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?

    Ruth Collins RAC
    Senior Regulatory Affairs Associate
    Euless TX
    United States

  • 2.  RE: Labels on cartons

    Posted 18-Sep-2015 17:40

    You are referring to 21 CFR 201.7, which has been repealed.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

    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


    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

    Franky Dubois
    Regulatory Officer