USP Survey on Tablet/Capsule Identification

Current and alternative approaches to imprint coding

Current Approach

The Federal Regulations [21 CFR Part 206] charge the FDA with responsibility for ensuring that all solid dosage forms approved in the United States carry unique identifiers. In the current scheme, manufacturers generate their own company-specific imprint codes covering tablet and capsule products and strengths. The imprint, in conjunction with other characteristics (product shape, color, size) must uniquely identify the active ingredients, dosage strength, and the manufacturer or distributor.

Alternative Approaches

Some people involved in identifying tablets/capsules have perceived inadequacies in the current approach. Therefore, two alternative approaches have been suggested as described below. USP acknowledges that there may be other approaches.

Standardized Imprint Code Approach

A unique and easily recognizable 2 to 5-character alpha-numeric code would be imprinted on all tablets and capsules. The code will be standardized —all manufacturers of a given drug product tablet or capsule of a specific strength will apply the same code to their dosage form. For example, if the designated code for a 25 mg xyz tablet or capsule is "AB123," all manufacturers of that tablet or capsule product will affix the "AB123" imprint code on their tablets or capsules, in addition to their own desired company logos. Thus, a green tablet with "AB123" on it, a blue tablet with "AB123" on it, and a yellow capsule with "AB123" on it would correspond to the same active ingredient and strength (25 mg of xyz).

This standardized imprint code may enable rapid identification of the active(s), their strengths, and the release characteristic of the dosage form. This information would be made available to practitioners and the public (toll-free number, internet access, printed reference, etc.). An automated response could rapidly provide the above data, plus relevant additional information such as major side effects and remedies for over-dosage.

Database Approach

This approach maintains the current system of manufacturer-assigned codes, but proposes that the pharmaceutical industry partner with the FDA to catalog all existing and future solid dosage form identifiers in an accurate, readily accessible online database. This database would be constructed in such a manner as to be accessible to the public and to facilitate easy and rapid identification information retrieval via toll-free number, Internet access, printed reference, etc.