[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: 21CFR73.1645]
 
 [Page 372]
 
                         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. 73.1645  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]