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New (Draft) Guidance on Standardized Numerical Identification (SNI) for Drug Products

During drug development and/or during the review of a submission, FDA regulations may change.  Changes can be made immediately or they can appear as drafts.  Proposed regulations or guidances are presented in draft form to seek public comment.  In any case, it is important to monitor any changes – actual or proposed, to assure the success of your drug development program.

In order to comply with the Food and Drug Administration Act of 2007, and to take one of a number of incremental steps to enhance the security of the drug supply chain against counterfeit, diverted, sub-potent, substandard, adulterated, misbranded, or expired drugs, FDA has proposed in a draft guidance that firms employ a serialized NDC number on all individual drug packages.  The number would consist of the NDC number for the product an 8 digit serial number:

NDC                                                      SERIAL NUMBER

                        5555566677                         +                               11111111

Labeler code + product code +package code               unique 8 digit for package

The FDA expects that this SNI would be presented on each package in both human readable and machine readable form.    FDA does not specify a location other than it does not obstruct any FDA required labeling information.