DSCSA Compliance - Pharmacy Technician Certification Exam Ptce

What DSCSA term describes a product with reason to believe it is counterfeit, diverted, or stolen?

Suspect product. Suspect products are flagged based on indicators like unusual packaging or sourcing, requiring further verification.
What is a product identifier (PI) under DSCSA for a package of prescription drug product?

NDC + serial number + lot number + expiration date. The product identifier standardizes package-level information to enable verification and traceability throughout the supply chain.
Identify the DSCSA requirement: a pharmacy receives product with no TI/TS documentation. What must it do?

Do not accept; request required transaction data from the supplier. DSCSA prohibits acceptance without proper documentation to ensure all transactions are traceable and compliant.
What does DSCSA require a dispenser to do upon identifying a suspect product in inventory?

Quarantine the product and investigate. Quarantining and investigating suspect products prevents potential distribution of illegitimate drugs, protecting public health.
What must a dispenser (pharmacy) verify before accepting a DSCSA-traced prescription drug shipment?

That the seller is an authorized trading partner. Verification of the seller's ATP status ensures purchases are only from legitimate sources, maintaining supply chain integrity.
Which DSCSA record is most directly used to respond to a request to trace a product's prior ownership?

Transaction History (TH). TH provides the ownership chain needed to trace a product's history back to the manufacturer for investigative purposes.
Which data carrier is commonly used to encode the DSCSA product identifier on packages?

2D DataMatrix barcode. The 2D DataMatrix barcode efficiently encodes the required product identifier elements in a compact, scannable format.
What is the immediate DSCSA action if a product is determined to be illegitimate?

Do not dispense; quarantine and notify appropriate parties. Immediate quarantine and notification prevent harm and enable coordinated response to confirmed supply chain threats.
What is the DSCSA definition of an authorized trading partner (ATP)?

Manufacturer, repackager, wholesaler, or dispenser properly licensed/registered. ATPs are entities authorized under federal law to handle prescription drugs, ensuring a secure supply chain.
What DSCSA term describes a product confirmed to be counterfeit, diverted, stolen, or otherwise illegitimate?

Illegitimate product. Illegitimate products are verified as non-compliant, necessitating removal from the supply chain to ensure safety.
Which option is a correct DSCSA product identifier element: NDC, serial, lot, or prescriber NPI?

Lot number. Lot number is a required element of the product identifier for tracking specific batches in recalls or investigations.
What DSCSA term means the paper or electronic statement of prior ownership of the product?

Transaction History (TH). TH documents the chain of ownership from manufacturer to current holder, supporting traceability and verification.
What DSCSA term means the record of a transaction that includes product and parties involved?

Transaction Information (TI). TI details the product's specifics, quantity, and involved parties to ensure transparency in each supply chain transaction.
Which DSCSA activity is best described as following product movement forward to recipients?

Tracking. Tracking monitors the product's forward movement to downstream recipients to facilitate distribution and recall management.
Identify the DSCSA issue: a supplier is not licensed in your state. What is the correct classification?

Not an authorized trading partner. Unlicensed suppliers fail to meet ATP criteria, violating DSCSA requirements for secure trading partnerships.
Identify the DSCSA step: a package has a damaged or unreadable 2D barcode. What should the pharmacy do first?

Quarantine and investigate before dispensing. Unreadable barcodes indicate potential tampering or illegitimacy, requiring quarantine to safeguard patient safety.
What does 'serialization' mean under DSCSA for prescription drug packages?

Assigning a unique serial number to each package. Serialization provides unique identification for each package to facilitate tracking and prevent counterfeiting.
What DSCSA term means the statement that the entity complied with DSCSA requirements for the transaction?

Transaction Statement (TS). TS affirms the transferring entity's compliance with DSCSA standards, ensuring accountability in the supply chain.
Which DSCSA practice best prevents reintroduction of quarantined suspect product into dispensing stock?

Physically segregate and clearly label as quarantined. Physical segregation and labeling ensure quarantined products are not accidentally returned to active inventory.
What is the DSCSA minimum retention time for transaction records a dispenser must keep?

At least $6$ years. The 6-year retention period allows for audits, recalls, and investigations to uphold long-term supply chain security.
Which DSCSA documentation set is commonly referred to as 'T3' information?

TI + TH + TS. T3 encompasses all necessary documentation to verify product legitimacy and transaction compliance under DSCSA.
Find the correct DSCSA action: a recall notice requests lot-level tracing. Which record should you retrieve first?

Transaction Information (TI) for the affected lot. TI contains lot-specific details essential for identifying and tracing affected products during a recall.
What does DSCSA stand for in United States prescription drug supply chain compliance?

Drug Supply Chain Security Act. DSCSA is the federal legislation enacted in 2013 to enhance the security of the prescription drug distribution chain in the United States.
Which DSCSA activity is best described as locating a product's movement through the supply chain?

Tracing. Tracing reconstructs the product's historical path backward through the supply chain for verification and recall purposes.

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