HIDA Government Affairs Alert

FDA Issues Exemptions/Exclusions Under DSCSA During COVID-19

May 13, 2020

Due to the COVID-19 pandemic, the Food and Drug Administration (FDA) has announced exclusions and exemptions under the Drug Supply Chain Security Act (DSCSA) in an effort to mitigate any disruptions to the prescription drug supply chain during the COVID-19 outbreak. These policies are intended to remain in place only through the duration of the COVID-19 public health emergency.

Specifically, the FDA has issued a statutory exemption and exclusion for the distribution of covered COVID-19 products including those prescription drugs which receive an emergency use authorization (EUA) designation by the FDA, or products which FDA approves for the diagnosis, cure, mitigation, or treatment of COVID-19.9 p

For the excluded and exempted products, trading partners will not be required to comply with tracing and identification requirements triggered by a “transaction.” The exemption does not apply to DSCSA requirements not triggered by a “transaction.” For the distribution activities related to the COVID-19 emergency, wholesale distributors are not required to comply with the licensure provisions, reporting requirements, or wholesale distributor requirements under DSCSA.

Read FDA Guidance Document (PDF)►

If you have any questions, please reach out to HIDA Government Affairs at HIDAGovAffairs@HIDA.org or 703-549-4432.