Public Health Emergencies and DSCSA Requirements
When the Secretary of Health and Human Services declares a public health emergency under section 319 of the Public Health Service Act, there may be a need to facilitate the effective distribution of prescription drugs under emergency conditions. FDA is committed to ensuring that U.S patients receive needed medications during these situations.
A public health emergency is considered an “emergency medical reason” under the Drug Supply Chain Security Act (DSCSA). Upon declaration of a public health emergency, certain activities are automatically excluded through the time period of the declaration. Notably, product distribution for such emergency medical reasons is excluded from the DSCSA definitions of “transaction” and “wholesale distribution.” Therefore, the DSCSA requirements related to product tracing and wholesale distribution do not apply to trading partner activities that address the public health emergency declaration. All other DSCSA requirements apply.
Entities engaged in these distribution activities should maintain the security of the supply chain as these prescription drugs are distributed to address the urgent public health need. When the public health emergency declaration expires, all DSCSA requirements apply.
Public health emergency declarations last until the Secretary declares that the public health emergency no longer exists or expires 90-days after the date of the declaration, whichever occurs first. The Secretary may extend the public health emergency declaration for subsequent 90-day periods for as long as the public health emergency continues to exist, and may terminate the declaration when the Secretary determines that the public health emergency no longer exists. Information about whether a declaration exists can be found at www.phe.gov.