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 lactatePolyoxyethylene 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.------------------------------------------------------------------------