Labeling Requirements Changed for Parenteral Products
06/03/2003
Federal Register Final rule: 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 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 1/26/00 Federal Register is delayed until 7/26/04. The agency is taking these actions in response to a request from industry. To view this notice, click here.
