This electronic document was downloaded from the GPO web site, August 2002, and is provided for information purposes only. The Code of Federal Regulations, Title 21, is updated each year in early summer. The most current version of the regulations may be found at the GPO web site or from the current printed version.

 
 [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: 21CFR73.1646]
 
 [Page 372-373]
 
                         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. 73.1646  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<greek-m> (95 percent minimum).
 
 [[Page 373]]
 
 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]


Color Additive Regulations
Foods Home   |   FDA Home   |   Search/Subject Index   |   Disclaimers & Privacy Policy   |   Accessibility/Help