FDA finalizes guidance on DSCSA waivers, exceptions and exemptions
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This guidance finalizes a draft guidance issued in May 2018.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Accessible Medicines (AAM) and the Healthcare Distribution Alliance (HDA) sought changes in comments submitted on the draft guidance in 2019. (RELATED: AAM, HDA Weigh Draft Guidance on DSCSA waivers, Regulatory Focus 9 July 2018)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.
Changes from the draft guidance to the final guidance include new language stating that requests for waivers, exceptions or exemptions be submitted electronically.
Also included is a new section describing how an authorized trading partner may request that FDA reconsider the scope of a waiver, exception or exemption request that has already been granted. The guidance states that “new information” should be provided to FDA to justify a change in in the agency’s prior conclusions concerning the scope of the waiver, exception or exception request.
The guidance also includes a new section specifying how FDA will reconsider a denied request. These requests should be submitted to the agency no later than 12 business date after the request was denied.
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The guidance specifies that WEEs will be reviewed every two years. “During this review, the Agency intended to assess, among other things, whether a material changes in circumstances has occurred, thereby making the waiver, exception or exemption unwarranted.”
FDA final guidance
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