US Department of Health and Human Services Food and Drug Administration Centre for Drug Evaluation and Research (CDER) has issued Guidance to the Industry on Tablet Scoring: Nomenclature, Labelling, and Data for Evaluation.

The regulatory major is seeking comments before 90 days which is by November end.

The office of pharmaceutical science in the CDER at the Food and Drug Administration has prepared the guidelines.

The guidance provides recommendations to sponsors of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) regarding on the criteria to be met to facilitate the evaluation and labelling of tablets that have been scored. A scoring feature facilitates the practice of tablet splitting.

The guidance does not address specific finished-product release testing, where additional requirements may be appropriate for scored tablets. The document, does not establish legally enforceable responsibilities. Instead, it  describes the regulatory authority’s current thinking on a topic and therefore  should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

FDA had previously considered tablet scoring as an issue when determining whether a generic drug product is the same as the reference listed drug (RLD). One characteristic of a tablet dosage form is that it may be manufactured with a score or scores. The characteristic is useful because the score can be used to facilitate the splitting of the tablet into fractions when  less than a full tablet is desired for a dose.

Although there are no regulatory requirements that specifically address scoring of tablets, FDA recognizes the need for consistent scoring between a generic product and its RLD.

CDER’s Drug Safety Oversight Board considered the practice of tablet splitting at its October 2009 and November 2010 meetings. During those meetings, they discussed how insurance companies and doctors are increasingly recommending that patients split tablets, either to adjust the  dose or as a cost-saving measure. Because of this, the Agency conducted internal 55 research on tablet splitting and concluded that in some cases, there are possible safety issues, especially when tablets are not scored or evaluated for splitting.

The Agency’s concerns with splitting a tablet included 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. In  addition, there may be stability issues with splitting tablets.

Tablet splitting also is addressed in pharmacopoeia standards. The European Pharmacopoeia (EP) currently applies accuracy of subdivision standards for scored tablets and has at various times  also included standards for content uniformity, weight variation, and loss of mass, according to US FDA.

FDA considers tablet splitting to be manufacturing under the Federal Food, Drug, and Cosmetic Act. Therefore, establishments that engage in tablet splitting must register with FDA and comply with the Agency’s current Good Manufacturing Practice (cGMP) regulations in 21 CFR parts 210 and 211. Furthermore, unless the tablet splitting is conducted pursuant to the drug product’s approved labelling, the resultant split drugs are considered new drugs under the FD&C Act. Therefore it would require an approved NDA.