ABSTRACT
This chapter discusses the regulatory standards for approval of locally acting topical dermatological drug products based on the different types of submissions. Topical dermatological drug products are available in an array of dosage forms ranging from simple to complex. In the 1950s, manufacturers applied to the US Food and Drug Administration for approval to market topical dermatological corticosteroids as over-the-counter (OTC) products. An OTC monograph consists of the active ingredient specific, public and a “kind of recipe” book covering acceptable ingredients, doses, formulations, labeling and, in some cases, testing parameters. The drug application site and the disease state have a direct relation to the selection of the appropriate dosage form to elicit the desired therapeutic effect. OTC drug products can be brought to the market using the new drug application process or under an OTC monograph. Bioequivalence studies with clinical endpoints are commonly required for the approval of generic topical drug products.
