[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: 21CFR73.1070]

[Page 364]
 
                        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. 73.1070  Calcium carbonate.

    (a) Identity. (1) The color additive calcium carbonate is a fine, 
white, synthetically prepared powder consisting essentially of 
precipitated calcium carbonate (CaCO3).
    (2) Color additive mixtures for drug use made with calcium carbonate 
may contain only those diluents listed in this subpart as safe and 
suitable for use in color additive mixtures for coloring drugs.
    (b) Specifications. Calcium carbonate shall meet the specifications 
for precipitated calcium carbonate in the United States Pharmacopeia XX 
(1980).
    (c) Uses and restrictions. Calcium carbonate may be safely used in 
amounts consistent with good manudacturing 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.

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