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

View all text of Subpart B [§ 73.1001 - § 73.1991]

§ 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 § 73.1(a) and the following:

Substances	Definitions and specifications	Restrictions	Alcohol, specially denatured	As set forth in 26 CFR, pt. 212	As set forth in 26 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 monostearate (Polysorbate 60)	As set forth in sec. 172.836 of this chapter		Polyoxyethylene (20) sorbitan tristearate (Polysorbate 65)	As set forth in 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, § 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:

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