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)2. 2. The barrier is locked in the absence of the pharmacist.
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(3)(c)4. 4. Pharmacy technicians may only perform duties allowed by s. Phar 7.015 (2).
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 6.05Sanitation. 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 6.06Laws 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)(a) (a) Drug enforcement administration regulations, 21 CFR 1300 to end.
Phar 6.06(1j)(b) (b) Wisconsin pharmacy laws, ch. 450, Stats.
Phar 6.06(1j)(c) (c) Wisconsin controlled substances act, ch. 961, Stats.
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 Phar 6.07Storage.
Phar 6.07(1) (1) The professional service area shall have a refrigerator adequate for the storage of biological and other drugs requiring refrigeration.
Phar 6.07(2) (2) The professional service area shall have sufficient shelf, drawer or cabinet space for the proper storage of a representative stock of prescription labels, an assorted stock of prescription containers, and an adequate stock of prescription drugs, chemicals and required pharmacy equipment.
Phar 6.07(3) (3) 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.
Phar 6.07 History History: Cr. Register, January, 1983, No. 325, eff. 2-1-83.
Phar 6.075 Phar 6.075Temperature; Humidity.
Phar 6.075(1) (1)Definitions. In this section:
Phar 6.075(1)(a) (a) “Business day” means a day the pharmacy is open for business.
Phar 6.075(1)(b) (b) “Dry place” means a place that does not exceed 40% average relative humidity at 68 degrees Fahrenheit or the equivalent water vapor pressure at other temperatures.
Phar 6.075(1)(c) (c) “Freezer” means a place in which the temperature is maintained between -13 and +14 degrees Fahrenheit.
Phar 6.075(1)(d) (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.
Phar 6.075(1)(e) (e) “Refrigerator” means a place in which the temperature is maintained between 36 and 46 degrees Fahrenheit.
Phar 6.075(2) (2)Storage. Drugs shall be stored at appropriate temperature and under appropriate conditions, including in a dry place, according to the manufacturer recommendation or an official pharmaceutical compendium.
Phar 6.075(3) (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.
Phar 6.075(4) (4)frequency. The temperature of the refrigerator, freezer and pharmacy shall be monitored at least once during each business day. A minimum and maximum temperature over the course of the time a pharmacy is closed shall be obtained.
Phar 6.075(5) (5)Records. Temperature and humidity records shall be maintained for a minimum of 5 years.
Phar 6.075(6) (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.
Phar 6.075 History 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.
Phar 6.08 Phar 6.08Security. 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.
Phar 6.08 History 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.
Published under s. 35.93, Stats. Updated on the first day of each month. Entire code is always current. The Register date on each page is the date the chapter was last published.