A pharmacist-driven Food and Drug Administration incident surveillance and response program for compounded drugs

• Published in: American journal of health-system pharmacy Vol. 78; no. 15; pp. 1438 - 1443
• Main Authors: Janusziewicz, Ashlee N, Glueck, Shannon N, Park, Sophia Y, Nguyen, Dien N, Rimmel, Susan C, Cascio, Laurelle A, Doh, Gina Y, Martin-Yeboah, Garrette F
• Format: Journal Article
• Language: English
• Published: US Oxford University Press 01.08.2021
• Subjects: Descriptive Report; adverse drug reaction reporting systems; adverse drug event; drug compounding; United States Food and Drug Administration

Abstract Purpose To provide an overview of compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, and to describe the pharmacist’s role within the US Food and Drug Administration’s (FDA’s) Compounding Incidents Program, whose efforts are aimed at protecting the public...