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National Drug Codes for HCT/Ps

National Drug Codes for HCT/Ps. Public Meeting December 11, 2006 M. Allene Carr-Greer, MT, ASCP(SBB) Deputy Director, Regulatory Affairs, AABB. AABB America’s Blood Centers American Red Cross American Society for Blood and Marrow Transplantation Foundation for the Accreditation of

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National Drug Codes for HCT/Ps

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  1. National Drug Codes for HCT/Ps Public Meeting December 11, 2006 M. Allene Carr-Greer, MT, ASCP(SBB) Deputy Director, Regulatory Affairs, AABB

  2. AABB • America’s Blood Centers • American Red Cross • American Society for Blood and Marrow Transplantation • Foundation for the Accreditation of Cellular Therapy • ICCBBA • International Society for Cellular Therapies • National Marrow Donor Program

  3. Hematopoietic Progenitor Cells HPC, APHERESIS HPC, CORD BLOOD HPC, WHOLE BLOOD Therapeutic Cells TC, APHERESIS TC, WHOLE BLOOD TC, CORD BLOOD TC-T CELLS TC- CTL TC- T REG CELLS TC- DC TC- NK CELLS TC- TUMOR DERIVED TC- MSC TC-APC

  4. 21 CFR Part 201, Subpart A, Section 201.25 (d) Can a drug be exempted from the bar code requirement? (1) On our own initiative, or in response to a written request from a manufacturer, repacker, relabeler or private label distributor, we may exempt a drug product from the bar code label requirements set forth in this section. The exemption request must document why: ….; or an alternative regulatory program or method of product use renders the bar code unnecessary for patient safety.

  5. Bar Code Rule and Hematopoietic Progenitor Cells / Therapeutic Cells • NDC - Square Peg for a Round Hole • ISBT 128 Standard • Negative Impact of Implementing NDCs

  6. Square Peg for a Round Hole • Biological nature of HPCs and TCs • Variable contents of HPCs and TCs • HPCs and TCs are not mass-produced • HPCs and TCs do not fit the NDC system • Overly burdensome with no increase to patient safety • NDC number is not a useful reference in any federally maintained database - products are infused / transplanted by the time the NDC number is available.

  7. ISBT 128 Standard • Greater benefits and increase to patient safety than an NDC • Globally unique product identifier • Cellular Therapy Coding and Labeling Advisory Group - AABB, ASBMT, EBMT, FACT, ICCBBA, ISBT/SITS, ISCT, ISCT Europe, JACIE, NMDP and WMDA • Industry familiarity with ISBT 128 • Excellent traceability and trackability of products • Contains more information than the NDC code

  8. Negative Impact of Implementing NDCs on HPCs and TCs • Current information systems cannot accommodate the NDC system • Small package size of some products will not accommodate the NDC label • Loss of standardization • Multiple products and attributes of cellular products are not easily managed • Overly burdensome and duplicative with no increase to patient safety • Loss of confidentiality

  9. NDC - no increase in patient safety. • Implementing NDC will interfere with progress on ISBT 128 • Tracking using two different labeling systems will • Have a negative impact on patient safety • Introduce opportunities for error • NDC will not replace the need to use ISBT 128

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