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74.1303 FD&C Red No. 3.

Home > Regulations > Listing of color additives subject to certification > 74.1303 FD&C Red No. 3.






[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: 21CFR74.1303]



[Page 398-399]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 74_LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION--Table of 

Contents

 

                             Subpart B_Drugs

 

Sec.  74.1303  FD&C Red No. 3.



    (a) Identity and specifications. (1) The color additive FD&C Red No. 

3 shall conform in identity and specifications to the requirements of 

Sec.  74.303(a)(1) and (b).



[[Page 399]]



    (2) Color additive mixtures for ingested drug used made with FD&C 

Red No. 3 may contain only those diluents that are suitable and that are 

listed in part 73 of this chapter as safe for use in color additive 

mixtures for coloring ingested drugs.

    (b) Uses and restrictions. FD&C Red No. 3 may be safely used for 

coloring ingested drugs in amounts consistent with good manufacturing 

practice.

    (c) Labeling. The label of the color additive and any mixtures 

prepared therefrom intended solely or in part for coloring purposes 

shall conform to the requirements of Sec.  70.25 of this chapter.

    (d) Certification. All batches of FD&C Red No. 3 shall be certified 

in accordance with regulations in part 80 of this chapter.










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 74, Section 1303


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