[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: 21CFR73.1327]
[Page 365]
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
Subpart B Drugs
Sec. 73.1327 Chromium oxide greens.
(a) Identity. (1) The color additive chromium oxide greens is
principally chromic sesquioxide (Cr2O3).
(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 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
Cr2O3 (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.
Cr2O3, 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]
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