Listing of Color Additives for Coloring Sutures; D&C Violet No. 2; Confirmation of Effective Date

Streszczenie

The Food and Drug Administration (FDA) is confirming the effective date of August 29, 2000 (65 FR 46342), for the final rule that appeared in the Federal Register of July 28, 2000, and that amended the color additive regulations to provide for the safe use of D&C Violet No. 2 as a color additive in absorbable sutures prepared from homopolymers of glycolide for general surgery. The agency also revised the nomenclature "polyglactin 910 (glycolic-lactic acid polyester)" to the generic nomenclature "copolymers of 90 percent glycolide and 10 percent L-lactide."