64B13-18.002: Formulary of Topical Ocular Pharmaceutical Agents
PURPOSE AND EFFECT: The purpose of the amendment is to correct the maximum permitted concentration of olopatadine.
SUMMARY: The proposed rule will increase the amount of olopatadine in topical ocular pharmaceutical agents.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared. The Board has determined that the proposed rule amendments will not have an impact on small business.
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.
SPECIFIC AUTHORITY: 463.005, 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 FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Joe Baker, Jr., Executive Director, Board of Optometry, 4052 Bald Cypress Way, Bin #C07, Tallahassee, Florida 32399-3257
THE FULL TEXT OF THE PROPOSED RULE IS:
64B13-18.002 Formulary of Topical Ocular Pharmaceutical Agents.
The topical ocular pharmaceutical formulary consists of pharmaceutical agents which a certified optometrist is qualified to administer and prescribe in the practice of optometry pursuant to Section 463.0055(2)(a), F.S. The topical ocular pharmaceutical agents in the formulary include the following legend drugs alone or in combination in concentrations up to those specified, or any lesser concentration that is commercially available:
(1) through (5) No change.
(6) ANTIHISTAMINES, MAST CELL STABILIZERS AND ANTI-ALLERGY AGENTS
(a) through (b) No change.
(c) Olopatadine HCl – 0.2%
(d) through (g) No change.
(7) through (9) No change.
Specific Authority 463.005, 463.0055(2)(a) FS. Law Implemented 463.0055 FS. History–New 3-30-87, Amended 4-5-88, 5-7-90, Formerly 21-18.002, Amended 5-10-92, 1-29-93, Formerly 21Q-18.002, Amended 8-31-93, 7-30-94, Formerly 61F8-18.002, Amended 2-11-96, 4-21-96, 1-12-97, 6-8-97, Formerly 59V-18.002, Amended 6-15-00, 6-7-05, 6-10-06, 6-26-08, 10-16-08, 3-23-09,_______.