[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: 21CFR73.1647]
 
 [Page 373]
 
                         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. 73.1647  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 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<greek-m> (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]