FDA issues final guidance on generic drug appearance

The Food and Drug Administration recently issued its final guidance on the appearance of generic pharmaceuticals, recommending that drugs made by generic manufacturers closely mimic the physical attributes, including the size, shape and color, of the drugs that 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,” the FDA stated 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.”



The FDA also recommended that generic drugs not be larger than any drug already equal to or greater than 17 mm in its largest dimension. Products also should 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 to the reference drug.