DEFINITIONS. In this section:
(a) "Business day" means a day the pharmacy
is open for business.
means a place in which the temperature is maintained between -13 and +14
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
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
(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.
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.,
November 2017 No. 743, eff.
Amended by, CR
19-165: r. (1) (b), am. (2), r. and recr. (4)
July 2020 No. 775, eff. 8/1/2020