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: 21CFR73.3100]
 
 [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. 73.3100  1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester copolymers.
 
     (a) Identity. The color additives are 1,4-bis[(2-
 hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester (CAS Reg.
 No. 109561-07-1) copolymerized either with glyceryl methacrylate, methyl
 methacrylate, and ethylene glycol dimethacrylate monomers, or with N, N-
 dimethyl acrylamide, methyl methacrylate, and ethylene glycol
 dimethacrylate 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 the contact lens 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.
 
 [61 FR 51586, Oct. 3, 1996]


Color Additive Regulations
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