CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

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

[Code of Federal Regulations]

[Title 21, Volume 1]

[CITE: 21CFR74.1706]

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. 74.1706 FD&C Yellow No. 6.

(a) Identity and specifications. (1) The color additive FD&C Yellow No. 6 shall conform in identity and specifications to the requirements of § 74.706(a)(1) and (b).

(2) Color additive mixtures for drug use made with FD&C Yellow No. 6 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) Uses and restrictions. FD&C Yellow No. 6 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice.

(c) Labeling requirements. (1) The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of § 70.25 of this chapter.

(2) [Reserved]

(d) Certification. All batches of FD&C Yellow No. 6 shall be certified in accordance with regulations in part 80 of this chapter.

[51 FR 41782, Nov. 19, 1986, as amended at 52 FR 21508, June 8, 1987; 53 FR 49138, Dec. 6, 1988]