Code of Federal Regulations: 21 CFR 74.3106

This electronic document was downloaded from the GPO web site, September 2002, and is provided for information purposes only. The Code of Federal Regulations, Title 21, is updated each year in early summer. The most current version of the regulations may be found at the GPO web site or from the current printed version.

[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: 21CFR74.3106] [Page 424-425] 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. 74.3106 D&C Blue No. 6. (a) Identity. The color additive D&C Blue No. 6 is principally [[<greek-D><greek-e><greek-l><greek-t><greek-a>]Y2,2' -biindoline]-3,3' dione (CAS Reg. No. 482-89-3). (b) Specifications. D&C Blue No. 6 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: Volatile matter at 135 deg.C (275 deg.F), not more than 3 percent. Matter insoluble in N,N- dimethylformamide, not more than 1 percent. Isatin, not more than 0.3 percent. Anthranilic acid, not more than 0.3 percent. Indirubin, not more than 1 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 95 percent. (c) Uses and restrictions. (1) D&C Blue No. 6 may be safely used at a level-- [[Page 425]] (i) Not to exceed 0.2 percent by weight of the suture material for coloring polyethylene terephthalate surgical sutures for general surgical use; (ii) Not to exceed 0.25 percent by weight of the suture material for coloring plain or chromic collagen absorbable sutures for general surgical use; (iii) Not to exceed 0.5 percent by weight of the suture material for coloring plain or chromic collagen absorbable sutures for ophthalmic surgical use; (iv) Not to exceed 0.5 percent by weight of the suture material for coloring polypropylene surgical sutures for general surgical use; and (v) Not to exceed 0.5 percent by weight of the suture material for coloring polydioxanone synthetic absorbable sutures for ophthalmic and general surgical use. (2) Authorization for 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 is used. (d) Labeling. The label of the color additive shall conform to the requirements of Sec. 70.25 of this chapter. (e) Certification. All batches of D&C Blue No. 6 shall be certified in accordance with regulations in part 80 of this chapter. [49 FR 29956, July 25, 1984; 49 FR 34447, Aug. 31, 1984, as amended at 50 FR 30698, July 29, 1985]