The Pharmacy Examining Board reviewed the storage requirements in light of health care evolving and recognizing that there are different types of pharmacies which may not require the specific items required in the current rule.
In addition, stakeholders raised concerns regarding the implementation of CR 16-073 and the Pharmacy Examining Board made clarifications to the temperature and humidity provisions as a result of the concerns raised. 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 and none were received.
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 Daniel.Hereth@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, 4822 Madison Yards Way, P.O. Box 8366, Madison, Wisconsin 53708; telephone 608-261-2377; email at DSPSAdminRules@wisconsin.gov. ---------------------------------------------------------------------------------------------------------------------
TEXT OF RULE
Section 1. Phar 6.07 (1) is repealed and recreated to read:
Phar 6.07 (1) The storage of drugs shall be secure, neat, clean and orderly.
Section 2. Phar 6.07 (2) is repealed.
Section 3. Phar 6.07 (3) is amended to read:
Phar 6.07 (3) Controlled All controlled substances shall be stored in a securely locked, substantially-constructed cabinet or dispersed throughout the inventory of non-controlled substances in a manner that obstructs theft or diversion.
Section 4. Repeal Phar 6.075 (1) (b) is repealed.
Section 5. Phar 6.075 (2) is amended to read:
Phar 6.075 (2) Storage. Drugs shall be stored at appropriate temperature and under appropriate conditions, including in a dry place temperature and humidity, according to the manufacturer recommendation or an official pharmaceutical compendium prevent drug adulteration.
Section 6. Phar 6.075 (4) is repealed and recreated to read:
Phar 6.075 (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.
Section 7. 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 June 4, 2020 Agency 
Chair of the Pharmacy Examining Board
