Pharmacy Examining Board
IN THE MATTER OF RULE-MAKING PROCEEDINGS BEFORE THE
PHARMACY EXAMINING BOARD
PROPOSED ORDER OF THE PHARMACY EXAMINING BOARD
ADOPTING RULES
(CLEARINGHOUSE RULE )
PROPOSED ORDER
An order of the Pharmacy Examining Board to create s. Phar 6.075 relating to temperature and humidity in pharmacies. Analysis prepared by the Department of Safety and Professional Services.
ANALYSIS
Explanation of agency authority:
The Board shall promulgate rules for its own guidance and for the guidance of the trade or profession to which it pertains, and define and enforce professional conduct and unethical practices not inconsistent with the law relating to the particular trade or profession. [s. 15.08 (5) (b), Stats.] 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 sae 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 Jeffrey.Weigand @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. Place where comments are to be submitted and deadline for submission:
Comments may be submitted to Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Board Services, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, WI 53708-8366, or by email to DSPSAdminRules@wisconsin.gov. Comments must be received at or before the public hearing to be held on December 14, 2016 to be included in the record of rule-making proceedings. ---------------------------------------------------------------------------------------------------------------------
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 is 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.
