[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: 21CFR73.1025]

[Page 363]
 
                        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. 73.1025  Ferric ammonium citrate.

    (a) Identity. The color additive ferric ammonium citrate consists of 
complex chelates prepared by the interaction of ferric hydroxide with 
citric acid in the presence of ammonia. The complex chelates occur in 
brown and green forms, are deliquescent in air, and are reducible by 
light.
    (b) Specifications. Ferric ammonium citrate 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:

Iron (as Fe), not less than 14.5 percent and not more than 18.5 percent.
Lead (as Pb), not more than 20 p/m.
Arsenic (as As), not more than 3 p/m.

    (c) Uses and restrictions. Ferric ammonium citrate may be safely 
used in combination with pyrogallol (as listed in Sec. 73.1375), for 
coloring plain and chromic catgut sutures for use in general and 
ophthalmic surgery subject to the following conditions:
    (1) The dyed suture shall conform in all respects to the 
requirements of the United States Pharmacopeia XX (1980).
    (2) The level of the ferric ammonium citrate-pyrogallol complex 
shall not exceed 3 percent of the total weight of the suture material.
    (3) When the sutures are used for the purposes specified in their 
labeling, there is no migration of the color additive to the surrounding 
tissue.
    (4) If the suture is a new drug, an approved new drug application, 
pursuant to section 505 of the act, is in effect for it.
    (d) Labeling. The labeling of the color-additive 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 requirements of section 
721(c) of the act.

[42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984]