FDA Amends Requirements for Two Red Dyes Used in Drugs & Cosmetics
The Food and Drug Administration amended its requirements for D&C Red No. 6 and D&C Red No. 7 by replacing the current specification for “Ether-soluble matter” with a maximum limit of 0.015 percent for the recently identified impurity 1-[(4-methylphenyl)azo]-2-naphthalenol, in…
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response to a petition filed by Sun Chemical Corp, it said in a final rule. The rule is effective August 7, 2012, except for any provisions that may be stayed by the filing of proper objections. Such objections and requests for hearings may be submitted by August 6, 2012.