Listing of Color Additives for Coloring Bone Cement; FD&C Blue No. 2-Aluminum Lake on Alumina
fda-food · Food and Drug Administration · Rule · Published 1999-09-03 · Effective 1999-10-05 · 64 FR 48288
Document
Document number
99-22994
Federal Register citation
64 FR 48288
CFR reference
21 CFR 74
Type
Rule
Action
Final rule.
Category
fda-food
Sub-agency
Food and Drug Administration
Publication date
1999-09-03
Effective date
1999-10-05
HHS docket
Docket No. 92C-0348
Abstract
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.