Parenteral Rule Delayed
by Erik Swain, Senior Editor
FDA has further delayed implementation of a rule imposing new requirements on aluminum-containing, large-volume parenterals (LVPs), small-volume parenterals (SVPs), and pharmacy bulk packages (PBPs) used in total parenteral nutrition.
The rule would mandate certain labeling requirements for such products, restrict the amount of aluminum allowed in LVPs, and require applicants to submit FDA-validated assay methods for determining aluminum content in parenterals. The rule was scheduled to be implemented January 26, 2003, but will now take effect January 26, 2004.
The reason for the delay is that FDA proposed an amendment to the new rule on August 12, 2002. The amendment would allow SVPs and PBPs containing 25 micro g/L or less of aluminum to state, "Contains no more than 25 micro g/L of aluminum" on the label, rather than specify the exact amount. The agency says there was not enough time to finalize the amendment before January 2003, so an implementation delay was necessary. Enforcement of the rule had already been pushed back a year once before.