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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[CITE: 21CFR73.1001]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A - GENERAL

PART 73 -- LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

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 § 73.1(a) and the following:

Substances Definitions and specifications Restrictions
Alcohol, specially denaturedAs set forth in 26 CFR, pt. 212As set forth in 26 CFR, pt. 211.
Cetyl alcoholAs 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 80As set forth in sec. 172.840 of this chapter
Polyvinyl-pyrrolidoneAs set forth in sec. 173.55 of this chapter
Sorbitan monooleate
Sorbitan monostearateAs 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 alcoholAs set forth in N.F. XI.
Ethyl celluloseAs set forth in § 172.868 of this chapter.
Hydroxyethyl cellulose
Hydroxypropyl celluloseAs set forth in § 172.870 of this chapter.
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