[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: 21CFR73.1410]
 
 [Page 370-371]
 
                         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. 73.1410  Logwood extract.
 
     (a) Identity. The color additive logwood extract is a reddish brown-
 to-black solid material extracted from the heartwood of the leguminous
 tree Haematoxylon campechianum. The active colorant substance is
 principally hematein. The latent coloring material is the unoxidized or
 leuco form of hematein called hematoxylin. The leuco form is oxidized by
 air.
     (b) Specifications. Logwood extract shall conform to the following
 specifications and shall be free from impurities other than those named
 to the extent that such imnurities may be avoided by good manufacturing
 practice:
 
 Volatile matter (at 110 [deg]C), not more than 15 percent.
 Sulfated ash, not more than 20 percent.
 Hematein, not less than 5 percent and not more than 20 percent.
 Lead (as Pb), not more than 70 parts per million.
 Arsenic (as As), not more than 4 parts per million.
 Mercury (as Hg), not more than 3 parts per million.
 
     (c) Use and restrictions. Logwood extract may be safely used to
 color nylon 66 (the copolymer of hexamethylenediamine and adipic acid),
 nylon 6 (the polymer of e-caprolactam), or silk non-absorable sutures
 for use in general and ophthalmic surgery subject to the following
 restrictions:
     (1) The quantity of color additive does not exceed 1.0 percent by
 weight of the suture.
     (2) When the sutures are used for the purposes specified in their
 labeling, there is no migration of the color additive to the surrounding
 tissue.
 
 [[Page 371]]
 
     (3) 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 52393, Sept. 30, 1977; 43 FR 1490, Jan. 10, 1978]