2. Documentation indicating accepting responsibility for compliance with this section, signed and dated by both the managing pharmacist and supervising delegate-check-delegate pharmacist, indicating the name of the supervising delegate-check-delegate pharmacist, and the dates the supervision responsibilities begin and end.
3. Quality assurance audits and quarterly assessments.
(b) Records shall be made available to the board upon request.
Subchapter III — Central Shared Services
7.30 Definitions. In this subchapter:
(1) “Central shared services pharmacy" means a pharmacy licensed in this state acting as an agent of an originating pharmacy.
(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). (3) “Originating pharmacy" means a pharmacy licensed in this state that uses a central shared services pharmacy.
7.31 Requirements. An originating pharmacy may use a central shared services pharmacy only pursuant to the following requirements:
(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.
(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.
(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.
(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). (5) The prescription label attached to the container shall contain the name and address of the labeling 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. (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.
(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). Subchapter IV — Delivery Systems and Remote Dispensing
Phar 7.40 Definition. In this subchapter:
(1) “Delivery system” means a structure, controlled by a pharmacy licensed in this state, that a prescription is placed in for patient pick-up.
(2) “Supervising pharmacy” means a licensed pharmacy that oversees the operations and administration of remote dispensing.
Phar 7.41 Delivery system (1) 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.
(2) The delivery system shall be designed in a manner which does not disclose protected health information.
(3) The delivery system shall maintain appropriate environmental controls, including temperature and humidity, to prevent drug adulteration.
(4) The use of a delivery system does not create an exemption to s. 450.11 (1b), Stats. (5) A log shall be maintained by the dispensing pharmacy of all prescriptions delivered to the delivery system.
(6) The delivery system shall be inventoried at least weekly and a list of unclaimed prescriptions shall be reviewed by a pharmacist.
(7) The managing pharmacist shall establish written policies and procedures for all of the following:
(a) Stocking of the delivery system.
(b) Determining access to the delivery system.
(c) Detection and mitigation of diversion and theft.
Phar 7.42 Automated direct-to-patient dispensing system. (1) A pharmacy may utilize 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. (2) An automated direct-to-patient dispensing system shall be associated with a pharmacy. A prescriber may not dispense utilizing an automated direct-to-patient dispensing system. A prescriber may submit a prescription for dispensing by an automated direct-to-patient dispensing system.
(3) Individuals with access to the automated direct-to-patient dispensing system for the purpose of stocking, inventory, and monitoring shall be limited to a pharmacist or a pharmacist delegate.
(4) The automated direct-to-patient dispensing system shall label the prescription in compliance with s. Phar 7.05. (5) The automated direct-to-patient dispensing system shall maintain prescription records in compliance with s. Phar 7.11 (1). (6) If the associated pharmacy is open, the pharmacist shall do a drug utilization review under s. Phar 7.03 and consulting requirements in s. Phar 7.08. If the associated pharmacy is not open, then the prescriber is responsible for the drug utilization review and consulting. (7) The managing pharmacist is responsible for maintaining records of the automated direct-to-patient dispensing system.
(8) The managing pharmacist shall establish written policies and procedures for automated direct-to-patient dispensing system for all of the following:
(a) Stocking, including identifying the responsible pharmacist.
(b) Determining access.
(c) Detection and mitigation of diversion and theft.
(9) The use of a automated direct to patient dispensing system does not create an exemption to s. 450.11 (1b), Stats. Phar 7.43 Remote dispensing. (1) Location. A pharmacist or a person engaged in the practice of pharmacy under s. 450.03 (1) (f), (g), or (i) may dispense at any of the locations under s. 450.062 (1) to (4), Stats. (2) Title. No person may use or display the title “pharmacy”, “drugstore,” “apothecary,” or any other title, symbol or insignia having the same or similar meanings in connection with remote dispensing.
(3) Requirements. (a) A remote dispensing location shall display a sign, easily viewable by customers, that states all of the following:
1. Prescriptions may be filled at this location.
2. This remote dispensing location is being supervised by a pharmacist located at all of the following:
a. Name of pharmacy.
b. Address of pharmacy.
c. Telephone of pharmacy.
3. The pharmacist is available for consultation.
(b) Remote dispensing may not occur if the supervising pharmacy is closed.
(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.
(d) Remote dispensing locations shall have a centrally monitored alarm. For all after hour entries, the personnel entering the location shall record their name, and the date, time and purpose for entering the site in a log. All logs shall be retained for a minimum of 5 years.
(4) Dispensing requirements. Remote dispensing shall comply with all of the following:
(a) Visually inspecting all prescription orders, labels and dispensed product.
(b) Labeling requirements under s. Phar 7.05. The prescription label shall contain the name and address of the supervising pharmacy as the licensed facility from which the prescribed drug or device was dispensed. (d) Federal law if dispensing controlled substances.
(5) Responsibilities of managing pharmacist. (a) The managing pharmacist of the supervising pharmacy shall do all of the following:
1. Have written policies and procedures for system operation, safety, security, accuracy and access.
2. Implement an on-going 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.
3. 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.
4. Retain documentation of the visits at the remote dispensing location for a minimum of 5 years.
(b) The managing pharmacist at the supervising pharmacy is responsible for all remote dispensing connected to the supervising pharmacy.
(6) Delegate requirements. A person engaged in the practice of pharmacy under s. 450.03 (1) (f), (g), or (i), Stats., shall meet the following requirements to remote dispense: (a) Be 18 years of age or older.
(b) Be a high school graduate or have equivalent education.
(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.
Subchapter V — Institutional Pharmacies
Phar 7.50 Definitions. In this subchapter:
(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
(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, 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. (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 7.51 Chart orders. A chart order shall contain all of the following:
(1) First and last name of the patient.
(2) Patient’s medical record number or date of birth.
