[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR74.3602]
[Page 423-424]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 74 LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION--Table of Contents
Subpart D Medical Devices
Sec. 74.3602 D&C Violet No. 2.
(a) Identity and specifications. The color additive D&C Violet No. 2
shall conform in identity and specifications to the requirements of
Sec. 74.1602(a)(1) and (b).
(b) Uses and restrictions. (1) The color additive, D&C Violet No. 2,
may be safely used for coloring contact lenses in amounts not to exceed
the minimum reasonably required to accomplish the intended coloring
effect.
(2) D&C Violet No. 2 may be safely used for coloring sutures for use
in surgery subject to the following conditions:
(i) At a level not to exceed 0.2 percent by weight of the suture
material for coloring copolymers of 90 percent glycolide and 10 percent
L-lactide synthetic absorbable sutures for use in general and ophthalmic
surgery; and
(ii) At a level not to exceed 0.3 percent by weight of the suture
material for coloring polydioxanone synthetic absorbable sutures for use
in general and ophthalmic surgery.
(iii) At a level not to exceed 0.25 percent by weight of the suture
material for coloring poliglecaprone 25 ([egr]-caprolactone/glycolide
copolymer) synthetic absorbable sutures for use in general surgery.
(iv) At a level not to exceed 0.1 percent by weight of the suture
material for coloring poly([epsi]-caprolactone) absorbable sutures for
use in general surgery.
(v) At a level not to exceed 0.2 percent by weight of the suture
material for coloring glycolide/dioxanone/trimethylene carbonate
tripolymer absorbable sutures for use in general surgery.
(vi) At a level not to exceed 0.2 percent by weight of the suture
material
[[Page 424]]
for coloring absorbable sutures prepared from homopolymers of glycolide
for use in general surgery.
(3) The color additive, D&C Violet No. 2, may be safely used for
coloring polymethylmethacrylate intraocular lens haptics at a level not
to exceed 0.2 percent by weight of the haptic material.
(4) The color additive, D&C Violet No. 2, may be safely used for
coloring absorbable meniscal tacks made from poly (L-lactic acid) at a
level not to exceed 0.15 percent by weight of the tack material.
(5) Authorization for these uses shall not be construed as waiving
any of the requirements of sections 510(k), 515, and 520(g) of the
Federal Food, Drug, and Cosmetic Act with respect to the medical devices
in which the color additive is used.
(c) Labeling. The label of the color additive shall conform to the
requirements of Sec. 70.25 of this chapter.
(d) Certification. All batches of D&C Violet No. 2 shall be
certified in accordance with regulations in part 80 of this chapter.
[52 FR 19722, May 27, 1987, as amended at 55 FR 18868, May 7, 1990; 58
FR 60109, Nov. 15, 1993; 59 FR 11720, Mar. 14, 1994; 63 FR 20098, Apr.
23, 1998; 64 FR 32805, June 18, 1999; 65 FR 46344, July 28, 2000]
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