Wis. Admin. Code Phar — Pharmacy Examining Board

Chapter Phar 1 AUTHORITY AND DEFINITIONS

Wis. Admin. Code § Phar 1.01 Authority {#sec-phar-1.01 omnilex-key=us-wi-regs-official--agency-phar--Phar 1.01}

Rules in chs. Phar 1 to 19 are adopted under authority of ss. 15.08 (5) (b) and 227.11 (2), Stats., and ch. 450, Stats.

History

Cr. Register, January, 1983, No. 325, eff. 2-1-83; am. Register, August, 1991, No. 428, eff. 9-1-91; am., Register, December, 1998, No. 516, eff. 1-1-99; am., Register, March, 2000, No. 531, eff. 4-1-00; correction made under s. 13.93 (2m) (b) 7., Stats., Register January 2002 No. 553; CR 17-090: am. Register July 2018 No. 751, eff. 8-1-18; EmR2303: emerg. am., eff. 2-3-23; CR 23-072: am. Register August 2024 No. 824, eff. 9-1-24; correction made under s. 35.17, Stats., Register August 2024 No. 824.

Wis. Admin. Code § Phar 1.02 Definitions {#sec-phar-1.02 omnilex-key=us-wi-regs-official--agency-phar--Phar 1.02}

As used in chs. Phar 1 to 19:

(1) “Board” means the pharmacy examining board.

Note: The board office is located at 4822 Madison Yards Way, Madison, WI 53705.

(2) “Community pharmacy” means practice in a licensed pharmacy providing pharmaceutical services primarily on an outpatient basis.

(2m) “Department” means the Wisconsin department of safety and professional services.

(3) “DEA” means the drug enforcement administration.

(3m) “Direct supervision” means immediate, whether in person or real time video conferencing where all parties can communicate by simultaneous means of audio, video, or data communications, availability to continually coordinate, direct and inspect in real time the practice of another.

(4) “Institutional pharmacy” means practice in a licensed pharmacy providing pharmaceutical services primarily on an inpatient basis.

(4m) “Long term care facility” has the meaning given in 21 CFR 1300.01.

(5) “LTCF” means a long term care facility.

(6) “Managing pharmacist” means a pharmacist designated by the pharmacy owner to have responsibility for and direct control of pharmaceutical operations in a pharmacy.

(6m) “NABP” means the National Association of Boards of Pharmacy.

(7) “NAPLEX” means the North American Pharmacy Licensing Examination.

(8) “Pharmacist” has the meaning given in s. 450.01 (15), Stats.

(10) “Pharmacy” means any place of practice licensed by the board under s. 450.06 or 450.065, Stats., unless otherwise provided for in s. 450.065, Stats.

(10m) “Pharmacy graduate” means a graduate of a school of pharmacy approved by the board, who has submitted an application for pharmacist licensure or a qualified applicant awaiting examination for licensure approved by the board.

(11) “Pharmacy owner” means a person or entity to whom a pharmacy license is issued.

(11m) “Pharmacy technician” means a person registered by the board under s. 450.068, Stats.

(12) “Practice of pharmacy” has the meaning under s. 450.01 (16), Stats.

(13) “PRN” means renew as needed.

(14) “Professional service area” means the area of a pharmacy in which prescriptions are compounded or dispensed, hypodermic needles, syringes, poisons and schedule V controlled substances as listed in s. 961.22, Stats., and ch. CSB 2 are available, or where patients are consulted.

(14m) “Remote dispensing site” has the meaning given in s. 450.01 (21c), Stats.

(15) “Terminal illness” means an incurable condition caused by injury or illness that reasonable medical judgment finds would cause death.

History

Cr. Register, January, 1983, No. 325, eff. 2-1-83; am. (intro.), renum. (2) to (9) to be (6) to (12) and (14) and am. (8), (10) and (12), cr. (2) to (5) and (13), Register, August, 1991, No. 428, eff. 9-1-91; cr. (4m) and (15), Register, September, 1994, No. 465, eff. 10-1-94; am. (7), (8), (11) and (14), Register, December, 1998, No. 516, eff. 1-1-99; am. (intro.), Register, March, 2000, No. 531, eff. 4-1-00; emerg. cr. (3c), (4c), (4e), and (14m), eff. 1-1-02; correction in (intro.) made under s. 13.93 (2m) (b) 7., Stats., Register January 2002 No. 553; CR 14-023: am. (7) Register August 2014 No. 704, eff. 9-1-14; CR 15-064: am. (10) Register September 2016 No. 729, eff. 10-1-16; CR 16-017: cr. (6m) Register September 2016 No. 729, eff. 10-1-16; correction in (10) made under s. 35.17, Stats., Register September 2016 No. 729; 2017 Wis. Act 18: am. (4m) Register June 2017 No. 738, eff. July 1, 2017; CR 17-090: am. (intro.) Register July 2018 No. 751, eff. 8-1-18; EmR2213: emerg. r. (9), cr. (14m), eff. 11-1-22; CR 23-054; cr. (3m), r. (9), cr. (10m), (14m) Register August 2024 No. 824, eff. 9-1-24; EmR2303: emerg. am. (intro.), cr. (11m), eff. 2-3-23; CR 23-072: am. (intro.), cr. (2m), (11m) Register August 2024 No. 824, eff. 9-1-24.

Chapter Phar 2 APPLICATION FOR PHARMACIST LICENSE

Wis. Admin. Code § Phar 2.02 Application procedure for original licensure {#sec-phar-2.02 omnilex-key=us-wi-regs-official--agency-phar--Phar 2.02}

(1) Except as provided in s. Phar 2.06 (2), each applicant for original licensure as a pharmacist shall submit all of the following:

(a) Completed application form with the signature of the applicant.

(b) A statement from the dean of the school of pharmacy or the academic records office of the respective educational institution that the applicant has graduated from the pharmacy school.

(c) If the applicant was foreign educated, evidence satisfactory to the board that the applicant has obtained certification by the foreign pharmacy graduate examination committee.

(d) Evidence of having completed an internship in the practice of pharmacy, consisting of a minimum of 1,500 hours, which shall consist of one or more of the following:

A statement from the dean of the school of pharmacy or the academic records office certifying the number of hours that the applicant has successfully completed in a practical experience program of the respective educational institution.
A statement from a supervising pharmacist certifying the number of hours that the applicant was supervised by that supervising pharmacist in an internship in the practice of pharmacy described in ch. Phar 17.
Verification of practical experience acquired by the applicant in another state, which is approved and verified by the board or by the agency which is the equivalent of the board in the state in which the practical experience was acquired.

(e) The fees required under s. 440.05 (1), Stats.

(f) Evidence of having passed the NAPLEX.

(g) Evidence of having passed the multi-state pharmacy jurisprudence examination with Wisconsin as primary state.

Note: Applications are available upon request to the board office located at 1400 East Washington Avenue, P. O. Box 8935, Madison, WI 53708.

(2) Any change of name made prior to admission to examination shall be supported by an affidavit satisfactory to the board.

History

Cr. Register, January, 1983, No. 325, eff. 2-1-83; am. (1) (intro.) and (d), Register, December, 1998, No. 516, eff. 1-1-99; emerg. renum. (1) (d) to be (1) (e), cr. (1) (d), eff. 1-1-02; CR 01-134: renum. (1) (d) to be (1) (e), cr. (1) (d), Register July 2002 No. 559, eff. 8-1-02; CR 02-140: am. (1) (intro.) Register May 2003 No. 569, eff. 6-1-03; CR 02-150: r. (1) (c) Register May 2003 No. 569, eff. 6-1-03; CR 06-050: cr. (1) (c) Register October 2006 No. 610, eff. 11-1-06; CR 09-019: am. (1) (intro.) Register October 2009 No. 646, eff. 11-1-09; CR 16-017: am. (1) (intro.), (a), cr. (1) (f), (g) Register September 2016 No. 729, eff. 10-1-16; CR 19-164: am. 2.02 (1) (c), (d) (intro.), 1., 3. Register July 2020 No. 775, eff. 8-1-20; CR 21-028: am. (1) (intro.) Register April 2022 No. 796, eff. 5-1-22.

Wis. Admin. Code § Phar 2.05 Application procedure for persons licensed in another state {#sec-phar-2.05 omnilex-key=us-wi-regs-official--agency-phar--Phar 2.05}

Except as provided in s. Phar 2.06 (2), each applicant licensed as a pharmacist in another state shall submit all of the following:

(1) Completed application form with the signature of the applicant and fee as determined by the department under s. 440.05, Stats.

(2) NABP Clearinghouse license transfer application.

(3) Evidence of having passed the multi-state pharmacy jurisprudence examination with Wisconsin as primary state.

History

Renum. from Phar 3.02 and am. (1) (intro.), Register, December, 1998, No. 516, eff. 1-1-99; CR 09-019: am. (1) (intro.) Register October 2009 No. 646, eff. 11-1-09; CR 16-017: r. and recr. Register September 2016 No. 729, eff. 10-1-16; CR 21-028: am. (intro.) Register April 2022 No. 796, eff. 5-1-22.

Wis. Admin. Code § Phar 2.06 Application procedure for service members, former service members, and their spouses {#sec-phar-2.06 omnilex-key=us-wi-regs-official--agency-phar--Phar 2.06}

(1) In this section:

(a) “Former service member” has the meaning given in s. 440.09 (1) (a), Stats.

(b) “Service member” has the meaning given in s. 440.09 (1) (b), Stats.

(2) Each applicant for reciprocal licensure as a pharmacist shall submit all of the following, notwithstanding the items submitted under ss. Phar 2.02 and 2.05:

(a) A completed application form with the signature of the applicant.

(b) A fee as determined by the department under s. 440.05 (2), Stats.

(d) Documentation that the applicant is a service member, former service member, or the spouse of a service member or former service member. If an applicant is unable to provide the documentation, the applicant may submit an affidavit to the board stating that the applicant is a service member, former service member, or the spouse of a service member or former service member.

(e) Evidence the applicant is in good standing with the governmental authorities in every jurisdiction outside this state that have granted the applicant a license, certification, registration, or permit that qualifies the individual to perform acts authorized under a pharmacist license granted by the board.

Note: Applications forms are available from the department of safety and professional services’ website at www.dsps.wi.gov.

(3) A license granted under this section expires on the renewal date specified in s. 440.08 (2) (a) 55., Stats., except that if the first renewal date specified in s. 440.08 (2) (a) 55., Stats., after the date on which the license is granted is within 180 days of the date on which the license is granted, the license expires on the second renewal date specified in s. 440.08 (2) (a) 55., Stats., after the date on which the license is granted.

History

CR 21-028: cr. Register April 2022 No. 796, eff. 5-1-22; correction in numbering of (2) (c) to (e) made under s. 13.92 (4) (b) 1., Stats., Register April 2022 No. 796.

Chapter Phar 4 EXAMINATIONS

Wis. Admin. Code § Phar 4.02 Competencies tested {#sec-phar-4.02 omnilex-key=us-wi-regs-official--agency-phar--Phar 4.02}

Competencies are tested by examination as follows:

(1) The multi-state pharmacy jurisprudence examination shall determine an applicant’s competence to practice within federal laws and regulations and Wisconsin laws and rules governing the practice of pharmacy.

(3) NAPLEX shall determine an applicant’s competence in the basic principles and professional areas within the practice of pharmacy.

(4) An otherwise qualified applicant shall be provided with reasonable accommodations, as required by the Americans with disabilities act.

History

Cr. Register, January, 1983, No. 325, eff. 2-1-83; emerg. r. and recr. eff. 5-21-85; r. and recr. Register, November, 1985, No. 359, eff. 12-1-85; am. (1) and (2), Register, August, 1991, No. 428, eff. 9-1-91; am. (4), Register, January, 1996, No. 481, eff. 2-1-96; am. (1) and (5), r. (2), cr. (6), Register, December, 1998, No. 516, eff. 1-1-99; CR 00-157: r. (3), renum. and am. (4) to be (2) and renum. (5) and (6) to be (3) and (4) Register May 2002 No. 557, eff. 6-1-02; EmR0903: emerg. r. (2), eff. 2-28-09; CR 09-019: r. (2) Register October 2009 No. 646, eff. 11-1-09.

Wis. Admin. Code § Phar 4.03 Passing scores {#sec-phar-4.03 omnilex-key=us-wi-regs-official--agency-phar--Phar 4.03}

(1) The passing scores set by the board represent the minimum competency required to protect public health and safety. The board may adopt the recommended passing score of the examination provider.

(2) Each examination specified in s. Phar 4.02 is scored separately. An applicant shall achieve a passing score on each required examination to qualify for licensure.

History

Cr. Register, January, 1983, No. 325, eff. 2-1-83; emerg. am. (2), r. and recr. (3) and (4), r. (5) and (6), eff. 5-21-85; am. (2), r. and recr. (3) and (4), r. (5) and (6), Register, November, 1985, No. 359, eff. 12-1-85; r. (3), renum. (4) to be (3) and am. Register, May, 1986, No. 365, eff. 6-1-86; r. and recr. (3), Register, December, 1998, No. 516, eff. 1-1-99; CR 16-017: am. (1), r. (3) Register September 2016 No. 729, eff. 10-1-16.

Wis. Admin. Code § Phar 4.035 Unauthorized assistance {#sec-phar-4.035 omnilex-key=us-wi-regs-official--agency-phar--Phar 4.035}

An applicant may not give or receive unauthorized assistance during the examination. The action taken by the board when unauthorized assistance occurs shall be related to the seriousness of the offense. These actions may include withholding the scope of the applicant, entering a failing grade for the applicant, and suspending the ability of the applicant to sit for the next scheduled examination after the examination in which the unauthorized assistance occurred.

History

Cr., Register, December, 1998, No. 516, eff. 1-1-99.

Chapter Phar 5 LICENSE RENEWAL

Wis. Admin. Code § Phar 5.01 Requirements {#sec-phar-5.01 omnilex-key=us-wi-regs-official--agency-phar--Phar 5.01}

(1) Pharmacists, pharmacies, manufacturers, distributors, and home medical oxygen providers licensed under ch. 450, Stats., and otherwise qualified for renewal, may continue to be licensed biennially by applying for renewal and paying the fee as determined by the department under s. 440.03 (9) (a), Stats.

(2) No one without a current renewal certificate may engage in the practice of pharmacy, nor hold himself or herself out to be a pharmacist nor use the title or letters “Pharmacist” or “Registered Pharmacist”or “R.Ph.”

(3) No pharmacy, manufacturer, distributor, or home medical oxygen provider may operate without a current license.

(4) For the purposes of this chapter and pursuant to s. 450.09 (1) (a), Stats., pharmacies shall include remote dispensing sites.

History

Cr. Register, January, 1983, No. 325, eff. 2-1-83; am. (1) and (2), Register, December, 1998, No. 516, eff. 1-1-99; CR 15-081: am. (1), (3) Register September 2016 No. 729, eff. 10-1-16; EmR2213: emerg. cr. (4), eff. 11-1-22; CR 23-054: cr. (4) Register August 2024 No. 824, eff. 9-1-24.

Wis. Admin. Code § Phar 5.02 Change of name or address {#sec-phar-5.02 omnilex-key=us-wi-regs-official--agency-phar--Phar 5.02}

(1) A pharmacist shall notify the board when a pharmacist’s name has been legally changed, within 30 days of the change.

(2) A pharmacist shall notify the board when a pharmacist’s address has been changed, within 30 days of the change.

History

Cr. Register, January, 1983, No. 325, eff. 2-1-83; am. (1) and (2), Register, December, 1998, No. 516, eff. 1-1-99; CR 21-074: am. Register June 2023 No. 810, eff. 7-1-23.

Wis. Admin. Code § Phar 5.04 Renewal prohibited {#sec-phar-5.04 omnilex-key=us-wi-regs-official--agency-phar--Phar 5.04}

Any person whose license is currently suspended or revoked may not renew his or her license.

History

Cr. Register, January, 1983, No. 325, eff. 2-1-83; am., Register, December, 1998, No. 516, eff. 1-1-99; CR 15-081: am. Register September 2016 No. 729, eff. 10-1-16.

Wis. Admin. Code § Phar 5.05 Renewal {#sec-phar-5.05 omnilex-key=us-wi-regs-official--agency-phar--Phar 5.05}

(1) General. A person with an expired license may not reapply for a license using the initial application process.

(2) Renewal within 5 years. A person renewing the license within 5 years shall do all of the following:

(a) Pay the renewal fee as determined by the department under s. 440.03 (9) (a), Stats., and any applicable late renewal fee.

(b) Certify the completion of 30 hours of continuing education during the last biennium.

