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74.1102 FD&C Blue No. 2.

Home > Regulations > Listing of color additives subject to certification > 74.1102 FD&C Blue No. 2.






[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: 21CFR74.1102]



[Page 393]

 

                        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.  74.1102  FD&C Blue No. 2.



    (a) Identity. (1) The color additive FD&C Blue No. 2 shall conform 

in identity to the requirements of Sec.  74.102(a)(1).

    (2) Color additive mixtures for use in ingested drugs made with FD&C 

Blue No. 2 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 drugs.

    (b) The color additive FD&C Blue No. 2 for use in coloring ingested 

drugs shall conform to the specifications in Sec.  74.102(b).

    (c) The color additive FD&C Blue No. 2 may be safely used for 

coloring ingested drugs in amounts consistent with current good 

manufacturing practice.

    (d) 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.

    (e) Certification. All batches of FD&C Blue No. 2 shall be certified 

in accordance with regulations in part 80 of this chapter.



[48 FR 5260, Feb. 4, 1983, as amended at 49 FR 10090, Mar. 19, 1984; 64 

FR 48290, Sept. 3, 1999]










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 74, Section 1102


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