(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 § 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]
Title 21 published on 2012-04-01
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