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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2018]
[CITE: 21CFR74.1102]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL

PART 74 -- LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION

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 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 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 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]

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