The Board proposes the substantial rewrite of the rule to update the existing rule and to develop procedures regarding the formulary of topical ocular pharmaceutical agents as authorized by Chapter 2013-26, Laws of Florida and to renumber the rule ...

 

DEPARTMENT OF HEALTH

Board of Optometry

RULE NO.:RULE TITLE:

64B13-18.003Procedures Regarding Topical Ocular Pharmaceutical Agents

PURPOSE AND EFFECT: The Board proposes the substantial rewrite of the rule to update the existing rule and to develop procedures regarding the formulary of topical ocular pharmaceutical agents as authorized by Chapter 2013-26, Laws of Florida and to renumber the rule accordingly.

SUMMARY: The substantial rewrite of the rule will update the existing rule and will develop procedures regarding the formulary of topical ocular pharmaceutical agents as authorized by Chapter 2013-26, Laws of Florida and to renumber the rule accordingly.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of this rule at its meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 463.005, 463.0055(2) FS.

LAW IMPLEMENTED: 463.0055 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: William Miller, Executive Director, Board of Optometry/MQA, 4052 Bald Cypress Way, Bin #C07, Tallahassee, Florida 32399-3257

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

(Substantial rewording of the Rule 64B13-18.003 follows. See Florida Administrative Code for the present text)

 

64B13-18.003 Procedures Regarding Topical Ocular Pharmaceutical Agents

(1) Requests for the addition, deletion or modification of the formulary of topical ocular pharmaceutical agents shall be filed with the Board. The request shall be in writing and shall contain the following information:

(a) The name, address, and telephone number of the individual or entity filing the request;

(b) The chemical name of the agent;

(c) The brand name(s) of the agent;

(d) The concentration of the agent;

(e) The United States FDA approved information sheet for the agent;

(f) The date the FDA released the agent for sale; and

(g) An explanation why the requested addition, deletion or modification is consistent with the provisions of Section 463.0055, F.S. and should be made.

(2) If after receipt of a request as specified in subsection (1), the Board determines an addition, deletion, or modification of the formulary should be made, the Board shall initiate rulemaking to accomplish said change.

(3) A current list of all topical ocular pharmaceutical agents which certified optometrists are authorized to prescribe or administer shall be maintained by the Board and shall be available upon request.

(4) The Board shall cause a notice of each addition, deletion, and modification to the formulary to be distributed to each certified optometrist and to each pharmacy licensed by the State of Florida.

Rulemaking Authority 463.005, 463.0055(2)(a) FS. Law Implemented 463.0055 FS. History–New 5-15-97, Formerly 59V-18.003, Amended__________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Optometry

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Optometry

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 23, 2013

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: September 17, 2013