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73.1085 Caramel.

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[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR73.1085]



[Page 359]

 

                        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.










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 73, Section 1085


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