Alert! This chapter may be affected by an emergency rule:
Phar 7.04(3)(e)5. 5. The name, address, DEA registration number, and prescription number from the pharmacy that originally filled the prescription, if different.
Phar 7.04(4) (4) Use of shared computer system. A shared computer system used for transferring prescription order information shall, in addition to meeting the requirements of s. Phar 7.11 (2) (a), contain a shared real time electronic file database with a complete record of all prescriptions filled and dispensed.
Phar 7.04 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction in (3) (d) (intro.) made under s. 35.17, Stats., Register December 2020 No. 780; CR 21-074: am. (3) (intro.) Register June 2023 No. 810, eff. 7-1-23.
Phar 7.05 Phar 7.05Label requirements.
Phar 7.05(1)(1)This section does not apply to institutional pharmacies as defined in s. Phar 7.50 (3).
Phar 7.05(2) (2) All prescribed drugs or devices shall have a label attached to the container disclosing all of the following:
Phar 7.05(2)(a) (a) Identification of the patient by one of the following:
Phar 7.05(2)(a)1. 1. Except as provided in subds. 2. to 5., the first and last name of the patient.
Phar 7.05(2)(a)2. 2. For an antimicrobial drug dispensed under s. 450.11 (1g), Stats., the first and last name of the patient, if known, or the words, “expedited partner therapy” or the letters “EPT”.
Phar 7.05(2)(a)3. 3. For an opioid antagonist when delivered under s. 450.11 (1i), Stats., the first and last name of the person to whom the opioid antagonist is delivered.
Phar 7.05(2)(a)4. 4. For an epinephrine auto-injector prescribed under s. 118.2925 (3) or 255.07 (2), Stats., the name of the school, authorized entity, or other person specified under s. 255.07 (3), Stats.
Phar 7.05(2)(a)5. 5. If the patient is an animal, the last name of the owner, name of the animal and animal species.
Phar 7.05(2)(b) (b) Symptom or purpose for which the drug is being prescribed if the prescription order specifies the symptom or purpose.
Phar 7.05(2)(c) (c) Name and strength of the prescribed drug product or device dispensed, unless the prescribing practitioner requests omission of the name and strength of the drug product or device.
Phar 7.05(2)(d) (d) The date for which the medication shall not be used after.
Phar 7.05(2)(e) (e) Pharmacy name, address and telephone number.
Phar 7.05(2)(f) (f) Prescriber name.
Phar 7.05(2)(g) (g) Date the prescription was filled.
Phar 7.05(2)(h) (h) Prescription order number.
Phar 7.05(2)(i) (i) Quantity.
Phar 7.05(2)(j) (j) Number of refills or quantity remaining.
Phar 7.05(2)(k) (k) Directions for use of the prescribed drug or device as contained in the prescription order.
Phar 7.05(3) (3) A label for prescribed drugs or devices may include the following:
Phar 7.05(3)(a) (a) Symptom or purpose for which the drug is being prescribed if requested by the patient.
Phar 7.05(3)(b) (b) Both the generic name of the drug product equivalent and the brand name specified in the prescription order may be listed on the label if the brand name is listed on the prescription and the drug product equivalent is dispensed, unless the prescribing practitioner requests that the brand name be omitted from the label.
Phar 7.05(3)(c) (c) Written or graphic product descriptions.
Phar 7.05(3)(d) (d) Any cautions or other provisions.
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 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.
Phar 7.06 Phar 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)(a) (a) Drug name, strength, form and beyond use date.
Phar 7.06(4)(b) (b) One of the following identifiers:
Phar 7.06(4)(b)1. 1. Pharmacy control number.
Phar 7.06(4)(b)2. 2. NDC number and manufacturer lot number.
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)(c) (c) Manufacturer lot number.
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(5)(f) (f) Date of repackaging.
Phar 7.06(5)(g) (g) Any pharmacy control numbers.
Phar 7.06 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.
Phar 7.07 Phar 7.07 Final check.
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(1)(b) (b) Verifying the drug product or device is correct.
Phar 7.07(1)(c) (c) Completion of the drug utilization review.
Phar 7.07(2) (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 delegate performing the check.
Phar 7.07 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.
Phar 7.08 Phar 7.08 Patient consultation.
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)(a) (a) Has not been dispensed previously to the patient.
Phar 7.08(1)(b) (b) Is a change in therapy.
Phar 7.08(1)(c) (c) Upon request of a patient or patient's agent.
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(2)(b) (b) A patient or patient's agent refuses consultation.
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)(a) (a) Name and description of the drug.
Phar 7.08(3)(b) (b) Form, dose, route of administration and duration for drug therapy.
Phar 7.08(3)(c) (c) Intended use of the drug and expected action.
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)(f) (f) Techniques for self-monitoring drug therapy.
Phar 7.08(3)(g) (g) Action to be taken in the event of a missed dose.
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 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 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.
Loading...
Loading...
Published under s. 35.93, Stats. Updated on the first day of each month. Entire code is always current. The Register date on each page is the date the chapter was last published.