CR 21-074 Rule Text

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:

The proposed rules were posted for a period of 14 days to solicit public comment on economic impact, including how the proposed rules may affect businesses, local government units, and individuals. No comments were received.

Fiscal Estimate and Economic Impact Analysis:

A fiscal estimate and economic impact analysis are 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].

Place where comments are to be submitted and deadline for submission:

Comments may be submitted to Nilajah Hardin, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, P.O. Box 8366, Madison, WI 53708-8366, or by email to [e-mail]. Comments must be received at or before the public hearing to be held on December 2, 2021, at a time to be determined, to be included in the record of rule-making proceedings.

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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 2. Phar 6.04 (2) is repealed.

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

Phar 6.04 (3) (intro.) Professional service area requirements where pharmacist is absent Requirements when the professional service area is closed

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:

(am) A 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 4. Phar 6.04 (3) (a) 2. and 3. are repealed.

Section 5. 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) (a) 5.(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.

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 Phar 6.04 (3) (a) 7., (b) and (c) and (4) are repealed.

Section 7. 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 8. Chapter Phar 11 is repealed.

Section 9. 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 (1984) and 21 CFR 210 and 211 (1985) federal and state laws and regulations.

Section 10. 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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(END OF TEXT OF RULE)

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