Phar 7.05(4)(4) Subsection (2) does not apply to complimentary samples of drug products or devices dispensed in original packaging by a practitioner to his or her patients. Phar 7.05 HistoryHistory: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21. Phar 7.06Phar 7.06 Repackaging for stock. A pharmacy repackaging for stock any non-sterile drugs shall do all of the following: Phar 7.06(1)(1) The repackaging for stock process is conducted under conditions that ensure the integrity of the drug. Phar 7.06(2)(2) Products repackaged for stock shall include a beyond use date that ensures the integrity of the drug. Phar 7.06(3)(3) The repackaged container shall be selected to mitigate adulteration from light, temperature and humidity. Phar 7.06(4)(4) The repackaged for stock drugs are labeled physically or electronically with all the following components: Phar 7.06(4)(b)3.3. Name of manufacturer or distributer of the drug product, and the manufacturer lot number. Phar 7.06(5)(5) Records of all repackaging for stock operations are maintained and include all the following: Phar 7.06(5)(a)(a) Name, strength, form, quantity per container, and quantity of containers. Phar 7.06(5)(b)(b) NDC number or the name of the manufacturer or distributor of the drug product. Phar 7.06(5)(d)(d) Original container’s expiration date and the beyond-use date for the new containers. Phar 7.06(5)(e)(e) First and last name of the pharmacist or delegate that repackaged the drug and the first and last name of the pharmacist that verified the accuracy of the repackaging. Phar 7.06 HistoryHistory: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21. Phar 7.07(1)(1) A final check of accuracy and correctness is required for any prescription drug product or device dispensed and shall include all of the following: Phar 7.07(1)(a)(a) Verifying label is correct and meets labeling requirements. Phar 7.07(2)(2) For all prescription drug products or devices dispensed by a pharmacist, the prescription record shall identify the pharmacist responsible for each part of the final check. If sub. (1) (a) or (b) is completed by a pharmacy product verification technician under s. Phar 7.14 or automated technology under s. Phar 7.55, the prescription record shall identify the pharmacy product verification technician performing the check. Phar 7.07 HistoryHistory: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; EmR2303: emerg. am. (2), eff. 2-3-23; CR 23-072: am. (2) Register August 2024 No. 824, eff 9-1-24. Phar 7.08(1)(1) A pharmacist shall provide the patient or patient’s agent consultation to optimize proper use of a prescription drug or device, that meets any of the following: Phar 7.08(1)(d)(d) Whenever deemed necessary based upon the professional judgement of the dispensing pharmacist. Phar 7.08(2)(2) Notwithstanding sub. (1), consultation is not required when one of the following occurs: Phar 7.08(2)(a)(a) A drug or device will be administered, by ingestion, inhalation, injection, or any other route, by or in the presence of one of the following: Phar 7.08(2)(a)1.1. An individual with a scope of practice that includes the administration of a drug or device. Phar 7.08(2)(a)2.2. A delegate of an individual with authority to delegate the administration of a drug or device. Phar 7.08(3)(3) Consultation shall contain any of the following information that, in the pharmacist’s professional judgment, serves the best interest of the patient: Phar 7.08(3)(b)(b) Form, dose, route of administration and duration for drug therapy. Phar 7.08(3)(d)(d) Directions and precautions for the preparation, administration, and use. Phar 7.08(3)(e)(e) Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur. Phar 7.08(3)(h)(h) Proper storage and appropriate disposal method of unwanted or unused medication. Phar 7.08(4)(4) The consultation required in this section shall be communicated verbally when in the pharmacist’s professional judgment it is in the best interest of the patient. Phar 7.08(5)(5) A pharmacist shall provide the patient or patient’s agent, for all consultations required under sub. (1), a written patient drug education monograph. Phar 7.08(6)(6) The consultation required in this section may occur before or after delivery of the prescription to the patient or patient’s agent. Phar 7.08(7)(7) Every licensed pharmacy dispensing directly to a patient or patient’s agent inside the pharmacy shall conspicuously post a board approved sign stating a patient’s rights to pharmacist consultation and information on how to file a complaint to the board. Phar 7.08(8)(8) A prescription drug or device delivered by common carrier, mail, or delivery service or picked up at a drive through window shall include a copy of information which is board-approved stating a patient’s rights to pharmacist consultation and information on how to file a complaint to the board. Phar 7.08 HistoryHistory: 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 7.085Phar 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)(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 HistoryHistory: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21. Phar 7.09Phar 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 HistoryHistory: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21. Phar 7.10Phar 7.10 Return or exchange of health items. 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 NoteNote: 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 NoteNote: 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 HistoryHistory: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21. 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)(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.
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