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

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§ 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.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code

Title 21 published on 2015-12-03

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 73 after this date.

  • 2016-12-14; vol. 81 # 240 - Wednesday, December 14, 2016
    1. 81 FR 90267 - Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry; Availability
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notification of availability.
      Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 13, 2017.
      21 CFR Part 73
The section you are viewing is cited by the following CFR sections.

Title 21 published on 2015-12-03.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2016-11-01; vol. 81 # 211 - Tuesday, November 1, 2016
    1. 81 FR 75689 - Listing of Color Additives Exempt From Certification; Titanium Dioxide and Listing of Color Additives Subject to Certification; [Phthalocyaninato (2-)] Copper
      GPO FDSys: XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective December 2, 2016. See section IX for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by December 1, 2016.
      21 CFR Parts 73 and 74