Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 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.

Where this section sits in the code

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

(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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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