(3) Renewal after expiration date. Notwithstanding sub. (2), if a pharmacist fails to obtain renewal on or before the applicable renewal date, the board may suspend the pharmacist’s license and may require the pharmacist to pass an examination to the satisfaction of the board to restore that license.

(4) Renewal after 5 years. This subsection does not apply to license holders who have unmet disciplinary requirements. A person renewing the license after 5 years shall do all of the following:

(a) Pay the renewal fee as determined by the department under s. 440.03 (9) (a), Stats., and the renewal late fee.

(b) Evidence of having passed the multi-state pharmacy jurisprudence examination with Wisconsin designated as the primary state.

(c) If the person renewing the license does not have 2000 hours of practice as a pharmacist within last 24 months of submitting the application for renewal, the person shall meet one of the following requirements:

If the license has been expired for at least 5 years but not more than 10 years, the person shall submit evidence of all of the following:

a. Completion of 160 hours of internship for each year the pharmacist license was expired, not to exceed 1000 hours.

b. Completion of 15 hours of continuing education for each year the pharmacist license was expired or within the last two years passing the NAPLEX.

If the license has been expired for more than 10 years, the person shall submit evidence of all of the following:

a. Completion of 1000 hours of internship.

b. Passing the NAPLEX.

History

Cr. Register, December, 1998, No. 516, eff. 1-1-99; CR 15-081: r. and recr. Register September 2016 No. 729, eff. 10-1-16.

Wis. Admin. Code § Phar 5.06 Reinstatement {#sec-phar-5.06 omnilex-key=us-wi-regs-official--agency-phar--Phar 5.06}

A licensee who has unmet disciplinary requirements and failed to renew the license within 5 years or whose license has been surrendered or revoked may apply to have the license reinstated in accordance with all of the following:

(1) Evidence of completion of the requirements in s. Phar 5.05 (4) if the license has not been active within 5 years.

(2) Evidence of completion of the disciplinary requirements, if applicable.

(3) Evidence of rehabilitation or change in circumstances warranting reinstatement.

History

CR 15-081: cr. Register September 2016 No. 729; correction in (1) made under s. 35.17, Stats., Register September 2016 No. 729.

Wis. Admin. Code § Phar 5.07 Pharmacy technicians {#sec-phar-5.07 omnilex-key=us-wi-regs-official--agency-phar--Phar 5.07}

(1) All requirements for renewal and reinstatement of a pharmacy technician registration are specified in ch. Phar 19.

(2) No pharmacist whose license has been denied, revoked, suspended, or restricted for disciplinary purposes is eligible to be registered as a pharmacy technician.

History

EmR2303: emerg. cr., eff. 2-3-23; CR 23-072: cr. Register August 2024 No. 824, eff. 9-1-24.

Chapter Phar 6 PHARMACY LICENSES AND EQUIPMENT

Wis. Admin. Code § Phar 6.01 Licenses; application {#sec-phar-6.01 omnilex-key=us-wi-regs-official--agency-phar--Phar 6.01}

Requirements and procedures for applying for a pharmacy license are specified in s. 450.06, Stats. Approved application forms are available from the board. Appointments for the required pharmacy inspection may be made by contacting the board office. A license application and fee shall be on file with the board at least 30 days prior to the granting of the pharmacy license. A pharmacy may not operate unless a pharmacy license has been granted. Board action shall be taken within 60 business days of receipt of a completed pharmacy application, as provided in s. SPS 4.03.

Note: Applications are available upon request to the board office located at 1400 East Washington Avenue, P.O. Box 8935, Madison, Wisconsin 53708.

History

Cr. Register, January, 1983, No. 325, eff. 2-1-83; correction made under s. 13.93 (2m) (b) 7., Stats., Register, January, 1989, No. 397; am. Register, August, 1991, No. 428, eff. 9-1-91; am., Register, December, 1998, No. 516, eff. 1-1-99; correction made under s. 13.92 (4) (b) 7., Stats., Register November 2011 No. 671.

Wis. Admin. Code § Phar 6.02 Licenses; change of location or ownership {#sec-phar-6.02 omnilex-key=us-wi-regs-official--agency-phar--Phar 6.02}

(1) A pharmacy license authorizes a pharmacy to operate only at the location designated on the license. Licenses may not be transferred to another location.

(1m) A hospital which has a pharmacy area providing outpatient pharmacy services which is physically separate from, and not contiguous to the area from which inpatient pharmacy services are provided, shall have a pharmacy license for the outpatient pharmacy in addition to a license for the inpatient pharmacy.

(2) Any change in pharmacy ownership shall be reported to the board office and the pharmacy license of the former owner returned. A pharmacy license shall be granted to the new pharmacy owner before the pharmacy may operate.

History

Cr. Register, January, 1983, No. 325, eff. 2-1-83; am. Register, August, 1991, No. 428, eff. 9-1-91; cr. (1m), Register, February, 1996, No. 482, eff. 3-1-96.

Wis. Admin. Code § Phar 6.025 Licenses; remote dispensing sites {#sec-phar-6.025 omnilex-key=us-wi-regs-official--agency-phar--Phar 6.025}

A pharmacy may be subject to rules in this section that apply only to remote dispensing sites, if a pharmacist remotely supervises the location for any period of time. The following conditions shall also be met:

(1) The licensee provides notice to the board of all of the information outlined in s. 450.06, Stats.

(2) The site meets all of the requirements listed in s. Phar 7.43.

(3) The site is any of the location types listed under s. 450.09 (2) (b) 1., Stats.

(4) A managing pharmacist shall report to the board if they are responsible for 5 or more remote dispensing sites. A managing pharmacist may not be responsible for more than 10 remote dispensing sites at any given time without approval from the board.

History

EmR2213: emerg. cr., eff. 11-1-22; CR 23-054: cr. Register August 2024 No. 824, eff. 9-1-24.

Wis. Admin. Code § Phar 6.03 Changes in managing pharmacist {#sec-phar-6.03 omnilex-key=us-wi-regs-official--agency-phar--Phar 6.03}

The pharmacy owner shall report to the board any change of managing pharmacist within 5 days following the change.

History

Cr. Register, January, 1983, No. 325, eff. 2-1-83.

Wis. Admin. Code § Phar 6.04 Floor design {#sec-phar-6.04 omnilex-key=us-wi-regs-official--agency-phar--Phar 6.04}

(1) Professional service area. If the building is open at any time while the professional service area is closed, the professional service area shall be secured as specified in sub. (3).

(3) Requirements when the professional service area is closed. When the pharmacy professional service area is closed, the pharmacy shall meet all of the following requirements:

(am) A locked, secure physical barrier surrounds the professional service area of the pharmacy and precludes access to the area by unauthorized personnel. A secured barrier may be constructed of other than a solid material with a continuous surface. If constructed of other than a solid material, the openings or interstices in the material shall not be large enough to permit removal of items from the professional service area by any means. Any material used in the construction of the barrier shall be of sufficient strength and thickness that it cannot be readily or easily removed, penetrated, or bent. The plans and specifications of the barrier shall be submitted to the board for approval.

(bm) Signs of reasonable size are posted at the professional service area which prominently display the hours the professional services are available.

(cm) The manner in which the telephone is answered does not imply that the professional services are available.

History

Cr. Register, January, 1983, No. 325, eff. 2-1-83; cr. (4), Register, August, 1991, No. 428, eff. 9-1-91; r. (3) (a) 4., Register, January, 1996, No. 481, eff. 2-1-96; CR 03-096: am. (3) (a) (intro.), cr. (3) (c) Register May 2004 No. 581, eff. 6-1-04; CR 21-074: am. (1), r. (2), r. and recr. (3) (title), renum. (3) (a) (intro.), 1. to (3) (intro.), (am) and am., r. (3) (a) 2., 3., renum. (3) (a) 5., 6. to (3) (bm), (cm), r. (3) (a) 7., (b), (c), (4) Register June 2023 No. 810, eff. 7-1-23; correction in renumbering (3) (intro.) made under s. 13.92 (4) (b) 1., Register June 2023 No. 810.

Wis. Admin. Code § Phar 6.05 Sanitation {#sec-phar-6.05 omnilex-key=us-wi-regs-official--agency-phar--Phar 6.05}

The professional service area of a pharmacy shall have a sink convenient and suitable for cleaning pharmaceutical equipment and supplied with hot and cold running water. Detergent and a waste disposal container also shall be provided in the professional service area.

History

Cr. Register, January, 1983, No. 325, eff. 2-1-83.

Wis. Admin. Code § Phar 6.06 Laws and other references {#sec-phar-6.06 omnilex-key=us-wi-regs-official--agency-phar--Phar 6.06}

The professional service area of a pharmacy shall have equipment of appropriate design and size for the intended pharmacy practice and shall have all of the following:

(1j) The latest available or immediately accessible version of federal and state pharmacy laws consisting of:

(a) Drug enforcement administration regulations, 21 CFR 1300 to end.

(b) Wisconsin pharmacy laws, ch. 450, Stats.

(d) Wisconsin administrative code, rules of the pharmacy examining board.

(2k) References appropriate to the individual pharmacy practice. These references should include, but are not limited to, the following topics: drug interactions; patient counseling; compounding and pharmaceutical calculations; and generic substitution.

(3L) The telephone number of a poison center. This number shall be conspicuously posted in the prescription department.

History

Cr. Register, January, 1983, No. 325, eff. 2-1-83; r. and recr. Register, January, 1989, No. 397, eff. 2-1-89; correction in (2) made under s. 13.93 (2m) (b) 6., Stats., Register, January, 1989, No. 397; am. (1) (j) 3., Register, December, 1998, No. 516, eff. 1-1-99; CR 01-023: am. (1) (intro.) and (a) to (c), (j) (intro.) and (k), Register, August 2001 No. 548 eff. 9-1-01; 2017 Wis. Act 18: r. and recr. (title), renum. (1) (intro.) to (intro.) and am., r. (1) (a) to (i), renum. (1) (j), (k), (L) to (1j), (2k), (3L), r. (2) Register June 2017 No. 738, eff. 7-1-17.

Wis. Admin. Code § Phar 6.07 Storage {#sec-phar-6.07 omnilex-key=us-wi-regs-official--agency-phar--Phar 6.07}

(1) The storage of drugs shall be secure, neat, clean and orderly.

(3) All controlled substances shall be stored in a securely locked, substantially-constructed cabinet or dispersed throughout the inventory of non-controlled substances in a manner that obstructs theft or diversion.

History

Cr. Register, January, 1983, No. 325, eff. 2-1-83; CR 19-165: r. and recr. (1), r. (2), am. (3) Register July 2020 No. 775, eff. 8-1-20.

Wis. Admin. Code § Phar 6.075 Temperature; Humidity {#sec-phar-6.075 omnilex-key=us-wi-regs-official--agency-phar--Phar 6.075}

(1) Definitions. In this section:

(a) “Business day” means a day the pharmacy is open for business.

(d) “Mean kinetic temperature” means the calculated temperature at which the total amount of degradation over a particular period is equal to the sum of the individual degradations that would occur at various temperatures.

(e) “Refrigerator” means a place in which the temperature is maintained between 36 and 46 degrees Fahrenheit.

(2) Storage. Drugs shall be stored at appropriate conditions, including temperature and humidity, to prevent drug adulteration.

(3) Recording devices. Manual, electromechanical or electronic temperature and humidity recording devices shall be placed within the storage space to accurately determine the area’s temperature and humidity.

(4) frequency. The temperature of the refrigerator, freezer and pharmacy and the humidity of the pharmacy shall be continuously monitored. At least once each business day, the minimum and maximum temperature and humidity since the previous documented reading shall be recorded.

(5) Records. Temperature and humidity records shall be maintained for a minimum of 5 years.

(6) Dispensing of safe drugs. The pharmacist shall use professional judgment, including consideration of the mean kinetic temperature, to determine whether a drug is safe to be dispensed.

History

CR 16-073: cr. Register November 2017 No. 743, eff. 12-1-17; corrections in (1) (b) and (c), (6) made under s. 35.17, Stats., Register November 2017 No. 743; CR 19-165: r. (1) (b), am. (2), r. and recr. (4) Register July 2020 No. 775, eff. 8-1-20.

Wis. Admin. Code § Phar 6.08 Security {#sec-phar-6.08 omnilex-key=us-wi-regs-official--agency-phar--Phar 6.08}

A pharmacy shall have a centrally monitored alarm system in the pharmacy. A security system or plan that does not utilize a centrally monitored alarm system may be used if reviewed by and prior approval is obtained from the board.

History

Cr. Register, December, 1998, No. 516, eff. 1-1-99; CR 05-001: am. Register August 2005 No. 596, eff. 9-1-05; CR 09-098: am. Register May 2010 No. 653, eff. 6-1-10.

Chapter Phar 7 PHARMACY PRACTICE

Subchapter I General

Wis. Admin. Code § Phar 7.01 Definitions {#sec-phar-7.01 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.01}

In this chapter:

(1) “Control number” means a unique number used to identify a repackaged drug or drug product in reference to a record that contains NDC, expiration date, and lot number.

(2) “Managing pharmacist” means a pharmacist who accepts responsibility for the operation of a pharmacy in conformance with all laws and rules pertinent to the practice of pharmacy, and who is personally in full and actual charge of the pharmacy and personnel.

(3) “NDC” means national drug code.

(4) “Repackaging for stock” means transferring a non-sterile drug product from the stock container in which it was distributed by the original manufacturer and placing it into a different stock container as a source for subsequent prescription dispensing without further manipulation of the drug.

(5) “Standing order” means an order transmitted electronically or in writing by a practitioner for a drug or device that does not identify a particular patient at the time it is issued for the purpose of drug or device dispensing or administration to individuals that meet criteria of the order.

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

Wis. Admin. Code § Phar 7.02 Prescription {#sec-phar-7.02 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.02}

(1) Requirements. A prescription drug order shall include all of the following:

(a) Date of issue.

(b) First and last name and address of the practitioner.

(c) Prescriptions ordered by a delegate of the practitioner shall include the first and last name of the delegate and the first and last name and address of the practitioner.

(d) Name, strength, and quantity of the drug product or device.

(e) Directions for use of the drug product or device.

(f) Refills, if any.

(g) Symptom or purpose for which the drug is being prescribed if the patient indicates in writing to the practitioner that the patient wants the symptom or purpose for the prescription to be disclosed on the label.

(h) Name and address of the patient except as provided in ss. 118.2925 (3), 255.07 (2), 441.18 (2) (a) 1., 448.035 (2) and 448.037 (2) (a) 1., Stats.

(i) If prescription is issued under s. 118.2925 (3), Stats., the name and address of the school.

(j) If prescription is issued under s. 255.07 (2), Stats., the name and address of the authorized entity or individual.

(k) Practitioner’s written signature, or electronic or digital signature.

(2) Standing order.

(a) A prescription pursuant to a standing order shall include all of the following:

Date of issue.
First and last name and address of the practitioner.
Prescriptions ordered by a delegate of the practitioner shall include the first and last name of the delegate and the first and last name and address of the practitioner.
Name, strength, and quantity of the drug product or device.
Directions for use of the drug product or device.
Refills, if any.
Name and address of the patient except as provided in ss. 118.2925 (3), 255.07 (2), 441.18 (2) (a)1., 448.035 (2) and 448.037 (2) (a) 1., Stats.
If prescription is issued under s. 118.2925 (3), Stats., the name and address of the school.
If prescription is issued under s. 255.07 (2), Stats., the name and address of the authorized entity or individual.
An indication that the prescription is pursuant to a standing order.

(b) A copy of the standing order shall be retained under s. Phar 7.11 (1).

(3) electronic prescription.

(a) Except as provided in s. 89.068 (1) (c) 4., Stats., and as otherwise prohibited by law, a practitioner may transmit a prescription order electronically only if the patient approves the transmission and the prescription order is transmitted to a pharmacy designated by the patient. Prescription orders transmitted by facsimile machine are not considered electronic prescription orders; but rather, written prescription orders.

(b) The prescribing practitioner’s electronic signature, or other secure method of validation shall be provided electronically with a prescription order.

(4) Verbal prescription. Verbal prescription orders may be received at a pharmacy via a direct conversation, telephone answering device or voice mail. The verbal prescription shall be reduced to writing or entered into a computer system under s. Phar 7.11 (2) and the prescription record shall indicate the pharmacist responsible for the accuracy of the prescription information.

(5) Alterations. Any alterations that modify the original intent of a prescription shall be documented including the identification of the pharmacist responsible for the alteration and the practitioner or practitioner’s delegate who authorized the alteration.

