Amendment of Regulations on Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition

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The Food and Drug Administration (FDA) proposes to amend its regulations to change the labeling requirements concerning aluminum in small volume parenterals (SVPs) and pharmacy bulk packages (PBPs) used in total parenteral nutrition (TPN). FDA proposes that the immediate container labels of SVPs and PBPs containing 25 micrograms per liter (mcg/L) or less of aluminum may state: "Contains no more than 25 mcg/L of aluminum" instead of stating the exact amount of aluminum they contain. FDA is taking this action in response to a request from industry.