FDA guidance on Size, Shape, and Other Physical Attributes of Generic Tablets

FDA has issued final guidance regarding Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.

The guidance is intended to address concerns that differences in size, shape, and other physical characteristics between generic tablets/capsules and the reference listed (brand) drug (“RLD”) may affect patient compliance and acceptability of medication regimens or could lead to medication errors.

According to the guidance:

“While generic formulations of these drug products are required to be both pharmaceutically and therapeutically equivalent to a reference listed drug (RLD), we are concerned that differences in physical characteristics (e.g., size and shape of the tablet or capsule) may affect patient compliance and acceptability of medication regimens or could lead to medication errors. We believe these patient safety concerns are important, and we are recommending that generic drug manufacturers consider physical attributes when they develop quality target product profiles (QTPPs) for their generic product candidates.”

To access the guidance, see FDA

Posted by Tim Sandle