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74.1101 FD&C Blue No. 1

Home > Regulations > Listing of color additives subject to certification > 74.1101 FD&C Blue No. 1






[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: 21CFR74.1101]



[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.  74.1101  FD&C Blue No. 1





    (a) Identity. (1) For ingested drugs, the color additive FD&C Blue 

No. 1 shall conform in identity to the requirements of Sec.  

74.101(a)(1).

    (2) For externally applied drugs, the color additive FD&C Blue No. 1 

shall conform in identity to the requirements of Sec.  74.2101(a).

    (3) Color additive mixtures for drug use made with FD&C Blue No. 1 

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) Specifications. (1) The color additive FD&C Blue No. 1 for use 

in coloring drugs generally shall conform in specifications to the 

requirements of Sec.  74.101(b).

    (2) FD&C Blue No. 1 Aluminum Lake shall be prepared in accordance 

with the requirements of Sec.  82.51 of this chapter.

    (c) Uses and restrictions. (1) FD&C Blue No. 1 may be safely used 

for coloring drugs, including drugs intended for use in the area of the 

eye, in amounts consistent with current good manufacturing practice.

    (2) FD&C Blue No. 1 Aluminum Lake may be safely used for coloring 

drugs intended for use in the area of the eye, in amounts consistent 

with current good manufacturing practice, subject to the restrictions on 

the use of color additives in Sec.  70.5(b) and (c) of this chapter.

    (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. 1 shall be certified 

in accordance with regulations in part 80 of this chapter.



[47 FR 42565, Sept. 28, 1982, as amended at 59 FR 7638, Feb. 16, 1994]










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 74, Section 1101


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