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 delegate 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)(a)(a) A minimum of 5% of each delegate's product verifications shall be audited by a licensed pharmacist. The accuracy of each delegate shall be tracked individually.
Phar 7.14(4)(b)
(b) A record of each delegate-check-delegate audit shall include all of the following:
Phar 7.14(4)(c)
(c) On a quarterly basis, the supervising pharmacist shall perform an assessment of each delegate's previous 12 months accuracy and correctness of delegate-check-delegate product verifications including a review of the quality assurance log.
Phar 7.14(4)(d)
(d) A delegate shall be revalidated if the delegate 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 delegate-check-delegate product 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 delegate-check-delegate which shall be made available to the board upon request.
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 delegate 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 delegate-check-delegate pharmacist, indicating the name of the supervising delegate-check-delegate pharmacist, and the dates the supervision responsibilities begin and end.
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.
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.
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(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(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 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:
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(1)(1)
In this section, “supervising pharmacist” means a Wisconsin licensed pharmacist, appointed by the managing pharmacist, who is responsible for the remote dispensing and compliance with this section.
Phar 7.43(3)
(3)
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.
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)2.
2. This remote dispensing location is being supervised by a pharmacist located at all of the following:
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 the supervising pharmacy is closed.
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(4)(d)
(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.
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.
