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: 21CFR73.3125]
[Page 389]
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. 73.3125 Iron oxides.
(a) Identity and specifications. The color additive iron oxides (CAS
Reg. No. 977053-38-5), Color Index No. 77491, shall conform in identity
and specifications to the requirements of Sec. 73.2250 (a) and (b).
(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 with respect to
the contact lens in which the additive is used.
(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.
[51 FR 24816, July 9, 1986]