FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?

The Food and Drug Administration (FDA) recently issued exemptions for eligible trading partners to comply with the final requirements of the Drug Supply Chain Security Act (DSCSA). The announcement was a welcome step by the agency after calls from numerous industry groups, including the Healthcare Distribution Alliance (HDA), and members of Congress to grant additional time to work through the complex processes necessary for compliance.

HDA’s Vice President of Regulatory Affairs, Kala Shankle, and Bernstein Rx Solutions, LLC’s President, Ilisa Bernstein, sat down with Drug Topics to discuss how their organizations are working to make the DSCSA process smooth for pharmacies nationwide. They also examined what the FDA’s decision means for the pharmaceutical industry and how pharmacists can best prepare to meet the law’s final requirements.

Healthcare Distribution Alliance

“FDA isn't giving a free pass. They gave that during the first stabilization period. They...are giving more time because they recognize that trading partners are at different levels of implementation and need just a bit more time to further stabilize,” said Bernstein.

“HDA has long supported the successful implementation of this law, and we will continue to do so throughout this period. We regularly communicate with…the whole pharmacy community and produce significant educational resources for those stakeholders,” said Shankle.