CFR - Code of Federal Regulations Title 21

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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: 21CFR74.3710]

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. 74.3710 D&C Yellow No. 10.

(a) Identity. The color additive D&C Yellow No. 10 shall conform to the identity requirements of § 74.1710(a).

(b) Specifications. The color additive D&C Yellow No. 10 for use in contact lenses shall conform to the specifications of § 74.1710(b).

(c) Uses and restrictions. (1) The color additive D&C Yellow No. 10 may be used for coloring contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.

(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 in which the color additive is used.

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

(e) Certification. All batches of D&C Yellow No. 10 shall be certified in accordance with regulations in part 80 of this chapter.

[52 FR 28690, Aug. 3, 1987]