[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.