Timeline for an FDA Order to Determine a Drug is Not GRAS/E

Timeline for FDA consideration of changes to the general recognition status of an OTC monograph ingredient under the standard procedure.¹

¹ In March 2020, a new law took effect that updated the system for how the Food and Drug Administration regulates most over-the-counter (OTC) medicines.  These updates to the OTC Monograph system, supported by an OTC Monograph user fee program (OMUFA), achieved a long-sought goal of CHPA, and had broad stakeholder, FDA, and bipartisan/bicameral support. The substantive changes in the law are in Section 505G of the federal Food, Drug, and Cosmetic Act.  The law provides different timelines for different types of administrative orders.