(b) NDC number. If NDC number is unavailable the name of the manufacturer or distributor of the drug product.
(c) Manufacturer lot number.
(d) Original container’s expiration date and the beyond-use date for the new containers.
(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.
(f) Date of repackaging.
Phar 7.07 Final check (1) The final check on the accuracy and correctness of the prescription drug product or device dispensing includes all of the following:
(a) Labeling requirements.
(b) Correct drug product or device.
(c) Completion of the drug utilization review.
(2) For all prescription drug product or device dispensing, the prescription record shall identify the pharmacist responsible for each part of the final check. If sub. (1) (a) or (b) is completed by delegate check delegate under s. Phar 7.14 or automated technology under s. Phar 7.55, the prescription record shall identify the supervising pharmacist. Phar 7.08 Patient consultation. (1) Patient consultation shall include all of the following:
(a) Name and description of the drug.
(b) Form, dose, route of administration and duration for drug therapy.
(c) Intended use of the drug and expected action.
(d) Special directions and precautions for preparation, administration and use by the patient.
(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.
(f) Techniques for self-monitoring drug therapy.
(g) Proper storage and appropriate disposal method of unwanted or unused medication.
(h) Action to be taken in the event of a missed dose.
(2) A pharmacist shall give the patient or patient’s agent consultation relative to the prescription for any new drug product or device which has not been dispensed previously to the patient or any change in the patient’s therapy. Patient consultation shall meet all of the following requirements:
(a) Contain all of the following information, unless in the pharmacist’s professional judgment it serves the best interest of the patient to omit or vary the content of the consultation:
1. Name and description of the drug.
2. Form, dose, route of administration and duration for drug therapy.
3. Intended use of the drug and expected action.
4. Special directions and precautions for preparation, administration and use by the patient.
5. 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.
6. Techniques for self-monitoring drug therapy.
7. Proper storage and appropriate disposal method of unwanted or unused medication.
8. Action to be taken in the event of a missed dose.
(b) Be communicated orally unless in the pharmacist’s professional judgment it is not in the best interest of the patient or patient’s agent to be communicated orally.
(c) Provide written documentation of the information in par. (a) 1. to 8.
(d) Advise the patient or patient’s agent the method which the pharmacist may be contacted for consultation.
(3) The consultation requirement is not satisfied by only offering to provide consultation.
(4) Every licensed pharmacy directly serving patients at a physical location must conspicuously post a sign approved by the board stating a patient’s rights to consultation and information on how to file a complaint to the Board for failure to consult. A copy of the sign must be included in any delivery by common carrier or delivery service.
(5) Consultation is required upon patient request.
(6) A pharmacist shall utilize professional judgement in determining whether to give the patient or patient’s agent appropriate consultation relative to the prescription for any refill.
(7) Notwithstanding sub. (2), a consultation is not required when a health care provider is administering the medication or if a patient or patient’s agent refuses consultation.
Phar 7.085 Delivery by common carrier or delivery services. Utilization of common carrier or delivery services to deliver a prescription from the pharmacy which fills the prescription to the patient or patient’s agent shall ensure all of the following:
(1) The delivery method maintains appropriate environmental controls, including temperature and humidity, to prevent drug adulteration.
(2) The delivery method provides for verification of receipt of all controlled substances.
(3) 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:
(a) Timeliness of delivery.
(b) Condition of the prescription drug upon delivery.
(c) Failure to receive the proper prescription drug product or device.
(4) Any prescription drug product or device which is compromised by delivery shall be replaced by the pharmacy. The pharmacy shall replace at no additional cost to the patient the prescription drug product or device by next-day delivery or the pharmacist shall contact the patient’s practitioner to arrange for a prescription for a minimum 7 day supply of the prescription drug product to be dispensed to the patient by a pharmacy of the patient’s choice.
Phar 7.09 Procurement, recall and out-of-date drugs and devices.
(1) Procurement of prescription drugs and devices shall be from a drug wholesaler licensed by the board or U.S. food and drug administration to distribute to pharmacies or from another licensed pharmacy or licensed practitioner located in the United States.
(2) A pharmacy shall have a system for identifying any drugs or devices subjected to a product recall and for taking appropriate actions as required by the recall notice.
(3) Any 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.
7.10 Return or exchange of health items. (1) In this section:
(a) “Health item” means drugs, devices, hypodermic syringes, needles or other objects for injecting a drug product, or items of personal hygiene.
(b) “Original container” means the container in which a health item was sold, distributed, or dispensed.
(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.
(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:
(a) Where the health item was dispensed in error, was defective, adulterated, or misbranded.
(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.
(c) A health item that is prepackaged for consumer use without a prescription when returned in compliance with all applicable state and federal laws.
Note: The DEA does not permit the return of controlled substances to a pharmacy from a non-DEA registrant under any circumstances.
(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.
(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.
Note: The DEA does not permit the return of controlled substances to a pharmacy from a non-DEA registrant under any circumstances.
(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.
(6) This section does not prohibit participation in a drug repository program in accordance with ch. DHS 148. Phar 7.11 Pharmacy records. (1) General. Pharmacy records shall be maintained for a minimum period of five years unless otherwise specified in state or federal law.
(2) Prescription records. (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:
1. Capable of producing a printout of any prescription data which the user pharmacy is responsible for maintaining.
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.
(b) A record of all prescriptions dispensed shall be maintained for a minimum period of 5 years after the date of the last refill.
(c) All systems used for maintaining a record of any prescription dispensing shall contain all items required in the medical profile record system.
(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.
(3) Medication profile record system. (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.
(b) The following minimum information shall be retrievable:
1. Patient’s first and last name, or if not human, name of pet, species and last name of owner.
2. Address of the patient.
3. Birth date of the patient or if not human birthdate of the owner.
4. Name of the drug product or device dispensed.
5. Strength of the drug product or device dispensed.
6. Form of the drug product or device dispensed.
7. Quantity of the drug product or device prescribed, dispensed and remaining.
8. Number of refills prescribed.
9. Directions for use.
10. Prescription order number.
11. Original date of issue.