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction in (1) (j), (2) (a) 9., 10. made under s. 35.17, Stats., Register December 2020 No. 780.

Wis. Admin. Code § Phar 7.03 Drug utilization review {#sec-phar-7.03 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.03}

(1) A pharmacist shall complete a drug utilization review by reviewing the patient record prior to dispensing each prescription drug order for all of the following:

(a) Known allergies.

(b) Rational therapy.

(d) Reasonable dose, duration of use, and route of administration, considering the age and other patient factors.

(e) Reasonable directions for use.

(f) Potential or actual adverse drug reactions.

(g) Drug interactions with food, beverages, other drugs or medical conditions.

(h) Therapeutic duplication.

(i) Reasonable utilization and optimum therapeutic outcomes.

(j) Potential abuse or misuse.

(2) Upon recognizing a concern with any of the items in sub. (1) (a) to (j), the pharmacist shall take steps to mitigate or resolve the problem.

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction in (1) (d) made under s. 35.17, Stats., Register December 2020 No. 780.

Wis. Admin. Code § Phar 7.04 Transferring prescription order information {#sec-phar-7.04 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.04}

(1) General requirements.

(a) A transfer of prescription order information between pharmacies licensed in this state or another state, for the purpose of original or refill dispensing of non-controlled substances and refills of controlled substances, may occur if all of the following conditions are satisfied:

The transfer of prescription order information is communicated in one of the following ways:

a. Verbal communication between two pharmacists.

b. Electronically or by facsimile machine between the two pharmacies.

A transfer of prescription information verbally shall be reduced to writing or entered into a computer system under s. Phar 7.11 (2) and the prescription record shall indicate the pharmacist responsible for the accuracy of the prescription information.

(b) A pharmacist shall transfer a prescription upon patient request pursuant to this section.

(2) Non-controlled substances. The transfer of prescription order information for non-controlled substances for the purposes of original or refill dispensing is permissible pursuant to the following requirements:

(a) The prescription record of the transferred prescription shall include the following information:

The word “VOID” is written on the face of the invalidated prescription order or recorded in a similar manner to “VOID” on a prescription order in a computer system meeting the requirements of s. Phar 7.11 (2) (a).
The name and address of the pharmacy to which it was transferred, the date and the first and last name of the pharmacist transferring the information are recorded on the invalidated prescription order or in a computer system meeting the requirements s. Phar 7.11 (2) (a).

(b) Unless a computer system meeting the requirements in sub. (4) is used, the transferred prescription order information shall include the following:

The word “TRANSFER” on the face of the transferred prescription order or recorded in a similar manner in a computer system.
The first and last name and address of the patient, the first and last name and address of the prescribing practitioner.
Name, strength, form and quantity of the drug product or device prescribed and the directions for use.
The date of issuance of the original prescription order, the original prescription order number, the original number of refills authorized on the original prescription order and the date of original dispensing if the prescription order has previously been dispensed.
The number of valid refills or total quantity remaining and the date of the last refill.
The pharmacy’s name and address from which the prescription order information was transferred.
The first and last name of the pharmacist transferring and receiving the prescription order information.

(3) Controlled substances. The transfer of original prescription information for a controlled substance listed in Schedule III – V shall meet the following requirements:

(a) The transfer of prescription order information is permissible only on a one-time basis. Pharmacies electronically sharing a computer system meeting the requirements of sub. (4) may transfer up to the maximum refills permitted by law and the prescriber’s authorization.

(b) Notwithstanding sub. (1) (a), the transfer shall be communicated directly between 2 licensed pharmacists.

Write the word “VOID” on the face of the invalidated prescription. For electronic prescriptions, information that the prescription has been transferred shall be added to the prescription record.
Record on the reverse of the invalidated prescription or in the electronic prescription record all of the following:

a. Name, address and DEA registration number of the pharmacy to which it was transferred.

b. The first and last name of the pharmacist receiving the prescription order.

Record the date of the transfer.
Record the first and last name of the pharmacist transferring the information.

(d) For paper prescriptions and prescriptions received verbally and reduced to writing by the pharmacist, the pharmacist receiving the transferred prescription information shall write the word “TRANSFER” on the face of the transferred prescription and reduce to writing all information required to be on the prescription, including all of the following:

Date of issuance of the original prescription order.
Original number of refills authorized on the original prescription order.
Date of original dispensing.
Number of valid refills remaining and the dates and locations of previous refills.
Pharmacy’s name, address, DEA registration number, and prescription number from which the prescription information was transferred.
First and last name of the pharmacist making the transfer.
Pharmacy’s name, address, DEA registration number, and prescription number from which the prescription was originally filled.

(e) For electronic prescriptions being transferred electronically, the transferring pharmacist shall provide the receiving pharmacist with the original electronic prescription data and all of the following:

The date of the original dispensing.
The number of refills remaining and the dates and locations of previous refills.
The transferring pharmacy’s name, address, DEA registration number, and prescription number for each dispensing.
The first and last name of the pharmacist transferring the prescription.
The name, address, DEA registration number, and prescription number from the pharmacy that originally filled the prescription, if different.

(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.

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.

Wis. Admin. Code § Phar 7.05 Label requirements {#sec-phar-7.05 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.05}

(1) This section does not apply to institutional pharmacies as defined in s. Phar 7.50 (3).

(2) All prescribed drugs or devices shall have a label attached to the container disclosing all of the following:

(a) Identification of the patient by one of the following:

Except as provided in subds. 2. to 5., the first and last name of the patient.
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”.
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.
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.
If the patient is an animal, the last name of the owner, name of the animal and animal species.

(b) Symptom or purpose for which the drug is being prescribed if the prescription order specifies the symptom or purpose.

(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.

(d) The date for which the medication shall not be used after.

(e) Pharmacy name, address and telephone number.

(f) Prescriber name.

(g) Date the prescription was filled.

(h) Prescription order number.

(i) Quantity.

(j) Number of refills or quantity remaining.

(k) Directions for use of the prescribed drug or device as contained in the prescription order.

(3) A label for prescribed drugs or devices may include the following:

(a) Symptom or purpose for which the drug is being prescribed if requested by the patient.

(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.

(d) Any cautions or other provisions.

(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.

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

Wis. Admin. Code § Phar 7.06 Repackaging for stock {#sec-phar-7.06 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.06}

A pharmacy repackaging for stock any non-sterile drugs shall do all of the following:

(1) The repackaging for stock process is conducted under conditions that ensure the integrity of the drug.

(2) Products repackaged for stock shall include a beyond use date that ensures the integrity of the drug.

(3) The repackaged container shall be selected to mitigate adulteration from light, temperature and humidity.

(4) The repackaged for stock drugs are labeled physically or electronically with all the following components:

(a) Drug name, strength, form and beyond use date.

(b) One of the following identifiers:

Pharmacy control number.
NDC number and manufacturer lot number.
Name of manufacturer or distributer of the drug product, and the manufacturer lot number.

(5) Records of all repackaging for stock operations are maintained and include all the following:

(a) Name, strength, form, quantity per container, and quantity of containers.

(b) NDC number or the name of the manufacturer or distributor of the drug product.

(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.

(g) Any pharmacy control numbers.

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

Wis. Admin. Code § Phar 7.07 Final check {#sec-phar-7.07 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.07}

(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:

(a) Verifying label is correct and meets labeling requirements.

(b) Verifying the drug product or device is correct.

(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.

History

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.

Wis. Admin. Code § Phar 7.08 Patient consultation {#sec-phar-7.08 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.08}

(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:

(a) Has not been dispensed previously to the patient.

(b) Is a change in therapy.

(d) Whenever deemed necessary based upon the professional judgement of the dispensing pharmacist.

(2) Notwithstanding sub. (1), consultation is not required when one of the following occurs:

(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:

An individual with a scope of practice that includes the administration of a drug or device.
A delegate of an individual with authority to delegate the administration of a drug or device.

(b) A patient or patient’s agent refuses consultation.

(3) Consultation shall contain any of the following information that, in the pharmacist’s professional judgment, serves the best interest of the patient:

(a) Name and description of the drug.

(b) Form, dose, route of administration and duration for drug therapy.

(d) Directions and precautions for the preparation, administration, and use.

(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) Action to be taken in the event of a missed dose.

(h) Proper storage and appropriate disposal method of unwanted or unused medication.

(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.

(5) A pharmacist shall provide the patient or patient’s agent, for all consultations required under sub. (1), a written patient drug education monograph.

(6) The consultation required in this section may occur before or after delivery of the prescription to the patient or patient’s agent.

(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.

(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.

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.

Wis. Admin. Code § Phar 7.085 Delivery by common carrier or delivery services {#sec-phar-7.085 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.085}

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:

(1) The delivery method is appropriate to prevent drug adulteration.

(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:

(a) Timeliness of delivery.

(b) Condition of the prescription drug upon delivery.

(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.

Note: A delivery driver engaged solely in the delivery of a prescription in compliance with this section does not need to be registered as a pharmacy technician.

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

Wis. Admin. Code § Phar 7.09 Procurement, recall and out-of-date drugs and devices {#sec-phar-7.09 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.09}

(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.

(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.

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

Wis. Admin. Code § Phar 7.10 Return or exchange of health items {#sec-phar-7.10 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.10}

(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.

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

Wis. Admin. Code § Phar 7.11 Pharmacy records {#sec-phar-7.11 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.11}

(1) General. Pharmacy records shall be maintained for a minimum period of 5 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:

Capable of producing a printout of any prescription data which the user pharmacy is responsible for maintaining.
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:

Patient’s first and last name, or if not human, name of pet, species and last name of owner.
Address of the patient.
Birth date of the patient or, if not human, birth date of the owner.
Name of the drug product or device dispensed.
Strength of the drug product or device dispensed.
Form of the drug product or device dispensed.
Quantity of the drug product or device prescribed, dispensed and remaining.
Number of refills prescribed.
Directions for use.
Prescription order number.
Original date of issue.
Dates of dispensing.
Prescriber’s first and last name.

(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.

(d) Medication profile records shall be maintained for a minimum period of 5 years following the date of the last dispensing.

History

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.

Wis. Admin. Code § Phar 7.12 Delegation by a physician {#sec-phar-7.12 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.12}

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.

History

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.

Wis. Admin. Code § Phar 7.13 Administration of drug products and devices other than vaccines {#sec-phar-7.13 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.13}

(1) In this section, “course of study” means one or more classes, workshops, seminars, or continuing education programs.

(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.

(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.

(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:

(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.

(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.

(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.

(5) The board may approve courses of study which meet criteria substantially equivalent to criteria used by the Accreditation Council for Pharmacy Education.

(6) A course of study and training in administration technique shall include all of the following topics:

(a) Safe injection practices to prevent infections.

(b) Anatomy.

(d) The 5 rights of administration including right patient, right drug, right dose, right route, and right time.

(e) Patient reassessment after administration including signs and symptoms of adverse drug reactions.

(f) Best practices in documentation of the medication administration.

(7) This section does not apply to the administration of vaccines.

Note: To administer a vaccine a pharmacist must meet the requirements in s. 450.035, Stats.

History

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.

Wis. Admin. Code § Phar 7.14 Pharmacy product verification technician-check-pharmacy technician {#sec-phar-7.14 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.14}

(1) Definitions. In this section:

(a) “Pharmacy product verification technician” means a registered pharmacy technician to whom the pharmacist has delegated the task of product verification.

(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.

(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.

(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.

(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:

(b) Completed an accredited pharmacy technician training program or has a minimum of 500 hours of experience in product selection, labeling and packaging.

(c) Completed a didactic and practical training curriculum approved by the supervising and managing pharmacist that includes training in all of the following:

Elements of correct product including all of the following:

a. Drug name.

b. Strength.

c. Formulation.

d. Expiration date.

e. Beyond use date.

Common dispensing medication errors and concepts including all of the following:

a. Wrong medication.

b. Wrong strength.

c. Wrong formulation.

d. Extra or insufficient quantity.

e. Omitted medications if utilizing unit dose or compliance packaging.

f. Expired medication.

g. Look-alike or sound-alike errors.

h. High-alert medications.

Eligible products for pharmacy product verification technician-check-pharmacy technician.
Organizational policies and procedures on reporting of medication errors.
Overview of the medication use process including all of the following:

a. Procurement.

b. Ordering.

c. Dispensing.

d. Administration.

e. Monitoring.

A practical training designed to assess the competency of the pharmacy technician prior to starting the validation process. The practical training shall include simulation of at least 2 occurrences of each of the following:

a. Wrong drug.

b. Wrong strength.

c. Wrong formulation.

d. Omitted medication, if utilizing unit dose or compliance packaging.

(d) Completed the following validation process:

The pharmacy technician being validated shall make a product verification on the work of a pharmacist or another pharmacy technician for accuracy and correctness of a minimum of 500 product verifications over a minimum of 5 separate days and achieve an accuracy rate of at least 99.8%.
A pharmacist shall audit 100% of the product verifications made by the pharmacy technician during the validation process.

(e) Notwithstanding pars. (b) to (d), an individual who completed the board’s pilot program validation process between October 1, 2016 and September 30, 2019, meets the pharmacy product verification technician qualifications unless the individual fails to meet the quality assurance standards under sub. (4).

(3) Eligible product.

(a) Institutional pharmacies. The pharmacy product verification technician may do the product verification in an institutional pharmacy if all of the following requirements are met:

The source drug product or device is in an original package from a manufacturer or a licensed pharmacist has ensured that the source package is labeled with the correct name, strength, form, control or lot number, and beyond use or expiration date.
A drug utilization review performed by a pharmacist prior to dispensing.
The drug product will be administered by an individual authorized to administer medications at the institution where the medication is administered.

(b) Community pharmacies. The pharmacy product verification technician may do the product verification in a community pharmacy if all of the following requirements are met:

The source drug product or device is in an original package from a manufacturer or a licensed pharmacist has ensured that the source package is labeled with the correct name, strength, form, control or lot number, and beyond use or expiration date.
A drug utilization review performed by a pharmacist prior to dispensing.
A non-pharmacist shall be able to check the accuracy of the medication by one of the following:

a. The drug product or device is in the original packaging from a manufacturer.

b. The drug product or device includes a description of the drug product or device on the prescription label.

c. The pharmacist shows the patient or patient’s agent the drug product or device and provides a monograph that includes a description of the drug product or device.

(4) Quality assurance.

(a) A minimum of 5% of each pharmacy product verification technician’s verifications shall be audited by a licensed pharmacist. The accuracy of each pharmacy product verification technician shall be tracked individually.

(b) A record of each pharmacy product verification technician-check-pharmacy technician audit shall include all of the following:

Name of the pharmacy product verification technician.
Total number of product verifications performed.
Number of product verifications audited by the pharmacist.
Percentage of product verifications audited by pharmacist.
Percentage of accuracy.
Number of product verification errors identified.
Type of error under sub. (2) (c) 2. a. to c. and e.

(c) On a quarterly basis, the supervising pharmacist shall perform an assessment of each pharmacy product verification technician’s previous 12 months accuracy and correctness of pharmacy product verifications including a review of the quality assurance log.

(d) A pharmacy product verification technician shall be revalidated if the individual fails to maintain a product verification accuracy rate of 99.8% based on the quarterly assessment of the previous 12 months or has not performed verifications within the last 6 months.

(5) Policies and procedures. Each pharmacy shall maintain policies, procedures, and training materials for the pharmacy product verification by technicians which shall be made available to the board upon request.

(6) Records.

(a) Each pharmacy shall maintain for 5 years the following records:

All validation records of each pharmacy product verification technician that include the dates that the validation occurred, the number of product verifications performed, the number of product verification errors, and overall accuracy rate.
Documentation indicating accepting responsibility for compliance with this section, signed and dated by both the managing pharmacist and supervising pharmacist, indicating the name of the supervising pharmacist, and the dates the supervision responsibilities begin and end.
Quality assurance audits and quarterly assessments.

(b) Records shall be made available to the board upon request.

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; corrections in (2) (e) made under ss. 13.92 (4) (b) 12. and 35.17, Stats., and correction in (2) (c) 6. (intro.), (4) (b) 7. made under s. 35.17, Stats., Register December 2020 No. 780; EmR2303: emerg. am. (title), (1) (a), (b), (d), (2) (intro.), r. (2) (a), am. (2) (b), (c) 3., 6., (d) 1., 2., (e), (3) (a) (intro.), (b), (4) (a), (b) (intro.), 1., (c), (d), (5), (6) (a) 1., 2., eff. 2-3-23; CR 23-072: r. and recr. (title), am. (1) (a), (b), (d), (2) (intro.), r. (2) (a), am. (2) (b), (c) 3., 6., (d) 1., 2., (e), (3) (a) (intro.), (b) (intro.), 1., (c), (d), (5), (6) (a) 1., 2. Register August 2024 No. 824, eff. 9-1-24.

