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Rx DRUG PRODUCT IDENTIFICATION MARKINGS REQUESTED BY NAPM

Executive Summary

Rx DRUG PRODUCT IDENTIFICATION MARKINGS REQUESTED BY NAPM in a recent petition to FDA. The Natl. Assn. of Pharmaceutical Mfrs. is petitioning FDA to issue "a regulation requiring manufacturers or distributors of solid dosage form prescription pharmaceutical products to imprint a code identifying the active ingredients in the drug." NAPM argued that a federally mandated drug identification system is needed in order to identify a product in an emegency. The assn. stated that "in the many instances where small children or adults have overdosed on pharmaceuticals and require immediate and proper medical attention, the existence of loose pills without a vial to identify their source can bring only a small hope that proper treatment can be administered in time to save the patient's life or to avoid permanent, serious injury." The assn. noted that it takes 11 minutes, on average, to identify a tablet or capsule without identifying marks compared to 14 seconds for a product with identifying marks. Noting that the Natl. Assn. of Boards of Pharmacy and the American Pharmaceutical Assn. have advocated a national drug code system, NAPM said FDA has rejected the idea "citing its opinion that the evidence was unclear that such a measure was necessary for protection of public health, and emphasizing that the benefits did not clearly outweigh the risk." The "'costs' that FDA referred to in declining to adopt a uniform system are negligible, if not illusory," the petition asserts. "Moreover, the cost of not implementing such a system could be quite high." The "real issue preventing implementation of an 'I.D. system' is one of a perceived competitive one," NAPM declared. "Many large 'brandname' companies apparently fear that people will equate the products of generic and brandname companies if both bear the same code number." The brandname companies' concern "is not a valid concern," NAPM contended. "A uniform system will merely require a designation of the active ingredients. The system can and should allow for a separate prefix or logo to identify the mfr." NAPM further argued that while 24 states now have requirements for the identification of individual solid dosage forms, the state laws "do not have any cohesive scheme that could be implemented on a nationwide basis . . . and do not mandate publication of lists" of the I.D. numbers for distribution to health care facilities. The assn. recommended that as part of a national I.D. program, a list "utilizing an alpha-numeric system which would permit unique logos or other mfr. numbers to supplement the base numbers," be prepared and "incorporated into a universally distributed medical source book such as the Redbook." The assn. also commented that the regulation could include an exemption procedure "permitting mfrs. of solid dosage forms which were too small or too soft [for imprinting] to petition for the exemption of those products."
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