About GPO   |   Newsroom/Media   |   Congressional Relations   |   Inspector General   |   Careers   |   Contact   |   askGPO   |   Help  
 
Home   |   Customers   |   Vendors   |   Libraries  

The Electronic Code of Federal Regulations (e-CFR) is a regularly updated, unofficial editorial compilation of CFR material and Federal Register amendments produced by the National Archives and Records Administration's Office of the Federal Register (OFR) and the Government Printing Office.

Parallel Table of Authorities and Rules for the Code of Federal Regulations and the United States Code
Text | PDF

Find, review, and submit comments on Federal rules that are open for comment and published in the Federal Register using Regulations.gov.

Purchase individual CFR titles from the U.S. Government Online Bookstore.

Find issues of the CFR (including issues prior to 1996) at a local Federal depository library.

[2]
 
 

Electronic Code of Federal Regulations

e-CFR Data is current as of April 16, 2014

Title 21: Food and Drugs
PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
Subpart B—Drugs


§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]



For questions or comments regarding e-CFR editorial content, features, or design, email ecfr@nara.gov.
For questions concerning e-CFR programming and delivery issues, email webteam@gpo.gov.