Does the SNI include expiration date and/or lot or batch number?
Expiration date and/or lot or batch numbers are not part of the recommended SNI. Expiration date and/or lot or batch numbers are already accessible because FDA regulations require the inclusion of this information on the label of each drug product. (See 21 CFR ยงยง 201.17, 201.18, 211.130, 211.137, 610.60, and 610.61.) In addition, the SNI can be linked to databases containing this and other information. Addition of this information within the SNI will unnecessarily increase the length of, and introduce complexity into, the SNI. However, if a manufacturer or repackager chooses to include expiration date and/or lot or batch number with the SNI, it should ensure that the resulting number still permits users to distinguish and make use of the SNI. For example, expiration date and lot or batch number may be incorporated in accordance with the GS1 standards for use of Global Trade Item Numbers (GTIN)6 (discussed below in Section F).
