Listing of Color Additives for Coloring Sutures; D&C Violet No. 2
fda-food · Food and Drug Administration · Rule · Published 2000-07-28 · Effective 2000-08-29 · 65 FR 46342
Document
Document number
00-19047
Federal Register citation
65 FR 46342
CFR reference
21 CFR 74
Type
Rule
Action
Final rule.
Category
fda-food
Sub-agency
Food and Drug Administration
Publication date
2000-07-28
Effective date
2000-08-29
HHS docket
Docket No. 99C-1455
Abstract
The Food and Drug Administration (FDA) is amending 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 is also revising the nomenclature "polyglactin 910 (glycolic-lactic acid polyester)" to the generic nomenclature "copolymers of 90 percent glycolide and 10 percent L-lactide." This action responds to a petition filed by Genzyme Surgical Products Corp.