Prioritizing Compliance with the Drug Supply Chain Security Act (DSCSA) Before November 27, 2026

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Prioritizing Compliance with the Drug Supply Chain Security Act (DSCSA) Before November 27, 2026

How hospital pharmacies can prepare and why it matters now

 

Published: April 2026

 

The Drug Supply Chain Security Act (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.1

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.3

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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

Interested in learning more about DSCSA and how your hospital can prepare? Fill out the form below to continue reading this article.

 

References

1 Drug Supply Chain Security Act (DSCSA). US Food & Drug Administration. Updated October 16, 2025. Accessed April 6, 2026. 
https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa

2 Spano K. DSCSA: safeguarding the drug supply chain. Accreditation Commission for Health Care. January 2, 2026. Accessed April 6, 2026. https://achc.org/dscsa-safeguarding-the-drug-supply-chain/

3 Waivers and exemptions beyond the stabilization period. US Food & Drug Administration. Updated October 9, 2024. Accessed April 6, 2026. https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/waivers-and-exemptions-beyond-stabilization-period 

4 Eglovitch JS. Cavazzoni: no more ‘kicking the can’ down the road for DSCSA compliance. Regulatory Affairs Professionals Society. May 16, 2024. Accessed April 6, 2026. https://www.raps.org/resource/cavazzoni-no-more-kicking-the-can-down-theroad-f.html   

 

 

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