Minimum procedures for compounding and dispensing. Phar 7.01(1)(1)
Except as provided in sub. (4)
, a pharmacist or pharmacist-intern who compounds or dispenses according to a prescription order shall follow the procedures described in this rule and other applicable procedures. The pharmacist or pharmacist-intern as directed and supervised by a pharmacist shall:
Receive electronic or oral prescription orders of a prescriber, review all original and renewal prescription orders, whether electronic, written or oral, and determine therapeutic compatibility and legality of the prescription order. The review shall include, when indicated or appropriate, consultation with the prescriber.
Read and interpret a prescriber's directions for use for the purpose of accurately transferring the instructions to the prescription label.
Select, compound, mix, combine, measure, count and otherwise prepare drugs needed to dispense a prescription except that an agent of the pharmacist may procure, measure or count prefabricated dosage forms if a pharmacist verifies accuracy of the agent's action.
Make a final check on the accuracy and correctness of the prescription. For all original and renewed prescriptions, the prescription order record shall identify the pharmacist responsible for the prescription.
Give the patient or agent appropriate consultation relative to the prescription except that prescriptions may be delivered by an agent of the pharmacist to a patient's residence if the delivery is accompanied by appropriate directions and an indication that consultation is available by contacting the pharmacist. The consultation requirement applies to original and renewal prescription orders and, except when prescriptions are delivered to a patient's residence, is not satisfied by only offering to provide consultation.
Transfer the prescription to the patient or agent of the patient.
Receive, when required by law and standard professional practice, permission to renew from authorized prescribers, and note on the prescription order, medication profile record or uniformly maintained and readily retrievable document the following information:
Name of practitioner authorizing renewal, if different from the original prescriber.
(2) Subsection (1) (d)
does not prohibit institutional pharmacists or community pharmacists serving institutions from receiving prescription orders, dispensing and returning prescription medications consistent with accepted inpatient institutional drug distribution systems. Subsection (1)
applies to any institutional pharmacy dispensing to outpatients, including prescriptions for discharged patients.
A pharmacist may supervise no more than one pharmacy intern and 4 pharmacy technicians engaged in compounding and dispensing activities as described in sub. (1)
, except a higher ratio may be authorized by the board upon request to and approval by the board of a specific plan describing the manner in which additional interns or pharmacy technicians shall be supervised.
A system for compounding and dispensing not in conformance with subs. (1)
may be used if reviewed and approved by the board.
Phar 7.01 History
Cr. Register, January, 1983, No. 325
, eff. 2-1-83; am. (1) (intro.), (d) and (f) (intro.), Register, August, 1991, No. 428
, eff. 9-1-91; am. (1) (e), Register, January, 1996, No. 481
, eff. 2-1-96; am. (1) (a), (e), (f) (intro)., (3) and cr. (1) (em), Register, December, 1998, No. 516
, eff. 1-1-99; am. (1) (a), Register, November, 1999, No. 527
, eff. 12-1-99; am. (3), Register, April, 2001, No. 544
, eff. 5-1-01.
As used in this section, "pharmacy technician" means a non-pharmacist or non-pharmacist intern who, under the general supervision of a pharmacist who regularly coordinates, directs and inspects the activities of the pharmacy technician, assists the pharmacist in the technical and nonjudgmental functions related to the practice of pharmacy in the processing of prescription orders and inventory management. "Pharmacy technician" does not include ancillary persons which include, clerks, secretaries, cashiers or delivery persons, who may be present in the pharmacy.
A pharmacist may delegate technical dispensing functions to a pharmacy technician, but only under the general supervision of the pharmacist where the delegated functions are performed. Technical dispensing functions include:
Accepting written or electronic prescription orders of the prescribing practitioner or from the prescribing practitioner's agent.
Accepting original oral prescription orders from the prescribing practitioner or prescribing practitioner's agent, if the conversation is recorded and listened to and verified by the pharmacist prior to dispensing.
Requesting authorization for a refill from the prescribing practitioner.
Accepting oral authorization for a refill from the prescribing practitioner or prescribing practitioner's agent, provided there are no changes to the original prescription order.
