[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: 21CFR73.1085]
[Page 361]
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. 73.1085 Caramel.
(a) Identity and specifications. (1) The color additive caramel
shall conform in identity and specifications to the requirements of
Sec. 73.85(a) (1), (2), and (3) and (b).
(2) The diluents in color additive mixtures for drug use containing
caramel shall be limited to those listed in this subpart as safe and
suitable in color additive mixtures for coloring drugs.
(b) Uses and restrictions. Caramel may be used for coloring ingested
and topically applied drugs generally in amounts consistent with good
manufacturing practice.
(c) 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 requirement
of section 721(c) of the act.
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