INSIGHTS
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DSCSA aims to prevent harmful drugs from entering the US supply chain, detect any
incidents as soon as possible, and enable a rapid response for prompt removal.
In achieving this goal, DSCSA requires manufacturers and dispensers (i.e., pharmacies)
to implement a fully electronic and interoperable way to identify and trace certain
prescription drugs at the package level as they move through the supply chain in
real time.1,2
After numerous delays, the FDA mandated phased DSCSA compliance by November
2025; however, some pharmacies (i.e., those with 25 or fewer full-time employees
licensed as pharmacists or qualified as pharmacy technicians) received an exemption
from certain enhanced drug distribution security requirements until late 2026.3
Moving forward, the FDA has stated it does not intend to further delay DSCSA
enforcement — so now is the time for leadership in all hospital and health system
pharmacies to act.4
Prioritizing Compliance with the
Drug Supply Chain Security Act
(DSCSA) Before November 27, 2026
How hospital pharmacies can prepare and why it matters now.
Revised DSCSA
Compliance Deadlines3
• May 27, 2025
Manufacturers & Re-Packagers
• August 27, 2025
Wholesale Distributors
• November 27, 2025
Large Dispensers
• November 27, 2026
Small Dispensers
NOTE: Some pharmacies utilized that
extra time to work towards DSCSA
compliance, but others have delayed its
implementation.5
Pharmacy Leadership Survey: DSCSA Compliance Readiness6
As of Late 2025
28%
do not routinely receive
complete transaction
information for at least 80%
of purchased products.
38%
do not actively assess the
quality and accuracy of
transaction information
they receive.
25%
do not have interoperable
electronic systems and
processes to verify product
serial numbers.