FDA’s November 5th hearing on the future format of the NDC is now complete and the industry is surprisingly in sync.
Overwhelmingly the presenters, including RXTransparent have chosen to shelve all three of the stop gap proposals for dealing with the upcoming depletion of the drug manufacturer labeler codes and recommend moving to a harmonized 12 digit format. There are approximately 20,000 labeler codes remaining within the current 5-4-2 NDC format. FDA notified the participants at the hearing and online that once the 5 digit labeled codes are depleted they will immediately begin releasing a six digit labeler code. FDA estimates that at the rate of new drug manufacturer requests the current pool of 20,000 labeler codes will be depleted in the next 10 to 15 years. FDA solicited stakeholders to submit short presentations to the Agency in order to get a broad cross section of industry opinions.
Presentations were given by drug companies, solutions providers(RXTransparent), regulatory organizations (GS1), Non-profit industry associations like the National Association of Chain Drug Stores and data service providers like First Data Bank. The implementation of a 12 digit NDC will create problems with the new serialized bar code and the GTIN standard from GS1, these issues will be need to addressed in future meetings. RXTransparent had the opportunity to add our voice to this hearing, the replay of our presentation can be found online at:
Prior to this public hearing we conducted an informal survey of our social media contacts and in a few short days we gathered over 150 responses. The link to the survey results is available on our website:
If you would like to add your feedback to FDA’s public docket you can do so by clicking here.