This electronic document was downloaded from the GPO web site, August 2002,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated each year in early summer.
The most current version of the regulations may be found at the
GPO web site or from the current
printed version.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.3106]
[Page 383-384]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table of Contents
Subpart D--Medical Devices
Sec. 73.3106 1,4-Bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone copolymers.
(a) Identity. The color additive is 1,4-bis[4-(2-methacryloxyethyl)
phenylamino]anthraquinone (CAS Reg. No. 121888-69-5), copolymerized with
hydroxyethyl methacrylate monomer, or a blend of hydroxyethyl
methacrylate and N-vinyl pyrrolidone monomers, or a blend of 3-
[tris(trimethylsiloxy)silyl]propyl vinyl
[[Page 384]]
carbamate (CAS Reg. No. 134072-99-4) and N-vinyl pyrrolidone monomers to
form the contact lens material.
(b) Uses and restrictions. (1) The substances listed in paragraph
(a) of this section may be used in amounts not to exceed the minimum
reasonably required to accomplish the intended coloring effect.
(2) Authorization and compliance with 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 (the act) with
respect to contact lenses made from the color additives.
(c) Labeling. The label of the color additives shall conform to the
requirements of Sec. 70.25 of this chapter.
(d) Exemption from certification. Certification of these color
additives is not necessary for the protection of the public health and,
therefore, the color additives are exempt from the certification
requirements of section 721(c) of the act.
[58 FR 17507, Apr. 5, 1993, as amended at 60 FR 10497, Feb. 27, 1995]