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FDA DRUG IMPRINTING REG: INDUSTRY HAS TWO YEARS TO COMPLY

This article was originally published in The Tan Sheet

Executive Summary

FDA DRUG IMPRINTING REG: INDUSTRY HAS TWO YEARS TO COMPLY with the requirements of a final rule scheduled for publication in the Sept. 13 Federal Register. FDA proposed the imprinting reg for all solid oral dosage form prescription and OTC drugs, biologicals and homeopathic medicines in May 1991. The agency originally proposed that any final rule take effect one year after publication. In response to "many comments" stating that "this was insufficient time for industry to develop imprint designs and equipment necessitated by the final rule," FDA decided to allow a two-year implementation period. Manufacturers who choose to imprint their drugs with ink will be required to file for supplemental approval. However, for immediate-release products with embossed, debossed or engraved imprints, manufacturers only will need to update labeling and file an annual report that shows the dissolution profile of the product has not been affected. Imprints on any modified-release products will require pre-approved supplements. FDA estimated that 70% of OTC drugs and 90%-95% of all prescription drugs are imprinted. The agency believes that most existing imprints already comply with the proposed rule; any minor changes to existing imprints only need an annual report, the rule states. Products with pending supplements will be exempt from the rule until FDA completes its review. The final rule maintains the proposed rule's flexible approach to imprinting. FDA is not requiring a uniform code and instead is allowing manufacturers to design an imprint which, together with the product's color, shape and size, is sufficient to identify it. While the proposed rule would have required at least one alphanumeric character in the imprint (in addition to any company logo or other symbol), the final rule makes the inclusion of a number or letter voluntary. "Because of the effectiveness of the current imprinting system and the disruption that could result from requiring specific elements in a code imprint, this final rule does not require an imprint to contain a letter or a number," the notice states. "However, FDA strongly recommends the inclusion of at least one alphanumeric component." The final rule maintains exemptions for investigational drug products, drugs compounded solely for a single patient's use and drugs with physical characteristics that make imprinting impossible. Requests for waivers based on physical characteristics are to be submitted to the appropriate FDA review division where they will be evaluated on a case-by-case basis, the rule states. Based on the few exemptions granted by states that have imprinting requirements, FDA said it "believes that most solid oral dosage form drug products can and should be imprinted."
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