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73.1550 Talc.

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[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: 21CFR73.1550]



[Page 366]

 

                        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.  73.1550  Talc.



    (a) Identity. (1) The color additive talc is a finely powdered, 

native, hydrous magnesium silicate sometimes containing a small 

proportion of aluminum silicate.

    (2) Color additive mixtures for drug use made with talc may contain 

only those diluents listed in this subpart as safe and suitable for use 

in color additive mixtures for coloring drugs.

    (b) Specifications. Talc shall meet the specifications for talc in 

the United States Pharmacopeia XX (1980) and the following:



Lead (as Pb), not more than 20 parts per million.

Arsenic (as As), not more than 3 parts per million.





Lead and arsenic shall be determined in the solution obtained by boiling 

10 grams of the talc for 15 minutes in 50 milliliters of 0.5N 

hydrochloric acid.

    (c) Uses and restrictions. Talc may be safely used in amounts 

consistent with good manufacturing practice to color drugs generally.

    (d) Labeling requirements. The label of the color additive and of 

any mixtures prepared therefrom intended solely or in part for coloring 

purposes 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 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984)










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 73, Section 1550


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