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: 21CFR73.1327]
 
 [Page 368-369]
 
                         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 B--Drugs
 
 Sec. 73.1327  Chromium oxide greens.
 
     (a) Identity. (1) The color additive chromium oxide greens is
 principally chromic sesquioxide (Cr<INF>2</INF>O<INF>3</INF>).
     (2) Color additive mixtures for drug use made with chromium oxide
 greens may contain only those diluents listed in this subpart as safe
 and suitable for use in color additive mixtures for coloring drugs.
     (b) Specifications. the color additive chormium oxide greens shall
 conform to the following specifications and shall be free from
 impurities other
 
 [[Page 369]]
 
 than those named to the extent that such impurities may be avoided by
 good manufacturing practice:
 
 Chromium in 2% NaOH extract, not more than 0.075% as
 Cr<INF>2</INF>O<INF>3</INF> (based on sample weight).
 Arsenic (as As), not more than 3 parts per million.
 Lead (as Pb), not more than 20 parts per million.
 Mercury (as Hg), not more than 1 part per million.
 Cr<INF>2</INF>O<INF>3,</INF> not less than 95%.
 
     (c) Uses and restrictions. Chromium oxide greens is safe for use in
 coloring externally applied drugs, including those intended for use in
 the area of eye, in amounts consistent with good manufacturing practice.
     (d) Labeling. The color additive and any mixture prepared therefrom
 intended solely or in part for coloring purposes shall bear, in addition
 to any information required by law, labeling in accordance with
 Sec. 70.25 of this chapter.
     (e) Exemption from certification. Certification of this color
 additive is not necessary for the protection of the public health, and
 therefore batches therof are exempt from certification pursuant to
 section 721(c) of the act.
 
 [42 FR 36451, July 15, 1977]


Color Additive Regulations
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