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
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
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.
ENFORCEMENT INSIGHT
The FDA has reinforced that DSCSA oversight is already integrated into their routine surveillance activity.8
60%
of hospital executives worry about regulatory disruption in their drug supply chain.9
The Risk: What’s the Cost of DSCSA Noncompliance?
Regulatory enforcement across the health care sector is a top priority for both federal and state agencies in 2026 and beyond. With this increased scrutiny, an issue that may have previously been handled as a single compliance matter can now quickly escalate to numerous investigations, multi-agency actions, and larger litigations.7
DSCSA’s prolonged enforcement can make it easy for hospital pharmacies to ignore, but the cost of waiting is higher than most may realize.5
For dispensers, noncompliance with DSCSA can have serious consequences:2
- Civil fines up to $500,000 per violation
- Criminal charges, including imprisonment, for intentional violations
- Temporary operational shutdowns or permanent revocation of dispensing licenses
- Confiscation or recall of illegitimate or non-traceable products
- Loss of partnerships with authorized trading partners
- Lasting reputational damage
The Solution: What’s the Next Step for Pharmacy Leaders?
Since DSCSA compliance will require multiple connections and data exchanges across third-party trading partners, dispensers that delay further action until closer to the deadline could be too late, creating an overwhelming crisis.5
Proactive readiness is a strong defense to protect both the organization and patient safety.
Pharmacy leaders who start working towards DSCSA compliance today can be champions for both their teams and hospital executives tomorrow. By working with an industry expert like CPS Solutions, LLC (CPS), on-site leadership can gain access to dedicated compliance specialists, advanced technology, and detailed assessments and resources that can save time, reduce risk, and enjoy peace of mind.
Pharmacy Excellence by the Numbers
CPS Partnership Benefits: Expertise, Process, & Technology
800+
Hospital & Health
System Customers
Nationwide
2.5k+
Pharmacy Professionals
& Subject Matter
Experts
3.5k+
Up-to-Date Digital
Templates, Tools, &
Resources
Pharmacy Leadership Survey:
Most Significant Operational Challenge6
#2
Ensuring Regulatory Compliance with DSCSA and 340B
Trusted Pharmacy Expertise: Maximize Performance & Minimize Risk with Tailored Support
Explore how CPS’ technology and expertise could help your organization enhance compliance and reduce risk by contacting our experts today: discover.cps.com/contact-us
About CPS Solutions, LLC (CPS)
Founded 50+ years ago, CPS is one of the nation’s leading pharmacy and hospital service providers, employing 2,500+ pharmacy professionals and servicing 800+ healthcare facilities nationwide. Through our innovative technology, expertise, and proven solutions, we drive transformative results to maximize performance and minimize risk.
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-the-road-f.html
5 Cao R. DSCSA for small dispensers: why “doing nothing” is still a decision (and how to make compliance feel manageable). LSPedia blog. April 6, Accessed April 6, 2026. https://www.lspedia.com/blog/dscsa-for-small dispensers-why-doing-nothing-is-still-a-decision-and-how-to-makecompliance-feel-manageable
6 Partnership for DSCSA Governance. DSCSA Implementation Survey Results. October 2025. Accessed April 6, 2026. https://dscsagovernance.org/ wp-content/uploads/2025/10/pdg-stabilization-survey-results-report-9 24.pdf
7 Scannapieco GH, Danzig AM. 2026 DOJ and state AG enforcement trends for health care and life sciences. Medical Economics blog. March 2, Accessed April 6, 2026. https://www.medicaleconomics.com/view/2026-doj and-state-ag-enforcement-trends-for-health-care-and-lifesciences
8 Cao R. 2026 distribution management conference (HDA) key highlights. LSPedia blog. March 30, 2026. Accessed April 6, 2026. https://www.lspedia.com/blog/2026-distribution-management-conference-hda-key-highlights
9 Tecsys. The Visibility Crisis in Health System Pharmacies. January 2026. Accessed April 6, 2026. https://tecsys.com/hubfs/Report/The-VisibilityCrisis-in-Health-System-Pharmacies.pdf
