With the final Drug Supply Chain Security Act (DSCSA) compliance deadline less than a year away for small dispensers, pharmacies that have not yet implemented electronic tracing and verification systems should act now to assess their readiness. Failure to comply may expose pharmacies to regulatory scrutiny, supply chain disruptions, and operational challenges in purchasing and dispensing prescription drugs.
Why DSCSA Compliance Matters for Pharmacies
The DSCSA was enacted by Congress to enhance the security and integrity of the pharmaceutical supply chain through a nationwide system for tracing prescription drug products and identifying illegitimate, counterfeit, diverted, or otherwise suspect products before they reach patients.
Key Deadlines and Who Is Affected
The final implementation phase of the DSCSA is rapidly approaching.
For pharmacies that employ 25 or fewer full-time, licensed pharmacists or pharmacy technicians (i.e. small dispensers), the critical compliance deadline is November 27, 2026. Pharmacies employing 26 or more such personnel (i.e. large dispensers) had a grace period that expired on November 27, 2025.
In practical terms, the enhanced DSCSA requirements require trading partners to electronically exchange transaction data, verify products at the package level, and maintain systems capable of tracing products throughout the pharmaceutical supply chain.
The law requires a fully electronic, interoperable system for tracing pharmaceutical products at the package level to ensure patient safety and supply chain integrity. This involves the exchange of transaction information (TI) and transaction statements (TS) through secure electronic systems that support interoperability across authorized trading partners. Many organizations are utilizing Electronic Product Code Information Services (EPCIS), a GS1-developed standard that facilitates DSCSA-compliant data exchange and product verification.
What the DSCSA Does Not Cover
DSCSA requirements do not apply to intracompany transfers between different facilities of the same company, veterinary drugs, blood or blood components intended for transfusion, certain intravenous products such as large volume infusion solutions, lawfully compounded drugs, radiopharmaceuticals and imaging drugs, medical gases, or homeopathic and over-the-counter medications.
Steps to Ensure Compliance
Transitioning to DSCSA compliance requires more than implementing technology. Pharmacies should evaluate their operational workflows, vendor relationships, policies and procedures, and employee training programs to ensure they can satisfy both regulatory and practical compliance obligations.
Organizations should consider the following:
- Confirm that all trading partners qualify as “authorized trading partners” and implement procedures for ongoing verification.
- Develop and maintain policies and procedures addressing receipt and storage of transaction data, product tracing, package-level verification, suspect and illegitimate product investigations, saleable returns processing, regulatory inspections, and responses to FDA requests.
- Review agreements with wholesalers, technology vendors, and other trading partners to confirm responsibility for DSCSA-related data exchange, retention, verification, and notification obligations.
- Educate and train personnel regarding DSCSA requirements, including identification of suspect or illegitimate products, quarantine procedures, investigation protocols, FDA and trading partner notification requirements, and recordkeeping obligations.
- Conduct a readiness assessment or mock compliance review before the applicable deadline to identify operational or technological gaps.
How Frier Levitt Can Help
The November 2026 deadline is approaching quickly. Pharmacies that delay implementation may face significant challenges integrating technology solutions, updating internal procedures, and coordinating compliance efforts with trading partners.
Frier Levitt’s Life Sciences attorneys advise pharmacies, wholesalers, manufacturers, and other healthcare industry stakeholders on DSCSA compliance, supply chain security requirements, regulatory investigations, operational policies and procedures, vendor contracting, and enforcement matters.
Contact Frier Levitt to discuss your organization’s DSCSA readiness before the November 2026 deadline. Whether your organization is beginning its compliance efforts or seeking to validate an existing DSCSA program, our attorneys can assist with compliance assessments, policy development, contractual risk allocation, vendor and trading partner agreements, regulatory response strategies, and DSCSA implementation planning.
References:
- Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act Guidance for Industry
- DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs
- Drug Supply Chain Security Act Product Tracing Requirements: Frequently Asked Questions
