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

Resumen

The Food and Drug Administration (FDA) is confirming the effective date of October 5, 1999 (64 FR 48288), for the final rule that appeared in the Federal Register of September 3, 1999, and that amended the color additive regulations to provide for the safe use of FD&C Blue No. 2-Aluminum Lake on alumina to color bone cement. The agency also transferred the listing for the use of FD&C Blue No. 2 in sutures to reflect that sutures in which this color additive is used are devices, not drugs.