[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: 21CFR73.1645]
[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. 73.1645 Aluminum powder.
(a) Identity. (1) The color additive aluminum powder shall be
composed of finely divided particles of aluminum prepared from virgin
aluminum. It is free from admixture with other substances.
(2) Color additive mixtures for external drug use made with aluminum
powder may contain only those diluents listed in this subpart as safe
and suitable in color additive mixtures for coloring externally applied
drugs.
(b) Specifications. Aluminum 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:
Fineness, 100 percent shall pass through a 200-mesh screen and 95
percent shall pass through a 325-mesh screen.
Mercury, not more than 1 part per million.
Arsenic, not more than 3 parts per million.
Lead, not more than 20 parts per million.
Aluminum, not less than 99 percent.
(c) Uses and restrictions. Aluminum powder is safe for use in
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 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 38563, July 29, 1977]
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