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Electronic Code of Federal Regulations
Title 21: Food and Drugs
§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:
(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:
Polyoxyethylene sorbitan monolaurate (20)
(b) Externally applied drugs. Diluents listed in paragraph (a)(1) of this section and the following: