Fla. Admin. Code R. 64B13-18.002

Current through Reg. 50, No. 235-239, December 10, 2024

Section 64B13-18.002 - Formulary of Topical Ocular Pharmaceutical Agents

The formulary of topical ocular pharmaceutical agents consists of pharmaceutical agents that are appropriate to treat or diagnose ocular disease and disorders and 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:

(1) CYCLOPLEGIC AND MYDRIATICS

(a) atropine sulfate - 1.0% (solution and ointment);

(b) phenylepherine hydrochloride - 2.5%;

(c) cyclopentolate hydrochloride - 1.0%;

(d) scopolamine hydrobromide - 0.25%;

(e) homatropine hydrobromide - 5.0%;

(f) tropicamide - 1.0%;

(g) hydroxyamphetamine hydrobromide - 1.0% (in combination).

(2) LOCAL ANESTHETICS

(a) tetracaine - 0.5%;

(b) proparacaine hydrochloride - 0.5%;

(c) benoxinate HCl - 0.4% (in combination with fluorescein);

(d) lidocaine hydrochloride ophthalmic gel or solution - 4.0%.

(3) DIAGNOSTIC PRODUCTS

(a) fluorescein paper strips - 9 mg per strip;

(b) Lissamine Green - 1.5 mg per strip;

(c) Rose Bengal - 1.3 mg per strip;

(d) phenol red thread;

(e) Schirmer test strips;

(f) hypromellose ophthalmic demulcent solution - 2.5%.

(4) ANTIBACTERIAL

(a) erythromycin - 0.5%;

(b) bacitracin - 500 units/g (ointment alone and in combination);

(c) polymyxin - 10,000 units/g (only in combination);

(d) neomycin - 3.50 mg/g (only in combination);

(e) gentamicin - 0.3% (solution and ointment);

(f) tobramycin - 0.3% (solution and ointment in combination);

(g) gramicidin - 0.025 mg/ml (only in combination);

(h) ciprofloxacin hydrochloride - 0.3% (solution and ointment);

(i) trimethoprim - 1.0 mg/ml (only in combination);

(j) ofloxaxin - 0.3%;

(k) levofloxacin - 1.5%;

(l) gatifloxacin - 0.5%;

(m) moxifloxacin - 0.5%;

(n) sodium sulfacetamide - 10.0% (alone and in combination);

(o) azithromycin - 1.0 %; and,

(p) besifloxacin ophthalmic suspension - 0.6%.

(5) NON-STEROIDAL AND STEROIDAL ANTI-INFLAMMATORY AGENTS

(a) medrysone - 1.0%;

(b) prednisolone acetate - 1.0% (alone and in combination);

(c) prednisolone sodium phosphate - 1.0% (alone and in combination);

(d) flurometholone - 0.25% (suspension and ointment, alone and in combination);

(e) dexamethasone - 1.0% (suspension and ointment, alone and in combination), 0.4 mg ophthalmic insert;

(f) fluorometholone acetate - 0.1%;

(g) rimexolone - 1.0%;

(h) loteprednol etabonate - 0.5% (alone and in combination);

(i) diclofenac sodium - 0.1%;

(j) ketorolac tromethamine - 0.5%;

(k) hydrocortisone - 1.0% (only in combination);

(l) bromfenac - 0.09%;

(m) nepafenac - 0.1%;

(n) difluprednate ophthalmic emulsion - 0.05%

(o) loteprednol etabonate ophthalmic suspension - 1.0%.

(6) ANTIHISTAMINES, MAST CELL STABILIZERS AND ANTI-ALLERGY AGENTS

(a) cromolyn sodium - 4.0%;

(b) lodoxamide tromethamine - 0.1%;

(c) olopatadine hydrochloride - 0.7%;

(d) nedocromil sodium - 2.0%;

(e) azelastine hydrochloride - 0.05%:

(f) pemirolast potassium - 0.1%;

(g) epinastine hydrochloride - 0.05%;

(h) bepotastine besilate - 1.5%;

(i) alcaftadine - 0.25%;

(j) cetirizine ophthalmic solution - 0.24%.

(7) ANTIVIRAL AGENTS

(a) trifluridine - 1.0%;

(b) ganciclovir - 0.15%;

(c) povidone-iodine ophthalmic solution - 5.0%

(d) acyclovir ophthalmic ointment - 3.0%

(8) ANTI-GLAUCOMA AGENTS

(a) Beta Blockers.

1. betaxolol hydrochloride - 0.5%;

2. levobunolol hydrochloride - 0.5%;

3. metipranolol hydrochloride - 0.3%;

4. timolol maleate or hemihydrate - 0.5% (solution and gel, alone and in combination);

5. carteolol hydrochloride - 1.0%.

(b) Miotics, Direct-acting

1. carbachol - 3.0%;

2. pilocarpine hydrochloride - 4.0%;

3. phentolamine ophthalmic solution - 0.75%

(c) Prostaglandins

1. latanoprost - 0.005%;

2. bimatoprost - 0.03%;

3. travoprost - 0.004%;

4. tafluprost - 0.0015%;

5. unoprostone isoprophyl - 0.15%;

6. latanoprostene bunod ophthalmic solution - 0.024%.

(d) Alpha₂ Adrenergic Agonist

1. brimonidine tartrate - 0.2%;

2. apraclonidine hydrochloride - 0.5%.

(e) Carbonic Anhydrase Inhibitors (CAI's)

1. brinzolamide - 1.0%;

2. dorzolamide hydrochloride - 2.0% (alone and in combination).

(f) Rho Kinase Inhibitor

1. netarsudil - 0.02%.

(9) MISCELLANEOUS

(a) hydroxypropyl cellulose ophthalmic insert;

(b) dapiprazole - 0.5%;

(c) cyclosporine emulsion or solution - 0.1%;

(d) polyvinyl pyrrolidone solution - 2.0%;

(e) natamycin ophthalmic suspension 5.0%;

(f) lifitegrast ophthalmic solution 5.0%; and,

(g) cenergermin-bkbj - 0.002%;

(h) oxymetazoline hydrochloride ophthalmic solution 0.1%;

(i) hypochlorous acid - 0.02%

(j) varenicline solution - 0.03mg

(k) lotilaner ophthalmic solution - 0.25%

(l) 100% perfluorohexyloctane ophthalmic solution

Fla. Admin. Code Ann. R. 64B13-18.002

Rulemaking Authority 463.005, 463.0055(2)(a) FS. Law Implemented 463.0055 FS.

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, 12-26-10, 7-21-11, 11-11-12, 11-29-13, 12-9-13, 4-10-14, Amended by Florida Register Volume 41, Number 121, June 23, 2015 effective 8/14/2015, Amended by Florida Register Volume 42, Number 230, November 29, 2016 effective 1/20/2017, Amended by Florida Register Volume 44, Number 133, July 10, 2018 effective 8/31/2018, Amended by Florida Register Volume 44, Number 234, December 4, 2018 effective 1/25/2019, Amended by Florida Register Volume 45, Number 113, June 11, 2019 effective 8/5/2019, Amended by Florida Register Volume 46, Number 014, January 22, 2020 effective 3/13/2020, Amended by Florida Register Volume 46, Number 220, November 10, 2020 effective 1/5/2021, Amended by Florida Register Volume 47, Number 134, July 13, 2021 effective 9/4/2021, Amended by Florida Register Volume 48, Number 061, March 29, 2022 effective 5/23/2022, Amended by Florida Register Volume 49, Number 202, October 17, 2023 effective 11/2/2023, Amended by Florida Register Volume 50, Number 207, October 22, 2024 effective 11/4/2024.