Chapter Phar 7

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:

Phar 7.42(3)(a) (a) Stocking.

Phar 7.42(3)(b) (b) Determining access.

Phar 7.42(3)(c) (c) Detection and mitigation of diversion and theft.

Phar 7.42 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction in (2) (intro.) made under s. 35.17, Stats., and correction in numbering of (3) (a) to (c) made under s. 13.92 (4) (b) 7., Stats., Register December 2020 No. 780.

Phar 7.43 Phar 7.43 Remote dispensing.

Phar 7.43(2) (2) Location. A person engaged in the practice of pharmacy under s. 450.03 (1) (f) or (g), Stats., a pharmacy technician registered under s. 450.068, Stats., or a pharmacy graduate as defined in s. Phar 1.02 (10m) may dispense at any of the locations under s. 450.09 (2) (b) 1. a. to d., Stats.

Phar 7.43(4) (4) Requirements.

Phar 7.43(4)(a) (a) A remote dispensing location shall display a sign, easily viewable by customers, that states all of the following:

Phar 7.43(4)(a)1. 1. Prescriptions may be filled at this location.

Phar 7.43(4)(a)2. 2. This remote dispensing location is being supervised by a pharmacist employed by:

Phar 7.43(4)(a)2.a. a. Name of pharmacy.

Phar 7.43(4)(a)2.b. b. Address of pharmacy.

Phar 7.43(4)(a)2.c. c. Telephone of pharmacy.

Phar 7.43(4)(a)3. 3. Patient has a right to pharmacist consultation and information on how to file a complaint to the board.

Phar 7.43(4)(b) (b) Remote dispensing may not occur if a pharmacist is not available remotely.

Phar 7.43(4)(c) (c) A prescribed drug or device may not be dispensed in the absence of the ability of a patient and pharmacist’s delegate to communicate with a pharmacist.

Phar 7.43(5) (5) Dispensing requirements. Remote dispensing shall comply with all of the following:

Phar 7.43(5)(a) (a) Visually inspecting all prescription orders, labels and dispensed product.

Phar 7.43(5)(b) (b) Labeling requirements under s. Phar 7.05. The prescription label shall contain the name and address of the remote dispensing site as the licensed facility from which the prescribed drug or device was dispensed.

Phar 7.43(5)(c) (c) Final check under s. Phar 7.07.

Phar 7.43(5)(d) (d) Federal law if dispensing controlled substances.

Phar 7.43(6) (6) Responsibilities of managing pharmacist. The managing pharmacist responsible for the remote dispensing pharmacy shall do all of the following:

Phar 7.43(6)(a) (a) Have written policies and procedures for system operation, safety, security, accuracy and access.

Phar 7.43(6)(b) (b) Implement an ongoing quality assurance program that monitors performance that includes the number of prescriptions dispensed per month, number of medication errors documented, loss or diversion, and documentation of remedial training to prevent future errors.

Phar 7.43(6)(c) (c) Visit the remote dispensing location at least monthly to confirm delivery status of all drugs, to ensure written policies and procedures are being followed, and to ensure that remote dispensing personnel comply with all federal and state laws regulating the practice of pharmacy.

Phar 7.43(6)(d) (d) Retain documentation of the visits at the remote dispensing location for a minimum of 5 years.

Phar 7.43(6)(e) (e) Documentation indicating accepting responsibility for compliance with this section, signed and dated by the managing pharmacist.

Phar 7.43(7) (7) Delegate requirements. A person engaged in the practice of pharmacy under s. 450.03 (1) (f) or (g), Stats., a pharmacy technician registered under s. 450.068, Stats., or a pharmacy graduate as defined in s. Phar 1.02 (10m) shall meet the following requirements to remote dispense:

Phar 7.43(7)(a) (a) Be 18 years of age or older.

Phar 7.43(7)(b) (b) Be a high school graduate or have equivalent education.

Phar 7.43(7)(c) (c) Have completed 1500 hours of work as a pharmacist delegate within the 3 years prior to engaging in remote dispensing or completed an accredited pharmacy technician training program.

Phar 7.43 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction in (2), (4) (a) 1. made under s. 35.17, Stats., Register December 2020 No. 780; EmR2213: emerg. r. (1), am. (2), (4) (b), (5) (b), (6) (title), (a) (intro.), 5., (b), eff. 11-1-22; CR 23-054: r. (1), am. (2), r. (3), am. (4) (a) 2. (intro.), (b), r. (4) (d), am. (5) (b), r. and recr. (6), am. (7) (intro.) Register August 2024 No. 824, eff. 9-1-24.

subch. IV of ch. Phar 7 Subchapter IV — Institutional Pharmacies

Phar 7.50 Phar 7.50 Definitions. In this subchapter:

Phar 7.50(1) (1) “Chart order” means an order entered on the chart or a medical record of an inpatient or resident of an institutional facility by a practitioner or practitioner’s delegate for a drug product or device.

Phar 7.50(2) (2) “Institutional facility” means a facility, as defined in s. 647.01 (4), Stats.; any hospital, nursing home, community-based residential facility, county home, county infirmary, county hospital, county mental health complex, or other place licensed or approved by the department of health services under s. 49.70, 49.71, 49.72, 50.03, 50.032, 50.033, 50.034, 50.35, 51.08, or 51.09, Stats.; a facility under s. 45.50, 51.05, 51.06, 146.903 (1) (b), 233.40, 233.41, 233.42, or 252.10, Stats.; a hospice facility under s. 50.90 (1) (c), Stats.; a county jail; and a correctional facility operated under the authority of the department of corrections.

Phar 7.50(3) (3) “Institutional pharmacy” means a pharmacy that provides pharmacy services to an institutional facility. This definition is not for purposes under s. 450.09 (1) (a), Stats.

Phar 7.50 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

Phar 7.51 Phar 7.51 Chart orders. A chart order shall contain all of the following:

Phar 7.51(1) (1) First and last name of the patient.

Phar 7.51(2) (2) Patient’s medical record number or date of birth.

Phar 7.51(3) (3) Date of issuance.

Phar 7.51(4) (4) Name, strength, and form of the drug product or device prescribed.

Phar 7.51(5) (5) Directions for use.

Phar 7.51(6) (6) The signature by one of the following methods:

Phar 7.51(6)(a) (a) If handwritten, the practitioner’s or delegate’s signature.

Phar 7.51(6)(b) (b) Electronic signature of the practitioner or delegate.

Phar 7.51(7) (7) Chart orders prepared by a delegate of the practitioner shall include the first and last name of the delegate and the first and last name of the practitioner.

Phar 7.51 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

Phar 7.52 Phar 7.52 Labels. All prescribed drug products and devices dispensed for administration by a health care provider at the institutional facility shall have a label attached to the container disclosing all of the following:

Phar 7.52(1) (1) Drug name, strength and form.

Phar 7.52(2) (2) Beyond use date or expiration date.

Phar 7.52(3) (3) Special storage conditions, if required.

Phar 7.52 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

Phar 7.53 Phar 7.53 Security and access.

Phar 7.53(1) (1) Arrangements shall be made in advance by the managing pharmacist for access of drugs by the health care staff of the institutional facility when dispensing by a pharmacist is not available.

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.