[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: 21CFR73.1200]
 
 [Page 366-367]
 
                         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. 73.1200  Synthetic iron oxide.
 
     (a) Identity. (1) The color additive synthetic iron oxide consists
 of any one or any combination of synthetically prepared iron oxides,
 including the hydrated forms. It is free from admixture with other
 substances.
 
 [[Page 367]]
 
     (2) Color additive mixtures for drug use made with synthetic iron
 oxide may contain only those diluents listed in this subpart as safe and
 suitable in color additive mixtures for coloring drugs.
     (b) Specifications. Synthetic iron oxide shall conform to the
 following specifications, all on an ``as is'' basis:
 
 Arsenic (as As), not more than 3 parts per million.
 Lead (as Pb), not more than 10 parts per million.
 Mercury (as Hg), not more than 3 parts per million.
 
     (c) Uses and restrictions. The color additive synthetic iron oxide
 may be safely used to color ingested or topically applied drugs
 generally subject to the restriction that if the color additive is used
 in drugs ingested by man the amount consumed in accordance with labeled
 or prescribed dosages shall not exceed 5 milligrams, calculated as
 elemental iron, per day.
     (d) Labeling requirements. The label of the color additive and any
 mixtures intended solely or in part for coloring purposes prepared
 therefrom 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.