FDA issues final guidance on generic drug appearance

WASHINGTON — The Food and Drug Administration recently issued its final guidance on the appearance of generic pharmaceuticals, recommending drugs made by generic manufacturers closely mimic the physical attributes, including the size, shape and color, of the drugs they reference.

 

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"[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," FDA wrote in its guidance. "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 for their generic product candidates."

 

FDA also recommended generic drugs not be larger than any drug already equal to or greater than 17 mm in its largest dimension. Products should also be of a similar shape to the reference drug, and have other physical similarities which make it as easy to swallow as the original. For example, a product's weight, surface area, tablet coating and disintegration time should all be similar.