Regulatory Open Forum

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  • 1.  Minimum labeling for blisters

    Posted 16-Aug-2016 18:50

    I've gotten conflicting information regarding the minimum labeling required on a blister.  I have a client with blister card of three tablets, card goes into a box.  They are trying to fit lots of info on the card including drug name, company name, city, state, zip, the word's "push through," lot number, expiration date and, these days, the UID.  What really is required when all of this can be easily put on the box the card comes in?

     

    Christopher Smith, CQE, RAC

    President, Coastal Pharmaceutical Consultants, Inc. ®

    7950 Old River Road, Burgaw, NC 28425 USA

    910-259-8877 (land)

    910-789-1232 (mobile)

    chrissmith@coastalpharmaconsultants.com

     



  • 2.  RE: Minimum labeling for blisters

    Posted 18-Aug-2016 13:36

    Most of the users normally throw away the box and keep the blisters (I know, I do that all that time). That is why it is important to have the critical information like Drug name,lot number and expiry date on the blister itself. All the information that you have listed is required on the label by various sections of the regulation and managing the label real estate is always a challenge.

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    Prema Chandra
    Lawrence MA

    Original Message