FDA Guidance for Industry
Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
Tablets and capsules are widely manufactured and prescribed and may provide a number of advantages over other dosage forms, including ease of storage, portability, ease of administration, and accuracy in dosing.
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.
The recommendations in this guidance apply to abbreviated new drug applications (ANDAs) and their supplements for additional strengths that are submitted to the Office of Generic Drugs (OGD).
This guidance does not apply to approved ANDAs (generic drugs) already on the market.
However, if the Agency determines that an approved product should be modified because the size or shape of a product poses a risk to public health, we will notify the holder of the ANDA.
This guidance is not intended to apply to other oral dosage forms (e.g., chewable tablets, oral tablets for suspension/solution, orally disintegrating tablets, sublingual tablets, troches, gums).