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Paul J. Larsen, Esq. CHPA Associate General Counsel & Secretary (Speaker)

Paul J. Larsen, Esq. CHPA Associate General Counsel & Secretary (Speaker). FDA Public Meeting – Proposed Changes to the National Drug Code (NDC) Number System December 11, 2006. Key Points. CHPA supports the development of an interactive, electronic system Potential benefits include –

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Paul J. Larsen, Esq. CHPA Associate General Counsel & Secretary (Speaker)

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  1. Paul J. Larsen, Esq.CHPA Associate General Counsel & Secretary(Speaker) FDA Public Meeting – Proposed Changes to the National Drug Code (NDC) Number System December 11, 2006

  2. Key Points • CHPA supports the development of an interactive, electronic system • Potential benefits include – • Increased efficiency • Detection/prevention of errors and omissions • CHPA supports the existing NDC number system • CHPA recommendations • Adoption of a stepwise approach • Issuance of draft guidance and technical specifications • CHPA would like to work with FDA

  3. Benefits of the Existing NDC Number System • The current system affords needed flexibility • No pre-market review by FDA needed for OTC monograph drugs • Timely consumer access • Early assignment of NDC numbers • Trade channel requirements • Short-term promotional SKUs

  4. Benefits of the Existing NDC Number System • Avoid confusion and delays in case of product changes • Changes after the request for an NDC number is submitted • Multiple NDC numbers and requests • Changes after the product has an NDC number or is in the marketplace • Internal records • Manufacturing and control documents • Embedded UPC • New labels

  5. Benefits of the Existing NDC Number System • No need for inactive ingredient information in the existing NDC number system • Changes in inactive ingredient information can occur regularly for any number of reasons • Avoids confusion and delays which would occur if multiple NDC numbers had to be requested and assigned for the same product • Over-inclusive inactive ingredient labeling is allowed • Existing regulatory and related requirements are adequate

  6. Need for revision of the “appropriate NDC number” • Definition of “manufacturing” • Four functional types • “Specification developers” not covered under this definition • Unable to obtain NDC number • Contract manufacturer “forcibly” delegated this authority • CHPA encourages FDA to revise the proposed definition of “manufacturer” • To include specification developers

  7. Extend Timeframe for Reviewing and Updating Information for Listed Drugs Beyond 9 Months • Proposed timeframe is inadequate because – • Many products affected • Complexity of the proposal’s NDC number requirements • Products with multiple inactive ingredient combinations • Information entered by FDA into the drug listing database is itself not up-to-date

  8. Human-readable NDC Number on the Label • Concur with the Eastern Research Group findings • Space on the label concerns • Allow the use of “N” or “NDC” • Requiring the NDC number on secondary packaging • May create additional burdens for labeling of 2-in-1s

  9. Conclusion • CHPA supports an interactive, electronic system • Utilizes current NDC number system • Would serve FDA, the regulated industry, and the American consumer • Stepwise approach coupled with draft guidance and technical specifications • Look forward to working together

  10. Contact Information • Paul J. Larsen, Esq. CHPA Associate General Counsel & Secretary (202) 429-9260 plarsen@chpa-info.org Thank you, FDA

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