INACTIVE INGREDIENTS IN PHARMACEUTICAL PRODUCTS - UPDATE (SUBJECT REVIEW)

Because of an increasing number of reports of adverse reactions associ ated with pharmaceutical excipients, in 1985 the Committee on Drugs is sued a position statement(1) recommending that the Food and Drug Admin istration mandate labeling of over-the-counter and prescription formul ations to include a qualitative list of inactive ingredients. However, labeling of inactive ingredients remains voluntary. Adverse reactions continue to be reported, although some are no longer considered clini cally significant, and other new reactions have emerged. The original statement, therefore, has been updated and its information expanded.