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20 FL X Certified Designated Representative Exam (Florida
Board of Pharmacy – Designated Representative for
Prescription Drug Distributors ACTUAL QUESTIONS AND
ANSWERS
20-FL-X Certified Designated Representative Exam (Florida Board of Pharmacy – Designated
Representative for Prescription Drug Distributors), each with an answer and a summarized rationale
based on Florida Statutes, Florida Administrative Code, and federal regulations.
The questions begin after a point-form summary of actual exam coverage areas.
Summarized Exam Topics Covered (Point Form – Accurate for FL Designated Representative Exam)
• Definitions (Rule 64B16-27.100, F.A.C.): Designated Representative, Prescription Drug
Distributor, Wholesale Distribution, Third-Party Logistics Provider (3PL), Manufacturer,
Repackager
• Licensing & Registration: Florida Board of Pharmacy (Department of Health) issues permits;
separate permits for retail pharmacy, wholesale distributor, 3PL, manufacturer, repackager
• Designated Representative Qualifications: Must be at least 18 years old, good moral character,
high school diploma or equivalent, complete a Board-approved training program, pass
examination
• Designated Representative Responsibilities: Supervise prescription drug wholesale distribution
activities, maintain records, ensure compliance with state and federal laws
• Prohibited Acts (Florida Statute 499.005, 499.006): Sale of adulterated/misbranded drugs,
unlicensed wholesale distribution, false pedigree paper, sale of expired drugs, failure to
maintain records
• Pedigree Paper & DSCSA (Drug Supply Chain Security Act): Transaction history, transaction
information, transaction statements; electronic tracing; authorized trading partners
• Recordkeeping (Rule 64B16-27.600, F.A.C.): Maintain records of all wholesale distributions for 3
years; lot numbers, NDC, quantity, expiration dates, names of trading partners
• Storage & Handling (21 CFR 205, Rule 64B16-27.500): Temperature control (controlled room
temperature 68-77°F, excursions permitted 59-86°F), validated storage areas, security,
sanitation
• Returned Drugs & Recalls: Procedures for handling returns (salvage, destruction), quarantining
recalled products
• Wholesale Distributor Permit Application (Rule 64B16-27.300): Submit fee, background check,
facility diagram, list of responsible persons, policies and procedures
• Inspections & Enforcement: Board of Pharmacy authority to inspect facilities; administrative
fines, suspension, revocation
• Unauthorized Practice of Pharmacy: Designated Representatives cannot dispense or
compound; cannot engage in retail pharmacy without a pharmacy permit
• Federal vs. State Law: Must comply with both; stricter law applies
• Storage Conditions: Refrigerated (36-46°F), freezer (−4 to 14°F), controlled room temperature
(CRT), excusions permitted (≤ 24 hours)
• Class I, II, III Recalls: Class I (dangerous), Class II (possible adverse events), Class III (unlikely to
cause adverse effects)
• DEA & Controlled Substances: Distributors of controlled substances must register with DEA
separately; comply with CSA
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• Electronic Records: Signatures, time stamps, backup, audit trails
• Suspicious Orders & Diversion (21 USC 823): Identify, report suspicious orders; due diligence
• Handling of Investigational Drugs: Not for commercial distribution; specific rules
• Hazardous Drugs (NIOSH): Handling requirements, spill procedures, PPE
• Cosmetics, Medical Devices, Dietary Supplements: Not regulated by Board of Pharmacy if not
prescription drugs
• Florida Department of Health (DOH): Board of Pharmacy is within DOH
• Wholesale Distribution: Sale to pharmacies, hospitals, clinics, other wholesalers
• Consequences of Violations: Fines (up to $5,000 per violation), imprisonment, license discipline
1. A designated representative is responsible for supervising wholesale distribution of prescription
drugs. Which of the following activities is a designated representative NOT authorized to perform?
A) Signing for receipt of a controlled substance shipment
B) Dispensing a prescription directly to a patient
C) Authorizing the return of expired drugs to the manufacturer
D) Investigating a temperature excursion in the storage area
Answer: B
Rationale: A designated representative is not licensed to practice pharmacy; dispensing directly to
patients is a pharmacist function.
