[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: 21CFR73.1299]

[Page 367-368]
 
                        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. 73.1299  Ferric ferrocyanide.

    (a) Identity. (1) The color additive ferric ferrocyanide is a ferric 
hexacyanoferrate pigment characterized by the structual formula 
Fe4[Fe(CN)6]3[middot]XH2O, 
which may contain small amounts of ferric sodium ferrocyanide and ferric 
potassium ferrocyanide.

[[Page 368]]

    (2) Color additive mixtures for drug use made with ferric 
ferrocyanide may contain only those diluents listed in this subpart as 
safe and suitable for use in color additive mixtures for coloring drugs.
    (b) Specifications. Ferric ferrocyanide 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:

Water soluble cyanide, not more than 10 parts per million.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Nickel (as Ni), not more than 200 parts per million.
Cobalt (as Co), not more than 200 parts per million.
Mercury (as Hg), not more than 1 part per million.
Oxalic acid, not more than 0.1 percent.
Water soluble matter, not more than 3 percent.
Volatile matter, not more than 10 percent.
Total iron (as Fe corrected for volatile matter), not less than 37 
percent and not more than 45 percent.

    (c) Uses and restrictions. Ferric ferrocyanide may be safely used in 
amounts consistent with good manufacturing practice to color externally 
applied drugs including those intended for use in the area of the eye.
    (d) Labeling requirements. The label of the color additive and of 
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 certification requirements of 
section 721(c) of the act.

[43 FR 54235, Nov. 21, 1978]