The Board may promulgate rules relating to the manufacture of drugs and the distribution and dispensing of prescription drugs. [s. 450.02 (3) (a), Stats.] 450.02(3)(d) The Board may promulgate rules necessary for the administration and enforcement of this chapter and ch. 961. [s. 450.02 (3) (d), Stats.] 450.02(3)(e) The Board may promulgate rules establishing minimum standards for the practice of pharmacy. [s. 450.02 (3) (e), Stats.] The board shall prescribe, by rule, minimum standards of professional and technical equipment [s. 450.09 (3), Stats.] Related statute or rule: N/A
Plain language analysis:
Section 1 creates a section on temperature and humidity. The requirements include: drugs being stored at appropriate temperature and conditions based upon the manufacturer recommendation or an official pharmaceutical compendium; the pharmacy having a temperature and humidity recording device within the storage space; to monitor at least once per business day the temperature of the refrigerator, freezer and pharmacy as well as obtaining a minimum and maximum temperature over the course of the time the pharmacy is closed; to maintain the records for a minimum of 5 years; and for the pharmacist to use professional judgement to determine whether a drug is safe to be dispensed.
Summary of, and comparison with, existing or proposed federal regulation: None
Comparison with rules in adjacent states:
Illinois: Illinois requires pharmacies to maintain temperature within a range compatible with the proper storage of drugs requiring refrigeration or freezing. [Section 1330.610, IL Admin Code]
Iowa: Iowa does not have rules relating to termperature or humidity in pharmacies. Wholesale pharmacies are required to have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space equipment and security conditions.
Michigan: Michigan does not have rules relating to termperature or humidity in pharmacies.
Minnesota: Minnesota does not have rules relating to termperature or humidity in pharmacies.
Summary of factual data and analytical methodologies:
The Pharmacy Examining Board recognized a rule was necessary to ensure drugs are properly stored.
Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis:
This rule was posted for economic comments for 14 days and none were received. Maintaining pharmaceuticals at the correct temperature and humidity is the current minimum standard of the profession and should not have an economic impact on pharmacies.
Fiscal Estimate and Economic Impact Analysis:
The Fiscal Estimate and Economic Impact Analysis is attached.
Effect on small business:
These proposed rules do not have an economic impact on small businesses, as defined in s. 227.114 (1), Stats. The Department’s Regulatory Review Coordinator may be contacted by email at Kirsten.Reader@wisconsin.gov, or by calling (608) 267-2435. 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
