STATE OF WISCONSIN
Pharmacy Examining Board
IN THE MATTER OF RULE-MAKING PROCEEDINGS BEFORE THE
PHARMACY EXAMINING BOARD
PROPOSED ORDER OF THE PHARMACY EXAMINING BOARD
(CLEARINGHOUSE RULE )
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.
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: