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CFR › Title 21 › Chapter I › Subchapter A › Part 73 › Subpart B › Section 73.1375

21 CFR 73.1375 - Pyrogallol.

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§ 73.1375
Pyrogallol.
(a) Identity. The color additive pyrogallol is 1,2,3-trihydroxybenzene.
(b) Specifications. Pyrogallol shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:
Melting point, between 130° and 133 °C.
Residue on ignition, not more than 0.1 percent.
Lead (as Pb), not more than 20 p/m (parts per million).
Arsenic (as As), not more than 3 p/m.
(c) Uses and restrictions. Pyrogallol may be safely used in combination with ferric ammonium citrate (as listed in § 73.1025 ), for coloring plain and chromic catgut sutures for use in general and ophthalmic surgery, subject to the following restrictions:
(1) The dyed suture shall conform in all respects to the requirements of the United States Pharmacopeia XX (1980).
(2) The level of the ferric ammonium citrate-pyrogallol complex shall not exceed 3 percent of the total weight of the suture material.
(3) When the sutures are used for the purposes specified in their labeling, there is no migration of the color additive to the surrounding tissues.
(4) If the suture is a new drug, an approved new drug application, pursuant to section 505 of the act, is in effect for it.
(d) Labeling. The label of the color additive 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 act.
[42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984]

Title 21 published on 2012-04-01

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.

  • 2013-04-01; vol. 78 # 62 - Monday, April 1, 2013
    1. 78 FR 19413 - Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective May 2, 2013. See section VII for related information on the filing of objections. Submit either electronic or written objections and requests for a hearing by May 1, 2013.
      21 CFR Part 73

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.

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United States Code
USC : Title 21 - FOOD AND DRUGS

§ 321 - Definitions; generally

§ 341 - Definitions and standards for food

§ 342 - Adulterated food

§ 343 - Misbranded food

§ 348 - Food additives

§ 351 - Adulterated drugs and devices

§ 352 - Misbranded drugs and devices

§ 355 - New drugs

§ 361 - Adulterated cosmetics

§ 362 - Misbranded cosmetics

§ 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics

Title 21 published on 2012-04-01

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

  • 2013-04-01; vol. 78 # 62 - Monday, April 1, 2013
    1. 78 FR 19413 - Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective May 2, 2013. See section VII for related information on the filing of objections. Submit either electronic or written objections and requests for a hearing by May 1, 2013.
      21 CFR Part 73