21 CFR 74.1208
§ 74.1208 D&C Green No. 8.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 74.1208, § 74.1208 D&C Green No. 8, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83753
- Permanent ID
ys:prov:83753@1- SHA-256
c8f6b8c018fc4bd02010b2692646eb36b12777e19d9ac318154adb8ed0cacf5f
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) Identity.
(1) The color additive D&C Green No. 8 is principally the trisodium salt of 8-hydroxy-1,3,6-pyrene-trisulfonic acid.
(2) Color additive mixtures for use in externally applied drugs made with D&C Green No. 8 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs.
(b) Specifications. D&C Green No. 8 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practices:
(c) Uses and restrictions. D&C Green No. 8 may be safely used in externally applied drugs in amounts not exceeding 0.01 percent by weight of the finished product.
(d) 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.
(e) Certification. All batches of D&C Green No. 8 shall be certified in accordance with regulations in part 80 of this chapter.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.