Phar 7.08 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction in (3) (d) made under s. 35.17, Stats., Register December 2020 No. 780.

Phar 7.085 Phar 7.085 Delivery by common carrier or delivery services. Utilization of common carrier or delivery services to deliver a prescription to a location of the patient’s choice from the pharmacy which fills the prescription to the patient or patient’s agent shall ensure all of the following:

Phar 7.085(1) (1) The delivery method is appropriate to prevent drug adulteration.

Phar 7.085(2) (2) The patient or patient’s agent is provided a method by which the patient or patient’s agent can notify the pharmacy as to any irregularity in the delivery of the prescription drug product or device, including all of the following:

Phar 7.085(2)(a) (a) Timeliness of delivery.

Phar 7.085(2)(b) (b) Condition of the prescription drug upon delivery.

Phar 7.085(2)(c) (c) Failure to receive the proper prescription drug product or device.

Phar 7.085(3) (3) Any prescription drug product or device which is compromised or lost shall be replaced by the pharmacy at no additional cost to the patient. If the timeliness of the replacement will lead to an interruption in therapy, a pharmacist at the dispensing pharmacy shall take steps to mitigate patient harm.

Phar 7.085 Note Note: A delivery driver engaged solely in the delivery of a prescription in compliance with this section does not need to be registered as a pharmacy technician.

Phar 7.085 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

Phar 7.09 Phar 7.09 Procurement, recall and out-of-date drugs and devices.

Phar 7.09(1) (1) A pharmacy shall have a system for identifying a drug or device subjected to a product recall and for taking appropriate actions as required by the recall notice.

Phar 7.09(2) (2) A drug or device may not be dispensed after the drug’s or device’s expiration date or beyond use date. Outdated drugs or devices shall be removed from dispensing stock and shall be quarantined until such drugs or devices are properly disposed.

Phar 7.09 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

Phar 7.10 Phar 7.10 Return or exchange of health items.

Phar 7.10(1) (1) In this section:

Phar 7.10(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 7.10(1)(b) (b) “Original container” means the container in which a health item was sold, distributed, or dispensed.

Phar 7.10(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 7.10(2) (2) No health item after taken from a pharmacy where sold, distributed or dispensed, may be returned to that pharmacy, except for any of the following:

Phar 7.10(2)(a) (a) Where the health item was dispensed in error, was defective, adulterated, or misbranded.

Phar 7.10(2)(b) (b) When in the professional judgment of the pharmacist substantial harm could result to the public or patient if it were to remain in the possession of the patient, patient’s family or agent, or other person.

Phar 7.10(2)(c) (c) A health item that is prepackaged for consumer use without a prescription when returned in compliance with all applicable state and federal laws.

Phar 7.10 Note Note: The DEA does not permit the return of controlled substances to a pharmacy from a non-DEA registrant under any circumstances.

Phar 7.10(3) (3) A health item returned to a pharmacy pursuant to sub. (2) (a) and (b), may not be sold, resold, or repackaged and sold or resold, given away, or otherwise distributed or dispensed. A returned health item shall either be destroyed at the pharmacy or delivered for destruction or other disposal by an authorized person or entity.

Phar 7.10(4) (4) It is not a return of a health care item if a patient or agent of a patient delivers a previously dispensed drug or device to a pharmacy for the purpose of repackaging and relabeling of that previously dispensed drug or device, and subsequent return of the drug or device is for the same patient’s use.

Phar 7.10 Note Note: The DEA does not permit the return of controlled substances to a pharmacy from a non-DEA registrant under any circumstances.

Phar 7.10(5) (5) It is not a return of a health care item if a patient or agent of a patient delivers a previously dispensed drug or device to a pharmacy for the purpose of destruction at the pharmacy or other disposal by an authorized person or entity.

Phar 7.10(6) (6) This section does not prohibit participation in a drug repository program in accordance with ch. DHS 148.