Code of Federal Regulations Title 21. Food and Drugs § 21.73.1647 Copper powder

(a) Identity.

(b) Specifications.Copper powder 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 practice:

Stearic or oleic acid, not more than 5 percent.

Cadmium (as Cd), not more than 15 parts per million.

Lead (as Pb), not more than 20 parts per million.

Arsenic (as As), not more than 3 parts per million.

Mercury (as Hg), not more than 1 part per million.

Copper (as Cu), not less than 95 percent.

Maximum particle size 45μ (95 percent minimum).

(c) Uses and restrictions.Copper powder may be safely used in coloring externally applied drugs, including those intended for use in the area of the eye, in amounts consistent with good manufacturing practice.

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

(e) Exemption from certification. Certification of the color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.