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74.3102 FD&C Blue No. 2.

Home > Regulations > Listing of color additives subject to certification > 74.3102 FD&C Blue No. 2.






[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR74.3102]



[Page 419-420]

 

                        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:





[[Page 420]]





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]










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 74, Section 3102


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