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Guidance Issuing OfficeCenter for Drug Evaluation and Research
Aluminum toxicity in parenteral nutrition (PN) represents a major safety concern, necessitating that PN products meet the requirements in 21 CFR 201.323 for aluminum content and labeling. Per the regulation, aluminum content of large volume parenteral (LVP) drug products used in total parenteral nutrition (TPN) therapy must not exceed 25 micrograms per liter (mcg/L). In contrast, the limits for the aluminum content of small volume parenteral (SVP) drug products and pharmacy bulk packages (PBPs) used in PN are not specified by statute or regulation. Further, the International Council for Harmonisation (ICH) has not established a permitted daily exposure (PDE) for aluminum.
To address this lack of information, this guidance clarifies the key factors in determining the aluminum content in an SVP drug product and/or a PBP intended as a component of PN and provides FDA’s recommendations regarding the aluminum concentration limits in SVP drug products and PBPs for PN.