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FDA DRUG IMPRINTING PROPOSAL ESCHEWS UNIFORM CODE

Executive Summary

FDA DRUG IMPRINTING PROPOSAL ESCHEWS UNIFORM CODE due to the costs involved in requiring that all solid oral doses conform to a new federally mandated standard, the agency explained in a notice of proposed rulemaking on capsule and tablet imprinting in the May 15 Federal Register. FDA said it believes that the advantages of a uniform code "do not at this time outweigh the costs associated with a requirement that all solid oral dosage form products, including the many thousands of prescription and OTC products that are already imprinted, conform to a Federally-mandated standard." FDA states in the notice that it "has tentatively concluded that it should not now propose to require adoption of a uniform code." However, the agency acknowledged that "a uniform code might be 'user-friendly' and ease the task of assembling a drug identification directory for distribution to hospitals, poison control centers, and others." Instead, FDA plans to allow imprint codes designed by manufacturers that include company logos and other symbols as long as one alphanumeric character is included. If adopted, the final rule would apply to all currently marketed OTC and prescription drugs, including drugs originally marketed before 1938 that do not require NDAs or ANDAs. FDA has tentatively concluded that homeopathic drug products should also be included in the proposed rule but has invited further comments on the subject. FDA noted that approximately 90%-95% of all prescription drug products, and approximately 70% of all OTC drug products are currently imprinted, most according to standards in compliance with the proposed rule. However, manufacturers of those drugs subject to premarket approval but not previously imprinted must submit a supplemental drug application to FDA. Biological products not previously imprinted must be granted a product license amendment, the notice says. Once the rule is in effect, changes in oral formulation imprints are to be reported to FDA in annual reports. A supplemental application would not be required unless the product fails to meet dissolution specifications and test procedures. Dissolution profiles of the imprinted drug must be similar to those of the pre-imprinted drug, the newly imprinted drug must be placed in a stability study, and the "Description" and "How supplied" sections of the package insert must be updated. Minor changes to existing imprints must also be detailed in the manufacturer's next annual report. FDA said that a final rule on this proposal will become effective one year from the date of its publication in the Federal Register. FDA's proposed rule also allows exemptions to the imprinting requirement for drugs intended for use only in clinical investigations, drugs compounded solely for the use of the patient to whom it is prescribed, and drugs for which size or other physical characteristics make imprinting impossible. Exemptions that fall in to this last category will be evaluated on a case-by- case basis. FDA is soliciting comments regarding the extension of the investigational drug exemption to drugs distributed under treatment INDs. In addition to identifying the drug product's active ingredients, the code proposed by FDA must clearly indicate the product's manufacturer or distributor. For drugs subject to premarket approval, the code must identify the holder of the approval. FDA is particularly interested in soliciting comments concerning the appropriateness of this procedure "for identifying the entity involved in marketing the drug product," according to the notice. At present, 23 states have statutes requiring the imprinting of prescription drugs; Washington state additionally requires the imprinting of OTC drugs. FDA, however, does not believe that the pre-emption of any state laws will be necessary in implementing its rule.
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