[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: 21CFR73.1150]
 
 [Page 366]
 
                         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. 73.1150  Dihydroxyacetone.
 
     (a) Identity. (1) The color additive dihydroxyacetone is 1,3-
 dihydroxy-2-propanone.
     (2) Color additive mixtures for drug use made with dihydroxyacetone
 may contain only those diluents that are listed in this subpart as safe
 and suitable in color additive mixtures for coloring externally applied
 drugs.
     (b) Specifications. Dihydroxyacetone 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:
 
 Volatile matter (at 34.6 deg.C. for 3 hours at a pressure of not more
 than 30 mm. mercury), not more than 0.5 percent.
 Residue on ignition, not more than 0.4 percent.
 Lead (as Pb), not more than 20 parts per million.
 Arsenic (as As), not more than 3 parts per million.
 Iron (as Fe), not more than 25 parts per million.
 1,3-dihydroxy-2-propanone, not less than 98 percent.
 
     (c) Uses and restrictions. Dihydroxyacetone may be safely used in
 amounts consistent with good manufacturing practice in externally
 applied drugs intended solely or in part to impart a color to the human
 body. Authorization for this use shall not be construed as waiving any
 of the requirements of section 505 of the act with respect to the drug
 in which it is used.
     (d) Labeling requirements. The label of the color additive and any
 mixtures 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 this 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.