Speaking of DSCSA exemptions…

NCPA July 2, 2024

We’ve noted this previously in qAM (see here) but as a reminder, trading partners including pharmacies who do not qualify for the small dispenser exemptions and are unable to meet the enhanced drug distribution security requirements of section 582 of the FD&C Act by Nov. 27, 2024, may request a waiver or exemption from those requirements. Although requests can be submitted at any time, the FDA recommends trading partners submit a waiver or an exemption request by Aug. 1, 2024. The agency cannot guarantee it will grant or deny the waiver or exemption by Nov. 27, 2024, but will make every effort to do so. For details, click here.

NCPA