(a) Identity. The color additive FD&C Blue No. 2 shall conform in identity to the requirements of § 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 °C (275 °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 § 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 § 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]
Title 21 published on 2012-04-01
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