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BETHESDA, MD, 06 April 2004 -- In an effort to limit patients' exposure to aluminum, beginning July 26, FDA is requiring manufacturers of large-volume parenterals (LVPs), small-volume parenterals (SVPs), and pharmacy bulk packages (PBPs) used in total parenteral nutrition (TPN) to add certain information to component products' labeling. The agency has specified a maximum aluminum concentration of 25 mcg/L in LVPs used in TPN. FDA's regulation applies to all LVPs used in TPN, including but not limited to parenteral amino acid solutions, highly concentrated dextrose solutions, parenteral lipid emulsions, sodium chloride and electrolyte solutions, and sterile water for injection, according to FDA. Manufacturers are required to state in the package inserts of LVPs used in TPN that the component product contains no more than 25 mcg/L of aluminum. There is no limit for the aluminum content in SVPs and PBPs, but manufacturers are required to include in the labeling of those products the maximum level of aluminum at expiry. The rule allows makers of SVPs and PBPs used in TPN to state in the labeling that the product "contains no more than 25 mcg/L" of aluminum, rather than declare the exact amount. FDA is implementing the rule because of "evidence linking the use of parenteral drug products containing aluminum to morbidity and mortality among patients on TPN therapy, especially premature neonates and patients with impaired kidney function," according to the rule. The rule does not require pharmacists to calculate a patient's total aluminum exposure, according to Jane Axelrad, director of FDA's Office of Regulatory Policy for the Center for Drug Evaluation and Research. The rule applies to drug manufacturers, not to pharmacists, she affirmed. |
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