Register July 2020 No. 775
Chapter Phar 6
PHARMACY LICENSES AND EQUIPMENT
Phar 6.01 Licenses; application.
Phar 6.02 Licenses; change of location or ownership.
Phar 6.03 Changes in managing pharmacist.
Phar 6.06 Laws and other references.
Phar 6.075 Temperature; Humidity.
Ch. Phar 6 Note
Note: Chapter Phar 6 as it existed on January 31, 1983, was repealed and a new chapter Phar 6 was created effective February 1, 1983.
Phar 6.01
Phar 6.01 Licenses; application. 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.
Phar 6.01 Note
Note: Applications are available upon request to the board office located at 1400 East Washington Avenue, P.O. Box 8935, Madison, Wisconsin 53708.
Phar 6.01 History
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.
Phar 6.02
Phar 6.02 Licenses; change of location or ownership. Phar 6.02(1)(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.
Phar 6.02(1m)
(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.
Phar 6.02(2)
(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.
Phar 6.02 History
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.
Phar 6.03
Phar 6.03 Changes in managing pharmacist. The pharmacy owner shall report to the board any change of managing pharmacist within 5 days following the change.
Phar 6.03 History
History: Cr.
Register, January, 1983, No. 325, eff. 2-1-83.
Phar 6.04(1)
(1)
Professional service area. The professional service area of a pharmacy shall not be less than 250 sq. ft. No more than 20% of the space may be used for storage of bulk pharmaceuticals. If the pharmacy is open at any time solely as a non-prescription or sundry outlet, without a pharmacist present, the professional service area shall be secured as specified in
sub. (3). A variance to the 250 sq. ft. professional service area requirement may be authorized by the board upon submission of a specific plan describing the manner in which the proposed professional service area plan varies from the requirement.
Phar 6.04(2)
(2) Prescription counter space. A pharmacy shall have a prescription counter with a free working surface of 18 or more inches in width and at least 12 square feet in area. This free-working surface must be used only for the compounding and dispensing of prescriptions.
Phar 6.04(3)
(3) Professional service area requirements where pharmacist is absent. Phar 6.04(3)(a)(a) Except as provided in
par. (c), if no pharmacist is present in the professional service area, a pharmacy may convert to a non-prescription or sundry outlet if the following requirements are met:
Phar 6.04(3)(a)1.
1. A secured, physical barrier surrounds the professional service area of the pharmacy and precludes access to the area by unlicensed 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.
Phar 6.04(3)(a)3.
3. A patient's telephone request to renew a certain prescription may be accepted, but a telephone message from a practitioner giving a new prescription order or renewal authority may not be accepted.
Phar 6.04(3)(a)5.
5. Signs of reasonable size are posted at the entrance of the building and the professional service area prominently displaying the hours the pharmacist will be on duty.
Phar 6.04(3)(a)6.
6. The manner in which the telephone is answered does not imply that the location is, at that time, operating as a pharmacy.
Phar 6.04(3)(a)7.
7. The pharmacy examining board office is notified of the hours during which the establishment is operated as a sundry outlet.
Phar 6.04(3)(b)
(b) The managing pharmacist is responsible for compliance with all professional service area security requirements.
Phar 6.04(3)(c)
(c) Where no pharmacist is present in the professional service area a pharmacy is not required to convert to a non-prescription or sundry outlet if the following requirements are met:
Phar 6.04(3)(c)1.
1. The pharmacist is absent for a time period of one half hour or less.
Phar 6.04(3)(c)2.
2. The pharmacist must be accessible for communication with the remaining pharmacy staff by phone, pager or other device.
Phar 6.04(3)(c)3.
3. The pharmacy must indicate that the pharmacist is not available in the professional service area and indicate the period of absence and the time of the pharmacist's return.
Phar 6.04(4)
(4) Professional service area remodeling. Any modifications of the approved floor plan shall be submitted to and approved by the board or its designee. Board action must be taken within 60 days.
Phar 6.04 History
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.
Phar 6.05
Phar 6.05 Sanitation. 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.
Phar 6.05 History
History: Cr.
Register, January, 1983, No. 325, eff. 2-1-83.
Phar 6.06
Phar 6.06 Laws and other references. 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:
Phar 6.06(1j)
(1j) The latest available or immediately accessible version of federal and state pharmacy laws consisting of:
Phar 6.06(1j)(d)
(d) Wisconsin administrative code, rules of the pharmacy examining board.
Phar 6.06(2k)
(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.
Phar 6.06(3L)
(3L) The telephone number of a poison center. This number shall be conspicuously posted in the prescription department.
Phar 6.06 History
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 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.
Phar 6.07(1)
(1) The storage of drugs shall be secure, neat, clean and orderly.
Phar 6.07(3)
(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.
Phar 6.07 History
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.
