Regulatory Open Forum

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  • 1.  Labels on cartons

    Posted 18-Sep-2015 15:00

    We are having a discussion regarding the contents of carton labels. We have a prescription drug product we are going to submit which is in a glass bottle and then packaged individually in a carton to which a pharmacist can attach a label. The label on the bottle contains all the required information like lot and expiration. We found 21 CFR 201.7 which requires the expiration date on the carton. We cannot find a CFR reference for the lot. Does anyone know if we are required to put the lot number on the carton if it is already on the bottle?

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    Ruth Collins RAC
    Senior Regulatory Affairs Associate
    Euless TX
    United States
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  • 2.  RE: Labels on cartons

    Posted 18-Sep-2015 17:40
    Ruth,

    You are referring to 21 CFR 201.7, which has been repealed.

    To answer your questions, please refer to 21 CFR Sections 201.10, -18, -26, -100. 

    You may refer to 2015 version of 21 CFR Part 201 in PDF at https://www.globalcomplianceseminar.com/21-cfr-part-201-labeling/

    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
    Phone (Toll-Free): 1-(800) 321-8567


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  • 3.  RE: Labels on cartons

    Posted 21-Sep-2015 01:53

    Hello,

    even if this is not yet mandatory now, it will be fully introducced by the UDI (unique device ientification)  introduction. This implementation is now already ongoing for class I and will become in place for class II by next year september.

    This is for medical devices, but I belive also for pharma

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    Franky Dubois
    Regulatory Officer
    Barco
    Kortrijk
    Belgium
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