Wis. Admin. Code § Phar 7.15 Consumer disclosures {#sec-phar-7.15 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.15}

(1) Each pharmacy shall post in a prominent place and maintain the consumer disclosures required in ss. 450.13 (5m) and 450.135 (8m), Stats.

(2) A link to the 100 most commonly prescribed generic drug product equivalents as determined by the board, shall be maintained on the department’s website as required in s. 450.13 (5m) (b), Stats.

Note: Copies of the required consumer disclosures are located on the Department of Safety and Professional Service’s website: https://dsps.wi.gov.

(3) Pursuant to s. 450.13 (5m) (c), Stats., each pharmacy shall maintain and make available to the public a list of the drugs from the list in sub. (2) that are available for purchase at that pharmacy. The list shall be updated monthly, with all of the following information included:

(a) Brand name.

(b) Generic equivalent drugs and biological products.

(d) Retail price.

(4) The list required under sub. (3) may differ depending on whether the drugs on the list from sub. (2) are available for purchase at a specific pharmacy.

History

CR 23-015: cr. Register April 2024 No. 820, eff. 5-1-24; correction in (2) made under s. 35.17, Stats., Register April 2024 No. 820.

Subchapter II Central Shared Services

Wis. Admin. Code § Phar 7.30 Definitions {#sec-phar-7.30 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.30}

In this subchapter:

(1) “Central shared services pharmacy” means a pharmacy licensed in this state acting as an agent of an originating pharmacy.

(2) “Labeling pharmacy” means the central shared services pharmacy or originating pharmacy which is responsible for product verification under s. Phar 7.07 (1) (a) and (b).

(3) “Originating pharmacy” means a pharmacy licensed in this state that uses a central shared services pharmacy.

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

Wis. Admin. Code § Phar 7.31 Requirements {#sec-phar-7.31 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.31}

An originating pharmacy may use a central shared services pharmacy only pursuant to the following requirements:

(1) The central shared services pharmacy either has the same owner as the originating pharmacy or has a written contract with the originating pharmacy outlining the services to be provided and the responsibilities of each pharmacy in fulfilling the terms of the contract.

(2) The central shared services pharmacy shall maintain a record of all originating pharmacies, including name, address and DEA number that it provides services to.

(3) The central shared services pharmacy and originating pharmacy maintain a written protocol delineating each pharmacy’s assumption of responsibility for compliance with state and federal law.

(4) Unless the central shared services pharmacy shares a computer system with the originating pharmacy meeting the requirements of s. Phar 7.04 (4) and contains the medication profile record under s. Phar 7.11 (3), it may not perform drug utilization review under s. Phar 7.03 to satisfy the final check requirement under s. Phar 7.07 (1) (c).

(5) The prescription label attached to the container shall contain the name and address of the labeling or originating pharmacy. The date on which the prescription was dispensed for purposes of s. 450.11 (4) (a) 2., Stats., shall be the date on which the labeling pharmacy filled the prescription order.

(6) The originating pharmacy or central shared services pharmacy shall maintain the original of all prescription orders received for purposes of filing and recordkeeping as required by state and federal law.

(7) In addition to meeting the other recordkeeping requirements required by state and federal law, the central shared services pharmacy and originating pharmacy shall each maintain records to identify each of its pharmacists responsible for the final check under s. Phar 7.07 (1).

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

Subchapter III Delivery Systems and Remote Dispensing

Wis. Admin. Code § Phar 7.40 Definitions {#sec-phar-7.40 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.40}

In this subchapter:

(1) “Delivery system” means a structure, controlled by a pharmacy licensed in this state, that a prescription is placed in for patient pick-up.

(2) “Supervising pharmacy” means a licensed pharmacy that oversees the operations and administration of remote dispensing.

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction in (title) made under s. 13.92 (4) (b) 2., Stats., Register December 2020 No. 780.

Wis. Admin. Code § Phar 7.41 Delivery system {#sec-phar-7.41 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.41}

(1) A prescription shall be stored in a secure delivery system immediately upon delivery to the location of the delivery system. Only the patient or patient’s agent shall be able to open the door or locker containing only the patient’s prescription.

(2) The delivery system shall be designed in a manner which does not disclose protected health information.

(3) The delivery system shall maintain appropriate environmental controls, including temperature and humidity, to prevent drug adulteration.

(4) The use of a delivery system does not create an exemption to s. 450.11 (1b), Stats.

(5) A log shall be maintained by the dispensing pharmacy of all prescriptions delivered to the delivery system.

(6) The delivery system shall be inventoried at least weekly and a list of unclaimed prescriptions shall be reviewed by a pharmacist.

(7) The managing pharmacist shall establish written policies and procedures for all of the following:

(a) Stocking of the delivery system.

(b) Determining access to the delivery system.

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction in (1) made under s. 35.17, Stats., Register December 2020 No. 780.

Wis. Admin. Code § Phar 7.42 Automated direct-to-patient dispensing system {#sec-phar-7.42 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.42}

(1) In this section “supervising practitioner” means the practitioner who is responsible for the operation of the automated direct-to-patient dispensing system and requirements of this section.

(2) An automated direct-to-patient dispensing system in a secure and professionally appropriate environment in any of the locations under s. 450.062 (1) to (4), Stats., may operate for purposes of practitioner dispensing. The supervising practitioner will ensure all of the following requirements are met:

(a) Individuals with access to the automated direct-to-patient dispensing system for the purpose of stocking, inventory, and monitoring shall be limited to the supervising practitioner or a delegate.

(b) The automated direct-to-patient dispensing system shall label the prescription in compliance with s. Phar 7.05.

(c) The automated direct-to-patient dispensing system shall maintain records of all prescription fills and dispenses in compliance with s. Phar 7.11 (1).

(d) The reporting of all monitored prescription drugs dispensed from the automated direct-to-patient dispensing system to the prescription drug monitoring program.

(3) The supervising practitioner or delegate shall establish written policies and procedures for automated direct-to-patient dispensing system for all of the following:

(a) Stocking.

(b) Determining access.

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction in (2) (intro.) made under s. 35.17, Stats., and correction in numbering of (3) (a) to (c) made under s. 13.92 (4) (b) 7., Stats., Register December 2020 No. 780.

Wis. Admin. Code § Phar 7.43 Remote dispensing {#sec-phar-7.43 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.43}

(2) Location. A person engaged in the practice of pharmacy under s. 450.03 (1) (f) or (g), Stats., a pharmacy technician registered under s. 450.068, Stats., or a pharmacy graduate as defined in s. Phar 1.02 (10m) may dispense at any of the locations under s. 450.09 (2) (b) 1. a. to d., Stats.

(4) Requirements.

(a) A remote dispensing location shall display a sign, easily viewable by customers, that states all of the following:

Prescriptions may be filled at this location.
This remote dispensing location is being supervised by a pharmacist employed by:

a. Name of pharmacy.

b. Address of pharmacy.

c. Telephone of pharmacy.

Patient has a right to pharmacist consultation and information on how to file a complaint to the board.

(b) Remote dispensing may not occur if a pharmacist is not available remotely.

(c) A prescribed drug or device may not be dispensed in the absence of the ability of a patient and pharmacist’s delegate to communicate with a pharmacist.

(5) Dispensing requirements. Remote dispensing shall comply with all of the following:

(a) Visually inspecting all prescription orders, labels and dispensed product.

(b) Labeling requirements under s. Phar 7.05. The prescription label shall contain the name and address of the remote dispensing site as the licensed facility from which the prescribed drug or device was dispensed.

(d) Federal law if dispensing controlled substances.

(6) Responsibilities of managing pharmacist. The managing pharmacist responsible for the remote dispensing pharmacy shall do all of the following:

(a) Have written policies and procedures for system operation, safety, security, accuracy and access.

(b) Implement an ongoing quality assurance program that monitors performance that includes the number of prescriptions dispensed per month, number of medication errors documented, loss or diversion, and documentation of remedial training to prevent future errors.

(c) Visit the remote dispensing location at least monthly to confirm delivery status of all drugs, to ensure written policies and procedures are being followed, and to ensure that remote dispensing personnel comply with all federal and state laws regulating the practice of pharmacy.

(d) Retain documentation of the visits at the remote dispensing location for a minimum of 5 years.

(e) Documentation indicating accepting responsibility for compliance with this section, signed and dated by the managing pharmacist.

(7) Delegate requirements. A person engaged in the practice of pharmacy under s. 450.03 (1) (f) or (g), Stats., a pharmacy technician registered under s. 450.068, Stats., or a pharmacy graduate as defined in s. Phar 1.02 (10m) shall meet the following requirements to remote dispense:

(a) Be 18 years of age or older.

(b) Be a high school graduate or have equivalent education.

(c) Have completed 1500 hours of work as a pharmacist delegate within the 3 years prior to engaging in remote dispensing or completed an accredited pharmacy technician training program.

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction in (2), (4) (a) 1. made under s. 35.17, Stats., Register December 2020 No. 780; EmR2213: emerg. r. (1), am. (2), (4) (b), (5) (b), (6) (title), (a) (intro.), 5., (b), eff. 11-1-22; CR 23-054: r. (1), am. (2), r. (3), am. (4) (a) 2. (intro.), (b), r. (4) (d), am. (5) (b), r. and recr. (6), am. (7) (intro.) Register August 2024 No. 824, eff. 9-1-24.

Subchapter IV Institutional Pharmacies

Wis. Admin. Code § Phar 7.50 Definitions {#sec-phar-7.50 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.50}

In this subchapter:

(1) “Chart order” means an order entered on the chart or a medical record of an inpatient or resident of an institutional facility by a practitioner or practitioner’s delegate for a drug product or device.

(2) “Institutional facility” means a facility, as defined in s. 647.01 (4), Stats.; any hospital, nursing home, community-based residential facility, county home, county infirmary, county hospital, county mental health complex, or other place licensed or approved by the department of health services under s. 49.70, 49.71, 49.72, 50.03, 50.032, 50.033, 50.034, 50.35, 51.08, or 51.09, Stats.; a facility under s. 45.50, 51.05, 51.06, 146.903 (1) (b), 233.40, 233.41, 233.42, or 252.10, Stats.; a hospice facility under s. 50.90 (1) (c), Stats.; a county jail; and a correctional facility operated under the authority of the department of corrections.

(3) “Institutional pharmacy” means a pharmacy that provides pharmacy services to an institutional facility. This definition is not for purposes under s. 450.09 (1) (a), Stats.

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

Wis. Admin. Code § Phar 7.51 Chart orders {#sec-phar-7.51 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.51}

A chart order shall contain all of the following:

(1) First and last name of the patient.

(2) Patient’s medical record number or date of birth.

(3) Date of issuance.

(4) Name, strength, and form of the drug product or device prescribed.

(5) Directions for use.

(6) The signature by one of the following methods:

(a) If handwritten, the practitioner’s or delegate’s signature.

(b) Electronic signature of the practitioner or delegate.

(7) Chart orders prepared by a delegate of the practitioner shall include the first and last name of the delegate and the first and last name of the practitioner.

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

Wis. Admin. Code § Phar 7.52 Labels {#sec-phar-7.52 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.52}

All prescribed drug products and devices dispensed for administration by a health care provider at the institutional facility shall have a label attached to the container disclosing all of the following:

(1) Drug name, strength and form.

(2) Beyond use date or expiration date.

(3) Special storage conditions, if required.

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

Wis. Admin. Code § Phar 7.53 Security and access {#sec-phar-7.53 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.53}

(1) Arrangements shall be made in advance by the managing pharmacist for access of drugs by the health care staff of the institutional facility when dispensing by a pharmacist is not available.

(2) In the absence of a pharmacist, drugs shall be stored in a manner in which only authorized personnel may obtain access and is sufficiently secure to deny access to unauthorized persons.

(3) The managing pharmacist shall develop policies and procedures in place to mitigate and prevent theft and diversion.

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

Wis. Admin. Code § Phar 7.54 Return or exchange of health items {#sec-phar-7.54 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.54}

(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.

(2) A health item which has been sold, distributed or dispensed, may be returned to the institutional pharmacy under s. Phar 7.10 (2) or if the health item has not left the control of the health care facility staff authorized to have access to prescription drug products.

(3) A health item returned to an institutional pharmacy may be sold, distributed, or dispensed to the institutional facility if all of the following apply:

(a) The health item was never in the possession and control of the patient.

(b) The health item was sold, distributed or dispensed in a tamper-evident package and, for a drug product, includes the beyond use date or expiration date and manufacturer’s lot number.

(c) The health item is in its original container and the pharmacist determines the contents are not adulterated or misbranded.

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction in (2), (3) (intro.) made under s. 35.17, Stats., Register December 2020 No. 780.

Wis. Admin. Code § Phar 7.55 Automated technology product verification {#sec-phar-7.55 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.55}

(1) Definitions. In this section:

(a) “Product verification” means doing a check of the accuracy and correctness of a product, including drug, strength, formulation, and expiration or beyond use date, as part of the final check.

(b) “Supervising pharmacist” means the pharmacist licensed in this state who is responsible for the operations and outcomes of the product verification done by an automated technology.

(2) Automated technology product verification qualifications. Product verification may be done only by an automated technology which meets all of the following:

(a) Located within a licensed pharmacy.

(b) Utilizing barcodes or another machine-readable technology to complete the product verification.

The automated technology shall make a product verification for accuracy and correctness of a minimum of 2500 product verifications and achieve an accuracy rate of at least 99.8%.
A pharmacist shall audit 100% of the product verifications made by the automated technology during the validation process.

(d) Revalidated if the software is upgraded or any component of the automated technology responsible for the accuracy and correctness of the product verification is replaced or serviced outside of the manufacturer’s standard maintenance recommendations.

(3) Eligible product. The automated technology may do the product verification if the product meets all of the following:

(a) Is dispensed in the original package from a manufacturer or if a licensed pharmacist has ensured that any repackaging results in a package that is labeled with the correct drug name, strength, formulation, control or lot number, and expiration or beyond use date.

(b) Has a drug utilization review performed by a pharmacist prior to delivery.

(c) Will be administered by an individual authorized to administer medications at the institution where the medication is administered.

(4) Policies and procedures. Each pharmacy shall maintain policies, procedures, and training materials for the automated technology product verification which shall be made available to the board upon request.

(5) Records.

(a) Each pharmacy shall maintain for 5 years the following records:

All validation records of each automated technology that include the dates that the validation occurred, the number of product verifications performed, the number of product verification errors, and overall accuracy rate.
Documentation indicating acceptance of responsibility for compliance with this section, signed and dated by both the managing pharmacist and supervising pharmacist, indicating the name of the supervising pharmacist and start and end dates of supervision.
Documentation of the completion of the manufacturer’s recommended maintenance and quality assurance measures.
Documentation of the dates of all software upgrades.
Documentation of all service performed outside of the manufacturer’s standard maintenance recommendations.

(b) Records shall be made available to the board upon request.

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.

Subchapter V Uncredentialed Pharmacy Staff

Wis. Admin. Code § Phar 7.60 Definition {#sec-phar-7.60 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.60}

In this subchapter, “uncredentialed pharmacy staff” means any staff practicing in the pharmacy who are not otherwise licensed or registered under s. 450.03 (1) (f), (g), or (gm), Stats.

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; EmR2303: emerg. cr. (intro.), (3), eff. 2-3-23; CR 23-072: r. and recr. Register August 2024 No. 824, eff. 9-1-24.

Wis. Admin. Code § Phar 7.62 Uncredentialed pharmacy staff {#sec-phar-7.62 omnilex-key=us-wi-regs-official--agency-phar--Phar 7.62}

(1) This section does not apply to a person practicing pharmacy under s. 450.03 (1) (f) or (g), Stats., or a pharmacy graduate as defined in s. Phar 1.02 (10m).

(2) A pharmacist shall provide direct supervision of uncredentialed pharmacy staff. A pharmacist shall be available to the uncredentialed pharmacy staff person for consultation either in person or contact by telecommunication means.

(3) An uncredentialed pharmacy staff person may not engage in the practice of pharmacy as defined in s. 450.01 (16), Stats., or the practice of a pharmacy technician as defined in s. Phar 19.02.

(4) The prohibitions in sub. (3), do not apply to a person completing an internship for purposes of meeting the internship requirement under s. 450.03 (2) (b), Stats.

(5) A managing pharmacist shall provide training to or verify competency of an uncredentialed pharmacy staff person prior to the uncredentialed pharmacy staff person performing a delegated act.

