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Phar 7.09 Phar 7.09 Procurement, recall and out-of-date drugs and devices.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 Outdated drugs or devices shall be removed from dispensing stock and shall be quarantined until such drugs or devices are properly disposed.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.

Phar 7.10 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

Phar 7.11 Phar 7.11 Pharmacy records.

Phar 7.11(1) (1) General. Pharmacy records shall be maintained for a minimum period of 5 years unless otherwise specified in state or federal law.

Phar 7.11(2) (2) Prescription records.

Phar 7.11(2)(a) (a) A computerized system may be used for maintaining a record, as required under this section, of prescription dispensing and transfers of prescription order information for the purposes of original or refill dispensing if the system is:

Phar 7.11(2)(a)1. 1. Capable of producing a printout of any prescription data which the user pharmacy is responsible for maintaining.

Phar 7.11(2)(a)2. 2. Equipped with an auxiliary procedure which, during periods of down-time, shall be used for documentation of prescription dispensing. The auxiliary procedure shall ensure that prescription refills are authorized by the original prescription order, that the maximum number of prescription refills has not been exceeded and that all of the appropriate data are retained for on-line entry as soon as the computer system is again available for use.

Phar 7.11(2)(b) (b) A record of all prescriptions dispensed shall be maintained for a minimum period of 5 years after the date of the last refill.

Phar 7.11(2)(c) (c) All systems used for maintaining a record of any prescription dispensing shall contain all items required in the medical profile record system.