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TABLET I.D. IMPRINT SYSTEM IS UNDER ACTIVE REVIEW AT FDA

Executive Summary

TABLET I.D. IMPRINT SYSTEM IS UNDER ACTIVE REVIEW AT FDA, Office of Drug Standards Director Peter Rheinstein, MD, told the National Association of Pharmaceutical Manufacturers annual meeting in Dorado Beach, Puerto Rico on Jan. 30. Rheinstein said that the agency will be publishing a Federal Register notice "shortly" asking for comments on a petition submitted by the NAPM urging the adoption of a coding system. "We will also be asking people to send in samples of the existing coding systems which they have," he said. One type of imprint system could incorporate an abbreviation for both the active ingredient and the product manufacturer, Rheinstein observed. For instance, a three or four-letter abbreviation of the active ingredient with the number of milligrams might appear on one side of the tablet and a similar abbreviation for the manufacturer on the other. Rheinstein said that the agency was also considering the inclusion of a batch identifier "or something that could identify roughly when it was made and when it expired" to allow for easier identification and removal of problem products. FDA would probably use a "phase-in" period for submission of an imprint system on solid oral dosage forms, Rheinstein noted. "Also there will be the usual mechanism to apply for exemptions if your dosage form is just too small to get all the required information in there." An imprint system requirement has been actively sought by the NAPM over the last few years. NAPM Counsel Milton Bass (New York City law firm Bass & Ullman) explained at the session that added impetus for a uniform identification system has come from a U.S. Defense Department requirement that government orders contain an identification code. "If you have 15 companies applying for that government order you are going to have 15 different codes for that same active ingredient," Bass said. "I believe that this will be a very persuasive factor for why we have to adopt the kind of code that NAPM is suggesting." Rheinstein added that Congress has also expressed an interest in developing a uniform coding system to help in emergency tracking of products and to improve consumer awareness of specific drugs.

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