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News From the Food and Drug Administration
February 4, 2020

FDA’s New Effort to Improve Compounded Drug Quality

JAMA. 2020;323(5):408. doi:10.1001/jama.2020.0223

Inspections of compounding facilities in recent years that have turned up unsanitary conditions and prompted some compounders to recall their products or cease operations have led the FDA to launch a new initiative: the Compounding Quality Center of Excellence.

The effort is aimed at outsourcing facilities that produce compounded drugs for hospitals, clinics, and other health care providers and must comply with current good manufacturing practices (CGMP). “By providing comprehensive, accessible learning tools, we will support outsourcing facilities in reliably producing high-quality compounded products that meet FDA’s standards,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

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