[Code of Federal Regulations]
 [Title 21, Volume 1]
 [Revised as of April 1, 2002]
 From the U.S. Government Printing Office via GPO Access
 [CITE: 21CFR73.1085]
 
 [Page 364]
 
                         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 Contents
 
                             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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