

Phar 7.40 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction in (title) made under s. 13.92 (4) (b) 2., Stats., Register December 2020 No. 780.

Phar 7.41 Phar 7.41 Delivery system.

Phar 7.41(1) (1) A prescription shall be stored in a secure delivery system immediately upon delivery to the location of the delivery system. Only the patient or patient’s agent shall be able to open the door or locker containing only the patient’s prescription.

Phar 7.41(2) (2) The delivery system shall be designed in a manner which does not disclose protected health information.

Phar 7.41(3) (3) The delivery system shall maintain appropriate environmental controls, including temperature and humidity, to prevent drug adulteration.

Phar 7.41(4) (4) The use of a delivery system does not create an exemption to s. 450.11 (1b), Stats.

Phar 7.41(5) (5) A log shall be maintained by the dispensing pharmacy of all prescriptions delivered to the delivery system.

Phar 7.41(6) (6) The delivery system shall be inventoried at least weekly and a list of unclaimed prescriptions shall be reviewed by a pharmacist.

Phar 7.41(7) (7) The managing pharmacist shall establish written policies and procedures for all of the following:

Phar 7.41(7)(a) (a) Stocking of the delivery system.

Phar 7.41(7)(b) (b) Determining access to the delivery system.

Phar 7.41(7)(c) (c) Detection and mitigation of diversion and theft.

Phar 7.41 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction in (1) made under s. 35.17, Stats., Register December 2020 No. 780.

Phar 7.42 Phar 7.42 Automated direct-to-patient dispensing system.

Phar 7.42(1) (1) In this section “supervising practitioner” means the practitioner who is responsible for the operation of the automated direct-to-patient dispensing system and requirements of this section.

Phar 7.42(2) (2) An automated direct-to-patient dispensing system in a secure and professionally appropriate environment in any of the locations under s. 450.062 (1) to (4), Stats., may operate for purposes of practitioner dispensing. The supervising practitioner will ensure all of the following requirements are met:

Phar 7.42(2)(a) (a) Individuals with access to the automated direct-to-patient dispensing system for the purpose of stocking, inventory, and monitoring shall be limited to the supervising practitioner or a delegate.

Phar 7.42(2)(b) (b) The automated direct-to-patient dispensing system shall label the prescription in compliance with s. Phar 7.05.

Phar 7.42(2)(c) (c) The automated direct-to-patient dispensing system shall maintain records of all prescription fills and dispenses in compliance with s. Phar 7.11 (1).

Phar 7.42(2)(d) (d) The reporting of all monitored prescription drugs dispensed from the automated direct-to-patient dispensing system to the prescription drug monitoring program.

Phar 7.42(3) (3) The supervising practitioner or delegate shall establish written policies and procedures for automated direct-to-patient dispensing system for all of the following: