[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: 21CFR73.1010]

[Page 362]
 
                        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. 73.1010  Alumina (dried aluminum hydroxide).

    (a) Identity. (1) The color additive alumina (dried aluminum 
hydroxide) is a white, odorless, tasteless, amorphous powder consisting 
essentially of aluminum hydroxide (Al2 O3[middot] 
XH2 O).
    (2) Color additive mixtures for drug use made with alumina (dried 
aluminum hydroxide) may contain only those diluents listed in this 
subpart as safe and suitable for use in color additive mixtures for 
coloring drugs.
    (b) Specifications. Alumina (dried aluminum hydroxide) shall conform 
to the following specifications:

Acidity or alkalinity: Agitate 1 gram of the color additive with 25 
milliliters of water and filter. The filtrate shall be neutral to litmus 
paper.
Matter insoluble in dilute hydrochloric acid, not more than 0.5 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 1 part per million.
Mercury (as Hg), not more than 1 part per million.
Aluminum oxide (Al2 O3), not less than 50 percent.

    (c) Uses and restrictions. Alumina (dried aluminum hydroxide) may be 
safely used in amounts consistent with good manufacturing practice to 
color drugs generally.
    (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 the certification requirements 
of section 721(c) of the act.