Formulary decisions for pre-1938 medications

Abstract

A process is described for formulary revisions consistent with the Food and Drug Administration (FDA)'s current initiative to ensure that all drugs marketed in the United States have been approved for safety and efficacy. A list of pre-1938 drugs (i.e., formulations marketed before the Federal Food, Drug, and Cosmetic Act established safety requirements) was compiled from USP DI Volume III and International Journal of Pharmaceutical Compounding lists. Products on the resulting list were reviewed for current marketing and FDA approval status and for availability. The project team recommended formulary addition or retention if a product had been used and been purchased more than once at the hospital in the past year, if no formulary alternative was available, or if the product had been approved by FDA. Nonformulary status was recommended if none of these criteria applied or the product was no longer available. Of 88 pre-1938 formulations of 59 drugs, only 3 had been approved by FDA before 1962 (when evidence of efficacy was first required) and 14 thereafter. Of the 88 formulations, 47 were on the hospital's formulary. The team recommended that 37 formulations be retained on or added to the formulary and that 51 be maintained or designated as nonformulary. The hospital's pharmacy and therapeutics (P&T) committee accepted the recommendations, provided that the 30 nonapproved formulations recommended for formulary status be reviewed as FDA continues its effort to have manufacturers either apply for approval of their products or remove them from the market. The recommendations were also accepted by the health system's P&T committee. A systematic approach to reviewing pre-1938 medications for the purpose of formulary revision was successful in addressing safety concerns about these older drug formulations.