Rule-Making Notices (Hearing Notices)

Time:   9:15 A.M.

Location:   1400 East Washington Avenue

  Room 294B

  Madison, Wisconsin

Appearances at the Hearing

Interested persons are invited to present information at the hearing. Persons appearing may make an oral presentation but are urged to submit facts, opinions and argument in writing as well. Facts, opinions and argument may also be submitted in writing without a personal appearance by mail addressed to the Department of Regulation and Licensing, Office of Legal Counsel, Room 171, P.O. Box 8935, Madison, Wisconsin 53708. Comments must be received by April 23, 2005 to be included in the record of rule-making proceedings.

Analysis prepared by the Department of Regulation and Licensing.

Statute interpreted: Section 450.02 (3) (b), (d) and (e), Stats.

Statutory authority: Sections 15.08 (5) (b). 227.11 (2) and 450.02 (3) (b), (d) and (e), Stats.

Explanation of agency authority: The Wisconsin Pharmacy Examining Board is granted the authority to protect the public health, safety and welfare by establishing security standards for pharmacists, enforcing chapters 450 and 96l, Stats., and establishing minimum standards for the practice of pharmacy.

Related statute or rule: Chapter Phar 6 (Pharmacy licenses and equipment).

Plain language analysis

The purpose of this proposed rule-making order is to ensure safe access to, and safe dispensing of, secured pharmaceuticals where a natural disaster or one created by human beings has disrupted the conditions upon which the pharmacy license was originally granted by the Pharmacy Examining Board. In order to allow for the continued operation of pharmacies affected by disasters, the board herein creates a mechanism to allow for the continuation of practice. The board or a person designated by the board would be empowered to grant a variance to a licensed pharmacy when the pharmacy makes a request for variance. There is a 90 day limit on the variance term which may be extended if the pharmacy makes a request.

SECTION 1 specifies the duties of the requesting pharmacy and the board when a natural disaster or one created by human beings disrupts the operation of a licensed pharmacy. The pharmacy must make a request for a variance specific to the need to continue practice under circumstances that may not meet the conditions upon which original licensure was granted, yet maintains protection of public health and safety. The board may act directly on such a request or refer the request to a designee of the board who will decide whether and on what conditions to grant the variance. In this proposed rule-making order the board limits the duration of variances granted to 90 days. If a request for extension is made by the pharmacy, the board or its designee may increase the term of the variance.

Summary of, and comparison with, existing or proposed federal regulation

None.

Comparison with rules in adjacent states

Michigan – None.

Minnesota – None.

Iowa – None.

Illinois

Section 1330.110 Granting Variances

a) The Director may grant variances from these rules in individual cases where he/she finds that:

1) The provision from which the variance is granted is not statutorily mandated;

2) No party will be injured by the granting of the variance; and

3) The rule from which the variance is granted would, in the particular case, be unreasonable or unnecessarily burdensome.

b) The Director shall notify the State Board of Pharmacy of the granting of such variance, and the reasons therefor, at the next meeting of the Board.

Indiana

856 IAC 1-7-3 Relocation of pharmacy

Authority: IC 25-26-13-4

Affected: IC 25-26-13-4; IC 25-26-13-11; IC 25-26-13-18

Sec. 3. To be eligible for relocation of a pharmacy an applicant must show to the satisfaction of the board that the requirements for the eligibility for a pharmacy permit as set out in IC 25-26-13-18 will be met. Prior to relocating a pharmacy the proprietor shall file an application, on a form prescribed and furnished by the board, setting out all information so requested on such form. Prior to moving a pharmacy, after receipt of board approval, the permit holder shall submit the premises to a qualifying inspection by a representative of the board. (Indiana Board of Pharmacy; Reg 7, Sec 3; filed Jun 18, 1962, 10:00 am: Rules and Regs. 1963, p. 121; filed Dec 3, 1985, 3:02 pm: 9 IR 770; readopted filed Sep 14, 2001, 3:04 p.m.: 25 IR 532; readopted filed Nov 13, 2001, 3:55 p.m.: 25 IR 1330)

Rule 36. Temporary Variances

856 IAC 1-36-1 Exceptions

Authority: IC 25-26-13-4

Affected: IC 25-26-13

Sec. 1. A person subject to the regulations of the board may request that the board grant a temporary variance from any rule adopted by the board, except rules concerning examinations, experience hours, and requirements for licensure. (Indiana Board of Pharmacy; 856 IAC 1-36-1; filed Jul 23, 1998, 4:43 p.m.: 21 IR 4534; readopted filed Nov 13, 2001, 3:55 p.m.: 25 IR 1330)

856 IAC 1-36-2 Submission of a request for temporary variance

Authority: IC 25-26-13-4

Affected: IC 25-26-13

Sec. 2. A request for a temporary variance must be submitted to the board in writing. Each request must contain the following information:

(1) The name, address, and license or permit number of the applicant.

(2) The name of the responsible pharmacist and the specific location at which activities will be conducted under the temporary variance.

(3) The citation to the specific rule from which the applicant seeks a temporary variance.

(4) A detailed explanation of the purpose of the temporary variance.

(5) An assessment of the impact on the public if the variance is granted.

(6) A statement of the conditions which would cause the applicant to apply for renewal of the temporary variance.

(7) The beginning, midpoint, and ending dates of the proposed demonstration project.

