[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: 21CFR74.3102]
 
[Page 424]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                                SERVICES
 
PART 74--LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION--Table of Contents
 
                       Subpart D--Medical Devices
 
Sec. 74.3102  FD&C Blue No. 2.
 
    (a) Identity. The color additive FD&C Blue No. 2 shall conform in
identity to the requirements of Sec. 74.102(a)(1).
    (b) Specifications. (1) The color additive FD&C Blue No. 2 for use
in coloring surgical sutures 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 current good
manufacturing practice:
 
    Sum of volatile matter at 135 deg.C (275 deg.F) and chlorides and
sulfates (calculated as sodium salts), not more than 15 percent.
    Water insoluble matter, not more than 0.4 percent.
    Isatin-5-sulfonic acid, not more than 0.4 percent.
    Isomeric colors, not more than 18 percent.
    Lower sulfonated subsidiary colors, not more than 5 percent.
    Lead (as Pb), not more than 10 parts per million.
    Arsenic (as As), not more than 3 parts per million.
    Total color, not less than 85 percent.
 
    (2) The color additive FD&C Blue No. 2-Aluminum Lake on alumina for
use in bone cement shall be prepared in accordance with the requirements
of Sec. 82.51 of this chapter.
    (c) Uses and restrictions. (1) The color additive FD&C Blue No. 2
may be safely used for coloring nylon (the copolymer of adipic acid and
hexamethylene diamine) surgical sutures for use in general surgery
subject to the following restrictions:
    (i) The quantity of color additive does not exceed 1 percent by
weight of the suture;
    (ii) The dyed suture shall conform in all respects to the
requirements of the United States Pharmacopeia XX (1980); and
    (iii) When the sutures are used for the purposes specified in their
labeling, the color additive does not migrate to the surrounding
tissues.
    (2) The color additive FD&C Blue No. 2-Aluminum Lake on alumina may
be safely used for coloring bone cement at a level not to exceed 0.1
percent by weight of the bone cement.
    (3) Authorization and compliance with these uses shall not be
construed as waiving any of the requirements of sections 510(k), 515,
and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to
the medical device in which the color additive FD&C Blue No. 2 and the
color additive FD&C Blue No. 2-Aluminum Lake on alumina are used.
    (d) Labeling. The labels of the color additive FD&C Blue No. 2 and
the color additive FD&C Blue No. 2-Aluminum Lake on alumina shall
conform to the requirements of Sec. 70.25 of this chapter.
    (e) Certification. All batches of FD&C Blue No. 2 and its lake shall
be certified in accordance with regulations in part 80 of this chapter.
 
[64 FR 48290, Sept. 3, 1999]