Drug Supply Chain Security Act (DSCSA)
Protecting Patients. Empowering Pharmacies. Ensuring Compliance.
The Drug Supply Chain Security Act (DSCSA) was enacted to enhance the security of the U.S. pharmaceutical supply chain. Its goal is simple: protect patients from counterfeit, stolen, or contaminated medications by requiring secure, transparent, and interoperable recordkeeping across every step of the drug distribution system.
As a dispenser, staying compliant with DSCSA is not optional—it’s the law. StockMeds helps independent pharmacies simplify compliance while focusing on what matters most: caring for patients.
Section 582(d)(1)(A)(ii) of the FD&C Act states “a dispenser . . . prior to, or at the time of, each transaction in which the dispenser transfers ownership of a product (but not including dispensing to a patient or returns) shall provide the subsequent owner with transaction history, transaction information, and a transaction statement for the product, except that the requirements of this clause shall not apply to sales by a dispenser to another dispenser to fulfill a specific patient need”. Our platform meticulously maintains safe, secure, and accurate electronic transaction records for all dispenser-to-dispenser transactions, alleviating concerns related to pharmaceutical traceability and regulatory compliance. Independent pharmacies can now rest assured that they are operating within the bounds of the law while serving their patients’ needs.
What Dispensers Must Provide Under DSCSA
Pharmacies transferring ownership of a product must supply:
Transaction Information (TI)
Product name, strength, dosage form, NDC, lot number, transaction dates, and more.Transaction History (TH)
A record of each prior transaction, tracing the product back to the manufacturer.Transaction Statement (TS)
An attestation that the entity is authorized and compliant with DSCSA requirements.
Exemptions: These requirements do not apply to dispensing directly to patients or to transactions made to meet a specific patient need.
How StockMeds Supports Compliance
Automated Recordkeeping – Every TI/TH/TS securely stored in one place.
Instant Audit Readiness – Be prepared for FDA or state inspections with a click.
Seamless Workflow Integration – Compliance tools built into your daily operations.
Peace of Mind – Focus on patient care, while we ensure the records are accurate and compliant.
DSCSA Compliance Timeline
2013 – DSCSA enacted.
2015 – Requirements for dispensers to capture and provide TI/TH/TS began.
2023 – Full system interoperability requirements established.
November 2024 – Start of FDA’s enforcement after stabilization period.
StockMeds keeps you aligned with every milestone—past, present, and futu
