Excipient Development Stagnation

The existing structure for review of excipient ingredients has several structural defects that result in significant disincentives in the development of novel excipients. Currently, only excipients that have been approved in an NDA are subject to a USP/NF monograph, or excipients that have an FDA- or a JECFA-sanctioned food 

The lack of acceptance of new excipients by regulatory agencies, and therefore pharmaceutical manufacturers, creates disincentives for companies to develop innovative new excipients. The risks of not obtaining acceptance by potential buyers for new excipients make development of these ingredients economically unacceptable. 

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