Fla. Admin. Code R. 64B16-27.500
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:
Fla. Admin. Code Ann. R. 64B16-27.500
Rulemaking Authority 465.005, 465.025(6) FS., Chapter 2001-146, Laws of Florida. Law Implemented 465.025(6) FS., Chapter 2001-146, Laws of Florida.
New 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, 3-18-10.