(6) The managing pharmacist shall determine which acts may be delegated in a pharmacy. The managing pharmacist has a duty to notify all pharmacists practicing in that pharmacy which acts may be delegated to specific uncredentialed pharmacy staff. This record shall be provided to the board upon request.

(7) A pharmacist may delegate to an uncredentialed pharmacy staff person any delegated act approved by the managing pharmacist outside of the restrictions in sub. (3).

History

CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction in (3) (b), (4), (5) made under s. 35.17, Stats., Register December 2020 No. 780; CR 23-054: am. (1) Register August 2024 No. 824, eff. 9-1-24; EmR2303: emerg. am. (title), (1), (2), renum. (3) (intro.) to (3) and am., r. (3) (a) to (d), am. (5) to (7), eff. 2-3-23; CR 23-072: r. and recr. (title), am. (2), renum. (3) (intro.) to (3) and am., r. (3) (a) to (d), am. (5) to (7) Register August 2024 No. 824, eff. 9-1-24.

Chapter Phar 8 REQUIREMENTS FOR CONTROLLED SUBSTANCES

Wis. Admin. Code § Phar 8.01 Federal registration and compliance with federal, state, and local laws and regulations {#sec-phar-8.01 omnilex-key=us-wi-regs-official--agency-phar--Phar 8.01}

(1) Federal registration required. To possess, manufacture, distribute, dispense, or conduct research with controlled substances in this state, pharmacies and pharmacists shall register with the drug enforcement administration as required under federal law.

(2) Controlled substances authorization under federal registration. As provided under s. 961.32 (1m) (a), Stats., pharmacies and pharmacists registered under federal law to manufacture, distribute, dispense, or conduct research with controlled substances may possess, manufacture, distribute, dispense, and conduct research with those substances in this state to the extent authorized by their federal registration and in conformity with the provisions of ch. 961, Stats.

(3) Compliance with laws and regulations. Failure to register with the drug enforcement administration or otherwise comply with applicable federal, state, and local laws and regulations relating to possessing, manufacturing, distributing, dispensing, or conducting research with controlled substances constitutes unprofessional conduct for purposes of s. 450.10, Stats.

Note: The United States Department of Justice Drug Enforcement Administration has published a pharmacist’s manual, which provides an informational outline of the federal Controlled Substances Act. It can be found online at: https://www.deadiversion.usdoj.gov/pubs/manuals/index.html.

(4) Emergency kits in long-term care facilities. Nothing in these rules shall prohibit long-term care facilities from obtaining an emergency kit, from a DEA registered pharmacy, in compliance with federal law.

(5) Remote dispensing sites. For the purposes of this chapter and pursuant to s. 450.09 (1) (a), Stats., pharmacies shall include remote dispensing sites.

History

CR 21-071: cr. Register September 2022 No. 801, eff. 10-1-22; EmR2213: emerg. cr. (5), eff. 11-1-22; CR 23-054: cr. (5) Register August 2024 No. 824, eff. 9-1-24.

Wis. Admin. Code § Phar 8.02 Purpose of issue of prescription order {#sec-phar-8.02 omnilex-key=us-wi-regs-official--agency-phar--Phar 8.02}

Prescription orders for controlled substances shall be issued for a legitimate medical purpose by individual practitioners acting in the usual course of professional practice. Responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who dispenses the prescription.

History

CR 21-071: cr. Register September 2022 No. 801, eff. 10-1-22.

Wis. Admin. Code § Phar 8.03 Valid prescription requirements {#sec-phar-8.03 omnilex-key=us-wi-regs-official--agency-phar--Phar 8.03}

(1) A pharmacist may not dispense controlled substances for a prescription the pharmacist knows, or reasonably should know, is not a valid prescription under applicable federal, state, and local laws and regulations.

(2) An order purporting to be a prescription order not issued in the usual course of professional treatment or in legitimate and authorized research is not a valid prescription order within the meaning and intent of ss. 450.01 (21) and 961.38, Stats. A prescription order issued by a practitioner to obtain controlled substances for the purpose of general dispensing or administration to patients by the practitioner is not valid. A pharmacist knowingly dispensing pursuant to such a purported order, as well as the practitioner issuing it, shall be subject to the penalties provided for violation of the provision of law relating to controlled substances.

(3) A pharmacist may use professional judgment to contact prescribers for changes to controlled substances prescriptions as needed and in accordance with federal law and s. Phar 7.02 (5).

History

CR 21-071: cr. Register September 2022 No. 801, eff. 10-1-22; EmR2411: emerg. cr. (3), eff. 10-1-24; CR 24-070: cr. (3) Register June 2025 No. 834, eff. 7-1-25.

Wis. Admin. Code § Phar 8.04 Notification of theft or loss of controlled substances {#sec-phar-8.04 omnilex-key=us-wi-regs-official--agency-phar--Phar 8.04}

A pharmacy or pharmacist shall notify the board of a theft or loss of controlled substances on the same day notification is required to be provided to the drug enforcement administration. Notification to the board shall include all of the information required to be provided in the notification to the drug enforcement administration.

History

CR 21-071: cr. Register September 2022 No. 801, eff. 10-1-22; EmR2411: emerg. am., eff. 10-1-24; CR 24-070: am. Register June 2025 No. 834, eff. 7-1-25.

Wis. Admin. Code § Phar 8.05 Recordkeeping {#sec-phar-8.05 omnilex-key=us-wi-regs-official--agency-phar--Phar 8.05}

(1) Records shall be maintained as required by the federal controlled substances act, ch. 961, Stats., and s. 450.11 (2), Stats.

(2) The managing pharmacist shall oversee quarterly inspections, maintenance, and reconciliation of all controlled substances, including maintaining a perpetual inventory for all Schedule II controlled substances.

History

CR 21-071: cr. Register September 2022 No. 801, eff. 10-1-22.

Wis. Admin. Code § Phar 8.06 Identification card requirement under s. 450.11 (1b), Stats {#sec-phar-8.06 omnilex-key=us-wi-regs-official--agency-phar--Phar 8.06}

(1) Definition. In this section and s. 450.11 (1b) (e) 3., Stats., “health care facility” means a facility, as defined in s. 647.01 (4), Stats.; any hospital, nursing home, community-based residential facility, county home, county infirmary, county hospital, county mental health complex, or other place licensed or approved by the department of health services under s. 49.70, 49.71, 49.72, 50.03, 50.032, 50.033, 50.034, 50.35, 51.08, or 51.09, Stats.; a facility under s. 45.50, 51.05, 51.06, 233.40, 233.41, 233.42, or 252.10, Stats.; and a hospice facility under s. 50.90 (1) (c), Stats.

(2) Exemption. There shall be an exemption to the requirement for an identification card when the drug is lawfully delivered to the patient’s home, or any address requested by the patient, through mail, common carrier or delivery service. A valid signature is required upon delivery.

History

CR 21-071: cr. Register September 2022 No. 801, eff. 10-1-22.

Wis. Admin. Code § Phar 8.07 Partial dispensing {#sec-phar-8.07 omnilex-key=us-wi-regs-official--agency-phar--Phar 8.07}

A pharmacist may partially dispense a controlled substance in accordance with federal law.

History

CR 21-071: cr. Register September 2022 No. 801, eff. 10-1-22; correction in numbering in (2) made under s. 13.92 (4) (b) 1., Stats., and correction in (2) (b), (3) made under s. 13.92 (4) (b) 7., Stats., Register September 2022 No. 801; EmR2411: emerg. r. and recr., eff. 10-1-24; CR 24-070: r. and recr. Register June 2025 No. 834, eff. 7-1-25.

Wis. Admin. Code § Phar 8.08 Controlled substances in emergency kits for long-term care facilities {#sec-phar-8.08 omnilex-key=us-wi-regs-official--agency-phar--Phar 8.08}

long-term care facilities which are not registered with the DEA shall meet all of the following requirements regarding emergency kits containing controlled substances:

(1) The source of supply must be a DEA registered hospital, pharmacy or practitioner.

(2) The pharmaceutical services committee of the facility shall establish security safeguards for each emergency kit stored in the LTCF which shall include the designation of individuals who may have access to the emergency kits and a specific limitation of the type and quantity of controlled substances permitted to be placed in each emergency kit.

(3) A pharmacist shall be responsible for proper control and accountability for such emergency kits within the LTCF which includes the requirement that the LTCF and the providing DEA registered hospital, pharmacy or practitioner maintain complete and accurate records of the controlled substances placed in the emergency kits, the disposition of those controlled substances, plus the requirement to take at least monthly physical inventories.

(4) The pharmaceutical services committee will establish the emergency medical conditions under which the controlled substances may be administered to patients in the LTCF which shall include the requirement that medication be administered by authorized personnel only as expressly authorized by an individual DEA registered practitioner and in compliance with all applicable federal and state laws.

(5) Noncompliance with this section may result in revocation, denial or suspension of the privilege of having or placing emergency kits, containing controlled substances, in LTCF.

History

CR 21-071: cr. Register September 2022 No. 801, eff. 10-1-22; correction in (5) made under s. 13.92 (4) (b) 3., Stats., Register September 2022 No. 801.

Chapter Phar 9 PHARMACEUTICAL SERVICES REQUIREMENTS IN NURSING HOMES

Wis. Admin. Code § Phar 9.01 Pharmaceutical services requirements in nursing homes {#sec-phar-9.01 omnilex-key=us-wi-regs-official--agency-phar--Phar 9.01}

Requirements for pharmaceutical services provided in nursing homes are specified in ch. DHS 132.

History

Cr. Register, January, 1983, No. 325, eff. 2-1-83; correction made under s. 13.93 (2m) (b) 7., Stats., Register, June, 1994, No. 462; correction made under s. 13.93 (2m) (b) 7., Stats., Register, November, 1999, No. 527; correction made under s. 13.92 (4) (b) 7., Stats., Register November 2011 No. 671.

Chapter Phar 10 STANDARDS OF PROFESSIONAL CONDUCT

Wis. Admin. Code § Phar 10.01 Authority {#sec-phar-10.01 omnilex-key=us-wi-regs-official--agency-phar--Phar 10.01}

The rules in this chapter are adopted pursuant to the authority in ss. 15.08, 227.11 and 450.02, Stats.

History

Cr. Register, January, 1980, No. 289, eff. 2-1-80; renum. from Phar 5.01, Register, January, 1983, No. 325, eff. 2-1-83; correction made under s. 13.93 (2m) (b) 7., Stats., Register, July, 1993, No. 451.

Wis. Admin. Code § Phar 10.02 Definitions {#sec-phar-10.02 omnilex-key=us-wi-regs-official--agency-phar--Phar 10.02}

In this chapter:

(1) “Dispense” has the meaning given in s. 450.01 (7), Stats.

(2) “Drug” has the meaning given in s. 450.01 (10), Stats.

(3) “Patient” has the meaning given in s. 450.01 (14), Stats.

History

Cr. Register, January, 1980, No. 289, eff. 2-1-80; renum. from Phar 5.02 and r. (4), Register, January, 1983, No. 325, eff. 2-1-83; am. (1), (2) and (3), Register, December, 1998, No. 516, eff. 1-1-99.

Wis. Admin. Code § Phar 10.03 Unprofessional conduct {#sec-phar-10.03 omnilex-key=us-wi-regs-official--agency-phar--Phar 10.03}

The following, without limitation because of enumeration, are violations of standards of professional conduct and constitute unprofessional conduct in addition to those grounds specified under s. 450.10 (1), Stats.:

(1) Administering, dispensing, supplying or obtaining a drug other than in legitimate practice, or as prohibited by law.

(2) Engaging in any pharmacy practice which constitutes a danger to the health, welfare, or safety of patient or public, including but not limited to, practicing in a manner which substantially departs from the standard of care ordinarily exercised by a pharmacy, pharmacist or pharmacy technician which harmed or could have harmed a patient.

(3) Dispensing a drug which the pharmacist should have known would harm the patient for whom the medication was prescribed.

(4) Dispensing or causing to be dispensed a drug which is outdated or contaminated or known by the pharmacist to be unsafe for consumption.

(5) Falsifying patient records.

(6) Disclosing to the public information concerning a patient without the consent of the patient unless the information is requested by the board or the department of safety and professional services or unless release is otherwise authorized by law.

(7) Failing to report to the board any pharmacy practice which constitutes a danger to the health, safety or welfare of patient or public.

(7m) Failing to report to the board information that reasonably suggests there is a probability that a prescription drug or device dispensed by a pharmacist has caused or contributed to the substantial bodily injury or death of a customer or patient.

(8) Providing false information to the board or its agent.

(9) Refusing to render professional services to a person because of race, color, sex, religion, or age.

(10) Aiding or abetting the unlicensed practice of pharmacy.

(11) Advertising in a manner which is false, deceptive or misleading.

(12) Dispensing sample drug products for any financial consideration.

(13) Exercising undue influence on or taking unfair advantage of a patient in the promotion or sale of services, drugs or other products for the financial gain of the pharmacy, pharmacist or a third party.

(14) Participating in rebate or fee-splitting arrangements with health practitioners or with health care facilities.

(15) Furnishing a prescriber with any prescription order blanks imprinted with the name of a specific pharmacist or pharmacy.

(16) Using secret formula or code in connection with prescription orders.

(17) Having a credential granted by the board revoked or suspended in another state or United States jurisdiction or having been subject to other disciplinary action by the licensing authority thereof.

(18) Violating or attempting to violate any order of the board.

(19) Practicing without a current license or registration.

(20) Violating or attempting to violate any provision or term of ch. 450, Stats., or of any rule of the board.

(21) Failure to comply with s. 450.13 (5m) or 450.135 (8m), Stats.

(22) Violating any federal, state, or municipal law which substantially relates to the practice of the credential holder, or having a civil judgment entered against the credential holder which civil judgment substantially relates to the practice of the credential holder.

(23) Failure to provide competent supervision to a subordinate who is credentialed by the board.

(24) After a request by the board, failing to cooperate in a timely manner with the board’s investigation of a complaint filed against a credential holder. There is a rebuttable presumption that a credential holder who takes longer that 30 days to respond to a request of the board has not acted in a timely manner.

(25) Engaging or attempting to engage in the practice of pharmacy or practice of a pharmacy technician while the person’s ability to practice is impaired by alcohol or other drugs, or as a result of an illness which impairs the credential holder’s ability to appropriately carry out the functions delineated under the credential in a manner consistent with the safety of a client, patient, or the public.

History

Cr. Register, January, 1980, No. 289, eff. 2-1-80; renum. from Phar 5.03, Register, January, 1983, No. 325, eff. 2-1-83; am. (intro.), r. (1), (2), (7), (13) and (22), renum. (3) to (6), (8) to (12), (14) to (21) to be (1) to (17), Register, August, 1991, No. 428, eff. 9-1-91; am. (17), cr. (18), Register, July, 1993, No. 451, eff. 8-1-93; cr. (7m) and (19), Register, December, 1998, No. 516, eff. 1-1-99; correction in (6) made under s. 13.92 (4) (b) 6., Stats., Register February 2012 No. 674; CR 23-015: cr. (20), (21) Register April 2024 No. 820, eff. 5-1-24; correction in (21) made under s. 35.17, Stats., Register April 2024 No. 820; EmR2303: emerg. am. (2), (17), (19), eff. 2-3-23; CR 23-072: am. (1) to (7), (8) to (17), (19) Register August 2024 No. 824, eff. 9-1-24; EmR2601: emerg am. (2), (13), (17), eff. 2-3-26; CR 26-013: am. (2), (6), (7), (8), (13), (17), (18), cr. (22) to (25) Register May 2026 No. 845, eff. 6-1-26.

Chapter Phar 12 MANUFACTURER REQUIREMENTS

Wis. Admin. Code § Phar 12.01 Authority {#sec-phar-12.01 omnilex-key=us-wi-regs-official--agency-phar--Phar 12.01}

The rules in this chapter are adopted under authority in ss. 15.08 (5) (b), 227.11 (2) (a) and 450.07 (4), Stats.

History

Cr. Register, August, 1987, No. 380, eff. 9-1-87.

Wis. Admin. Code § Phar 12.02 Definitions {#sec-phar-12.02 omnilex-key=us-wi-regs-official--agency-phar--Phar 12.02}

In this chapter:

(1) “Device” has the meaning set forth in s. 450.01 (6), Stats.

(2) “Drug” has the meaning set forth in s. 450.01 (10), Stats.

(3) “Establishment” means a place of business under one management at one general physical location.

(4) “Manufacturer” means a person licensed by the board under this chapter.

(5) “Manufacturing” has the meaning set forth in s. 450.01 (13), Stats.

