HIDA Government Affairs Alert

December 12, 2014

FDA Draft Guidance for Annual Reporting by Prescription Drug

Wholesale Distributors and Third-Party Logistics Providers

HIDA has created a new fact sheet with checklist for your convenience as Phase 1 of pharmaceutical traceability begins on January 1, 2015.

Pharmaceutical Traceability:  The Drug Quality and Security Act (H.R. 3204), creates a national prescription drug pedigree solution and included HIDA’s key priorities:

  • Uniform, national policy to achieve federal pedigree preemption.
  • Key exemptions for convenience kits, some types of IV Solutions, combination products, etc.
  • Federal licensure standards for pharmaceutical distributors.

Starts January 1, 2015:  Phase I begins on January 1, 2015 and requires manufacturers, wholesalers and repackagers to comply with applicable traceability requirements and engage with only “authorized trading partners” (which are entities appropriately licensed in the state).

Please contact HIDA Government Affairs if you have any questions, HIDAGovAffairs@HIDA.org or 703-838-6133.