From: Michael E. Coughlin, President and CEO, ScriptPro
Date: July 26, 2002
Re: Food and Drug Administration (FDA), HHS, Public Meeting
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Barcode Label Requirements for Human Drug
Products
July 26,
2002, from 9 a.m. to 5 p.m.
Natcher Auditorium, Building 45
National Institutes of Health, Bethesda,
MD
RECOMMENDATIONS
FOR THE DEVELOPMENT OF A REGULATION ON BARCODE LABELING FOR
HUMAN DRUG PRODUCTS, INCLUDING BIOLOGIC PRODUCTS
INDEX
TO APPENDICES
APPENDIX
A. - PRESCRIPTION DISPENSING PROCESS
APPENDIX
B. - MULTI-VERSION DRUG PROBLEM
APPENDIX
C. - DISTRIBUTOR RELABELING PROBLEM
APPENDIX
D. - EXTERIOR-INTERIOR PACKAGING PROBLEM
APPENDIX
E. - BARCODE AND NDC COMPLETELY DIFFERENT
APPENDIX
F. - DIFFERENT 11-DIGIT NDCs PRODUCE SAME 10-DIGIT NDC
APPENDIX
G. - BARCODE TRANSLATION TO NDC PROBLEM
APPENDIX
H. - PACK SIZE INDICATES PROPERTY OF PRODUCT
APPENDIX
I. - MULTIPLE BARCODES REFERENCE SAME DRUG
APPENDIX
J. - VARIOUS TYPES OF BARCODES ON DRUGS AND MEDICAL SUPPLIES
APPENDIX
K. - TWO DIFFERENT DRUGS APPEAR AS ONLY DIFFERENT PACKAGE SIZES