[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: 21CFR74.3230]
[Page 423]
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. 74.3230 D&C Red No. 17.
(a) Identity and specifications. The color additive D&C Red No. 17
shall conform in identity and specifications to the requirements of
Sec. 74.1317(a)(1) 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 lens in
amounts not to exceed the minimum reasonably required to accomplish the
intended coloring effect.
(2) Authorization for this use shall not be construed as waiving any
of the requirements of section 510(k), 515, and 520(g) of the Federal
Food, Drug, and Cosmetic Act with respect to the contact lens 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 Red No. 17 shall be certified
in accordance with regulations in part 80 of this chapter.
[55 FR 22898, June 5, 1990]
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