A positive formulary of generic and brand name drug products is required of each community pharmacy pursuant to Florida Statutes § 465.025(5) Those medicinal drugs on the positive formulary shall be obtained from manufacturers or distributors holding an approved new drug application or abbreviated new drug application issued by the Food and Drug Administration, U.S. Department of Health, Education and Welfare permitting that manufacturer or distributor to market those medicinal drugs or when the former is non-applicable, those manufacturers or distributors supplying those medicinal drugs must show compliance with other applicable Federal Food and Drug Administration marketing requirements.
Rulemaking Authority 465.005 FS. Law Implemented 465.025(5) FS. History-New 12-7-77, Formerly 21S-5.03, 21S-5.003, 21S-27.520, 61F10-27.520, 59X-27.520.