Amendment of Regulations on Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition; Delay of Effective Date

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The Food and Drug Administration (FDA) is amending 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). The immediate container labels of SVPs and PBPs containing 25 micrograms per liter ([mu]g/L) or less of aluminum may state: "Contains no more than 25 [mu]g/L of aluminum" instead of stating the exact amount of aluminum they contain. In addition, the final rule revises the aluminum regulations to reflect the fact that the effective date of the final rule published in the Federal Register of January 26, 2000 (65 FR 4103) (the January 2000 final rule) is delayed until July 26, 2004. The agency is taking these actions in response to a request from industry.