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: 21CFR74.1303]

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. 74.1303 FD&C Red No. 3.

(a) Identity and specifications. (1) The color additive FD&C Red No. 3 shall conform in identity and specifications to the requirements of § 74.303(a)(1) and (b).

(2) Color additive mixtures for ingested drug used made with FD&C Red No. 3 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 ingested drugs.

(b) Uses and restrictions. FD&C Red No. 3 may be safely used for coloring ingested drugs in amounts consistent with good manufacturing practice.

(c) 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.

(d) Certification. All batches of FD&C Red No. 3 shall be certified in accordance with regulations in part 80 of this chapter.