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Experience with NDC Numbers

Experience with NDC Numbers. Manufacturer Packager/ Repackager Labeler/ Relabeler Distributor Private Label Distributors Trained by the FDA Participated in e-drug listing pilot program List with FDA on a quarterly basis ~ 7000 active NDC numbers.

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Experience with NDC Numbers

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  1. Experience with NDC Numbers • Manufacturer • Packager/ Repackager • Labeler/ Relabeler • Distributor • Private Label Distributors • Trained by the FDA • Participated in e-drug listing pilot program • List with FDA on a quarterly basis • ~ 7000 active NDC numbers

  2. Complexity Factors that Change NDC Numbers Today • Acquisitions • Changes in signature lines • Product reformulations that involve active ingredient changes • Private Label Distributor changes vendor

  3. Supply Chain Scenario Present Day Example

  4. Added Complexities of the Proposed RuleAdditional Factors That Will Change NDC Numbers • Change in inactive ingredients • Change in manufacturers • Change in contract packagers

  5. Supply Chain Scenario Proposed Rule Example

  6. Current Process: 90 NDC numbers to manage Infrequent NDC changes One label/size/PLD Able to react to product supply needs to prevent retail shortages $90K/ label conversion Proposed Process: 360 NDC numbers to manage Increase in frequency of changing NDC numbers Multiple labels/size/PLD Unable to react to product supply needs resulting in retail shortages $360K/label conversion Impact of Added ComplexityAn Average Product: 30 Customers, 3 Size Codes/Customer

  7. RESULT Volume + Complexity = Increase in Possibility of Errors

  8. Recommendations • Maintain the current rules for assigning NDC numbers • Remove the ability for Private Label Distributors to assign NDC numbers and drug list • Implement the electronic drug listing • Invest in education regarding current requirements • Offer FDA led classes • Guidance documents

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