Counterfeit Response - Mpje

1. Which lot/expiration characteristic is a counterfeit risk indicator: consistent across units or inconsistent/mismatched?

   Lot number or expiration date mismatch or alteration. Uniform lot and expiration details are required for traceability, and discrepancies may indicate fraudulent relabeling or counterfeiting in the supply chain.

2. Identify the required response when a wholesaler offers a brand product at an unusually low price and cannot provide complete TI/TH/TS.

   Do not purchase; treat as suspect supply and verify trading partner. DSCSA prohibits purchases without verifiable documentation and authorizes treating such offers as suspect to maintain supply chain security.

3. What documentation issue is a counterfeit risk indicator under DSCSA when receiving product?

   Missing or inconsistent TI/TH/TS documentation. DSCSA requires complete transaction documentation for traceability, with gaps indicating potential supply chain breaches or counterfeit insertion.

4. Identify the correct action if you discover product in inventory with altered expiration dates on multiple units.

   Quarantine and investigate as suspect; escalate if illegitimate. Altered details violate DSCSA traceability, necessitating quarantine and investigation to determine if the product is illegitimate.

5. What pricing pattern is a counterfeit risk indicator when acquiring prescription drugs?

   Price is unusually low compared with market norms. Market pricing reflects legitimate costs, so abnormally low prices often signal counterfeit goods bypassing standard supply chain economics under DSCSA.

6. Which label/packaging print quality finding is a counterfeit risk indicator: crisp printing or blurred/misaligned text?

   Blurred, smudged, or misaligned printing. High-quality printing is expected on legitimate pharmaceuticals, while poor quality often indicates counterfeit production methods under DSCSA guidelines.

7. What DSCSA action is required to begin evaluating a quarantined suspect product?

   Investigate and verify product legitimacy. Verification through manufacturer contact or documentation review is required under DSCSA to confirm or refute suspicions of illegitimacy.

8. What is the DSCSA term for a drug that is deliberately and fraudulently mislabeled as to identity or source?

   Counterfeit drug. DSCSA defines counterfeit drugs as those intentionally mislabeled regarding their identity or source to deceive, distinguishing them from legitimate products.

9. Identify the correct response if a patient returns a bottle with tablets that look different from the pharmacy's stock and no NDC change is documented.

   Quarantine remaining stock and initiate suspect product investigation. DSCSA requires quarantining and investigating unexplained discrepancies in product appearance to assess potential counterfeiting risks.

10. What DSCSA category includes a drug with a false transaction history, transaction information, or transaction statement?

    Suspect product. Under DSCSA, a suspect product is identified by potential illegitimacy indicators like falsified transaction documents, requiring further verification.

11. What is the required action for an illegitimate product that is quarantined in the pharmacy?

    Do not dispense; arrange disposition per instructions. DSCSA prohibits distribution of illegitimate products, requiring proper disposal to avoid public harm and comply with regulatory standards.

12. What supply chain circumstance is a counterfeit risk indicator: purchased from an authorized trading partner or unknown source?

    Purchased from a non-authorized or unknown source. DSCSA mandates transactions only with authorized partners to maintain chain integrity, making unknown sources a high risk for counterfeit infiltration.

13. What product appearance change is a counterfeit risk indicator for tablets or capsules compared with historical stock?

    Unexpected color, shape, imprint, or odor change. Consistency in physical characteristics ensures product authenticity, with deviations suggesting counterfeiting or tampering as per DSCSA risk assessments.

14. What DSCSA-required immediate action should occur when a pharmacy has reason to believe a product is suspect?

    Quarantine the product from sale and distribution. DSCSA mandates immediate isolation of suspect products to prevent distribution of potentially illegitimate drugs and protect public health.

15. Which action is required if a suspect product is cleared as legitimate after verification?

    Remove from quarantine and resume normal distribution. DSCSA allows resumption of distribution only after verification confirms legitimacy, ensuring supply chain integrity and patient safety.

16. Which DSCSA reporting action is required when a product is determined to be illegitimate?

    Notify FDA and trading partners of illegitimate product. Prompt notification under DSCSA ensures regulatory oversight and supply chain awareness to mitigate risks from confirmed illegitimate products.

17. Which packaging condition is a key counterfeit risk indicator: intact, tamper-evident features or broken/sealed inconsistently?

    Broken, missing, or resealed tamper-evident feature. Tamper-evident features are designed to reveal unauthorized access, so any compromise signals potential counterfeiting or adulteration in the supply chain.

18. Which option is the required action if you determine a quarantined product is illegitimate after verification attempts fail?

    Notify FDA and trading partners; maintain quarantine and disposition. DSCSA mandates notifications and continued quarantine for illegitimate products to facilitate regulatory action and proper disposition.

19. What DSCSA category applies to a drug determined to be counterfeit, diverted, stolen, intentionally adulterated, or unfit for distribution?

    Illegitimate product. DSCSA classifies illegitimate products as those confirmed to violate supply chain integrity through counterfeiting, diversion, or other compromising factors.

20. What physical shipping condition is a counterfeit risk indicator: normal shipping container or damaged/retaped container?

    Damaged, retaped, or otherwise compromised shipping container. Intact shipping containers protect product integrity, while damage suggests tampering or unauthorized access, a key counterfeit indicator per DSCSA.

21. What documentation action is required after investigating a suspect product under DSCSA?

    Document investigation and outcome; maintain required records. DSCSA mandates detailed records of investigations for traceability, compliance audits, and future reference in supply chain security.

22. Identify the correct response if a prescriber reports lack of therapeutic effect and you find inconsistent tablet imprints in the same lot.

    Quarantine, investigate as suspect, and notify trading partner if needed. Reports of inefficacy with physical inconsistencies warrant DSCSA suspect product protocols to verify legitimacy and alert partners if necessary.

23. Which action is required if FDA or a manufacturer alert identifies your lot number as counterfeit and you have units on hand?

    Quarantine immediately and follow illegitimate product notification steps. Confirmed counterfeit alerts under DSCSA classify products as illegitimate, requiring quarantine and mandatory notifications for public safety.

24. What is the required DSCSA action regarding trading partners during a suspect product investigation?

    Notify immediate trading partner(s) as appropriate. DSCSA requires alerting trading partners to enable coordinated investigations and prevent further distribution of potentially suspect products.

25. Which option is the required first step when receiving cases with retaped seals and mismatched lot numbers on inner vs outer packaging?

    Quarantine the shipment and start a suspect product investigation. Signs of tampering and inconsistencies trigger DSCSA protocols for immediate isolation and verification to prevent counterfeit distribution.

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