[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.1550]
[Page 368]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 73 LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table of
Subpart B Drugs
Sec. 73.1550 Talc.
(a) Identity. (1) The color additive talc is a finely powdered,
native, hydrous magnesium silicate sometimes containing a small
proportion of aluminum silicate.
(2) Color additive mixtures for drug use made with talc may contain
only those diluents listed in this subpart as safe and suitable for use
in color additive mixtures for coloring drugs.
(b) Specifications. Talc shall meet the specifications for talc in
the United States Pharmacopeia XX (1980) and the following:
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Lead and arsenic shall be determined in the solution obtained by boiling
10 grams of the talc for 15 minutes in 50 milliliters of 0.5N
hydrochloric acid.
(c) Uses and restrictions. Talc may be safely used in amounts
consistent with good manufacturing practice to color drugs generally.
(d) Labeling requirements. The label of the color additive and of
any mixtures prepared therefrom intended solely or in part for coloring
purposes shall conform to the requirements of Sec. 70.25 of this
chapter.
(e) Exemption from certification. Certification of this 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 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984)
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