[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.