(6) “Prescription drug” has the meaning set forth in s. 450.01 (20), Stats.

History

Cr. Register, August, 1987, No. 380, eff. 9-1-87; am. (3), Register, August, 1991, No. 428, eff. 9-1-91.

Wis. Admin. Code § Phar 12.03 License; application {#sec-phar-12.03 omnilex-key=us-wi-regs-official--agency-phar--Phar 12.03}

(1) No person may engage in the manufacturing of any drug or device in this state unless a license is granted to the person by the board under this chapter.

(2) To obtain a license a person shall do all of the following:

(a) Submit an application on a form provided by the board.

(b) Pay the fee specified in s. 440.05 (1), Stats.

(d) Register with the food and drug administration and comply with all applicable requirements of 21 CFR 200, 201, 202, 207, 210 and 211.

(e) If applicable, register with the drug enforcement administration and comply with all appropriate requirements of 21 CFR 1301, 1302, 1303, 1304, 1305, 1307, 1311 and 1312.

Note: An application form may be obtained from the board office, 1400 East Washington Avenue, Madison, Wisconsin 53702. Copies of federal applications, laws and regulations may be obtained from the Food and Drug Administration, 5600 Fischers Lane, Rockville, Maryland 20857 and the Drug Enforcement Administration, 500 Dirksen Federal Building, 219 Dearborn, Chicago, Illinois 60604.

(3) A manufacturer license may not be transferred from one establishment to another nor from one person to another. Each establishment requires a separate license.

(4) If the license is denied, the applicant may request a hearing before the board on the denial.

(5) The board shall act on the application for a license within 60 business days after receiving the completed application, as provided in s. SPS 4.03.

History

Cr. Register, August, 1987, No. 380, eff. 9-1-87; am. (2) (intro.), (a), (b), (c), (d) and (5), Register, December, 1998, No. 516, eff. 1-1-99; CR 00-157: am. (2) (d) and (e) Register May 2002 No. 557, eff. 6-1-02; correction in (5) made under s. 13.92 (4) (b) 7., Stats., Register November 2011 No. 671.

Wis. Admin. Code § Phar 12.04 Inspections {#sec-phar-12.04 omnilex-key=us-wi-regs-official--agency-phar--Phar 12.04}

Before a license is granted, an inspection of the establishment shall be conducted by the board or its representative to determine if the location meets the standards in 21 USC 351 and 352 (2022) and 21 CFR 210 and 211 (2022).

History

Cr. Register, August, 1987, No. 380, eff. 9-1-87; CR 21-074: am. Register June 2023 No. 810, eff. 7-1-23.

Wis. Admin. Code § Phar 12.05 Compliance {#sec-phar-12.05 omnilex-key=us-wi-regs-official--agency-phar--Phar 12.05}

Failure to comply with all applicable federal and state laws and regulations shall be subject to disciplinary action by the board under s. 450.10, Stats.

History

Cr. Register, August, 1987, No. 380, eff. 9-1-87.

Wis. Admin. Code § Phar 12.06 Authorized distributors of record {#sec-phar-12.06 omnilex-key=us-wi-regs-official--agency-phar--Phar 12.06}

A manufacturer shall maintain and update at least once per month a list of the manufacturer’s authorized distributors of record.

History

EmR0815: emerg. cr. eff. 6-1-08; CR 08-051: cr. Register November 2008 No. 635, eff. 12-1-08.

Chapter Phar 13 DISTRIBUTOR REQUIREMENTS

Wis. Admin. Code § Phar 13.01 Authority {#sec-phar-13.01 omnilex-key=us-wi-regs-official--agency-phar--Phar 13.01}

The rules in this chapter are adopted under authority in ss. 15.08 (5) (b), 227.11 (2) (a), 450.02 (3) (a) and 450.07 (4), Stats.

History

Cr. Register, July, 1992, No. 439, eff. 8-1-92.

Wis. Admin. Code § Phar 13.02 Definitions {#sec-phar-13.02 omnilex-key=us-wi-regs-official--agency-phar--Phar 13.02}

In this chapter:

(1) “Blood” means whole blood collected from a single donor and processed either for transfusion or further manufacturing.

(2) “Blood component” means that part of blood separated by physical or mechanical means.

(3) “Controlled substance” has the meaning set forth in s. 961.01 (4), Stats.

(3m) “Department” means the department of safety and professional services.

(4) “Device” has the meaning set forth in s. 450.01 (6), Stats.

(5) “Distribute” has the meaning set forth in s. 450.01 (8), Stats.

(7) “Drug sample” means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

(8) “Facility” means a location where a wholesale distributor stores, handles, repackages, or offers for sale prescription drugs.

(9) “Manufacturer” means a person licensed or approved by the federal food and drug administration to engage in the manufacture of drugs or devices, consistent with the definition of “manufacturer” under the federal food and drug administration’s regulations and interpreted guidance implementing the federal prescription drug marketing act.

(10) “Prescription drug” has the meaning set forth in s. 450.01 (20), Stats.

(11) “Wholesale distribution” means distribution of a prescription drug to a person other than a consumer or patient, but does not include any of the following:

(a) Intracompany sales of prescription drugs which include any transaction or transfer between any division, subsidiary, parent, affiliated or related company under common ownership or control of a corporate entity or any transaction between co-licensees or a co-licensed product.

(b) The sale, purchase, distribution, trade, or transfer of a prescription drug or offer to sell, purchase, distribute, trade, or transfer a prescription drug for emergency medical reasons.

(d) Drug returns, when conducted by a hospital, health care entity, or charitable institution as provided in 21 CFR 203.23.

(e) Distributions to a practitioner for the purpose of general dispensing by the practitioner to his or her patients if all of the following apply:

The total number of dosage units of all prescription drugs distributed to practitioners by the pharmacy during each calendar year in which the pharmacy is licensed does not exceed 5% of the total number of dosage units of all prescription drugs distributed and dispensed by the pharmacy during the same calendar year.
The total number of dosage units of all controlled substances distributed to practitioners by the pharmacy during each calendar year in which the pharmacy is licensed does not exceed 5% of the total number of dosage units of all controlled substances distributed and dispensed by the pharmacy during the same calendar year.

(f) The sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a prescription.

(g) The sale, transfer, merger, or consolidation of all or part of the business of a pharmacy from or with another pharmacy, whether accomplished as a purchase and sale of stock or business assets.

(h) The sale, purchase, distribution, trade, or transfer of a prescription drug from one authorized distributor of record to one additional authorized distributor of record, if the manufacturer states in writing to the receiving authorized distributor of record that the manufacturer is unable to supply the drug and the supplying authorized distributor of record states in writing that the drug has previously been exclusively in the normal distribution channel.

(i) The delivery of, or offer to deliver, a prescription drug by a common carrier solely in the common carrier’s usual course of business of transporting prescription drugs, if the common carrier does not store, warehouse, or take legal ownership of the drug.

(j) A transaction excluded from the definition of “wholesale distribution” under 21 CFR 203.3 (cc).

(k) The donation or distribution of a prescription drug under s. 255.056, Stats.

(L) The transfer from a retail pharmacy or pharmacy warehouse of an expired, damaged, returned, or recalled prescription drug to the original manufacturer or original wholesale distributor or to a 3rd-party returns processor or reverse distributor.

(m) The return of a prescription drug, if the return is authorized by the law of this state.

(12) “Wholesale distributor” means a person engaged in the wholesale distribution of prescription drugs, including manufacturers; repackagers; own-label distributors; private-label distributors; jobbers; brokers; warehouses, including manufacturers’ and distributors’ warehouses; manufacturers’ exclusive distributors; manufacturers’ authorized distributors of record; prescription drug wholesalers and distributors; independent wholesale prescription drug traders; retail pharmacies that conduct wholesale distribution; and chain pharmacy warehouses that conduct wholesale distribution.

History

Cr. Register, July, 1992, No. 439, eff. 8-1-92; cr. (11) (f), Register, February, 1996, No. 482, eff. 3-1-96; am. (3), Register, December, 1998, No. 516, eff. 1-1-99; EmR0815: emerg. cr. (3m), (11) (b) to (d) and (f) to (m), renum. (6) and (11) (f) to be (12) and (11) (e) and am. (12), am. (8), (9), (11) (intro.) and (a), r. (11) (b) to (e), eff. 6-1-08; CR 08-051: cr. (3m), (11) (b) to (d) and (f) to (m), renum. (6) and (11) (f) to be (12) and (11) (e) and am. (12), am. (8), (9), (11) (intro.) and (a), r. (11) (b) to (e) Register November 2008 No. 635, eff. 12-1-08; correction in (3m) made under s. 13.92 (4) (b) 6., Stats., Register November 2011 No. 671; CR 18-034: am. (12) Register October 2018 No. 754, eff. 11-1-18.

Wis. Admin. Code § Phar 13.05 License; other requirements {#sec-phar-13.05 omnilex-key=us-wi-regs-official--agency-phar--Phar 13.05}

In addition to providing the application information, to obtain a license a person shall:

(1) Pay the fee specified in s. 440.05 (1), Stats.

(2) Pass an inspection of the facility conducted by the board or its representative in the 3-year period immediately preceding the date of the application by the board, a pharmacy examining board of another state, the National Association of Boards of Pharmacy, or another accrediting body recognized by the board, with the date of each inspection to determine if the location meets standards specified in ss. Phar 13.08 to 13.11.

(3) Register with the drug enforcement administration, if intending to distribute controlled substances.

Note: Copies of federal applications may be obtained from the Drug Enforcement Administration, Suite 500, Dirksen Federal Building, 219 South Dearborn Street, Chicago, Illinois 60604. Copies of federal statutes and rules may be obtained from the Superintendent of Documents, Government Printing Office, Washington DC 20402-9325.

History

Cr. Register, July, 1992, No. 439, eff. 8-1-92; CR 00-157: am. (2) Register May 2002 No. 557, eff. 6-1-02; EmR0815: emerg. am. (2), eff. 6-1-08; CR 08-051: am. (2) Register November 2008 No. 635, eff. 12-1-08.

Wis. Admin. Code § Phar 13.055 Surety bond, irrevocable letter of credit {#sec-phar-13.055 omnilex-key=us-wi-regs-official--agency-phar--Phar 13.055}

The applicant shall supply a surety bond or irrevocable letter of credit in the amount of $5,000.00, which is issued by a company authorized to do business in Wisconsin. The form of the bond or letter of credit shall be approved by the department and conditioned so that the state shall be fully compensated or reimbursed for, and shall be used to, secure payment of fees or costs that relate to the issuance of a wholesale distributor’s license that have not been paid within 30 days after the fees or costs have become final. The bond or letter shall be valid for the entire period of an unexpired license issued to the applicant. No claim may be made against a bond or other security under this section more than one year after the date on which the applicant’s wholesale distributor’s license expires.

History

EmR0815: emerg. cr. eff. 6-1-08; CR 08-051: cr. Register November 2008 No. 635, eff. 12-1-08.

Wis. Admin. Code § Phar 13.06 License; factors considered {#sec-phar-13.06 omnilex-key=us-wi-regs-official--agency-phar--Phar 13.06}

In determining eligibility for a distributor’s license, the board shall consider the following factors:

(1) Any convictions of the applicant under any federal, state, or local laws relating to drug samples, wholesale or retail drug or device distribution, or distribution of controlled substances;

(2) Any felony convictions of the applicant under federal, state, or local laws, the circumstances of which are substantially related to the practice of a distributor;

(4) The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution;

(5) Suspension or revocation by federal, state, or local government of any license currently or previously held by the applicant for the manufacture or distribution of any devices or drugs, including controlled substances;

(6) Compliance with licensing requirements under previously granted licenses, if any;

(7) Compliance with the requirements to maintain or make available to a state licensing authority or to federal, state, or local law enforcement officials those records required to be maintained by wholesale drug or device distributors; and

(8) Any other factors or qualifications the board considers relevant to and consistent with the public health and safety.

History

Cr. Register, July, 1992, No. 439, eff. 8-1-92; EmR0815: emerg. r. (3), eff. 6-1-08; CR 08-051: r. (3) Register November 2008 No. 635, eff. 12-1-08.

Wis. Admin. Code § Phar 13.07 Application review {#sec-phar-13.07 omnilex-key=us-wi-regs-official--agency-phar--Phar 13.07}

The board shall act upon an application for a license within 60 business days after receiving the completed application, as provided in s. SPS 4.03. If the license is denied, the applicant may request a hearing pursuant to ch. SPS 1.

History

Cr. Register, July, 1992, No. 439, eff. 8-1-92; am., Register, December, 1998, No. 516, eff. 1-1-99; correction made under s. 13.92 (4) (b) 7., Stats., Register November 2011 No. 671.

Wis. Admin. Code § Phar 13.08 Personnel {#sec-phar-13.08 omnilex-key=us-wi-regs-official--agency-phar--Phar 13.08}

A distributor shall employ adequate personnel with the education and experience necessary to safely and lawfully engage in the wholesale distribution of drugs.

History

Cr. Register, July, 1992, No. 439, eff. 8-1-92; EmR0815: emerg. am. eff. 6-1-08; CR 08-051: am. Register November 2008 No. 635, eff. 12-1-08.

Wis. Admin. Code § Phar 13.09 Facility requirements {#sec-phar-13.09 omnilex-key=us-wi-regs-official--agency-phar--Phar 13.09}

All facilities at which prescription drugs are stored, warehoused, handled, held, offered, marketed, or displayed shall:

(1) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

(2) Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

(3) Have a quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed secondary containers that have been opened;

(4) Be maintained in a clean and orderly condition; and

(5) Be free from infestation by insects, rodents, birds, or vermin of any kind.

History

Cr. Register, July, 1992, No. 439, eff. 8-1-92; EmR0815: emerg. am. (intro.) and (3), eff. 6-1-08; CR 08-051: am. (intro.) and (3) Register November 2008 No. 635, eff. 12-1-08.

Wis. Admin. Code § Phar 13.10 Security requirements {#sec-phar-13.10 omnilex-key=us-wi-regs-official--agency-phar--Phar 13.10}

All facilities shall require that:

(1) Access from outside the premises is kept to a minimum and be well controlled;

(2) The outside perimeter of the premises is well lighted;

(3) Entry into areas where prescription drugs are held is limited to authorized personnel;

(4) An alarm system is maintained to detect entry after hours; and

(5) A security system is maintained that will provide suitable protection against theft and diversion, including, when appropriate, a system that provides protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.

History

Cr. Register, July, 1992, No. 439, eff. 8-1-92; EmR0815: emerg. am. (3), eff. 6-1-08; CR 08-051: am. (3) Register November 2008 No. 635, eff. 12-1-08.

Wis. Admin. Code § Phar 13.11 Storage requirements {#sec-phar-13.11 omnilex-key=us-wi-regs-official--agency-phar--Phar 13.11}

(1) All prescription drugs stored in a facility shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such products, or with requirements in the current edition of an official compendium.

(2) If no storage requirements are established for a prescription drug, the product may be held at a controlled room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected.

(3) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, or logs shall be utilized to document proper storage of prescription drugs.

(4) The recordkeeping requirements in s. Phar 13.14 shall be followed for all stored drugs.

History

Cr. Register, July, 1992, No. 439, eff. 8-1-92; EmR0815: emerg. am. eff. 6-1-08; CR 08-051: am. Register November 2008 No. 635, eff. 12-1-08.

Wis. Admin. Code § Phar 13.12 Examination of materials requirements {#sec-phar-13.12 omnilex-key=us-wi-regs-official--agency-phar--Phar 13.12}

(1) Upon receipt by a facility, each outside shipping container shall be visually examined for identity and to prevent the acceptance of contaminated prescription drugs, or prescription drugs that are otherwise unfit for distribution. This examination shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.

(2) Each outgoing shipment from a facility shall be carefully inspected for identity of the prescription drug and to ensure that there is no delivery of prescription drugs that have been damaged in storage or held under improper conditions.

(3) The recordkeeping requirements in s. Phar 13.14 shall be followed for all incoming and outgoing prescription drugs at a facility.

History

Cr. Register, July, 1992, No. 439, eff. 8-1-92; EmR0815: emerg. am. eff. 6-1-08; CR 08-051: am. Register November 2008 No. 635, eff. 12-1-08.

Wis. Admin. Code § Phar 13.13 Returned, damaged and outdated prescription drug requirements {#sec-phar-13.13 omnilex-key=us-wi-regs-official--agency-phar--Phar 13.13}

(1) Prescription drugs in a facility that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other prescription drugs until they are destroyed or returned to their supplier.

