Executive Summary
On October 28, 2015, the Food and Drug Administration (“FDA”) revised its June 30, 2015 guidance delaying the enforcement of key track and trace requirements of the Drug Supply Chain Security Act (“DSCSA”) for Dispensers1 (including pharmacies, health systems and physician offices) until March 1, 2016 (“Guidance”). Previously, on June 30, 2015, the FDA had delayed enforcement of these provisions until November 1, 2015. However, this week, the FDA indicated that it does not intend to take action against Dispensers that accept ownership of certain prescription drugs (“Product”) without receiving the Product tracing information until March 1, 2016. It is important to note that this enforcement delay does not impact obligations of manufacturers, distributors and repackagers to provide Product tracing information to Dispensers. As such, this enforcement delay only minimally impacts the ability to trace drugs, if necessary.
A copy of the Guidance is available here. Originally, enforcement of these requirements was to begin on July 1, 2015 and then was delayed until November 1, 2015. In further delaying the enforcement of these requirements for Dispensers, the FDA cited concerns raised by smaller independent Dispensers and health systems. Specifically, these Dispensers and health systems had concerns with their ability to work with trading partners to ensure compliance with the track and trace requirements before the November deadline. Additional background on Dispenser requirements can be found here.
Practical Takeaway
Dispensers should continue to put processes in place to ensure compliance with the DSCSA including, but not limited to, the DSCSA’s track and trace requirements. As part of this process, Dispensers and their trading partners should consider analyzing the types of prescription drug transfer activities in which they are involved to determine if such activity is subject to the track and trace requirements. For example, 340B Program contract pharmacy replenishment arrangements will require additional attention to ensure compliance with DSCSA requirements.
As with the previous guidance issued in June, this Guidance does not change or extend the requirements for Dispensers to only engage in transactions of Product with “authorized trading partners” nor does it change a Dispenser’s responsibility related to the verification of suspect and illegitimate Product.
If you have any questions or would like additional information about this topic, please contact:
- Todd Nova at 414.721.0464 or tnova@wp.hallrender.com;
- Nicholas Gonzales at 414.721.0486 or ngonzales@wp.hallrender.com; or
- Your regular Hall Render attorney.
Please visit the Hall Render Blog at http://blogs.hallrender.com/ or click here to sign up to receive Hall Render alerts on topics related to health care law.
1Under the DSCSA, a Dispenser includes a pharmacy that does not act as a wholesale distributor or any other person authorized by law to dispense or administer prescription drugs (subject to certain exceptions).
