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Code of Federal Regulations Title 21. Food and Drugs § 21.73.1001 Diluents in color additive mixtures for drug use exempt from certification

Current as of January 02, 2025 | Updated by Findlaw Staff

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.
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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.73.1001 Diluents in color additive mixtures for drug use exempt from certification - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-73-1001/

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