The US Food and Drug Administration (FDA) recently published a final guidance on its process for granting – or denying – waiver, exceptions and exemption (WEE) requests under the Drug Supply Chain Security Act (DSCSA).
The guidance also describes the process FDA will follow every two years to review and decide whether to renew a previously approved WEE.
This guidance finalizes a draft guidance issued in May 2018. The Association for Accessible Medicines (AAM) and the Healthcare Distribution Alliance (HDA) sought changes in comments submitted on the draft guidance in 2019. (RELATED: AAM, HDA Weigh Draft Guidance on DSCSA waivers, Regulatory Focus 9 July 2018)
DSCSA requires FDA to issue a guidance establishing a process by which an authorized manufacturer, repackager, wholesale distributor or dispenser may request a waiver from the tracking requirements if such tracking would impose an “undue economic hardship.” Waivers can also be granted under public health emergencies while exceptions can also be granted if a product is packaged in a container too small to accommodate a label with sufficient space to include the tracking information…
