Threat of Sanctions, Shortages, Spurs Talk of Standards for Atypical Actives
This article was originally published in The Gold Sheet
Executive Summary
As the pharmaceutical supply chain comes under increased regulatory scrutiny, FDA inspectors are finding manufacturers using excipients as active ingredients, even though they don’t meet active ingredient standards, and the industry is talking about establishing a new set of standards for these so-called atypical actives, and perhaps coaxing FDA into ratifying them via guidance.