Regulatory Open Forum

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  • 1.  Proposition 65 exposure v composition

    This message was posted by a user wishing to remain anonymous
    Posted 10-Jul-2018 12:49
    This message was posted by a user wishing to remain anonymous

    I would be very grateful if someone could help me to understand what is meant by "exposure" to Nickel means in the context of  Prop 65.
    Does having nickel plated components inside a device and not accessible to a user constitute exposure?  
    Regards
    Mike


  • 2.  RE: Proposition 65 exposure v composition

    Posted 11-Jul-2018 11:15
    ​I would say that if the nickel does not contact the drug product (in the case of a combination product) or the patient/user, then I would say there is no exposure. But you may want to consult your legal department.

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    Rachel Thornton
    Associate Director
    Smyrna GA
    United States
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