Understanding DSCSA Compliance

The Drug Supply Chain Security Act (DSCSA) aims to create a secure and transparent system for tracking prescription drugs throughout the U.S. supply chain. Compliance with DSCSA is critical for protecting consumers from counterfeit, stolen, contaminated, or otherwise harmful drugs. Our procedures are designed to fully comply with DSCSA mandates, ensuring the integrity and traceability of pharmaceutical products.

Frequently Asked Questions (FAQs)

• What is the Drug Supply Chain Security Act (DSCSA)?

The DSCSA is a federal law enacted in 2013, aiming to enhance the security of the pharmaceutical supply chain in the United States. It mandates the development of an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed across the country, helping protect consumers from counterfeit, stolen, or harmful drugs.

• Who needs to comply with DSCSA requirements?

Compliance with the DSCSA is required for all entities involved in the pharmaceutical supply chain, including manufacturers, repackagers, wholesale distributors, dispensers (such as pharmacies), and third-party logistics providers. Each stakeholder has specific responsibilities under the law to ensure the security and integrity of the drug supply chain.

• What are the key components of DSCSA compliance?

Key components include product identification (using a unique product identifier on certain prescription drug packages), product tracing (providing information about a drug and its movement through the supply chain), product verification (to ensure the legitimacy of the drug product), detection and response (to identify and handle suspect and illegitimate drugs), and notification (to inform the FDA and other stakeholders of illegitimate drugs).

• What is meant by Transaction Information (TI), Transaction History (TH), and Transaction Statement (TS)?

Under the DSCSA, Transaction Information (TI) refers to specific information about the drug being sold, including its name, strength, dosage form, and quantity. Transaction History (TH) is a record of all transactions related to the drug up to the point of sale, and Transaction Statement (TS) is a declaration from the seller that the transaction complies with the DSCSA.

• How does the DSCSA impact the way pharmaceuticals are tracked and traced?

The DSCSA significantly changes the tracking and tracing of pharmaceuticals by transitioning the industry from a system based on paper documentation to one that is electronic and interoperable. This allows for more efficient and accurate tracking of drug products as they move through the supply chain, enhancing the ability to quickly identify and respond to counterfeit, stolen, or contaminated pharmaceuticals, thereby increasing patient safety.

• Need Assistance?

If you have questions or need further assistance with your DSCSA transaction data request, our dedicated support team is here to help. Contact us for personalized support and guidance through the request process.