Abstract
The FDA is in the second stage of the most comprehensive scientific assessment of non-prescription drugs ever undertaken. Because of the sheer volume of OTC drugs, a product-by-product review is not feasible. We are therefore basing our review on the ingredients used in these products. Based upon that review, a tentative monograph, a standard of acceptable active ingredients and labeling has been completed for over 90 categories of drugs. The third and final phase of the process — which will take several more years — will result in a final monograph for each category of OTC products.
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