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: 21CFR73.3105]
[Page 383]
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. 73.3105 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione.
(a) Identity. The color additive is 1,4-bis[(2-methylphenyl)amino]-
9,10-anthracenedione (CAS Reg. No. 6737-68-4).
(b) Uses and restrictions. (1) The substance listed in paragraph (a)
of this section may be used as a color additive in contact lenses in
amounts not to exceed the minimum reasonably required to accomplish the
intended coloring effect.
(2) Authorization and compliance with this use 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). A
person intending to introduce a device containing 1,4-bis[(2-
methylphenyl)amino]-9,10-anthracenedione listed under this section into
commerce shall submit to the Food and Drug Administration either a
premarket notification in accordance with subpart E of part 807 of this
chapter, if the device is not subject to premarket approval, or submit
and receive approval of an original or supplemental premarket approval
application if the device is subject to premarket approval.
(c) Labeling. The label of the color additive shall conform to the
requirements of Sec. 70.25 of this chapter.
(d) Exemption from certification. Certification of this color
additive is not necessary for the protection of the public health, and
therefore the color additive is exempt from the certification
requirements of section 721(c) of the act.
[49 FR 30066, July 26, 1984]