FDA Publishes Powder-Blends Guidance

PQRI assists FDA with project.

In early November, the U.S. Food and Drug Administration (FDA) published a guidance intended to ensure uniformity of powder blends and finished dosage units. The guidance, dubbed Powder Blends and Finished Dosage Units—Stratified In-Process Dosage Unit Sampling and Assessment, provides recommendations on how to conduct analyses, establish criteria, analyze samples and other topics.

The Arlington, Va.-based Product Quality Research Institute assisted FDA on this project.