Agency contact person:
Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, Wisconsin 53708; telephone 608-261-2377; email at DSPSAdminRules@wisconsin.gov. ---------------------------------------------------------------------------------------------------------------------
TEXT OF RULE
Section 1. Phar 6.075 is created to read:
Phar 6.075 Temperature; Humidity. (1) Definitions. In this section:
(a) “Business day” means a day the pharmacy is open for business.
(b) “Dry place” means a place that does not exceed 40% average relative humidity at 68 degree Fahrenheit or the equivalent water vapor pressure at other temperatures.
(c) “Freezer” means a place in which the temperature is maintained between -13 and 14 degrees Fahrenheit.
(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 temperature and under appropriate conditions, including in a dry place, according to the manufacturer recommendation or an official pharmaceutical compendium.
(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 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.
(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 termperature, to determine whether a drug is safe to be dispensed.
Section 2. EFFECTIVE DATE. The rules adopted in this order shall take effect on the first day of the month following publication in the Wisconsin Administrative Register, pursuant to s. 227.22 (2) (intro.), Stats. ---------------------------------------------------------------------------------------------------------------------
(END OF TEXT OF RULE)
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Dated September 21, 2017 Agency
Chair of the Pharmacy Examining Board
