[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]