[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. [[Page 365]]