Dual Use Excipients

What is a “Dual Use Excipient”? 

• A substance that has a monograph in the USP but is manufactured and used predominantly as an excipient in a drug formulation
• Many of these may also be used as an “Active” in formulations or in applications that are  associated with ‘higher’ GMP expectations, e.g. parenterals and ophthalmics
• In some cases it is the only ingredient
• Another term is “Atypical Active”
• Not limited to excipients!  It may also be a food additive, a GRAS substance, a personal  care ingredient or even an industrial product