64B16-27.500: Negative Drug Formulary
PURPOSE AND EFFECT: The Board proposes the rule amendment in order to remove Levothyroxine Sodium from the negative drug formulary.
SUMMARY: Levothyroxine Sodium will be removed from the negative drug formulary.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared. The Board determined the proposed rule 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: 465.005, 465.025(6) FS., Ch. 2001-146, Laws of Florida.
LAW IMPLEMENTED: 465.025(6) FS., Ch. 2001-146, Laws of Florida.
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: Rebecca R. Poston, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254
THE FULL TEXT OF THE PROPOSED RULE IS:
64B16-27.500 Negative Drug Formulary.
The negative drug formulary is composed of medicinal drugs which have been specifically determined by the Board of Pharmacy and the Board of Medicine to demonstrate clinically significant biological or therapeutic inequivalence and which, if substituted, could produce adverse clinical effects, or could otherwise pose a threat to the health and safety of patients receiving such prescription medications. Except where certain dosage forms are included on the negative drug formulary as a class, all medicinal drugs are listed by their official United States Pharmacopoeia Non-Proprietary (generic) name. The generic name of a drug shall be applicable to and include all brand-name equivalents of such drug for which a prescriber may write a prescription. Substitution by a dispensing pharmacist on a prescription written for any brand name equivalent of a generic named drug product listed on the negative formulary or for a drug within the class of certain dosage forms as listed, is strictly prohibited. In cases where the prescription is written for a drug listed on the negative drug formulary but a brand name equivalent is not specified by the prescriber, the drug dispensed must be one obtained from a manufacturer or distributor holding an approved new drug application or abbreviated new drug application issued by the Food and Drug Administration, United States Department of Health and Welfare permitting that manufacturer or distributor to market those medicinal drugs or when the former is non-applicable, those manufacturers or distributors supplying such medicinal drugs must show compliance with other applicable Federal Food and Drug Administration marketing requirements. The following are included on the negative drug formulary:
(1) through (5) No change.
(6) Levothyroxine Sodium.
(6)(7) Pancrelipase (Oral Dosage Forms).
Rulemaking Specific Authority 465.005, 465.025(6) FS., Ch. 2001-146, Laws of Florida. Law Implemented 465.025(6) FS., Ch. 2001-146, Laws of Florida. HistoryNew 12-14-76, Amended 3-17-77, 7-2-79, 4-9-81, 9-14-82, 9-26-84, Formerly 21S-5.01, Amended 3-30-89, 7-1-90, Formerly 21S-5.001, Amended 12-25-90, 10-1-92, Formerly 21S-27.500, Amended 2-21-94, Formerly 61F10-27.500, 59X-27.500, Amended 12-4-01,________.