(Indiana Board of Pharmacy; 856 IAC 1-36-2; filed Jul 23, 1998, 4:43 p.m.: 21 IR 4534; readopted filed Nov 13, 2001, 3:55 p.m.: 25 IR 1330)

856 IAC 1-36-3 Positive impact on delivery of pharmaceutical care

Authority: IC 25-26-13-4

Affected: IC 25-26-13

Sec. 3. Temporary variances shall only be granted for demonstration projects which are expected to have a positive impact on the delivery of pharmaceutical care. Justification for that expectation shall be fully explained. The board shall not grant any temporary variance which threatens public health, safety, or welfare. (Indiana Board of Pharmacy; 856 IAC 1-36-3; filed Jul 23, 1998, 4:43 p.m.: 21 IR 4535; readopted filed Nov 13, 2001, 3:55 p.m.: 25 IR 1330)

856 IAC 1-36-4 Period of time

Authority: IC 25-26-13-4

Affected: IC 25-26-13

Sec. 4. The board shall grant a temporary variance for a period of no more than six (6) months. Any person who receives a temporary variance shall submit to the board a written report of the effects of the demonstration project at the midpoint and at the conclusion of the temporary variance. (Indiana Board of Pharmacy; 856 IAC 1-36-4; filed Jul 23, 1998, 4:43 p.m.: 21 IR 4535; readopted filed Nov 13, 2001, 3:55 p.m.: 25 IR 1330)

856 IAC 1-36-5 Renewal

Authority: IC 25-26-13-4

Affected: IC 25-26-13

Sec. 5. A temporary variance may be renewed by the Indiana board of pharmacy (board) for an additional six (6) months. A temporary variance shall not be renewed more than five (5) times. Requests for renewal of a variance shall be submitted in writing to the board not less than thirty (30) days prior to the expiration of the variance and shall contain at least the information required by section 2 of this rule. (Indiana Board of Pharmacy; 856 IAC 1-36-5; filed Jul 23, 1998, 4:43 p.m.: 21 IR 4535; readopted filed Dec 2, 2001, 12:35 p.m.: 25 IR 1340)

856 IAC 1-36-6 Revocation

Authority: IC 25-26-13-4

Affected: IC 25-26-13

Sec. 6. The board may revoke any temporary variance for cause, including, but not limited to, a finding that the temporary variance poses or may pose a threat to public health, safety, or welfare. The person requesting the temporary variance has the obligation to report any such potential threat to the board immediately upon the discovery of such potential threat, or as soon as possible after such discovery. (Indiana Board of Pharmacy; 856 IAC 1-36-6; filed Jul 23, 1998, 4:43 p.m.: 21 IR 4535; readopted filed Nov 13, 2001, 3:55 p.m.: 25 IR 1330)

856 IAC 1-36-7 Public notice

Authority: IC 25-26-13-4

Affected: IC 25-26-13

Sec. 7. The board shall give public notice of requests for temporary variances at not less than two (2) consecutive regular meetings before voting to grant or deny a request for a temporary variance. (Indiana Board of Pharmacy; 856 IAC 1-36-7; filed Jul 23, 1998, 4:43 p.m.: 21 IR 4535; readopted filed Nov 13, 2001, 3:55 p.m.: 25 IR 1330)

856 IAC 1-36-8 Justification of denial

Authority: IC 25-26-13-4

Affected: IC 25-26-13

Sec. 8. The board shall set forth in writing its reasons for granting or denying a temporary variance. (Indiana Board of Pharmacy; 856 IAC 1-36-8; filed Jul 23, 1998, 4:43 p.m.: 21 IR 4535; readopted filed Nov 13, 2001, 3:55 p.m.: 25 IR 1330)

856 IAC 1-36-9 Copies of requests

Authority: IC 25-26-13-4

Affected: IC 25-26-13-5

Sec. 9. The executive director shall retain copies of all requests for temporary variances and the board's reasons for granting or denying requests as part of the record of it proceedings maintained under IC 25-26-13-5. (Indiana Board of Pharmacy; 856 IAC 1-36-9; filed Jul 23, 1998, 4:43 p.m.: 21 IR 4535; readopted filed Nov 13, 2001, 3:55 p.m.: 25 IR 1330)

Summary of factual data and analytical methodologies

The Pharmacy Examining Board chose a regulatory approach that aims to achieve balance in maintaining licensure standards without eliminating access to pharmacy services at a time when those services may be needed. Board members have been asked by other members of the profession about how operations might continue when a pharmacy is damaged or operations are thwarted because of disasters, like a fire or tornado damage. The statutes and rules were analyzed to determine if the variance provisions currently provided would be sufficient to address disasters. The conclusion of the board was that a variance for disaster situations should be explicitly recognized in the rules.

Anticipated costs incurred by private sector

The department finds that this rule has no significant fiscal effect on the private sector.

Fiscal estimate

The proposed rule will have no impact on the department's funds.

Effect on small business

Pursuant to s. 227.114 (1) (a), Stats., these proposed rules will have no significant economic impact on a substantial number of small businesses. The Department's Small Business Regulatory Review Coordinator may be contacted by email at [e-mail], or by calling [phone].

Agency contact person

Copies of this proposed rule are available without cost upon request to: Pamela Haack, Department of Regulation and Licensing, Office of Legal Counsel, 1400 East Washington Avenue, Room 171, P.O. Box 8935, Madison, Wisconsin 53708-8935. Phone: [phone]. Email: [e-mail].

Place where comments are to be submitted and deadline for submission

Comments may be submitted to the addresses listed above. Comments must be received on or before April 25, 2005 to be included in the record of rule-making proceedings.