Track-and-trace enforcement pushed back to Nov. 1

June 30, 2015

ASHP and NCPA commended the FDA’s decision to postpone the compliance deadline to November 1, 2015.

 

The American Society of Health-System Pharmacists (ASHP) and the National Community Pharmacists Association (NCPA) commended the FDA’s decision to postpone the deadline for pharmacists to comply with the track-and-trace requirements for “dispensers.”

The enforcement of the new product tracing requirements under the Drug Supply Chain Security Act (DSCSA), which were set to take effect July 1, was moved to November 1, 2015, after the ASHP, NCPA, and other pharmacy groups asked the FDA to allow more time for pharmacists to comply.

“Pharmacists appreciate and support the FDA’s decision….which will help protect patients from disruptions in access to prescription drugs that may have otherwise and inadvertently occurred. Due to circumstances beyond their control, many pharmacies would have had difficulty complying with the July 1 statutory deadline,” said NCPA CEO B. Douglas Hoey, RPh.

“We are extremely pleased with the FDA’s extension of the July 1, 2015, deadline,” said ASHP CEO Paul W. Abramowitz, PharmD. “The leadership at the FDA was very engaging and understanding of the patient care challenges that the July deadline posed to ASHP members and others in the supply chain.”

Under the DSCSA requirements, pharmacists must receive and store transaction information, transaction history, and transaction statements for drug products at the lot level from wholesale distributors by November 1. ASHP expects to learn additional details on dispenser tracing requirements after a conference call with the FDA on July 1.

 When announcing the deadline delay this week, the FDA also posted a supporting webinar, “DSCSA Updates and Readiness Check: DSCSA  Requirements for Dispensers and other Trading Partners,” and plans to host a series of stakeholder calls in the coming weeks. Pharmacists can visit  http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm, to find the latest activities on the DSCSA.