[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.1030]

[Page 358]
 
                        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. 73.1030  Annatto extract.

    (a) Identity and specifications. (1) The color additive annatto 
extract shall conform in identity and specifications to the requirements 
of Sec. 73.30(a)(1) and (b).
    (2) Color additive mixtures for drug use made with annatto extract 
may contain only those diluents that are suitable and that are listed in 
this subpart as safe in color additive mixtures for coloring ingested 
drugs.
    (b) Uses and restrictions. Annatto extract may be safely used for 
coloring drugs generally, including those intended for use in the area 
of the eye, in amounts consistent with good manufacturing practice.
    (c) Labeling. The label of the color additive and any mixtures 
prepared therefrom and intended solely or in part for coloring purposes 
shall conform to the requirements of Sec. 70.25 of this chapter. Labels 
shall bear information showing that the color is derived from annatto 
seed. The requirements of Sec. 70.25(a) of this chapter that all 
ingredients shall be listed by name shall not be construed as requiring 
the declaration of residues of solvents listed in Sec. 73.30(a)(1)(ii) 
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 evempt from the certification requirements 
of section 721(c) of the act.

[42 FR 15643, Mar. 22, 1977, as amended at 42 FR 36994, July 19, 1977]