[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 73_LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table
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
(c) Uses and restrictions. Calcium carbonate may be safely used in
amounts consistent with good manudacturing practice to color drugs
(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
(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]
Additives that reference this regulation: