What does DSCSA stand for?
- DSCSA stands for the Drug Supply Chain Security Act, which is Title II of the Drug Quality and Security Act (DQSA).
What is it?
- DSCSA mandates a full supply chain traceability system from pharmaceutical manufacturer to pharmacy dispenser for prescription drugs being distributed in the United States.
- The law was signed by President Obama in November 2013, providing a national standard for drug security and replacing the patchwork of state-level Pedigree regulations that were in place.
Why is it important?
- The World Health Organization estimates that between 1% and 10% of drugs sold around the world are counterfeit, with that number reaching as high as 50% in some countries. DSCSA will help protect patient safety by enabling verification of products, improving the detection of suspect ones, and facilitating product recalls.
Which supply chain segments have a compliance requirement?
- Drug manufacturers, wholesale distributors, repackagers, and dispensers who work with prescription products in the U.S. have a requirement.
Who qualifies as a dispenser in the eyes of the law?
- Anyone who dispenses prescription products to patients -- including but not limited to pharmacies, clinics, hospitals, physicians, and long-term care facilities – is considered a dispenser.
- If your business dispenses to patients but also resells product to distributors or other dispensers, it falls under wholesale distributor requirements.
What does DSCSA mean for my dispenser business?
- The law has complex drug tracking, verification, and serialization regulations that impact your business and how you communicate with supply chain partners.
What will I need to do?
- Beginning July 1, 2015, DSCSA requires dispensers to:
- Track: Receive lot-level Transaction History (TH), Transaction Information (TI), and Transaction Statement (TS) documentation on every product they purchase.
- Verify: Retrieve, analyze, and provide TH/TI/TS within two business days during suspect product investigations and recalls; quarantine and investigate any product identified as suspect; and notify the FDA and supply chain partners.
- You must also retain product compliance documentation for six years.
- DSCSA does not require you to store data associated with patient-level prescriptions.
Will additional requirements come later?
- In 2020, serialization requirements will phase in, mandating that you purchase and sell only serialized drug products, and store serialization information for 6 years. There will also be enhanced verification processes in 2020.