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 Outdated drugs or devices shall be removed from dispensing stock and shall be quarantined until such drugs or devices are properly disposed.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. 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. Phar 7.11(2)(d)(d) A paper prescription for non-controlled substances may be scanned and stored electronically in the computer system under par. (a). For purposes of this chapter, the prescription becomes an electronic prescription. Phar 7.11(3)(a)(a) An individual medication profile record system shall be maintained in all pharmacies for humans and non-humans for whom prescriptions, original or refill, are dispensed. The system shall be capable of permitting the retrieval of information. Phar 7.11(3)(b)1.1. Patient’s first and last name, or if not human, name of pet, species and last name of owner. Phar 7.11(3)(b)3.3. Birth date of the patient or, if not human, birth date of the owner. Phar 7.11(3)(b)7.7. Quantity of the drug product or device prescribed, dispensed and remaining. Phar 7.11(3)(c)(c) The pharmacist shall be responsible for attempting to ascertain and record any patient allergies, adverse drug reactions, drug idiosyncrasies, and any chronic conditions which may affect drug therapy as communicated by the patient or agent of the patient. If none, this should be indicated. Phar 7.11(3)(d)(d) Medication profile records shall be maintained for a minimum period of 5 years following the date of the last dispensing. Phar 7.11 HistoryHistory: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction in (1), (3) (b) 3. made under s. 35.17, Stats., Register December 2020 No. 780. Phar 7.12Phar 7.12 Delegation by a physician. The pharmacist shall document the delegation by a physician under s. 450.033, Stats. The delegated act may not be started prior to the documentation. The documentation shall be maintained for a minimum of 5 years after the last delegated act under that delegation. Phar 7.12 HistoryHistory: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction made under s. 35.17, Stats., Register December 2020 No. 780. Phar 7.13Phar 7.13 Administration of drug products and devices other than vaccines. Phar 7.13(1)(1) In this section, “course of study” means one or more classes, workshops, seminars, or continuing education programs. Phar 7.13(2)(2) A pharmacist may administer a drug product, as defined in s. 450.01 (11), Stats., or device, as defined in s. 450.01 (6), Stats. After the pharmacist administers a prescribed drug product or device, the pharmacist, a person engaged in the practice of pharmacy under s. 450.03 (1) (f) or (g), Stats., or the pharmacist’s agent shall notify the prescribing practitioner or enter the information in a patient record system shared by the prescribing practitioner. Phar 7.13(3)(3) A pharmacist may not administer by injection a prescribed drug product or device unless the pharmacist has successfully completed a course of study and training in administration technique conducted by a course provider approved by the Accreditation Council for Pharmacy Education or the board. Phar 7.13(4)(4) A person engaged in the practice of pharmacy under s. 450.03 (1) (f) or (g), Stats., may not administer a prescribed drug product or device unless the person satisfies all of the following: Phar 7.13(4)(a)(a) Successfully completes a course of study and training in administration technique conducted by a course provider approved by the Accreditation Council for Pharmacy Education or the board. Phar 7.13(4)(b)(b) Administers the prescribed drug product or device only under the direct supervision of a pharmacist who has successfully completed a course of study and training in administration technique conducted by a course provider approved by the Accreditation Council of Pharmacy Education or the board. Phar 7.13(4)(c)(c) After administering the prescribed drug product or device, notifies the prescribing practitioner or enters the information in a patient record system shared by the prescribing practitioner. Phar 7.13(5)(5) The board may approve courses of study which meet criteria substantially equivalent to criteria used by the Accreditation Council for Pharmacy Education. Phar 7.13(6)(6) A course of study and training in administration technique shall include all of the following topics: Phar 7.13(6)(d)(d) The 5 rights of administration including right patient, right drug, right dose, right route, and right time. Phar 7.13(6)(e)(e) Patient reassessment after administration including signs and symptoms of adverse drug reactions. Phar 7.13(6)(f)(f) Best practices in documentation of the medication administration. Phar 7.13(7)(7) This section does not apply to the administration of vaccines. Phar 7.13 NoteNote: To administer a vaccine a pharmacist must meet the requirements in s. 450.035, Stats. Phar 7.13 HistoryHistory: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction in (6) (d) made under s. 35.17, Stats., Register December 2020 No. 780. Phar 7.14Phar 7.14 Pharmacy product verification technician-check-pharmacy technician. Phar 7.14(1)(a)(a) “Pharmacy product verification technician” means a registered pharmacy technician to whom the pharmacist has delegated the task of product verification. Phar 7.14(1)(b)(b) “Pharmacy product verification technician-check- pharmacy technician” means the process in which a pharmacy product verification technician conducts the task of product verification of technical dispensing functions completed by a pharmacy technician. A pharmacy product verification technician may not conduct product verification as part of the final check of their own product preparation. Phar 7.14(1)(c)(c) “Product verification” means doing a check of the accuracy and correctness of a product, including drug, strength, formulation, as part of the final check and ensure the product has not reached its expiration or beyond use date. Phar 7.14(1)(d)(d) “Supervising pharmacist” means the pharmacist licensed in this state, who is responsible for the operations and outcomes of product verification done by a pharmacy product verification technician and ensuring for direct supervision of the pharmacy product verification technician. Phar 7.14(2)(2) Pharmacy product verification technician qualifications. A pharmacist may delegate the product verification of a prescription or chart order to a pharmacy technician who meets all of the following: Phar 7.14(2)(b)(b) Completed an accredited pharmacy technician training program or has a minimum of 500 hours of experience in product selection, labeling and packaging. Phar 7.14(2)(c)(c) Completed a didactic and practical training curriculum approved by the supervising and managing pharmacist that includes training in all of the following: Phar 7.14(2)(c)2.2. Common dispensing medication errors and concepts including all of the following:
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