Accepting a request from a patient to refill a prescription.
Obtaining and entering patient or prescription data into the patient information system.
Retrieving medication from stock, counting or measuring medication, and placing the medication in its final container.
Compounding pharmaceuticals pursuant to written policies and procedures.
Prepackaging and labeling drugs for dispensing by a pharmacist.
Preparing unit dose carts for final review by a pharmacist.
Retrieving and transporting stock medication to and from pharmacist approved areas.
Other technical functions that do not require the professional judgment of a pharmacist.
Transferring the prescription to the patient or agent of the patient, provided that the pharmacist has first provided a patient consultation.
A pharmacy technician may not do any of the following:
Provide the final verification for the accuracy, validity, completeness, or appropriateness of a filled prescription or medication order.
Participate in final drug regimen screening, including screening for therapeutic duplication, drug-to-drug interactions, incorrect dosage, incorrect duration of treatment, drug allergy reactions and clinical abuse or misuse.
Provide patient counseling, consultation, or patient specific judgment, such as interpreting or applying information, including advice relating to therapeutic values, potential hazards and uses.
The pharmacist shall provide the final verification for the accuracy, validity, completeness, and appropriateness of the patient's prescription prior to the delivery of the prescription to the patient or the patient's representative.
Phar 7.015 History
Cr. Register, April, 2001, No. 544
, eff. 5-1-01; CR 07-099
: cr. (2) (q), r. (3) (d) Register May 2008 No. 629
, eff. 6-1-08.
Prescription label; name of drug or drug product dispensed.
No drug product may be dispensed unless the prescription label discloses the brand name and strength, or the generic name, strength, and manufacturer or distributor of the drug product dispensed unless the prescribing practitioner requests omission of the above information. If a pharmacist, pursuant to a prescription order that specifies a drug product by its brand name, dispenses the drug product equivalent of the drug product specified in the prescription order, the prescription label may include both the generic name of the drug product equivalent and the brand name specified in the prescription order, unless the prescribing practitioner requests that the brand name be omitted from the label. If a brand name drug product is dispensed, the prescription label may contain both the brand name and the generic name of the drug product equivalent dispensed unless the prescribing practitioner requests that the generic name of the drug product equivalent be omitted from the label.
Phar 7.02 History
Cr. Register, January, 1983, No. 325
, eff. 2-1-83; Register, August, 1991, No. 428
, eff. 9-1-91; am. Register, January, 1996, No. 481
, eff. 2-1-96; CR 07-097
: am. Register May 2008 No. 629
, eff. 6-1-08.
Prescription renewal limitations.
A prescription order for any drug other than controlled substances, which bears renewal authorization permitting the pharmacist to renew the prescription as needed (PRN) by the patient, shall not be renewed beyond one year from the date originally prescribed. No prescription order containing either specific or PRN renewal authorization is valid after the patient-physician relationship has ceased.
Return or exchange of health items. Phar 7.04(1)(a)
``Health item" means drugs, devices, hypodermic syringes, needles or other objects for injecting a drug, medicines, or items of personal hygiene.
``Inpatient health care facility" means any hospital, nursing home, county home, county mental hospital, tuberculosis sanitarium or similar facility, but does not include community-based residential facilities, jails or prison facilities.
"Original container" means the container in which a health item was sold, distributed or dispensed.
