FL CDR Sample questions module 1-8
"Readily retrievable," as it relates to audit trail records of prescription drug transactions for
In-State Florida permits, has been defined by the Florida rules as which of the following? -
ANS-A) Retrievable within minutes.*
B) Retrievable within a reasonable amount of time.
C) Retrievable within the same day.
D) Retrievable within 24 hours.
\*An Licensed Prescription drug wholesale distributor can buy prescription drugs from which of
the following entities? - ANS-A) A restricted prescription drug distributor permit.
B) A prescription drug repackager permit.*
C) A retail pharmacy drug wholesaler permit.
D) A limited prescription drug veterinary wholesaler distributor permit.
E) All of the above
\*The bond required to apply for a prescription drug wholesaler permit can be in the form of: -
ANS-A) A bond for $75,000.
B) A revocable letter of credit.
C) A cash deposit in a trust account payable to the Florida Professional Regulation Trust Fund.*
D) All of the above
E) None of the above
\*The following conditions require pre-notification to the Department: - ANS-A) Change of
address*
B) A greater than 30% change of ownership
C) Application to the DEA for a controlled substance permit
D) All of the above
\*The following must be accomplished upon applying for a new or renewal application for an Rx
drug wholesale distributor permit: - ANS-A) The application must be filed on forms furnished by
the Department
B) A surety bond must be obtained in the amount of $100,000. If the annual gross receipts of
the applicant's previous tax year are $10 million or less, a bond in the amount of $25,000.
C) All persons that own 10% of more of the company must complete a Personal Information
Statement and complete a background check
D) All of the above
E) A & B only are correct*
\*What permit would be appropriate for a veterinarian establishment to apply for if they wanted
to buy some human drugs to sell to veterinarians? - ANS-A) Limited Veterinarian Wholesaler*
B) Retail Veterinarian Wholesaler
C) Special Veterinarian Wholesaler
D) Closed System Veterinarian Wholesaler
\*Which of the following is true regarding a prescription drug repacker permit: - ANS-A) A
repacker can apply for a repacker permit both in FL and if they are outside of FL and plan to
ship into FL.
, B) A certified designated representative must be onsite during normal business hours.
C) This permittee may engage in the wholesale distribution of prescription drugs they repack*
D) No pedigree is required to be passed by a repacker permit.
\A broker only prescription drug wholesale distributor can only possess the following prescription
drugs: - ANS-A) Sample packages
B) Returns for destruction
C) No prescription drugs at all*
D) Starter packs and sample packages only
\A CDR must be present at the Rx drug wholesaler establishment except for in the following
situations: - ANS-A) Outside normal business hours*
B) While working at another Rx drug wholesale distributor
C) While training other CDR's
D) Whenever the Department is notified of the absence
E) All of the above
\A drug is considered "misbranded" if it has which of the following characteristics? - ANS-A) The
label of the product has not been reviewed by the State.
B) The product is expired.
C) The label of the product is in anyway false or misleading.*
D) The product is contaminated.
\A Florida licensed prescription drug wholesale distributor commits a ________________ if they
knowingly traffic in over $25,000 in contraband precription drugs? - ANS-A) A first degree
felony*
B) A second degree misdemeanor
C) A third degree felony
D) A regulatory violation
\A Florida product registration for prescription drugs must be renewed how often? - ANS-A)
Biennially
B) Every 2 years
C) Annually
D) Biannually
E) A & B are correct*
\A Non-resident prescription drug repacker must follow all the laws and rules of Chapter 499,
F.S. and F.A.C. 61N-1 but does not have to do the following: - ANS-A) Apply for a permit in
Florida in order to do business with Florida
B) Since they are out of the State they are not required to make their records available to a
State of Florida Inspector
C) Also obtain a Non-Resident Prescription drug wholesaler permit in the State of Florida.*
D) Provide Transactional history, information or statements to their Florida customers
E) The must do all of the above without exception.
