Wis. Admin. Code Pharmacy Examining Board § Phar 6.075 - Temperature; Humidity

Current through March 28, 2022

(1) DEFINITIONS. In this section:
(a) "Business day" means a day the pharmacy is open for business.
(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 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.

Notes

Wis. Admin. Code Pharmacy Examining Board § Phar 6.075
Adopted by, 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, eff. 12/1/2017 Amended by, CR 19-165: r. (1) (b), am. (2), r. and recr. (4) Register July 2020 No. 775, eff. 8/1/2020

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