64B13-18.002: Formulary of Topical Ocular Pharmaceutical Agents
PURPOSE AND EFFECT: The Board is correcting the concentration percentage of Bromfenac, increasing the concentration of Gatifloxacin and adding the anti-allergy medication Alcaftadine.
SUMMARY: This rule will correct the concentration percentage of Bromfenac, increase the concentration of Gatifloxain and add the anti-allergy medication Alcaftadine.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: 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. An SERC has not been prepared by the agency.
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)(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 FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Bruce Deterding, Executive Director, Board of Optometry/MQA, 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 (3) No change.
(4) ANTIBACTERIAL
(a) through (k) No change.
(l) Gatifloxacin - 0.5% 0.3%
(m) through (p) No change.
(5) NON-STEROIDAL AND STEROIDAL ANTI-INFLAMMATORY AGENTS
(a) through (l) No change.
(m) Bromfenac – .09% 0.90%
(n) through (o) No change.
(6) ANTIHISTAMINES, MAST CELL STABILIZERS AND ANTI-ALLERGY AGENTS
(a) through (h) No change.
(i) Alcaftadine – .25%
(7) through (9) No change.
Rulemaking 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, 6-28-09, 10-18-09, 4-21-10, 11-16-10,_______.