[Code of Federal Regulations]
 [Title 21, Volume 1]
 [Revised as of April 1, 2002]
 From the U.S. Government Printing Office via GPO Access
 [CITE: 21CFR73.1375]
 
 [Page 369-370]
 
                         TITLE 21--FOOD AND DRUGS
 
 CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                                 SERVICES
 
 PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table of Contents
 
                             Subpart B--Drugs
 
 Sec. 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 deg. and 133 deg.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 Sec. 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
 
 [[Page 370]]
 
 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 Sec. 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]