FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Revises Guidance on CGMPs for Outsourcing Facilities

Dec. 18, 2018

The FDA revised its recommendations on current good manufacturing practices for drug compounding outsourcing facilities, drawing a line between agency requirements for sterile and nonsterile drug products and outlining practices to protect against contamination.

“We want to advance policies that make it more feasible for outsourcing facilities to fulfill requests for office stock [kept on hand in healthcare settings] while maintaining product quality,” said Commissioner Scott Gottlieb and Deputy Commissioner Anna Abram in a joint statement Monday. “This revised draft guidance includes changes intended to help achieve this goal.”

The agency issued the revised draft because it has continues to find “concerning conditions and practices” in outsourcing facilities that can result in contaminated and mislabeled products, or cause drug products to be super- or sub-potent.

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