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73.1001 Diluents in color additive mixtures for drug use exempt from certification.

Home > Regulations > Listing of color additives exempt from certification > 73.1001 Diluents in color additive mixtures for drug use exempt from certification.






[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: 21CFR73.1001]



[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 trioleate............

------------------------------------------------------------------------



    (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.

------------------------------------------------------------------------










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 73, Section 1001


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