Regulatory Open Forum

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  • 1.  Environmental Impact Statement

    Posted 30-Nov-2016 10:38

    Hi Team,

    We are a second pharmaceutical packager. We don't take an ownership of a product. We were asked to provide Environmental Impact Statement. We have been providing cGMP Statement and Debarment Statement for CBE-30. However, I am not familiar with Environmental Impact Statement. Could someone please help me out if we do need to provide it as a second packager?

    Any feedback is much appreciated!

    Thanks,
    Trish

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    Trish Nguyen
    Saint Louis MO
    United States
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  • 2.  RE: Environmental Impact Statement

    Posted 01-Dec-2016 12:46

    Hi, Trish,

    According to the Office of NEPA Policy and Compliance "Environmental Impact Statements are detailed written statements that are required by section 102(2)(C) of NEPA for a proposed major Federal action significantly affecting the quality of the human environment."

    Who is asking for this statement and what is the context?

    It is common for regulatory bodies to request information regarding your manufacturing environment and controls.  I would think the DoE would not be looking for this statement from you as being a second packager does not constitute a proposed major Federal action significantly affecting the quality of the human environment.  If it is, the Office of NEPA Policy and Compliance has examples of statements you can use as a template on their website.  Before you do that, though, I would recommend you may ask them for clarification on why they are asking for this statement and why they think you are proposing such a significant action as to require the statement.

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    John Minier RAC
    Sr. Regulatory Compliance Consultant
    JMC Medical, LLC
    Highland Mills NY
    United States

    Original Message


  • 3.  RE: Environmental Impact Statement

    Posted 06-Dec-2016 02:21
      |   view attached

    Hi Trisha,

    See 21 CFR 25.15 for agency actions requiring environmental consideration. For human drugs, applications not requiring environmental assessment are listed in 21 CFR 25.31.

    Contents of an environmental impact statement are described in 21 CFR 25.42. See attached guidance for further information on applications that require a statement and how to prepare the statement.

    Kandarp

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    Kandarp Shah PHD
    Regulatory Affairs Specialist
    Yorba Linda CA
    United States

    Attachment(s)

    pdf
    1730fnl.pdf   187 KB 1 version
    Original Message


  • 4.  RE: Environmental Impact Statement

    This message was posted by a user wishing to remain anonymous
    Posted 02-May-2018 12:46
    This message was posted by a user wishing to remain anonymous

    ​Hello everyone,

    Could you kindly tell me if a similar guidance or any other guidance to assess the environmental impact of a biologic product in Canada?

    Thank you for your help!
    Original Message