STATE OF WISCONSIN
PHARMACY EXAMINING BOARD
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IN THE MATTER OF RULE-MAKING : PROPOSED ORDER OF THE
PROCEEDINGS BEFORE THE : PHARMACY EXAMINING BOARD
PHARMACY EXAMINING BOARD : ADOPTING RULES
: (CLEARINGHOUSE RULE )
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PROPOSED ORDER
An order of the Pharmacy Examining Board to repeal Phar 6.04 (2) and (3) (a) 2. and 3., Phar 6.04 (3) (a) 7. (b) and (c) and (4), and Phar 11; to renumber and amend Phar 6.04 (3) (a) (intro.), 1., 5., and 6.; and to amend s. Phar 5.02 (1) and (2), Phar 6.04 (1), Phar 7.04 (3) (intro.), and Phar 12.04, relating to name and address change, floor design, procedures for disciplinary proceedings, superseded references, and technical correction. Analysis prepared by the Department of Safety and Professional Services.
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ANALYSIS
Explanation of agency authority:
Each examining 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 distribution and dispensing of prescription drug and establishing security standards for pharmacies. [s. 450.02 (3) (a) and (b), Stats.] The Board may promulgate rules necessary for the administration and enforcement of this chapters 450 and 961, Stats. [s. 450.02 (3) (d), Stats.] No pharmacist may dispense at any location in this state that is not licensed as a pharmacy by the board. No person in this state may use or display the title “pharmacy," “drugstore," “apothecary," or any other title, symbol, or insignia having the same or similar meanings, except for a place of practice which is licensed under this section as a pharmacy by the board. [s. 450.06 (1), Stats.] Related statute or rule: N/A
Plain language analysis:
The Pharmacy Examining Board identified the following rules in its 2019 report filed with the Joint Committee for Review of Administrative Rules pursuant to s. 227.29, Stats. Phar 5.02 is revised to delete obsolete or unnecessary provisions to require the notification to the Board regarding name or address change to be submitted in writing.
Phar 6.04 is revised to delete economically burdensome requirements and requirements which do not correspond with the evolving types of pharmacies.
Phar 7.04 (3) is revised to correct a typographical error occurring in CR 19-145 related to which should refer to Schedule III – V drugs instead of Schedule III – IV drugs. The omission of Schedule V creates inconsistency with the federal law and confusion for pharmacists. Ch. Phar 11 is repealed as it is duplicative and unnecessary.
Phar 12.04 is revised as the federal standards referenced have been superseded.
Summary of, and comparison with, existing or proposed federal regulation: None
Comparison with rules in adjacent states:
Illinois: Statutes outlining Illinois’ Pharmacy Practice Act are found under 225 ILCS 85 and codified under IL 68/1330 for the Pharmacy Practice. Specifically, IL 68/1330.610 outlines the standards for pharmacy structure/equipment standards. The section does require a locked area for drugs. However, Illinois does not identify professional service area square footage requirements or signage requirements.
Iowa: The complete Iowa Board of Pharmacy rules are contained in 657 Iowa Administrative Code. The Iowa Pharmacy Practice Act is codified under administrative code chapter 155A, specifically related to licensed pharmacies under s. 155A.13. Rules do require a locked area for drugs. However, there are no comparable requirements for professional service area square footage or signage.
Michigan: Michigan administrative code MCL 338.536 for housing of pharmacies specifically requires pharmacies to have a prescription department that is devoted primarily to the practice of pharmacy that occupies not less than 150 square feet of space, and that it includes a prescription counter that provides not less than 10 square feet of free working surface. For each additional pharmacist on duty, workspace must be increased by not less than 4 square feet and pharmacies that occupy less than the entire area of the premises owned, leased, used, or controlled by the licensee must be permanently enclosed by partitions from the floor to the ceiling of substantial construction and must be securely lockable. There do not appear to be requirements for signage.
Minnesota: The Minnesota Administrative Code chapter 6800 related to pharmacies and pharmacists, provides the rules for the standards for pharmacies. Specifically, Minnesota Administrative Code section 6800.0700 provides minimum requirements for pharmacies. The pharmacy space requirements include the pharmacy must: contain more than 250 square feet in the dispensing and drug storage area; maintain a prescription dispensing counter at least 18 inches deep that provides 2 linear feet; maintain an aisle behind the prescription dispensing counter at least 36 inches wide, extending the full length of the counter; be surrounded by a continuous partition or wall extending from the floor to the permanent ceiling; and contain doors capable of being securely locked. There do not appear to be requirements for signage.
