[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: 21CFR73.1001]

[Page 356]
 
                        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. 73.1001  Diluents in color additive mixtures for drug use exempt from certification.


    The following diluents may be safely used in color additive mixtures 
that are exempt from certification and which are to be used for coloring 
drugs, subject to the condition that each straight color in the mixture 
has been exempted from certification or, if not so exempted, is from a 
batch that has previously been certified and has not changed in 
composition since certification. Such listing of diluents is not to be 
construed as superseding any of the other requirements of the Federal 
Food, Drug, and Cosmetic Act with respect to drugs, including new drugs. 
If a definition and specification for a particular diluent is not set 
forth in this subpart, the material shall be of a purity consistent with 
its intended use.
    (a) Ingested drugs--(1) General use. Diluents listed in Sec. 73.1(a) 
and the following:

------------------------------------------------------------------------
                                  Definitions and
          Substances               specifications        Restrictions
------------------------------------------------------------------------
Alcohol, specially denatured..  As set forth in 26   As set forth in 26
                                 CFR, pt. 212.        CFR, pt. 211.
Cetyl alcohol.................  As set forth in
                                 N.F. XI.
Isopropyl alcohol.............    .................  In color coatings
                                                      for pharmaceutical
                                                      forms, no residue.
Polyoxyethylene (20) sorbitan   As set forth in
 monostearate (Polysorbate 60).  sec. 172.836 of
                                 this chapter.
Polyoxyethylene (20) sorbitan   As set forth in
 tristearate (Polysorbate 65).   sec. 172.838 of
                                 this chapter.
Polysorbate 80................  As set forth in
                                 sec. 172.840 of
                                 this chapter.
Polyvinyl-pyrrolidone.........  As set forth in
                                 sec. 173.55 of
                                 this chapter.
Sorbitan monooleate...........
Sorbitan monostearate.........  As set forth in
                                 sec. 172.842 of
                                 this chapter.
Sorbitan triolease............
------------------------------------------------------------------------

    (2) Special use; inks for branding pharmaceutical forms. Items 
listed in paragraph (a)(1) of this section, Sec. 73.1(b)(1)(i), and the 
following:

Ethyl lactate
Polyoxyethylene sorbitan monolaurate (20)

    (b) Externally applied drugs. Diluents listed in paragraph (a)(1) of 
this section and the following:

------------------------------------------------------------------------
                                                  Definitions and
                Substances                         specifications
------------------------------------------------------------------------
Benzyl alcohol...........................  As set forth in N.F. XI.
Ethyl cellulose..........................  As set forth in Sec.  172.868
                                            of this chapter.
Hydroxyethyl cellulose...................
Hydroxypropyl cellulose..................  As set forth in Sec.  172.870
                                            of this chapter.
------------------------------------------------------------------------