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  • 1.  US serialization requirements – apply to free samples?

    Posted 19-Jan-2017 16:56

    The DSCSA serialization requirements come into effect in November of this year, and FDA has made clear in guidance that samples are included in the definition of "product".  Product that is introduced into commerce must be serialized.  What does this group think – are free samples subject to the serialization requirements? 

     

    Thanks for your input!

    ​​​​​

    Catherine M Anderson, PhD, RAC

    Senior Manager, Regulatory Affairs CMC

     



  • 2.  RE: US serialization requirements – apply to free samples?

    Posted 20-Jan-2017 07:08
    No loophole here.  Whether free or not, the samples are introduced into interstate commerce and fall under the requirements of the act.




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  • 3.  RE: US serialization requirements – apply to free samples?

    Posted 21-Jan-2017 12:39
    Agree, the DSCSA applied to samples

    Sent from my iPhone

    Elvira Marquez


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  • 4.  RE: US serialization requirements – apply to free samples?

    Posted 20-Jan-2017 08:14
    Catherine,

    I interpret "free samples" as "distribution of product samples."

    As long as such sample distribution is done by a manufacturer or a licensed wholesale distributor, it is exempt per Section 581(24)(B)(v).

    It is because sample distribution doesn't fall under the term "(DSCSA) transaction" (e.g., change of ownership).  

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567

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