21 CFR 73.1085 - Caramel.

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There are 3 Updates appearing in the Federal Register for 21 CFR Part 73. View below or at eCFR (GPOAccess)
§ 73.1085 Caramel.
(a) Identity and specifications.
(1) The color additive caramel shall conform in identity and specifications to the requirements of § 73.85(a) (1), (2), and (3) and (b).
(2) The diluents in color additive mixtures for drug use containing caramel shall be limited to those listed in this subpart as safe and suitable in color additive mixtures for coloring drugs.
(b) Uses and restrictions. Caramel may be used for coloring ingested and topically applied drugs generally in amounts consistent with good manufacturing practice.
(c) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirement of section 721(c) of the act.

Title 21 published on 2014-04-01.

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.

  • 2015-03-20; vol. 80 # 54 - Friday, March 20, 2015
    1. 80 FR 14839 - Listing of Color Additives Exempt From Certification; Synthetic Iron Oxide
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective April 21, 2015. See section X for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by April 20, 2015.
      21 CFR Part 73

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United States Code

Title 21 published on 2014-04-01

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

  • 2015-04-22; vol. 80 # 77 - Wednesday, April 22, 2015
    1. 80 FR 22449 - E. & J. Gallo Winery; Filing of Color Additive Petition
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notice of petition.
      The color additive petition was filed on March 19, 2015.
      21 CFR Part 73