2. A wholesale drug distributor receives a shipment of insulin that requires refrigeration. The shipping
container has a temperature data logger showing the product reached 50°F for 2 hours during transit.
The manufacturer’s storage requirement is 36-46°F. What is the appropriate action?
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A) Accept the shipment; 50°F is close to the limit
B) Reject the shipment and quarantine it, notifying the supplier of the temperature excursion
C) Move the product to the refrigerator immediately; the excursion is minor
D) Administer a quality control test to determine potency
Answer: B
Rationale: Insulin is temperature-sensitive. Excursions outside labeled storage conditions require
rejection or evaluation by the manufacturer. The distributor should quarantine and contact the supplier.
3. Under Florida Statute 499.005, which of the following is considered a prohibited act?
A) Selling a prescription drug that is within its expiration date
B) Selling a prescription drug from a licensed manufacturer
C) Selling a prescription drug that was previously dispensed to a patient and returned to the pharmacy
D) Selling a prescription drug in its original sealed container
Answer: C
Rationale: Florida law prohibits the wholesale distribution of prescription drugs that have been
previously dispensed to a patient (dispensed returned goods), unless specific conditions are met (e.g.,
nursing home emergency kits).
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4. A designated representative is preparing an application for a new wholesale distributor permit. Which
of the following must be submitted to the Florida Board of Pharmacy?
A) A copy of the applicant’s driver’s license
B) A diagram of the facility showing storage areas, security systems, and recordkeeping locations
C) A financial statement showing net worth
D) A letter of recommendation from a pharmacist
Answer: B
Rationale: Rule 64B16-27.300 requires a facility diagram as part of the permit application.
5. The Drug Supply Chain Security Act (DSCSA) requires that wholesale distributors provide what
documentation when transferring ownership of a prescription drug?
A) A certificate of analysis
B) Transaction information, transaction history, and transaction statement (pedigree)
C) A material safety data sheet
D) A return authorization form
Answer: B
20 FL X Certified Designated Representative Exam (Florida
Board of Pharmacy – Designated Representative for
Prescription Drug Distributors ACTUAL QUESTIONS AND
ANSWERS
20-FL-X Certified Designated Representative Exam (Florida Board of Pharmacy – Designated
Representative for Prescription Drug Distributors), each with an answer and a summarized rationale
based on Florida Statutes, Florida Administrative Code, and federal regulations.
The questions begin after a point-form summary of actual exam coverage areas.
Summarized Exam Topics Covered (Point Form – Accurate for FL Designated Representative Exam)
• Definitions (Rule 64B16-27.100, F.A.C.): Designated Representative, Prescription Drug
Distributor, Wholesale Distribution, Third-Party Logistics Provider (3PL), Manufacturer,
Repackager
• Licensing & Registration: Florida Board of Pharmacy (Department of Health) issues permits;
separate permits for retail pharmacy, wholesale distributor, 3PL, manufacturer, repackager
• Designated Representative Qualifications: Must be at least 18 years old, good moral character,
high school diploma or equivalent, complete a Board-approved training program, pass
examination
• Designated Representative Responsibilities: Supervise prescription drug wholesale distribution
activities, maintain records, ensure compliance with state and federal laws
• Prohibited Acts (Florida Statute 499.005, 499.006): Sale of adulterated/misbranded drugs,
unlicensed wholesale distribution, false pedigree paper, sale of expired drugs, failure to
maintain records
• Pedigree Paper & DSCSA (Drug Supply Chain Security Act): Transaction history, transaction
information, transaction statements; electronic tracing; authorized trading partners
• Recordkeeping (Rule 64B16-27.600, F.A.C.): Maintain records of all wholesale distributions for 3
years; lot numbers, NDC, quantity, expiration dates, names of trading partners
• Storage & Handling (21 CFR 205, Rule 64B16-27.500): Temperature control (controlled room
temperature 68-77°F, excursions permitted 59-86°F), validated storage areas, security,
sanitation
• Returned Drugs & Recalls: Procedures for handling returns (salvage, destruction), quarantining
recalled products