(2) Any prescription drugs in a facility whose immediate or sealed outer or sealed secondary containers have been opened or used shall be identified as such, and shall be quarantined and physically separated from other prescription drugs until they are either destroyed or returned to the supplier.

(3) If the conditions under which a prescription drug has been returned to a facility cast doubt on the product’s safety, identity, strength, quality, or purity, then the product shall be destroyed, or returned to the supplier, unless examination, testing, or other investigation proves that the product meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which a product has been returned cast doubt on its safety, identity, strength, quality, or purity, the distributor shall consider, among other things, the conditions under which the product has been held, stored, or shipped before or during its return and the condition of the product and its container, carton, or labeling, as a result of storage or shipping.

(4) The recordkeeping requirements in s. Phar 13.14 shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs.

History

Cr. Register, July, 1992, No. 439, eff. 8-1-92; EmR0815: emerg. am. eff. 6-1-08; CR 08-051: am. Register November 2008 No. 635, eff. 12-1-08.

Wis. Admin. Code § Phar 13.14 Recordkeeping requirements {#sec-phar-13.14 omnilex-key=us-wi-regs-official--agency-phar--Phar 13.14}

(1) A distributor shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription drugs. These records shall include the following information:

(a) The source of the drugs, including the name and principal address of the seller or transferor, and the address of the location from which the drugs were shipped:

(b) The identity and quantity of the drugs received and distributed or disposed of; and

(2) Inventories and records shall be made available for inspection and copying by the board, its authorized representatives, and authorized representatives of federal, state and local law enforcement agencies for a period of 3 years following distribution or other disposition of the drugs.

(3) Records described in this section that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within 2 working days of a request by the board or its authorized representative.

History

Cr. Register, July, 1992, No. 439, eff. 8-1-92; EmR0815: emerg. am. (1) and (2), eff. 6-1-08; CR 08-051: am. (1) and (2) Register November 2008 No. 635, eff. 12-1-08.

Wis. Admin. Code § Phar 13.15 Written policies and procedures {#sec-phar-13.15 omnilex-key=us-wi-regs-official--agency-phar--Phar 13.15}

A distributor shall establish, maintain, and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory, and distribution of prescription drugs, including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories. A distributor shall include in their written policies and procedures the following:

(1) A procedure to ensure that the oldest approved stock of a prescription drug is distributed first. The procedure may permit deviation from this requirement if the deviation is temporary and appropriate.

(2) A procedure to be followed for handling recalls and withdrawals of prescription drugs. The procedure shall be adequate to deal with recalls and withdrawals due to:

(a) Any action initiated at the request of the food and drug administration or other federal, state, or local law enforcement or other governmental agency, including the board;

(b) Any voluntary action by the manufacturer to remove defective or potentially defective drugs from the market; or

(c) Any action undertaken to promote public health and safety by the replacing of existing merchandise with an improved product or new package design.

(3) A procedure to ensure that a distributor prepares for, protects against, and handles any crisis that affects security or operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of local, state, or national emergency.

(4) A procedure to ensure that any outdated prescription drugs are segregated from other products and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of outdated prescription drugs. This documentation shall be maintained for 3 years after disposition of the outdated drugs.

History

Cr. Register, July, 1992, No. 439, eff. 8-1-92; EmR0815: emerg. am. (intro.), (1), (2) (intro.), (b) and (4), eff. 6-1-08; CR 08-051: am. (intro.), (1), (2) (intro.), (b) and (4) Register November 2008 No. 635, eff. 12-1-08.

Wis. Admin. Code § Phar 13.16 Responsible persons {#sec-phar-13.16 omnilex-key=us-wi-regs-official--agency-phar--Phar 13.16}

A distributor shall establish and maintain lists of officers, directors, managers, and the designated representative in charge of wholesale drug distribution, storage, and handling, including a description of their duties and a summary of their qualifications.

History

Cr. Register, July, 1992, No. 439, eff. 8-1-92; EmR0815: emerg. am. eff. 6-1-08; CR 08-051: am. Register November 2008 No. 635, eff. 12-1-08.

Wis. Admin. Code § Phar 13.17 Compliance with federal, state and local laws {#sec-phar-13.17 omnilex-key=us-wi-regs-official--agency-phar--Phar 13.17}

(1) A distributor shall operate in compliance with applicable federal, state, and local laws and regulations. A distributor shall operate in compliance with any applicable federal electronic track and trace pedigree system implemented after July 1, 2011, unless an earlier implementation date is mandated by federal law which explicitly preempts state law. A distributor that deals in controlled substances shall register with the drug enforcement administration.

(2) Failure to comply with applicable federal, state, and local laws and regulations constitutes unprofessional conduct for purposes of s. 450.10, Stats.

(3) A distributor shall permit the board or its authorized representatives and authorized federal, state and local law enforcement officials to enter and inspect their premises and delivery vehicles, and to audit their records and written operating procedures, at reasonable times and in a reasonable manner, to the extent authorized by law. Such officials shall be required to show appropriate identification prior to being permitted access to a distributor’s premises and delivery vehicles.

History

Cr. Register, July, 1992, No. 439, eff. 8-1-92; EmR0815: emerg. am. (1), eff. 6-1-08; CR 08-051: am. (1) Register November 2008 No. 635, eff. 12-1-08.

Chapter Phar 14 HOME MEDICAL OXYGEN PROVIDERS

Wis. Admin. Code § Phar 14.01 Application {#sec-phar-14.01 omnilex-key=us-wi-regs-official--agency-phar--Phar 14.01}

Each applicant for licensure as a home medical oxygen provider shall submit all of the following:

(1) An application for licensure on a form provided by the board.

(2) The fee specified in s. 440.05 (1), Stats.

(3) Evidence of accreditation by an organization deemed an accreditation organization for suppliers of durable medical equipment, prosthetics, orthotics, and supplies by the United States department of health and human services, centers for medicare and medicaid services.

History

CR 16-072: cr. Register November 2017 No. 743, eff. 12-1-17; correction in (1), (2) made under s. 35.17, Stats., Register November 2017 No. 743.

Wis. Admin. Code § Phar 14.02 Standards of Professional Conduct {#sec-phar-14.02 omnilex-key=us-wi-regs-official--agency-phar--Phar 14.02}

Licensed home medical oxygen providers and their employees and agents shall do all of the following:

(1) Maintain accreditation status by an organization deemed an accreditation organization for suppliers of durable medical equipment, prosthetics, orthotics, and supplies by the United States department of health and human services, centers for medicare and medicaid services.

(2) Comply with all federal and state laws regarding transporting oxygen in cylinder or liquid form.

(3) Comply with the United States food and drug administration rules and regulations regarding transporting medical oxygen systems.

(4) Demonstrate that oxygen provided to cylinder or liquid form meets purity standards for medical grade oxygen.

(5) Meet safety inspection requirements including all of the following:

(a) Maintain documentation demonstrating each piece of oxygen or respiratory equipment has been checked, is free of defect, and operates within the manufacturer’s specifications.

(b) Equipment shall not be modified to the extent that the modification may reasonably cause harm.

(d) Ensure that all appropriate warning labels, including tags, are present on the equipment provided.

(6) Maintain recall procedures including all of the following:

(a) Ensure that lot numbers and expiration dates are affixed to each cylinder delivered.

(b) Maintain a tracking system for all medical oxygen and gas delivered.

(c) Document all equipment serial numbers and model numbers to ensure that equipment can be retrieved if a recall is initiated.

(d) Maintain records for equipment that requires food and drug administration tracking.

(7) Comply with the all of the following maintenance and cleaning requirements:

(a) Maintain documentation demonstrating that a function and safety check of equipment was performed prior to set up.

(b) Maintain an established protocol for cleaning and disinfecting equipment which address both aerobic and anaerobic pathogens.

(c) Maintain a material safety data sheet on file for solutions and products used in cleaning and disinfecting procedures.

(d) Maintain segregated areas on the premises and in delivery vehicles for clean, dirty, and contaminated equipment.

(e) Clean and disinfect equipment according to manufacturers’ specifications.

(f) Instruct the patient on proper cleaning techniques as specified by the manufacturer.

(8) Implement a comprehensive preventative maintenance program that includes all of the following:

(a) Procedures for problem reporting, tracking, recall, and resolution.

(b) Performance of service as specified by the manufacturer and the documentation of such performance in the service records.

(c) Routine inspection, service, and maintenance of equipment located in the patient’s or customer’s residence according to manufacturer’s specifications.

(9) Maintain repair logs to document repair and maintenance of equipment, including oxygen concentrators, infant monitors, and mechanical ventilators. The repair log shall include all of the following:

(a) Type of equipment.

(b) Manufacturer.

(d) Serial number.

(e) Date of repair.

(f) Specific repair made.

(g) Name of person or company performing the repair.

(10) Maintain testing equipment to ensure accurate calibration. Testing equipment shall be appropriate for the level of service offered. Scales used to weigh liquid oxygen reservoirs shall be properly maintained to ensure accuracy.

(11) Provide counseling including all of the following:

(a) Utilize orientation checklists for review of all of the following:

Instructions for use of the equipment.
Safety precautions.
Cleaning procedures.
Maintenance procedures.
Return demonstrations on back up oxygen systems.

(b) Instruct the patient about emergency and routine contact procedures.

(c) Deliver and review written instruction materials to ensure that the patient receives information regarding the operation of the equipment.

(12) Develop, implement, and document a written plan of services in the patient record, including an assessment of the safety of the home environment, the caregiver or patient ability to comply with the prescription and the caregiver or patient ability to operate and clean the equipment as instructed.

(13) Maintain all required home medical oxygen records for a period of 5 years.

History

CR 16-072: cr. Register November 2017 No. 743, eff. 12-1-17; correction in (8) (intro.) made under s. 35.17, Stats., Register November 2017 No. 743.

Chapter Phar 15 PHARMACEUTICAL COMPOUNDING, SAFE HANDLING OF HAZARDOUS DRUGS, AND RADIOPHARMACEUTICALS

Wis. Admin. Code § Phar 15.01 Definitions {#sec-phar-15.01 omnilex-key=us-wi-regs-official--agency-phar--Phar 15.01}

In this chapter, “USP-NF” means the United States Pharmacopeia-National Formulary published by the United States Pharmacopeial Convention.

History

CR 24-092: cr. Register September 2025 No. 837, eff. 10-1-25.

Wis. Admin. Code § Phar 15.02 Incorporation of standards {#sec-phar-15.02 omnilex-key=us-wi-regs-official--agency-phar--Phar 15.02}

(1) Pharmaceutical compounding - nonsterile preparations. USP-NF general chapter 795, official as of November 1, 2023, is incorporated by reference into this chapter, subject to the exception that nonsterile compounding does not include the addition of nonallergenic, therapeutically inert flavoring agents to a conventionally manufactured drug product. The pharmacist shall also comply with the following requirements when adding flavoring agents to a drug product:

(a) The pharmacist shall ensure that the flavoring agent is not more than 5 percent of the product’s total volume.

(b) The pharmacist shall label the flavored drug with a beyond-use date no greater than 14 days past the date the flavoring agent is added if the drug is required to be stored in a refrigerator. A different beyond-use date or alternate storage conditions may be indicated if such variation is supported by peer-reviewed medical literature or manufacturer’s recommendations. The pharmacist shall electronically or manually document that a flavoring agent was added to a drug.

(c) The pharmacist shall document the addition of flavoring as part of the prescription record. The documentation shall include the type of flavoring agent, manufacturer, lot number, and expiration date.

(d) A prescription is required before a pharmacist may add flavoring to an over-the-counter product.

(2) Pharmaceutical compounding - sterile preparations. USP-NF general chapter 797, official as of November 1, 2023, is incorporated by reference into this chapter.

(3) Safe handling of hazardous drugs. USP-NF general chapter 800, official as of July 1, 2020, is incorporated by reference into this chapter.

(4) Radiopharmaceuticals. USP-NF general chapter 825, official as of January 1, 2024, is incorporated by reference into this chapter.

Note: Copies of the above standards are on file in the office of the legislative reference bureau. A copy of the USP-NF can be purchased from the United States Pharmacopeial Convention at https://usp.org.

History

CR 24-092: cr. Register September 2025 No. 837, eff. 10-1-25.

Wis. Admin. Code § Phar 15.03 Compliance {#sec-phar-15.03 omnilex-key=us-wi-regs-official--agency-phar--Phar 15.03}

(1) Unprofessional conduct. Noncompliance with ch. Phar 15 shall be considered a violation of s. Phar 10.03 and may result in disciplinary action by the board against a credential holder.

(2) Differing requirements.

(a) Where any board rule in this chapter differs from a requirement within a standard referenced in this chapter, the board rule shall govern.

(b) Except as provided in par. (a), where a provision of this chapter prescribes a general requirement and another provision of this chapter prescribes a specific or more detailed requirement regarding the same subject, the specific or more detailed requirement shall govern.

(c) Except as provided in pars. (a) and (b), where different sections of this chapter specify conflicting requirements. The most restrictive requirement, as determined by the board, shall govern.

History

CR 24-092: cr. Register September 2025 No. 837, eff. 10-1-25.

Chapter Phar 16 CONTINUING EDUCATION FOR PHARMACISTS

Wis. Admin. Code § Phar 16.01 Authority and purpose {#sec-phar-16.01 omnilex-key=us-wi-regs-official--agency-phar--Phar 16.01}

The rules in this chapter are adopted by the pharmacy examining board pursuant to the authority delegated by ss. 15.08 (5) (b), 227.11 (2) and 450.02 (2g) (a), Stats.

History

Cr. Register, November, 1999, No. 527, eff. 12-1-99.

Wis. Admin. Code § Phar 16.02 Continuing education required; waiver {#sec-phar-16.02 omnilex-key=us-wi-regs-official--agency-phar--Phar 16.02}

(1) Each pharmacist required to complete the continuing education requirement provided under s. 450.085, Stats., shall, at the time of making application for renewal of a license under s. 450.08 (2) (a), Stats., sign a statement on the application for renewal certifying that the pharmacist has completed at least 30 hours of acceptable continuing education programs within the 2-year period immediately preceding the date of his or her application for renewal. The 30 hours of continuing education for pharmacists first applies to applications that are submitted to the department to renew a license to practice pharmacy that expires on June 1, 2000. This subsection does not apply to an application for renewal of a license that expires on the first renewal date after the date on which the board initially granted the license.

(2) A pharmacist may apply to the board for waiver of the requirements of this chapter on grounds of exceptional circumstances such as prolonged illness, disability or other similar circumstances that the pharmacist indicates have prevented him or her from meeting the requirements. The board will consider each application for waiver individually on its merits.

History

Cr. Register, November, 1999, No. 527, eff. 12-1-99.

Wis. Admin. Code § Phar 16.03 Acceptable continuing educational programs {#sec-phar-16.03 omnilex-key=us-wi-regs-official--agency-phar--Phar 16.03}

The board recognizes only those educational programs offered by a provider approved by the Accreditation Council for Pharmacy Education at the time of attendance, or other board approved programs.

Note: As of August 9, 1999, the board has not approved any programs other than programs offered by a provider approved by the Accreditation Council for Pharmacy Education.

History

Cr. Register, November, 1999, No. 527, eff. 12-1-99; reprinted to correct printing error, Register, February, 2000, No. 530; CR 14-023: am. Register August 2014 No. 704, eff. 9-1-14.

Wis. Admin. Code § Phar 16.04 Evidence of compliance {#sec-phar-16.04 omnilex-key=us-wi-regs-official--agency-phar--Phar 16.04}

The board accepts as evidence of compliance with this chapter certification by a providing institution or organization that a pharmacist has attended and completed continuing education programs approved under the provisions of s. Phar 16.03. Certification may be the original, or verified copies of, documents certifying attendance and completion.

History

Cr. Register, November, 1999, No. 527, eff. 12-1-99.

Wis. Admin. Code § Phar 16.05 Retention requirement {#sec-phar-16.05 omnilex-key=us-wi-regs-official--agency-phar--Phar 16.05}

The pharmacist shall retain evidence of compliance for 3 years following the renewal date for the biennium for which 30 hours of credit are required for renewal of a license.

Note: For example, a pharmacist who renews his or her license on June 1, 2000, must retain proof of having obtained 30 hours of continuing education in the 2 years preceding renewal until June 1, 2003.

History

Cr. Register, November, 1999, No. 527, eff. 12-1-99.

Wis. Admin. Code § Phar 16.06 Audit {#sec-phar-16.06 omnilex-key=us-wi-regs-official--agency-phar--Phar 16.06}

The board may require any pharmacist to submit his or her evidence of compliance with the continuing education requirements to audit compliance.

