[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: 21CFR73.1647]
[Page 369-370]
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. 73.1647 Copper powder.
(a) Identity. (1) The color additive copper powder is a very fine
free-flowing metallic powder prepared from virgin electrolytic copper.
It contains
[[Page 370]]
small amounts of stearic or oleic acid as lubricants.
(2) Color additive mixtures for drug use made with copper 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. Copper 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.
Copper (as Cu), not less than 95 percent.
Maximum particle size 45[micro] (95 percent minimum).
(c) Uses and restrictions. Copper powder may be safely used in
coloring 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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