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 Nguyen
    Saint Louis MO
    United States

  • 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.


    Steven Pavlik
    Aidarex Pharmaceuticals, LLC
    Corona, CA