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]


Color Additive Regulations
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