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  • 1.  Bar code requirements for Pharmaceuticals - is GS1 registration required?

    Posted 08-Aug-2014 13:34
    Hello:

    I know that devices are required to have a UDI.  However, reviewing the guidance for pharmaceuticals, it does not indicate that GS1 registration is required.  It appears, based on a fair bit of web research, that GS1 is the only organization that is FDA approved to create a GTIN for pharmaceuticals.  Does anyone know of any other organizations capable of creating GTINs which are FDA acceptable?  Are GTINs required by the FDA for pharmaceuticals, or just recommended?  I look forward to your input.  

    Sincerely,
    Shawn

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    J. Shawn Roach
    Associate Director of Regulatory Affairs
    Clinipace Worldwide, Inc.
    Boulder CO
    United States
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  • 2.  RE: Bar code requirements for Pharmaceuticals - is GS1 registration required?

    Posted 08-Aug-2014 14:40
    Shawn,

    Yes for securing the drug supply chain as reflected in the finalized FDA guidance (issued March 2010 or here at http://wp.me/p2EoXX-1j4). However for biological products, ISBT 128 standards can be used, the ISBT 128 of which can also be used for applicable devices.

    This is to meet the requirements set out in the Act 505(D) and 21 USC 355e at http://www.regulatorydoctor.com/fdc-act-sec-505d-21-usc-355e-pharmaceutical-security/

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    President and CEO | REGULATORY DOCTOR
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