[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: 21CFR73.1100]
 
 [Page 365]
 
                         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. 73.1100  Cochineal extract; carmine.
 
     (a) Identity and specifications. (1) The color additives cochineal
 extract and carmine shall conform in identity and specifications to the
 requirements of Sec. 73.100(a) (1) and (2) and (b).
     (2) Color additive mixtures for drug use made with carmine and
 cochineal extract may contain only those diluents that are suitable and
 that are listed in this subpart as safe in color additive mixtures for
 coloring drugs.
     (b) Uses and restrictions. Cochineal extract and carmine may be
 safely used for coloring ingested and externally applied drugs in
 amounts consistent with good manufacturing practice.
     (c) Labeling requirements. The label of the color additives and any
 mixtures intended solely or in part for coloring purposes prepared
 therefrom shall conform to the requirements of Sec. 70.25 of this
 chapter.
     (d) Exemption from certification. Certification of these color
 additives 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.