A. The system
for numbering drug products should be fixed, so that the
FDA, manufacturers, repackagers, database developers, pharmacists,
patients and other interested parties can all reference
a drug using the same NDC number in a standard format.
B. The NDC
number should be displayed in a standard format on stock
bottles and packages for all dispensed drug products and
prescribed medical supplies. It should also be displayed
on these products in barcode form in a standard format,
possibly within an enhanced UPC barcode.
C. The lot
number and expiration date should be displayed on stock
bottles and packages for all dispensed drug products and
prescribed medical supplies. This information should also
be included in barcode form, within the barcode containing
the NDC number, in a standard format, possibly within an
enhanced UPC barcode.
D. A new
NDC (and barcode) should be assigned when the physical
appearance of the drug or its package changes.
E. A separate
NDC number (and barcode) should be assigned to each drug
package that can be dispensed.
F. There
should be only one barcode on a drug product or prescribed
medical supply item. If the existing UPC barcode cannot
be adapted to meet the needs of these products, a single
unifying barcode standard should be adopted.
SP 200
