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

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The Food and Drug Administration (FDA) is further delaying until January 26, 2004, the effective date of a final rule published in the Federal Register of January 26, 2000 (65 FR 4103) (aluminum final rule), and originally scheduled to become effective on January 26, 2001. In the Federal Register of January 26, 2001 (66 FR 7864), the agency delayed the effective date of the aluminum final rule until January 26, 2003. The aluminum final rule imposes certain requirements for aluminum-containing large volume parenterals (LVPs), small volume parenterals (SVPs), and pharmacy bulk packages (PBPs) used in total parenteral nutrition (TPN). FDA is delaying the effective date of the aluminum final rule to allow time for the agency to finalize an amendment to the aluminum final rule. The agency is also amending the aluminum final rule to change to January 26, 2004, the date that limits the use of historical levels to determine the maximum level of aluminum in SVPs and PBPs; this date corresponds to the effective date of the aluminum final rule, which is delayed until January 26, 2004, by this document.