Regulatory Open Forum

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  • 1.  Unit of Use vs. Unit of Dose

    Posted 17-Nov-2016 10:07

    Hi All,

    I have advised my new co-worker that Unit of Use signifies bottling and Unit of Dose signifies blistering. I was not able to look it up on the FDA's website. Can someone please provide some supporting document?

    Thank you in advance for your help!
    Trish

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    Trish Nguyen
    Saint Louis MO
    United States
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  • 2.  RE: Unit of Use vs. Unit of Dose

    Posted 18-Nov-2016 10:39

    Hi Trisha,

       CPG Sec 430.100 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms 

    The above link should support what you need there.  Working for a pharmaceutical repackager, you are correct, unit of use is bottling, and unit does usually signifies blisters.

    Best,

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    Steven Pavlik
    Aidarex Pharmaceuticals, LLC
    Corona, CA