The issue of differences in bioequivalence among different drug preparations has been a topic of debate in Florida for some time. In May 2001, revisions to the law defining the negative formulary list sought removal of four drugs: sodium warfarin, phenytoin, quinidine gluconate and digoxin (see Table). During the 2001 Legislative Session, Florida lawmakers passed the Negative Drug Formulary bill removing from the formulary list “those drugs where every commercially marketed equivalent [had been] ‘A’ rated as therapeutically equivalent to a reference listed drug or ... referred to by the FDA’s ‘Orange Book’ ”.
The FDA’s Orange Book identifies those drugs approved for therapeutic use by the Food and Drug Administration. It details guidelines for evaluating therapeutic equivalence and validates by research the use of drugs for therapy. An “A” coded drug is a product for which there is “no known or suspected bioequivalence problems or ... problems that have been resolved with adequate laboratory experimentation”. For more information, see http://www.fda.gov/cder/ob/docs/preface/ecpreface.htm