\A prescription drug for which the required Transaction history, information or statement is
missing or incomplete is considered: - ANS-A) Adulterated
B) Misbranded
C) Contraband
D) Only A & C*
"Readily retrievable," as it relates to audit trail records of prescription drug transactions for
In-State Florida permits, has been defined by the Florida rules as which of the following? -
ANS-A) Retrievable within minutes.*
B) Retrievable within a reasonable amount of time.
C) Retrievable within the same day.
D) Retrievable within 24 hours.
\*An Licensed Prescription drug wholesale distributor can buy prescription drugs from which of
the following entities? - ANS-A) A restricted prescription drug distributor permit.
B) A prescription drug repackager permit.*
C) A retail pharmacy drug wholesaler permit.
D) A limited prescription drug veterinary wholesaler distributor permit.
E) All of the above
\*The bond required to apply for a prescription drug wholesaler permit can be in the form of: -
ANS-A) A bond for $75,000.
B) A revocable letter of credit.
C) A cash deposit in a trust account payable to the Florida Professional Regulation Trust Fund.*
D) All of the above
E) None of the above
\*The following conditions require pre-notification to the Department: - ANS-A) Change of
address*
B) A greater than 30% change of ownership
C) Application to the DEA for a controlled substance permit
D) All of the above
\*The following must be accomplished upon applying for a new or renewal application for an Rx
drug wholesale distributor permit: - ANS-A) The application must be filed on forms furnished by
the Department
B) A surety bond must be obtained in the amount of $100,000. If the annual gross receipts of
the applicant's previous tax year are $10 million or less, a bond in the amount of $25,000.
C) All persons that own 10% of more of the company must complete a Personal Information
Statement and complete a background check
D) All of the above
E) A & B only are correct*
\*What permit would be appropriate for a veterinarian establishment to apply for if they wanted
to buy some human drugs to sell to veterinarians? - ANS-A) Limited Veterinarian Wholesaler*
B) Retail Veterinarian Wholesaler
C) Special Veterinarian Wholesaler
D) Closed System Veterinarian Wholesaler
\*Which of the following is true regarding a prescription drug repacker permit: - ANS-A) A
repacker can apply for a repacker permit both in FL and if they are outside of FL and plan to
ship into FL.
, B) A certified designated representative must be onsite during normal business hours.
C) This permittee may engage in the wholesale distribution of prescription drugs they repack*
D) No pedigree is required to be passed by a repacker permit.
\A broker only prescription drug wholesale distributor can only possess the following prescription
drugs: - ANS-A) Sample packages
B) Returns for destruction
C) No prescription drugs at all*
D) Starter packs and sample packages only
\A CDR must be present at the Rx drug wholesaler establishment except for in the following
situations: - ANS-A) Outside normal business hours*
B) While working at another Rx drug wholesale distributor
C) While training other CDR's
D) Whenever the Department is notified of the absence
E) All of the above
\A drug is considered "misbranded" if it has which of the following characteristics? - ANS-A) The
label of the product has not been reviewed by the State.
B) The product is expired.
C) The label of the product is in anyway false or misleading.*
D) The product is contaminated.
\A Florida licensed prescription drug wholesale distributor commits a ________________ if they
knowingly traffic in over $25,000 in contraband precription drugs? - ANS-A) A first degree
felony*
B) A second degree misdemeanor
C) A third degree felony
D) A regulatory violation
\A Florida product registration for prescription drugs must be renewed how often? - ANS-A)
Biennially
B) Every 2 years
C) Annually
D) Biannually
E) A & B are correct*
\A Non-resident prescription drug repacker must follow all the laws and rules of Chapter 499,
F.S. and F.A.C. 61N-1 but does not have to do the following: - ANS-A) Apply for a permit in
Florida in order to do business with Florida
B) Since they are out of the State they are not required to make their records available to a
State of Florida Inspector
C) Also obtain a Non-Resident Prescription drug wholesaler permit in the State of Florida.*
D) Provide Transactional history, information or statements to their Florida customers
E) The must do all of the above without exception.
\A prescription drug for which the required Transaction history, information or statement is
missing or incomplete is considered: - ANS-A) Adulterated
B) Misbranded
C) Contraband
D) Only A & C*
