The purpose of the rule amendment is to update the procedures for changing the formulary of topical ocular pharmaceutical agents.

 

DEPARTMENT OF HEALTH

Board of Optometry

RULE NO.:RULE TITLE:

64B13-18.003Procedures Regarding Topical Ocular Pharmaceutical Agents

PURPOSE AND EFFECT: The purpose of the rule amendment is to update the procedures for changing the formulary of topical ocular pharmaceutical agents.

SUMMARY: Update procedures.

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 Board meeting, the Board, based upon the expertise and experience of its members and the substance of the rule, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary because the rule has no impact on any persons or businesses; 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: 463.0055(2)(a), 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: Dr. Anthony Spivey, Executive Director, Board of Optometry, 4052 Bald Cypress Way, Bin #C07, Tallahassee, FL 32399-3255, telephone: [phone], or by electronic mail – [e-mail]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

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.

(2) 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) 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.

Rulemaking Authority 463.0055(2)(a) FS. Law Implemented 463.0055 FS. History–New 5-15-97, Formerly 59V-18.003, Amended 3-13-14,                 .

 

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: May 10, 2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 11, 2019