Size of Beads in Drug Products Labeled for Sprinkle Rev.1: Guidance for Industry

Issue Date: May 16, 2012
Issued by: Center for Drug Evaluation and Research
Topic(s): Chemistry, Manufacturing, and Controls (CMC), Pharmaceutical Quality
Status: Final

Size of Beads in Drug Products Labeled for Sprinkle Rev.1: Guidance for Industry

This guidance provides applicants preparing or submitting new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics licensing applications (BLAs) the Center for Drug Evaluation and Research’s current thinking on appropriate size ranges for beads in drug products that are labeled to be administered via sprinkling (e.g., capsules or packets containing beads).

Download the Guidance Document