EmR2213 Rule Text

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, 4822 Madison Yards Way, P.O. Box 8366, Madison, Wisconsin 53708; telephone [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, 4822 Madison Yards Way, P.O. Box 8366, Madison, WI 53708-8366, or by email to [e-mail]. Comments must be received on or before the public hearing, held on a date to be determined, to be included in the record of rule-making proceedings.

TEXT OF RULE

SECTION 1 Phar 1.02 (9) is repealed.

SECTION 2 Phar 1.02 (14m) is created to read:

Phar 1.02 (14m) “Remote dispensing site” has the meaning given in s. 450.01 (21c), Stats.

SECTION 3 Phar 5.01 (4) is created to read:

Phar 5.01 (4) For the purposes of this chapter and pursuant to s. 450.09 (1) (a), Stats., pharmacies shall include remote dispensing sites.

SECTION 4 Phar 6.025 is created to read:

Phar 6.025 Licenses; remote dispensing sites. A pharmacy may be subject to rules that apply only to remote dispensing sites if no pharmaceutical services is provided at that pharmacy by a pharmacist who is present in the pharmacy, and the following conditions have been met:

(1) The Licensee provides notice to the Board of all of the information outlined in s. 450.06, Stats.

(2) The site meets all of the requirements listed in Phar 7.43.

(3) The site is any of the location types listed under s. 450.09 (2) (b) 1., Stats.

(4) A managing pharmacist shall report to the Board if they are responsible for 5 or more remote dispensing sites. A managing pharmacist shall not be responsible for more than 10 remote dispensing sites at any given time without approval from the Board.

SECTION 5 Phar 7.43 (1) is repealed.

SECTION 6 Phar 7.43 (2); (4) (b); (5) (b); (6) (title), (6) (a), (6) (a) 5, and (6) (b) are

amended to read:

Phar 7.43 (2) LOCATION. A pharmacist or a person engaged in the practice of pharmacy under s. 450.03 (1) (f), (g), or (i), Stats., may dispense at any of the locations under s.

450.062 (1) to (4) 450.09 (2) (b) 1. a. to d., Stats.

(4) (b) Remote dispensing may not occur if the supervising pharmacy is closed a pharmacist is not available remotely.

(5) (b) Labeling requirements under s. Phar 7.05. The prescription label shall contain the name and address of the supervising pharmacy remote dispensing site as the licensed facility from which the prescribed drug or device was dispensed.

(6) (title) Responsibilities of managing pharmacist or supervising pharmacist.

(6) (a) The managing pharmacist of the supervising pharmacy or the supervising pharmacist shall do all of the following:

(6) (a) 5. Documentation indicating accepting responsibility for compliance with this section, signed and dated by both the managing pharmacist and supervising pharmacist, indicating the name of the supervising pharmacist, and the dates the supervision responsibilities begin and end.

(6) (b) The managing pharmacist at the supervising pharmacy or supervising pharmacist is responsible for all remote dispensing connected to the supervising pharmacy.

SECTION 7 Phar 8.01 (5) is created to read:

Phar 8.01 (5) REMOTE DISPENSING SITES. For the purposes of this chapter and pursuant to s. 450.09 (1) (a), stats., pharmacies shall include remote dispensing sites.

SECTION 8 Pursuant to 2021 Wisconsin Act 101 section 14 (1), this emergency rule shall take effect upon publication in the official state newspaper and remain in effect until May 1, 2024 or until the date on which permanent rules take effect, whichever is sooner.

(END OF TEXT OF RULE)