History

Cr. Register, November, 1999, No. 527, eff. 12-1-99.

Chapter Phar 17 PHARMACY INTERNSHIP

Wis. Admin. Code § Phar 17.01 Authority {#sec-phar-17.01 omnilex-key=us-wi-regs-official--agency-phar--Phar 17.01}

The rules in this chapter are adopted pursuant to the authority in ss. 15.08 (5) (b), 227.11 (2), and 450.02 (3) (d) and (e), Stats.

History

CR 01-134: cr. Register July 2002 No. 559, eff. 8-1-02; correction made under s. 13.92 (4) (b) 7., Stats., Register June 2015 No. 714; CR 19-164: am. Register July 2020 No. 775, eff. 8-1-20.

Wis. Admin. Code § Phar 17.02 Definitions {#sec-phar-17.02 omnilex-key=us-wi-regs-official--agency-phar--Phar 17.02}

In this chapter:

(3m) “General supervision” means to continually coordinate, direct and inspect the practice of another.

(4) “Intern” means a person completing an internship in order to meet the requirement under s. 450.03 (2) (b), Stats.

(9) “Supervising pharmacist” means a pharmacist who supervises and is responsible for the actions of an intern in the practice of pharmacy.

History

CR 01-134: cr. Register July 2002 No. 559, eff. 8-1-02; CR 19-164: r (1) to (3), cr. (3m), am. (4), r. (5) to (8) Register July 2020 No. 775, eff. 8-1-20.

Wis. Admin. Code § Phar 17.035 Internship {#sec-phar-17.035 omnilex-key=us-wi-regs-official--agency-phar--Phar 17.035}

(1) The internship is a practical experience consisting of the practice of pharmacy under the general supervision of a supervising pharmacist.

(2) A record of the internship hours shall be maintained by one of the following methods:

(a) The school of pharmacy in a manner determined by the school of pharmacy to track and record the hours and locations worked by an intern.

(b) The supervising pharmacist detailing the hours and location worked by an intern under the pharmacist’s supervision, signed by the intern and the supervising pharmacist.

(3) The written record of internship hours shall be disclosed to the board upon request.

History

CR 19-164: cr. Register July 2020 No. 775, eff. 8-1-20.

Chapter Phar 18 THIRD-PARTY LOGISTICS PROVIDERS

Wis. Admin. Code § Phar 18.01 Authority and applicability {#sec-phar-18.01 omnilex-key=us-wi-regs-official--agency-phar--Phar 18.01}

(1) The rules in this chapter are adopted pursuant to the authority delegated by ss. 15.08 (5) (b), 450.02 (3), and 450.075 (4), Stats.

(2) Pursuant to s. 450.075 (7) (b), Stats., the rules in this chapter only apply if the Pharmacy Examining Board makes a determination on a biennial basis, that continued licensure by this state of third-party logistics providers is required.

History

CR 23-031: cr. Register June 2024 No. 822, eff. 7-1-24; correction in (2) made under s. 35.17, Stats., Register June 2024 No. 822.

Wis. Admin. Code § Phar 18.02 Definitions {#sec-phar-18.02 omnilex-key=us-wi-regs-official--agency-phar--Phar 18.02}

In this chapter:

(1) “Designated representative” means an individual who functions on behalf of a third-party logistics provider or an out-of-state third-party logistic provider as specified in s. Phar 18.05.

(2) “Facility” has the meaning given in s. 450.01 (11m), Stats.

(3) “Out-of-state third-party logistics provider” has the meaning given s. 450.01 (13w), Stats.

(4) “Third-party logistics provider” has the meaning given in s. 450.01 (21s), Stats.

History

CR 23-031: cr. Register June 2024 No. 822, eff. 7-1-24; correction in (1) made under s. 35.17, Stats., Register June 2024 No. 822.

Wis. Admin. Code § Phar 18.03 Licensure, renewal, and reinstatement {#sec-phar-18.03 omnilex-key=us-wi-regs-official--agency-phar--Phar 18.03}

(1) License allowed. A person acting as a third-party logistics provider or an out-of-state third-party logistics provider of any drug or device may apply to obtain a license from the board.

(2) Licensure. Except as provided under sub. (4), the board shall grant a license to operate as a third-party logistics provider, or out-of-state third-party logistics provider, to any applicant that satisfies all of the following requirements, as determined by the board:

(a) Submits a completed application form.

Note: Application forms are available from the department of safety and professional services’ website at http://dsps.wi.gov.

(b) Pays the fee specified in s. 440.05, Stats.

Name, address, and telephone number.
Date and place of birth.
A photograph of the person taken within the 12-month period immediately preceding the date of the application.
A personal information statement that includes all of the following for the 7-year period immediately preceding the application:

a. Place of residence.

b. Occupations, positions of employment, and offices held.

c. The name and addresses for each business, corporation, or entity listed in subd. 4. b.

d. Whether the person has been the subject of any proceeding for the revocation of any business or professional licensure and the disposition of that proceeding.

e. Whether the person has been enjoined by a court, either temporarily or permanently, from possessing, controlling, or distributing any prescription drug, and a description of the circumstances surrounding the injunction.

f. A description of any involvement with any business, including investments other than the ownership of stock in a publicly traded company or mutual fund, that manufactured, administered, prescribed, distributed, or stored pharmaceutical products or drugs, and list of any lawsuits in which such a business was named as a party.

A description of any misdemeanor or felony criminal offense of which the person was, as an adult, found guilty, whether adjudication of guilt was withheld, or the person pleaded guilty or no contest. If the person is appealing a criminal conviction, the application shall include a copy of the notice of appeal, and the person shall submit a copy of the final disposition of the appeal not more than 15 days after a final disposition is reached.
Verification that the requirements in s. Phar 18.05 (1) have been met.
A statement that each facility used by the applicant for third-party logistics provider services has been inspected in the 3-year period immediately preceding the date of the application by the board, a pharmacy examining board of another state, the National Association of Boards of Pharmacy, or another accrediting body recognized by the board, with the date of each such inspection.

(d) Subject to ss. 111.321, 111.322, and 111.335, Stats., the applicant does not have an arrest or conviction record.

(2m) Multiple facilities. Where operations are conducted at more than one facility, a person acting as a third-party logistics provider or out-of-state logistics provider may apply for a license for each such facility.

(3) Renewal.

(a) Each licensee may elect to renew biennially. Renewal is required to maintain a license issued under this chapter. The renewal date and fee are specified by s. 440.08 (2), Stats.

(b) Every even-numbered year, each licensee shall complete a renewal application and return it with the required fee prior to July 1 of that year.

Note: Instructions for renewal applications can be found on the department of safety and professional services’ website at http://dsps.wi.gov.

(4) Reinstatement. A licensee who has unmet disciplinary requirements and failed to renew the license within 5 years or whose license has been surrendered or revoked may apply to have the license reinstated in accordance with all of the following:

(a) Evidence of completion of the requirements in sub. (2) if the license has not been active within 5 years.

(b) Evidence of completion of disciplinary requirements, if applicable.

History

CR 23-031: cr. Register June 2024 No. 822, eff. 7-1-24; s. 35.17 correction in (2) (intro.), (c) 4. c., 6., (4) (a) made under s. 35.17, Stats., renum. (2m) from (2) (e) under s. 13.92 (4) (b) 1., Stats., and create (2m) (title) under s. 13.92 (4) (b) 2., Stats., Register June 2024 No. 822.

Wis. Admin. Code § Phar 18.04 Inspections {#sec-phar-18.04 omnilex-key=us-wi-regs-official--agency-phar--Phar 18.04}

Pursuant to s. 450.075 (6), Stats., a third-party logistics provider or out-of-state third-party logistics provider regardless of licensure status shall permit the board or its authorized representatives and authorized federal, state, and local law enforcement officials to enter and inspect their premises and delivery vehicles, and to audit their records and written operating procedures, at reasonable times and in a reasonable manner, to the extent authorized by law. Such officials shall be required to show appropriate identification prior to being permitted access to the third-party logistics provider or out-of-state third-party logistics provider’s premises and delivery vehicles.

History

CR 23-031: cr. Register June 2024 No. 822, eff. 7-1-24; correction made under s. 35.17, Stats., Register June 2024.

Wis. Admin. Code § Phar 18.05 Responsible persons {#sec-phar-18.05 omnilex-key=us-wi-regs-official--agency-phar--Phar 18.05}

(1) Designated representative. The individual acting as the designated representative for a third-party logistics provider or an out-of-state third-party logistics provider shall meet all of the following requirements:

(a) Is at least 21 years old.

(b) Has been employed full-time for at least three years in a pharmacy or with a wholesale prescription drug distributor in a capacity related to the dispensing of and distribution of, and recordkeeping related to, prescription drugs.

(d) Is physically present at the third-party logistics provider’s or out-of-state third-party logistics provider’s facility during regular business hours. This paragraph does not preclude the person from taking authorized sick leave and vacation time or from being absent from the facility for other authorized business or personal purposes.

(e) Is actively involved in and aware of the daily operation of the third-party logistics provider or the out-of-state third-party logistics provider.

(f) Is a designated representative for only one applicant at any given time. This paragraph does not apply if more than one third-party logistics provider or out-of-state third-party logistics provider is located at the facility and the third-party logistics provider or out-of-state third-party logistics providers located at the facility are members of an affiliated group.

(g) Has not been convicted of violating any federal, state, or local law relating to distribution of a controlled substance.

(h) Has not been convicted of a felony.

(i) Submits to the department 2 fingerprint cards, each bearing a complete set of the person’s fingerprints. The department of justice shall provide for the submission of the fingerprint cards to the federal bureau of investigation for purposes of verifying the identity of the person and obtaining the person’s criminal arrest and conviction record.

(2) Officers, directors and managers. A third-party logistics provider or out-of-state third-party logistics provider licensed under this chapter shall maintain a list of officers, directors, and managers, including a description of their duties and a summary of their qualifications.

History

CR 23-031: cr. Register June 2024 No. 822, eff. 7-1-24; correction in (1) (d), (f) made under s. 13.92 (4) (b) 7., Stats., Register June 2024 No. 822.

Wis. Admin. Code § Phar 18.06 Facility and storage requirements {#sec-phar-18.06 omnilex-key=us-wi-regs-official--agency-phar--Phar 18.06}

All facilities licensed as third-party logistics providers or out-of-state third-party logistics providers shall:

(1) Maintain access to warehouse space of suitable size to facilitate safe operations, including a suitable area to quarantine suspect product.

(2) Have written policies and procedures to:

(a) Address receipt, security, storage, inventory, shipment, and distribution of a product.

(b) Identify, record, and report confirmed losses or thefts.

(d) Provide support for manufacturer recalls.

(e) Prepare for, protect against, and address any reasonably foreseeable crisis that affects security or operation at the facility, such as a strike, fire, or flood.

(f) Ensure that any expired product is segregated from other products and returned to the manufacturer or repackager or destroyed.

(g) Maintain the capability to trace the receipt and outbound distribution of a product, and supplies and records of inventory.

(h) Quarantine or destroy a suspect product if directed to do so by the respective manufacturer, wholesale distributor, dispenser, or an authorized government agency.

History

CR 23-031: cr. Register June 2024 No. 822, eff. 7-1-24.

Wis. Admin. Code § Phar 18.07 Security requirements {#sec-phar-18.07 omnilex-key=us-wi-regs-official--agency-phar--Phar 18.07}

All facilities shall require the following:

(1) Access from outside the premises is kept to a minimum and is well controlled.

(2) The outside perimeter of the premises is well lighted.

(3) Entry into areas where prescription drugs are held is limited to authorized personnel.

(4) An alarm system is maintained to detect entry after hours.

History

CR 23-031: cr. Register June 2024 No. 822, eff. 7-1-24.

Wis. Admin. Code § Phar 18.08 Compliance {#sec-phar-18.08 omnilex-key=us-wi-regs-official--agency-phar--Phar 18.08}

A third-party logistics provider or an out-of-state third-party logistics provider who elects to be licensed under this chapter and fails to comply with all applicable federal and state laws and regulations may be subject to disciplinary action by the board under s. 450.10, Stats.

History

CR 23-031: cr. Register June 2024 No. 822, eff. 7-1-24.

Chapter Phar 19 REGISTRATION OF PHARMACY TECHNICIANS

Wis. Admin. Code § Phar 19.01 Registration {#sec-phar-19.01 omnilex-key=us-wi-regs-official--agency-phar--Phar 19.01}

(1) No person may engage in the practice of a pharmacy technician or use the title “pharmacy technician” or “pharmacy tech” unless the person is registered as a pharmacy technician by the board.

(2) A person applying for a pharmacy technician registration shall satisfy all of the following:

(a) Submit a completed application form.

Note: Instructions for applications are available on the department of safety and professional services’ website at http://dsps.wi.gov.

(b) Pay the fee determined by the department under s. 440.05 (1), Stats.

(d) The applicant satisfies one of the following:

Is at least 18 years of age and has graduated from high school or has attained high school graduation equivalency as determined by the department of public instruction.
Is enrolled in a youth apprenticeship program for pharmacy technicians that is on the list of youth apprenticeship programs approved by the department of workforce development under s. 106.13 (2m), Stats.

(3) A person who has applied for a registration as a pharmacy technician and whose practice as a pharmacy technician is limited to performing duties under the direct supervision of a person licensed as a pharmacist by the board and during the period before which the board takes final action on the persons application may practice as a pharmacy technician.

History

EmR2303: emerg. cr., eff. 2-3-23; CR 23-072: cr. Register August 2024 No. 824, eff. 9-1-24.

Wis. Admin. Code § Phar 19.02 Scope of practice {#sec-phar-19.02 omnilex-key=us-wi-regs-official--agency-phar--Phar 19.02}

A pharmacy technician may administer vaccines as authorized under s. 450.035 (2h), Stats., and may perform technical dispensing functions, compounding, packaging, labeling and storage, pharmacy and inventory management, and other activities involved in the practice of pharmacy delegated by a pharmacist. A pharmacy technician may not perform any of the following:

(1) Except as allowed under s. Phar 7.14, provide the final verification for the accuracy, validity, completeness, or appropriateness of the filled prescription or medication order.

(2) Complete the drug utilization review under s. Phar 7.03.

(3) Administer any prescribed drug products, or devices under s. 450.035 (1t), Stats.

(4) Provide patient specific counseling or consultation.

(5) Make therapeutic alternate drug selections.

(6) Provide supervision over the practice of pharmacy to other pharmacy technicians.

History

EmR2303: emerg. cr., eff. 2-3-23; CR 23-072: cr. Register August 2024 No. 824, eff. 9-1-24; correction in (intro.) made under s. 35.17, Stats., Register August 2024 No. 824.

Wis. Admin. Code § Phar 19.03 Renewal and reinstatement {#sec-phar-19.03 omnilex-key=us-wi-regs-official--agency-phar--Phar 19.03}

(1) Renewal.

(a) A person with an expired pharmacy technician registration may not reapply for a registration using the initial application process.

(b) A person renewing their pharmacy technician registration shall do all of the following:

Submit a completed renewal application.

Note: Instructions for renewal applications are available on the department of safety and professional services’ website at http://dsps.wi.gov.

Pay the renewal fee as determined by the department under s. 440.03 (9) (a), Stats., and any applicable late renewal fee.

(c) Notwithstanding par. (b), if a pharmacy technician fails to obtain renewal on or before the applicable renewal date, the board may suspend the pharmacy technician’s registration.

(2) Reinstatement. A registration holder who has unmet disciplinary requirements and failed to renew the registration within 5 years or whose registration has been surrendered or revoked may apply to have the registration reinstated in accordance with all of the following:

(a) Evidence of completion of the requirements under s. Phar 19.01 (2).

(b) Evidence of completion of any disciplinary requirements.

History

EmR2303: emerg. cr., eff. 2-3-23; CR 23-072: cr. Register August 2024 No. 824, eff. 9-1-24; correction in (1) (b) 2. made under s. 35.17, Stats., Register August 2024 No. 824.

Wis. Admin. Code § Phar 19.04 Change of address, employer, or name {#sec-phar-19.04 omnilex-key=us-wi-regs-official--agency-phar--Phar 19.04}

Pursuant to ss. 440.11 (1) and 450.068 (3), Stats., each pharmacy technician shall notify the department of an address change or change of employer within 10 days of the change, and a name change within 30 days of the change.

Note: Instructions for providing notification of address change, change of employer, or a name change are available on the department of safety and professional services’ website at http://dsps.wi.gov.

History

EmR2303: emerg. cr., eff. 2-3-23; CR 23-072: cr. Register August 2024 No. 824, eff. 9-1-24.