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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 2020.

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, 2020]
[CITE: 21CFR74.1340]



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. 74.1340 FD&C Red No. 40.

(a) Identity and specifications. (1) The color additive FD&C red No. 40 shall conform in identity and specifications to the requirements of § 74.340(a)(1) and (b).

(2) Color additive mixtures for drug use made with FD&C red No. 40 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.

(3) The listing of this color additive includes lakes prepa red as described in §§ 82.51 and 82.1051 of this chapter, except that the color additive used is FD&C red No. 40 and the resultant lakes meet the specification and labeling requirements prescribed by §§ 82.51 or 82.1051 of this chapter.)

(b) Uses and restrictions. (1) FD&C red No. 40 and FD&C red No. 40 Aluminum Lake may be safely used in coloring drugs, including those intended for use in the area of the eye, subject to the restrictions on the use of color additives in § 70.5(b) and (c) of this chapter, in amounts consistent with current good manufacturing practice.

(2) Other lakes of FD&C red No. 40 may be safely used in coloring drugs, subject to the restrictions on the use of color additives in § 70.5 of this chapter, in amounts consistent with current good manufacturing practice.

(c) Labeling. The label of the color additive and any lakes or mixtures prepa red therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.

(d) Certification. All batches of FD&C red No. 40 and lakes thereof shall be certified in accordance with regulations, in part 80 of this chapter.

[42 FR 15654, Mar. 22, 1977, as amended at 59 FR 7636, Feb. 16, 1994]

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