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

The Food and Drug Administration (FDA) is delaying until January 26, 2003, the effective date of a final rule published in the Federal Register of January 26, 2000 (65 FR 4103), and originally scheduled to become effective on January 26, 2001. The final rule amends FDA's regulations to add certain labeling requirements for aluminum content in large volume parenterals (LVP's), small volume parenterals (SVP's), and pharmacy bulk packages (PBP's) used in total parenteral nutrition (TPN). The rule also specifies an upper limit of aluminum permitted in LVP's and requires applicants to submit to FDA validated assay methods for determining aluminum content in parenteral drug products. FDA is delaying the effective date of this rule to address concerns raised by affected parties about the possible inability to meet the requirements of the rule by the current effective date.