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73.1070 Calcium carbonate.

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[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR73.1070]



[Page 358]

 

                        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]



[[Page 359]]










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 73, Section 1070


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