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: 21CFR74.3708]

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 D - Medical Devices

Sec. 74.3708 D&C Yellow No. 8.

(a) Identity and specifications. The color additive D&C Yellow No. 8 shall conform in identity and specifications to the requirements of § 74.1708(a)(1) and (b).

(b) Uses and restrictions. (1) D&C Yellow No. 8 may be safely used for coloring contact lens solution for coloring disposable daily-wear hydrogel-based soft (hydrophilic) contact lenses at a level not to exceed 0.044 percent in the contact lens solution. Following excitation by ultraviolet light, the colored contact lenses fluoresce a yellow-green color. The contact lens solution colored with D&C Yellow No. 8 is distributed by prescription only and used in accordance with the supplied directions for use. Contact lens solutions containing D&C Yellow No. 8 are intended for use only for coloring contact lenses that are worn for infrequent, celebratory occasions, and not for regular or daily use.

(2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens solution in which the color additive is used.

(c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.

(d) Certification. All batches of D&C Yellow No. 8 shall be certified in accordance with regulations in part 80 of this chapter.

[83 FR 48375, Sept. 25, 2018]