[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: 21CFR73.1150]
[Page 362]
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. 73.1150 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.
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