Listing of Color Additives for Coloring Bone Cement; FD&C Blue No. 2-Aluminum Lake on Alumina

Resumen

The Food and Drug Administration (FDA) is amending the color additive regulations to provide for the safe use of FD&C Blue No. 2- Aluminum Lake on alumina to color bone cement. This action responds to a petition filed by Biomet, Inc. The agency also is transferring the listing for FD&C Blue No. 2 in sutures to reflect the suture in which this color additive is used are devices not drugs.