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Executive Summary

PARENTERAL DRUG FORMULATION DIFFERENTIATION BETWEEN SINGLE- AND MULTIPLE-DOSE containers "would require two separate production processes for the same product, thus duplicating effort and adversely affecting cost containment," and could "easily cause confusion in health care practice," the Parenteral Drug Assn. (PDA) stated in recent comments to FDA. Responding to FDA's announcement that the agency is considering restricting the use of benzyl alcohol or any antimicrobial preservative in single-dose parenteral products, the assn. said adequate label warnings could protect the product user, "while avoiding the risk of confusion and the penalty of increased costs." In addition to production problems, the assn. stated that elimination of benzyl alcohol from parenteral formulations would result in extensive reformulation which "would be expensive and time-consuming and would ultimately add to the cost of the product." Reformulation, the assn. maintained, would involve a lengthy development phase as well as possible clinical trials. Furthermore, FDA said, removal of antioxidants and stablilizers "would effectively remove some products from the market since there would be no suitable alternative to maintain the product stability." FDA said in a May 15 Federal Register notice that it was considering restricting use of the preservatives in single-dose parenterals and requiring a label warning for multi-dose parenterals because of reports linking use of parenterals containing an anti-microbial preservative to morbidity and mortality among low-weight newborn infants. PDA commented: "While there is clear evidence of the potential health hazard associated with administration of large amounts of benzyl alcohol to low-birth-weight neonates, the PDA is unaware of evidence of similar health hazards associated with use of products containing other antimicrobial preservatives or with the use of benzyl alcoholcontaining products in adults." PDA said the current label warning "Not for use in newborns" for bacteriostatic sodium chloride injection and bacteriostatic water for injection is "sufficient to prevent potential health hazards that could result from the administration of large quantities of preservatives." In previous comments, Ciba-Geigy maintained that single-dose parenterals are actually used as multi-dose units ("The Pink Sheet" July 22, T&G-11). The firm also maintained that the concentration of the preservative rather than the chemical entity itself might be the cause of toxic reactions. Carter-Glogau has submitted comments recommending that all antimicrobials be restricted in all parenterals in single-dose containers.

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