Abstract

Pharmaceutical excipients contribute unique functionalities to formulations, thereby largely determining the drug products quality and influencing its safety and efficacy. Changes and variations of excipients in licensed products are, therefore, placed under strict regulatory control. This article presents a proposed regulatory mechanism for pharmaceutical excipients by United States of Food and Drug Administration (USFDA). In Unites States, excipients are regulated by United States of Food and Drug Administration (USFDA). The United States of Food and Drug Administration (USFDA) is an agency of the United States Department of Health and Human Services. From a regulatory standpoint, the FDA’s concern regarding excipients involves GMP, toxicity, impurity, safety, quality assurance, stability, USP-NF monograph requirements, labelling regulations and approval or review mechanism.