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Medication Deferral List Revisions, Submit Comments and Questions

Updates to the MDL

The Medication Deferral List (MDL) Working Group (WG) is a sub group of the AABB Donor History Task Force (DHTF) and maintains the MDL. The MDL WG proposes updates to the MDL, which are then reviewed for approval by the DHTF.

The MDL WG uses several resources to identify new concerns that require evaluation for risks associated with blood donation. In some cases, it is unlikely that a drug would be used by blood donors, however, off-label use of a drug for reasons other than approved by FDA is possible.

The MDL WG:

  • Reviews new information from FDA that comes to the attention of AABB, and
  • Consults with pharmacy professionals for a comprehensive review and recommendations.

Implementation and Revision Date Versus “Effective Date”:

  • Blood establishments may replace their current medication list with the v2.0 MDL containing AABB’s updates (refer to the DHQ webpage) or modify their own materials. Under 21 CFR 601.12(d), licensed blood establishments are required to report this minor change and its implementation date in their next annual report.
  • When the MDL is updated with a shorter deferral period, blood establishments have the option to retain a longer deferral period without modifying the MDL because the deferral period is more restrictive.
  • The date found at the bottom right of the MDL captures the month and year of release by AABB and is not meant to imply that AABB is establishing an effective date for implementation of the new MDL. This clarifies that AABB considers this a release date rather than an implementation deadline.
  • The timeline and process for implementation is defined by each establishment’s standard operating procedures.

Comments and Questions

Please contact AABB Regulatory Affairs staff with your questions and comments on the Medication Deferral List , new drugs, or other regulatory issues.

History of Additions and Revisions to the v2.0 MDL

Effient (prasugrel)

Revised July 2019: Deferral period revised from 7 days to 3 days based on:

Zontivity (vorapaxar)

Revised July 2019: Deferral period revised from 14 days to 1 month based on:

Arixtra (fondaparinux)

Revised July 2019: Deferral period revised from 7 days to 2 days based on:

Thalomid (thalidomide)

Revised July 2019: Added to the MDL with a 4-week deferral based on:

Cellcept (mycophenolate mofetil)

Revised July 2019: Added to MDL with a 6-week deferral based on:

Arava (leflunomide)

Revised July 2019: Added to MDL with a 24-month deferral based on:

Experimental Medication or Unlicensed Vaccine
  • Revised July 2019: The language “or as indicated by Medical Director” has been removed to clarify that 12 months is the minimum deferral period.
Odomzo

Revised November 2017: Newly added to the MDL based on:

Erivedge

Revised April 2017: Change in deferral period from 7 months to 24 months. Updated based on: