BEBAC  Ing. Helmut Schütz

US – FDA

Draft Guidance for Industry: Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules

On 09 Dec 2013 FDA’s Center for Drug Evaluation and Research (CDER) published the drafted guidance for a 90-day public consultation period (i.e., until 10 March 2014).

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), the FDA is 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 believes these patient safety concerns are important, and is 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, the Agency will notify the holder of the ANDA.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit electronic comments on the draft guid­ance by March 10, 2014 to www.regulations.gov.
See also “Tips for Submitting Effective Comments”.

Update

Final guidance published on June 17, 2015.