[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: 21CFR73.1095]
 
 [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. 73.1095  <greek-b>-Carotene.
 
     (a) Identity and specifications. (1) The color additive <greek-b>-
 carotene shall conform in identity and specifications to the
 requirements of Sec. 73.95(a)(1) and (b).
     (2) The diluents in color additive mixtures for drug use containing
 <greek-b>-carotene are limited to those listed in this subpart as safe and
 suitable in color additive mixtures for coloring ingested drugs.
     (b) Uses and restrictions. The color additive <greek-b>-carotene may be
 safely used in coloring drugs generally, including those intended for
 use in the area of the eye, in amounts consistent with good
 manufacturing practice.
     (c) Labeling requirements. The labeling of the color additive 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 this color
 additive 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.
 
 [42 FR 15643, Mar. 22, 1977, as amended at 42 FR 33722, July 1, 1977]