21 CFR 73.1350 - Mica-based pearlescent pigments.

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There are 6 Updates appearing in the Federal Register for 21 CFR 73. View below or at eCFR (GPOAccess)
§ 73.1350 Mica-based pearlescent pigments.
(a) Identity.
(1) The color additive is formed by depositing titanium and/or iron salts onto mica, followed by heating to produce one of the following combinations: Titanium dioxide on mica; iron oxide on mica; titanium dioxide and iron oxide on mica. Mica used to manufacture the color additive shall conform in identity to the requirements of § 73.1496(a)(1).
(2) Color additive mixtures for drug use made with mica-based pearlescent pigments may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring ingested drugs.
(b) Specifications. Mica-based pearlescent pigments shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice:
(1) Lead (as Pb), not more than 4 parts per million (ppm).
(2) Arsenic (as As), not more than 3 ppm.
(3) Mercury (as Hg), not more than 1 ppm.
(c) Uses and restrictions. Mica-based pearlescent pigments may be safely used to color ingested drugs in amounts up to 3 percent, by weight, of the final drug product. The maximum amount of iron oxide to be used in producing said pigments is not to exceed 55 percent, by weight, in the finished pigment.
(d) Labeling. The label of the color additive and of any mixture prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.
(e) 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 requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act.
[70 FR 42273, July 22, 2005. Redesignated at 72 FR 10357, Mar. 8, 2007]

Title 21 published on 2013-04-01

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.

  • 2013-11-15; vol. 78 # 221 - Friday, November 15, 2013
    1. 78 FR 68713 - Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; confirmation of effective date.
      The effective date for the final rule published August 13, 2013 (78 FR 49117), is confirmed as September 13, 2013.
      21 CFR Part 73

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United States Code

Title 21 published on 2013-04-01

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

  • 2013-11-15; vol. 78 # 221 - Friday, November 15, 2013
    1. 78 FR 68713 - Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; confirmation of effective date.
      The effective date for the final rule published August 13, 2013 (78 FR 49117), is confirmed as September 13, 2013.
      21 CFR Part 73