DSCSA Compliance - Mpje

Which DSCSA document must a dispenser provide when transferring ownership of a prescription drug?

Provide TI/TH/TS to the receiving trading partner. Dispensers must provide these documents during ownership transfers to comply with tracing requirements.
What is the DSCSA definition of transaction history (TH) for a drug transaction?

Prior TI for each transaction back to the manufacturer. TH compiles all previous TI to provide a complete ownership chain back to the manufacturer for verification.
What does DSCSA mean by an "authorized trading partner" for dispensers?

Properly licensed/registered entity permitted to distribute the product. Authorized trading partners must meet licensing requirements to legally handle and distribute prescription drugs under DSCSA.
What is the first DSCSA action a dispenser must take when suspect product is identified?

Quarantine the product from saleable inventory. Quarantining prevents distribution of potentially harmful products while investigation proceeds under DSCSA protocols.
Identify the DSCSA rule for distributing a product that is confirmed illegitimate.

Distribution is prohibited; product must be removed and disposed/returned. DSCSA prohibits distribution of illegitimate products to safeguard the supply chain and public health.
Identify the correct DSCSA action if a wholesaler offers product but is not licensed in your state.

Reject the transaction; the seller is not an authorized trading partner. Unlicensed wholesalers are not authorized, so transactions must be rejected to comply with DSCSA.
What is the DSCSA definition of transaction statement (TS) from the transferring partner?

Attestation of authorized status and DSCSA compliance for the product. TS certifies that the seller is authorized and has complied with DSCSA requirements, ensuring product legitimacy.
What DSCSA concept describes requesting and providing product tracing data upon request?

Verification and tracing response obligations between trading partners. DSCSA establishes mutual obligations for partners to share tracing data to verify product authenticity upon request.
What DSCSA document set must a trading partner provide for each transaction of a prescription drug?

TI, TH, and TS (transaction information, history, statement). DSCSA requires trading partners to exchange these documents to ensure traceability and prevent counterfeit drugs in the supply chain.
What is the DSCSA requirement for the format or accessibility of tracing records for inspection?

Maintain records in a retrievable form for prompt access and review. DSCSA ensures records are accessible for regulatory inspections to verify compliance and investigate issues.
What does DSCSA require a dispenser to do if a suspect product is determined illegitimate?

Notify FDA and trading partners and arrange disposition (do not dispense). Notifications and proper disposition are required to alert authorities and prevent illegitimate products from entering commerce.
What is the DSCSA record retention period for product tracing documentation?

$6$ years. DSCSA mandates a $6$ -year retention to allow for inspections and investigations into product legitimacy over time.
Which DSCSA step is correct when a trading partner requests tracing data for a suspect lot you received?

Provide the requested TI/TH/TS for that lot from your records. DSCSA requires prompt response to verification requests to assist in investigating suspect products.
Which DSCSA step requires a dispenser to check tracing data to investigate a suspect product?

Investigation using TI/TH/TS and other relevant records. DSCSA requires thorough review of tracing documents to determine if a product is suspect or illegitimate.
Identify the DSCSA error: "We may dispense quarantined product while investigation is pending."

Dispensing is prohibited; quarantined product must not be distributed. DSCSA prohibits distribution of quarantined products to prevent potential harm during ongoing investigations.
What is the DSCSA definition of transaction information (TI) in product tracing?

Product, parties, dates, quantity, lot, and shipment details. TI includes specific details about the product and transaction to enable accurate tracing through the supply chain.
What DSCSA action is required if a package shows evidence of tampering and may be counterfeit?

Quarantine and investigate as suspect product. Tampering indicates potential counterfeiting, requiring quarantine and investigation per DSCSA protocols.
What is the DSCSA definition of a "suspect product"?

Product possibly counterfeit, diverted, stolen, adulterated, or unfit. Suspect products are those with indications of potential illegitimacy, requiring investigation to protect public health.
Which DSCSA requirement applies to a dispenser when receiving product from a trading partner?

Accept only from authorized trading partners and obtain TI/TH/TS. Dispensers must ensure transactions are with authorized entities and include required documentation to maintain supply chain integrity.
What is the DSCSA "verification" obligation for a dispenser related to product identifiers?

Verify product identifier for returned/suspect product as required. Dispensers must confirm identifiers on suspect or returned products to ensure they match manufacturer data.
Which DSCSA rule applies to receiving a shipment with missing TI/TH/TS documentation?

Do not accept as saleable; obtain missing tracing data from the sender. Incomplete documentation violates DSCSA tracing requirements, necessitating correction before acceptance.
What is the DSCSA definition of an "illegitimate product"?

Product confirmed counterfeit, diverted, stolen, adulterated, or unfit. Illegitimate products are verified as compromised, necessitating removal from the supply chain to prevent harm.
Which product details typically make up a DSCSA product identifier on a package?

NDC, serial number, lot number, and expiration date. The product identifier standardizes unique details for serialization and traceability in the supply chain.
What does DSCSA require before a dispenser may reintroduce a quarantined product to inventory?

Conclude it is not suspect/illegitimate and document the outcome. DSCSA requires clearance through investigation and documentation to confirm the product is safe for distribution.

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