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FDA Provides Guidance for Industry on Tablet Scoring
Recognizing the need for consistent tablet scoring that allows a patient to adjust a drug dose, FDA has provided a draft guidance for industry outlining the guidelines, data, and criteria that will facilitate the evaluation and labeling of scored tablets. In the draft “Guidance for Industry Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation” (PDF), FDA notes that tablet scoring is useful because it allows the patient to split a pill when the desired dose would be less than a full tablet. And while there are “no standards or regulatory requirements that specifically address scoring of tablets,” FDA “recognizes the need for consistent scoring between a generic product” and its reference listed drug to enable patients to switch between products. Following meetings of the Center for Drug Evaluation and Research Drug Safety Oversight Board and based on internal research, FDA determined that in some cases, there are possible safety issues, especially when tablets are not scored or evaluated for splitting. FDA concerns include “variations in the tablet content, weight, disintegration, or dissolution, which can affect how much drug is present in a split tablet and available for absorption,” as well as stability issues with splitting tablets. Comments and suggestions on the draft guidance should be submitted by November 28, 2011, by visiting www.regulations.gov, conducting a search for docket FDA-2011-D-0595, and following the instructions on the site.
