[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: 21CFR73.1646]
[Page 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
Subpart B Drugs
Sec. 73.1646 Bronze powder.
(a) Identity. (1) The color additive bronze powder is a very fine
metallic powder prepared from alloys consisting principally of virgin
electrolytic copper and zinc with small amounts of the virgin metals
aluminum and tin. It contains small amounts of stearic or oleic acid as
lubricants.
(2) Color additive mixtures for drug use made with bronze powder may
contain only those diluents listed in this subpart as safe and suitable
for use in color additive mixtures for coloring externally applied
drugs.
(b) Specifications. Bronze powder 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:
Stearic or oleic acid, not more than 5 percent.
Cadmium (as Cd), not more than 15 parts per million.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million
Aluminum (as Al), not more than 0.5 percent.
Tin (as Sn), not more than 0.5 percent.
Copper (as Cu), not more than 95 percent and not less than 70 percent.
Zinc (as Zn), not more than 30 percent.
Maximum particle size 45[micro] (95 percent minimum).
Aluminum, zinc, tin, and copper content shall be based on the weight of
the dried powder after being thoroughly washed with ether.
(c) Uses and restrictions. Bronze powder may be safely used in color
externally applied drugs, including those intended for use in the area
of the 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 conform to the
requirements of Sec. 70.25 of this chapter.
(e) Exemption from certification. Certification of the color
additive is not necessary for the protection of the public health, and
therefore batches thereof are exempt from the certification requirements
of section 721(c) of the act.
[42 FR 33723, July 1, 1977]
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