"Resident health care patient" means a patient residing in a community-based residential facility that controls a resident's prescribed and over-the-counter medications as specified by s. DHS 83.37
"Secured institutional health care patient" means any of the following:
A jail inmate patient whose dispensed health items are maintained under the custody and control of the jail pursuant to an approved policy and procedure manual under s. DOC 350.17
, containing policies and procedures for the control and administration of medications complying with s. DOC 350.20
A juvenile patient who resides in a secured correctional facility, as defined in s. 938.02 (15m)
, Stats.; a secured child caring institution, as defined in s. 938.02 (15g)
, Stats.; a secured group home, as defined in s. 938.02 (15p)
, Stats.; a secured detention facility, as defined in s. 938.02 (16)
, Stats.; or a juvenile portion of a county jail whose dispensed health items are maintained under the custody and control of the health services staff as defined in s. DOC 316.02 (6)
and provided to a juvenile patient under the provisions of s. DOC 316.03
Phar 7.04 Note
Section 938.02 (15m), Stats., was renumbered to s. 938.02 (10p), Stats., by 2005 Wis. Act 344
and the term "secured correctional facility" was changed to "juvenile correctional facility". Section 938.02 (15p), Stats., was repealed by 2005 Wis. Act 344
. Section 938.02 (16), Stats., was renumbered to s. 938.02 (10r), Stats., and "secure detention facility" ws changed to "juvenile detention facility" by 2005 Wis. Act 344
"Tamper-resistant package" means a container bearing a beyond use date that is sealed so that the contents cannot be used without obvious destruction of the seal.
No health items after taken from a pharmacy where sold, distributed or dispensed, may be returned to that pharmacy, except for any of the following:
From an inpatient health care facility, provided they are in their original containers and the pharmacist determines the contents are not adulterated or misbranded.
Where the health items were dispensed in error, were defective, adulterated, misbranded, or dispensed beyond their beyond use date.
When in the professional judgment of the pharmacist substantial harm could result to the public or a patient if they were to remain in the possession of the patient, patient's family or agent, or other person.
For a secured institutional health care patient or resident health care patient where all of the following apply:
The health item was never in the possession and control of the patient.
The health item was sold, distributed or dispensed in a tamper-resistant package and, for a drug, includes the beyond use date and manufacturer's lot number.
The health item is not commingled with a different health item unless the health item will be repackaged and redispensed to the same patient.
The health item is in its original container and the pharmacist determines the contents are not adulterated or misbranded.
A health item that is prepackaged for consumer use and labeled in compliance with all applicable state and federal laws where all of the following apply:
The pharmacist determines that the original package is unopened, sealed and intact and that package labeling is unaltered.
Health items returned to a pharmacy pursuant to sub. (2) (b)
, may not be sold, resold, or repackaged and sold or resold, given away, or otherwise distributed or dispensed. Returned health items shall either be destroyed at the pharmacy or delivered for destruction or other disposal by an authorized person or entity.
Health items returned from a secured institutional health care patient to a pharmacy pursuant to sub. (2) (d)
, must be segregated in the pharmacy and may not be sold, resold, or repackaged and sold or resold, given away, or otherwise sold, distributed or redispensed other than to a secured institutional health care patient.
It is not a ``return" for a patient or agent of a patient to deliver 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 for the same patient's use.
Phar 7.04 Note
Note: The DEA does not permit the return of controlled substances to a pharmacy from a non-DEA registrant under any circumstances.
It is not a "return" for a patient or agent of a patient to deliver 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 7.04 Note
Cancer and chronic disease drug returns and redispensing pursuant to ch. DHS 148
are allowed provided the pharmacy follows the requirements in ch. DHS 148
Phar 7.04 Note
A prescription drug that is returned to a pharmacy that primarily serves patients confined in a state prison is not addressed in this rule. Such a drug may be redispensed to a patient in a state prison provided the requirements of s. 450.09 (7m)
, Stats., are satisfied.
Phar 7.04 History
Cr. Register, January, 1983, No. 325
, eff. 2-1-83; am. Register, August, 1991, No. 428
, eff. 9-1-91; r. and recr., Register, December, 1998, No. 516
, eff. 1-1-99; CR 05-029
: cr. (1) (c) to (f), (2) (d) and (e), (3m) and (5), am. (2) (intro.) and (b) Register December 2005
No, 600, eff. 1-1-06; correction in (1) (d) made under s. 13.92 (4) (b) 7.
, Stats., Register March 2010 No. 651
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 capable of producing a printout of any prescription data which the user pharmacy is responsible for maintaining. The system shall be designed so that the pharmacy can receive the printout within 48 hours after requesting the printout.
Is 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.
A record of all prescriptions dispensed shall be maintained for a period of 5 years after the date of the last refill.
All systems used for maintaining a record of any prescription dispensing shall include: