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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2019]
[CITE: 21CFR73.1647]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL

PART 73 -- LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

Subpart B--Drugs

Sec. 73.1647 Copper powder.

(a) Identity. (1) The color additive copper powder is a very fine free-flowing metallic powder prepared from virgin electrolytic copper. It contains small amounts of stearic or oleic acid as lubricants.

(2) Color additive mixtures for drug use made with copper powder may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring externally applied drugs.

(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 45[micro] (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.

[42 FR 33723, July 1, 1977]

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