20-FL-X Certified Designated
Representative Exam With Actual
Questions & Verified Answers ,Plus
Explained Rationales/Expert Verified
For Guaranteed Pass 2026/Latest
Update/Instant Download Pdf
1. What is the primary role of a Designated Representative in a
prescription drug wholesale business?
A. To prescribe medications
B. To manage marketing operations
C. To ensure regulatory compliance in drug distribution
D. To manufacture pharmaceutical products
Rationale: Designated Representatives ensure compliance with
state and federal drug distribution laws.
2. Which agency oversees wholesale drug distributor licensing in
most states?
A. FDA
B. State Board of Pharmacy
C. DEA
D. CDC
Rationale: State Boards of Pharmacy regulate wholesale drug
distributors, including Designated Representatives.
,3. What must a Designated Representative ensure regarding drug
pedigree documentation?
A. It is only kept for brand-name drugs
B. It is complete, accurate, and retrievable
C. It is only provided during audits
D. It is optional for authorized wholesalers
Rationale: Pedigrees must be accurate and readily available to
track product integrity.
4. The Drug Supply Chain Security Act (DSCSA) primarily aims to:
A. Reduce drug prices
B. Increase marketing transparency
C. Enhance drug traceability and security
D. Limit generic drug approvals
Rationale: DSCSA improves traceability to prevent counterfeit or
diverted drugs.
5. Which entity enforces federal drug manufacturing standards?
A. CDC
B. FDA
C. WHO
D. FEMA
Rationale: The FDA regulates manufacturing and ensures
compliance with GMP.
6. A Designated Representative must maintain records for at least:
, A. 6 months
B. 1 year
C. 3 years
D. 10 years
Rationale: Most regulations require a minimum 3-year retention for
distribution records.
7. Which documentation proves product legitimacy in the supply
chain?
A. HIPAA waiver
B. Pharmacy invoice
C. Transaction history and transaction information
D. Customer satisfaction report
Rationale: DSCSA requires TI/TH/TS to track product movement.
8. Which of the following is required during an inspection?
A. Only financial documents
B. Only inventory reports
C. All records relevant to drug distribution
D. No documents unless subpoenaed
Rationale: Inspectors may review all documentation related to drug
storage, distribution, and compliance.
9. If a product appears suspicious, the Designated Representative
must:
A. Destroy it immediately
B. Quarantine and investigate it
Representative Exam With Actual
Questions & Verified Answers ,Plus
Explained Rationales/Expert Verified
For Guaranteed Pass 2026/Latest
Update/Instant Download Pdf
1. What is the primary role of a Designated Representative in a
prescription drug wholesale business?
A. To prescribe medications
B. To manage marketing operations
C. To ensure regulatory compliance in drug distribution
D. To manufacture pharmaceutical products
Rationale: Designated Representatives ensure compliance with
state and federal drug distribution laws.
2. Which agency oversees wholesale drug distributor licensing in
most states?
A. FDA
B. State Board of Pharmacy
C. DEA
D. CDC
Rationale: State Boards of Pharmacy regulate wholesale drug
distributors, including Designated Representatives.
,3. What must a Designated Representative ensure regarding drug
pedigree documentation?
A. It is only kept for brand-name drugs
B. It is complete, accurate, and retrievable
C. It is only provided during audits
D. It is optional for authorized wholesalers
Rationale: Pedigrees must be accurate and readily available to
track product integrity.
4. The Drug Supply Chain Security Act (DSCSA) primarily aims to:
A. Reduce drug prices
B. Increase marketing transparency
C. Enhance drug traceability and security
D. Limit generic drug approvals
Rationale: DSCSA improves traceability to prevent counterfeit or
diverted drugs.
5. Which entity enforces federal drug manufacturing standards?
A. CDC
B. FDA
C. WHO
D. FEMA
Rationale: The FDA regulates manufacturing and ensures
compliance with GMP.
6. A Designated Representative must maintain records for at least:
, A. 6 months
B. 1 year
C. 3 years
D. 10 years
Rationale: Most regulations require a minimum 3-year retention for
distribution records.
7. Which documentation proves product legitimacy in the supply
chain?
A. HIPAA waiver
B. Pharmacy invoice
C. Transaction history and transaction information
D. Customer satisfaction report
Rationale: DSCSA requires TI/TH/TS to track product movement.
8. Which of the following is required during an inspection?
A. Only financial documents
B. Only inventory reports
C. All records relevant to drug distribution
D. No documents unless subpoenaed
Rationale: Inspectors may review all documentation related to drug
storage, distribution, and compliance.
9. If a product appears suspicious, the Designated Representative
must:
A. Destroy it immediately
B. Quarantine and investigate it
