[Code of Federal Regulations]
 [Title 21, Volume 1]
 [Revised as of April 1, 2002]
 From the U.S. Government Printing Office via GPO Access
 [CITE: 21CFR74.1101]
 
 [Page 397-398]
 
                         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
 
 [[Page 398]]
 
 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]