The Board proposes the rule amendment to update the rule and the formulary of topical ocular pharmaceutical agents.

 

DEPARTMENT OF HEALTH

Board of Optometry

RULE NO.:RULE TITLE:

64B13-18.002Formulary of Topical Ocular Pharmaceutical Agents

PURPOSE AND EFFECT: The Board proposes the rule amendment to update the rule and the formulary of topical ocular pharmaceutical agents.

SUMMARY: The formulary of topical ocular pharmaceutical agents will be updated.

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: 463.005, 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 FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Christina McGinnis, Executive Director, Board of Optometry, 4052 Bald Cypress Way, Bin #C07, Tallahassee, FL 32399-3257. [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

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) aAtropine sulfate – 1.0% (solution and ointment);

(b) pPhenylepherine hydrochloride HCl – 2.5%;

(c) cCyclopentolate hydrochloride HCl – 0.5%, 1.0%;

(d) sScopolamine hydrobromide HBr – 0.25%;

(e) hHomatropine hydrobromide HBr – 2.0%, 5.0%;

(f) tTropicamide – 0.5%, 1.0%; and,

(g) hHydroxyamphetamine hydrobromide HBr – 1.0% (in combination) plus tropicamide – 0.25%.

(2) LOCAL ANESTHETICS

(a) tTetracaine – 0.5%;

(b) pProparacaine hydrochloride HCl – 0.5%; and,

(c) bBenoxinate HCl – 0.4% (in combination with fluorescein);.

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

(3) DIAGNOSTIC PRODUCTS

(a) fFluorescein paper strips – 1 mg, 9 mg per strip;.

(b) Lissamine Green – 1.5 mg per strip;

(c) Rose Bengal – 1.3 mg per strip;

(d) phenol red thread;

(ee) Schirmer test strips;

(f) hypromellose ophthalmic demulcent solution – 2.5%.

(4) ANTIBACTERIAL

(a) eErythromycin – 0.5%;

(b) bBacitracin – 400 units/g, 500 units/g (ointment alone and in combination);

(c) pPolymyxin – 10,000 units/g (only in combination);

(d) nNeomycin – 1.75 mg/g, 1.75 mg/ml, 3.50 mg/g (only in combination);

(e) gGentamicin – 0.3% (solution and ointment);

(f) tTobramycin – 0.3% (solution and ointment in combination);

(g) gGramicidin – 0.025 mg/ml (only in combination);

(h) cCiprofloxacin hydrochloride HCl – 0.3% (solution and ointment);

(i) tTrimethoprim – 1.0 mg/ml (only in combination);

(j) oOfloxaxin – 0.3%;

(k) lLevofloxacin – 1.5%;

(l) gGatifloxacin – 0.5%;

(m) mMoxifloxacin – 0.5%;

(n) sSodium sulfacetamide – 10.0% (alone and in combination);

(o) aAzithromycin – 1.0 %; and,

(p) bBesifloxacin oOphthalmic sSuspension – 0.6%.

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

(a) mMedrysone – 1.0%;

(b) pPrednisolone acetate – 0.12%, 0.125%, 0.2%, 0.5%, 0.6%, 1.0% (alone and in combination);

(c) pPrednisolone sodium phosphate – 0.125%, 0.25%, 1.0% (alone and in combination);

(d) fFlurometholone – 0.1%, 0.25% (suspension and ointment, alone and in combination);

(e) dDexamethasone – 0.1%, 1.0% (suspension and ointment, alone and in combination), 0.4 mg ophthalmic insert;

(f) fFluorometholone acetate – 0.1%;

(g) rRimexolone – 1.0%;

(h) lLoteprednol etabonate – 0.2%, 0.5% (alone and in combination);

(i) dDiclofenac sodium – 0.1%;

(j) kKetorolac tromethamine – 0.5%;

(k) hHydrocortisone – 1.0% (only in combination);

(l) bBromfenac – 0.09%;

(m) nNepafenac – 0.1%; and,

(n) dDifluprednate ophthalmic emulsion – 0.05%

(o) lLoteprednol etabonate ophthalmic suspension – 1.0%.

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

(a) cCromolyn sodium – 4.0%;

(b) lLodoxamide tromethamine – 0.1%;

(c) oOlopatadine hydrochloride HCl – 0.7%;

(d) nNedocromil sodium – 2.0%;

(e) aAzelastine hydrochloride HCl – 0.05%:

(f) pPemirolast potassium – 0.1%;

(g) eEpinastine hydrochloride HCl – 0.05%;

(h) bBepotastine besilate – 1.5%;

(i) aAlcaftadine – 0.25%; and

(j) cCetirizine oOphthalmic solution - 0.24%.

(7) ANTIVIRAL AGENTS

(a) tTrifluridine – 1.0%;

(b) gGanciclovir – 0.15%; and,

(c) pPovidone-iodine ophthalmic solution – 5.0%.

(d) acyclovir ophthalmic ointment – 3.0%

(8) ANTI-GLAUCOMA AGENTS

(a) Beta Blockers.

1. bBetaxolol hydrochloride HCl – 0.25%, 0.5%;

2. lLevobunolol hydrochloride HCl – 0.25%, 0.5%;

3. mMetipranolol hydrochloride HCl – 0.3%;

4. tTimolol maleate or hemihydrate – 0.25%, 0.5% (solution and gel, alone and in combination); and,

5. cCarteolol hydrochloride HCl – 1.0%.

(b) Miotics, Direct-acting

1. cCarbachol – 0.75%, 1.5%, 3.0%;

2. pPilocarpine hydrochloride HCl – 0.5%, 1.0%, 2.0%, 4.0%; and,

3. Pilocarpine gel – 4.0%.

(c) Prostaglandins

1. lLatanoprost – 0.005%;

2. bBimatoprost – 0.03%;

3. tTravoprost – 0.004%;

4. tTafluprost – 0.0015%;

5. uUnoprostone iIsoprophyl – 0.15%; and,

6. lLatanoprostene bBunod oOphthalmic sSolution – 0.024%.

(d) Alpha2 Adrenergic Agonist

1. bBrimonidine tartrate – 0.15%, 0.2%; and,

2. aApraclonidine hydrochloride HCl – 0.5%.

(e) Carbonic Anhydrase Inhibitors (CAI’s)

1. bBrinzolamide – 1.0%; and,

2. dDorzolamide hydrochloride HCl – 2.0% (alone and in combination).

(f) Rho Kinase Inhibitor –

1. nNetarsudil – 0.02%.;

(9) MISCELLANEOUS

(a) hHydroxypropyl cellulose ophthalmic iInsert;

(b) dDapiprazole – 0.5%;

(c) cCyclosporine emulsion or solution – 0.1%;

(d) pPolyvinylpyrrolidone solution – drops 2.0%;

(e) bBimatoprost – 0.03%;

(f) nNatamycin oOphthalmic sSuspension 5.0%;

(g) lLifitegrast ophthalmic solution 5.0%; and,

(h) Cyclosporine 0.09% Ophthalmic Solution.

(h)(i) Oxervate (Cenergermin-bkbj) - 0.002%; and

(i)(j) oOxymetazoline hydrochloride ophthalmic solution 0.1%;.

(j) hypochlorous acid – 0.02%

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, 12-26-10, 7-21-11, 11-11-12, 11-29-13, 12-9-13, 4-10-14, 8-14-15, 1-20-17, 8-31-18, 1-25-19, 8-5-19, 3-13-20, 1-5-21,                                  .

 

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: March 26, 2021

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 7, 2021