• Wholesale Distributor Permit Application (Rule 64B16-27.300): Submit fee, background check,
facility diagram, list of responsible persons, policies and procedures
• Inspections & Enforcement: Board of Pharmacy authority to inspect facilities; administrative
fines, suspension, revocation
• Unauthorized Practice of Pharmacy: Designated Representatives cannot dispense or
compound; cannot engage in retail pharmacy without a pharmacy permit
• Federal vs. State Law: Must comply with both; stricter law applies
• Storage Conditions: Refrigerated (36-46°F), freezer (−4 to 14°F), controlled room temperature
(CRT), excusions permitted (≤ 24 hours)
• Class I, II, III Recalls: Class I (dangerous), Class II (possible adverse events), Class III (unlikely to
cause adverse effects)
• DEA & Controlled Substances: Distributors of controlled substances must register with DEA
separately; comply with CSA
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• Electronic Records: Signatures, time stamps, backup, audit trails
• Suspicious Orders & Diversion (21 USC 823): Identify, report suspicious orders; due diligence
• Handling of Investigational Drugs: Not for commercial distribution; specific rules
• Hazardous Drugs (NIOSH): Handling requirements, spill procedures, PPE
• Cosmetics, Medical Devices, Dietary Supplements: Not regulated by Board of Pharmacy if not
prescription drugs
• Florida Department of Health (DOH): Board of Pharmacy is within DOH
• Wholesale Distribution: Sale to pharmacies, hospitals, clinics, other wholesalers
• Consequences of Violations: Fines (up to $5,000 per violation), imprisonment, license discipline
1. A designated representative is responsible for supervising wholesale distribution of prescription
drugs. Which of the following activities is a designated representative NOT authorized to perform?
A) Signing for receipt of a controlled substance shipment
B) Dispensing a prescription directly to a patient
C) Authorizing the return of expired drugs to the manufacturer
D) Investigating a temperature excursion in the storage area
Answer: B
Rationale: A designated representative is not licensed to practice pharmacy; dispensing directly to
patients is a pharmacist function.
2. A wholesale drug distributor receives a shipment of insulin that requires refrigeration. The shipping
container has a temperature data logger showing the product reached 50°F for 2 hours during transit.
The manufacturer’s storage requirement is 36-46°F. What is the appropriate action?
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A) Accept the shipment; 50°F is close to the limit
B) Reject the shipment and quarantine it, notifying the supplier of the temperature excursion
C) Move the product to the refrigerator immediately; the excursion is minor
D) Administer a quality control test to determine potency
Answer: B
Rationale: Insulin is temperature-sensitive. Excursions outside labeled storage conditions require
rejection or evaluation by the manufacturer. The distributor should quarantine and contact the supplier.
3. Under Florida Statute 499.005, which of the following is considered a prohibited act?
A) Selling a prescription drug that is within its expiration date
B) Selling a prescription drug from a licensed manufacturer
C) Selling a prescription drug that was previously dispensed to a patient and returned to the pharmacy
D) Selling a prescription drug in its original sealed container
Answer: C
Rationale: Florida law prohibits the wholesale distribution of prescription drugs that have been
previously dispensed to a patient (dispensed returned goods), unless specific conditions are met (e.g.,
nursing home emergency kits).
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4. A designated representative is preparing an application for a new wholesale distributor permit. Which
of the following must be submitted to the Florida Board of Pharmacy?
A) A copy of the applicant’s driver’s license
B) A diagram of the facility showing storage areas, security systems, and recordkeeping locations
C) A financial statement showing net worth
D) A letter of recommendation from a pharmacist
Answer: B
Rationale: Rule 64B16-27.300 requires a facility diagram as part of the permit application.
5. The Drug Supply Chain Security Act (DSCSA) requires that wholesale distributors provide what
documentation when transferring ownership of a prescription drug?
A) A certificate of analysis
B) Transaction information, transaction history, and transaction statement (pedigree)
C) A material safety data sheet
D) A return authorization form
Answer: B
