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.