LICENSING A DIETARY SUPPLEMENT AS A DRUG: INTEGRATION AND COMPARISON OF CURRENT GOOD MANUFACTURING PRACTICES OF DIETARY SUPPLEMENTS AND PHARMACEUTCALS

Abstract

The dietary supplement industry has seen many controversies over perceived antidotal vs. scientific validation of their products' health benefits and safety. With precedence set by a multivitamin and omega-3 licensed drug product, the possibilities of taking a supplement through the New Pharmaceutical Development Pathway may offer many advantages. Using supplement manufacturers currently compliant with Food and Drug Administration's (FDA) current Good Manufacturing Practices (cGMPs) for supplements, Client X asked the question: Can I use these facilities to manufacture a supplement as a compliant cGMP drug product for licensure? Facility cGMP audits were performed. The data was analyzed using percent compliance scores and Gap Analysis tool to examine the ability of supplement manufactures to comply with the drug regulation. The relationship between compliance and the number of production, Quality Control and Quality Assurance personnel was also examined to asses any affect on compliance. It was determined that compliance is possible.