CR 21-074 Rule Text

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 Phar 11 is repealed as it is duplicative and unnecessary.

Phar 12.04 is revised as the federal standards referenced have been superseded.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:

The practice of pharmacy is not regulated by the federal government and Wisconsin has its own controlled substances schedules. However, the federal government does regulate federally controlled substances and the vast majority of Wisconsin controlled substances are also federally controlled substances. Title 21 CFR Chapter II governs federally scheduled controlled substances, including: registration of manufacturers, distributors and dispensers of controlled substances; prescriptions; orders for schedule I and II controlled substances; requirements for electronic orders and prescriptions; and disposal.

Summary of public comments received on statement of scope and a description of how and to what extent those comments and feedback were taken into account in drafting the proposed rule: N/A

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.

Summary of factual data and analytical methodologies:

The Board conducted a full review of its administrative codes in compliance with the Legislative Report to the Joint Committee of Review of Administrative Rules under s. 227.29, Stats. The items in this rule project are a result of that review.

Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis:

This rule was posted for economic impact comments for 14 days. No comments 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 [e-mail], or by calling [phone].

Agency contact person:

Nilajah Hardin, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, P.O. Box 8366, Madison, Wisconsin 53708-8306; phone [phone]; email at [e-mail].

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TEXT OF RULE

Section 1. Phar 5.02 (1) and (2) are amended to read:

Phar 5.02 (1) A pharmacist shall notify the board in writing when his or her a pharmacist’s name has been legally changed, within 30 days of the change.

(2) A pharmacist shall notify the board in writing when his or her a pharmacist’s address has been changed, within 30 days of the change.

Section 2. Phar 6.04 (1) is amended to read:

Phar 6.04 (1) Professional service area. The professional service area of a pharmacy shall not be less than 250 sq. ft. No more than 20% of the space may be used for storage of bulk pharmaceuticals. If the pharmacy building is open at any time solely as a non-prescription or sundry outlet, without a pharmacist present while the professional service area is closed, the professional service area shall be secured as specified in sub. (3). A variance to the 250 sq. ft. professional service area requirement may be authorized by the board upon submission of a specific plan describing the manner in which the proposed professional service plan varies from the requirement.

Section 3. Phar 6.04 (2) is repealed.

Section 4. Phar 6.04 (3) (title) is repealed and recreated to read:

Phar 6.04 (3) (title) Requirements when the professional service area is closed.

Section 5. Phar 6.04 (3) (a) (intro) and 1. are renumbered Phar 6.04 (3) (a) and (am) and amended to read:

Phar 6.04 (3) (a) Except as provided in par. (c), if no pharmacist is present in the professional service area, a pharmacy may convert to a non-prescription or sundry outlet if When the pharmacy professional service area is closed, the pharmacy shall meet all of the following requirements are met:

Phar 6.04 (3) (am). A secured locked, secure physical barrier surrounds the professional service area of the pharmacy and precludes access to the area by unlicensed unauthorized personnel. A secured barrier may be constructed of other than a solid material with a continuous surface. If constructed of other than a solid material, the openings or interstices in the material shall not be large enough to permit removal of items from the professional service area by any means. Any material used in the construction of the barrier shall be of sufficient strength and thickness that it cannot be readily or easily removed, penetrated, or bent. The plans and specifications of the barrier shall be submitted to the board for approval.

Section 6. Phar 6.04 (3) (a) 2. and 3. are repealed.

Section 7. Phar 6.04 (3) (a) 5. and 6. are renumbered Phar 6.04 (3) (bm) and (cm) and amended to read:

Phar 6.04 (3) (bm) Signs of reasonable size are posted at the entrance of the building and the professional service area which prominently displaying display the hours the pharmacist will be on duty professional services are available.

(cm) The manner in which the telephone is answered does not imply that the location is, at that time, operating as a pharmacy professional services are available.

Section 8. Phar 6.04 (3) (a) 7., (b), (c), and (4) are repealed.

Section 9. Phar 7.04 (3) (intro.) is amended to read:

7.04 (3) (intro.) The transfer of original prescription information for a controlled substance listed in Schedule III – IVV shall meet the following requirements:

Section 10. Chapter Phar 11 is repealed.

Section 11. Phar 12.04 is amended to read:

Phar 12.04 Inspections. Before a license is granted, an inspection of the establishment shall be conducted by the board or its representative to determine if the location meets the standards in 21 USC 351 and 352 (19842022) and 21 CFR 210 and 211 (19852022).

Section 12. 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.

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