FL CDR Sample questions module 1-
8
Which of the following entities could be considered a Manufacturer as defined by Chapter 499? -
✔✔ correct answer a. a person who owns the ANDA or NDA
b. an affiliate of a person who owns the ANDA or NDA
c. an entity that manufactures the product
d. all of the above*
e. answers A and C are correct
Which of the following items are generally acceptable to be purchased, stored, sold or brokered in or
into the State of Florida by a properly licensed Prescription Drug Wholesale Distributor? - ✔✔
correct answer A) Veterinary Prescription Drug
B) Complimentary Prescription Drug
C) Active Pharmaceutical Ingredients (API)
D) Medical Gases
E) All of the above are correct EXCEPT B.*
Which of the following statements/definitions are correctly stated? - ✔✔ correct answer A) An
Intracompany transfer is the sale of a prescription drug between two companies owned by the same
company.
B) The definition of a "sale" includes a gift if ownership transfers.
C) An authorized recipient includes any entity that is properly permitted to purchase, recieve,
distribute, etc. prescription drugs.
D) All of the above are correct*
E) None of the above are correct.
The following alterations to a container would be "repackaging" under Florida laws and rules: - ✔✔
correct answer A) Changing the label in the bottle
B) Changing the labeling insert contained in the packaging
C) Breaking a multi-unit pack and selling an individual fully labeled unit
D) Only A & B
E) All of the above*
, FL CDR Sample questions module 1-
8
If a Certified Designated Representative is to have an "authorized absence", he/she must meet the
following requirements: - ✔✔ correct answer A) Inform their employer they will not be at work that
day and when they will return. If they are the owner, then inform the manager they will not be at
work that day and when they will return.
B) Cannot exceed 90 calendar days in a 365 day period for specifically defined family issues.
C) All extended absences are permitted as long as they are in writing and authorized by the owner
and/or manager of the permittee.
D) Cannot exceed 60 calendar days in a 365 day period for specifically defined family issues.*
E) Answers A & C are correct.
Who would be considered an "authorized recipient" of prescription drugs on a ocean going vessel -
✔✔ correct answer A) A licensed Ship Captain
B) The First Officer of the ship
C) An Agent of the ship
D) Any marine broker
E) Both A & B above are correct*
A broker only prescription drug wholesale distributor can only possess the following prescription
drugs: - ✔✔ correct answer A) Sample packages
B) Returns for destruction
C) No prescription drugs at all*
D) Starter packs and sample packages only
If a wholesale distributor sells a portion of his business to a new partner. the new partner would
have to purchase more than _____% of the controlled interest to be considered a change of
ownership by the Department. - ✔✔ correct answer A) 50%*
B) 30%
C) 40%
D) 60%
"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? - ✔✔ correct
answer A) Retrievable within minutes.*
8
Which of the following entities could be considered a Manufacturer as defined by Chapter 499? -
✔✔ correct answer a. a person who owns the ANDA or NDA
b. an affiliate of a person who owns the ANDA or NDA
c. an entity that manufactures the product
d. all of the above*
e. answers A and C are correct
Which of the following items are generally acceptable to be purchased, stored, sold or brokered in or
into the State of Florida by a properly licensed Prescription Drug Wholesale Distributor? - ✔✔
correct answer A) Veterinary Prescription Drug
B) Complimentary Prescription Drug
C) Active Pharmaceutical Ingredients (API)
D) Medical Gases
E) All of the above are correct EXCEPT B.*
Which of the following statements/definitions are correctly stated? - ✔✔ correct answer A) An
Intracompany transfer is the sale of a prescription drug between two companies owned by the same
company.
B) The definition of a "sale" includes a gift if ownership transfers.
C) An authorized recipient includes any entity that is properly permitted to purchase, recieve,
distribute, etc. prescription drugs.
D) All of the above are correct*
E) None of the above are correct.
The following alterations to a container would be "repackaging" under Florida laws and rules: - ✔✔
correct answer A) Changing the label in the bottle
B) Changing the labeling insert contained in the packaging
C) Breaking a multi-unit pack and selling an individual fully labeled unit
D) Only A & B
E) All of the above*
, FL CDR Sample questions module 1-
8
If a Certified Designated Representative is to have an "authorized absence", he/she must meet the
following requirements: - ✔✔ correct answer A) Inform their employer they will not be at work that
day and when they will return. If they are the owner, then inform the manager they will not be at
work that day and when they will return.
B) Cannot exceed 90 calendar days in a 365 day period for specifically defined family issues.
C) All extended absences are permitted as long as they are in writing and authorized by the owner
and/or manager of the permittee.
D) Cannot exceed 60 calendar days in a 365 day period for specifically defined family issues.*
E) Answers A & C are correct.
Who would be considered an "authorized recipient" of prescription drugs on a ocean going vessel -
✔✔ correct answer A) A licensed Ship Captain
B) The First Officer of the ship
C) An Agent of the ship
D) Any marine broker
E) Both A & B above are correct*
A broker only prescription drug wholesale distributor can only possess the following prescription
drugs: - ✔✔ correct answer A) Sample packages
B) Returns for destruction
C) No prescription drugs at all*
D) Starter packs and sample packages only
If a wholesale distributor sells a portion of his business to a new partner. the new partner would
have to purchase more than _____% of the controlled interest to be considered a change of
ownership by the Department. - ✔✔ correct answer A) 50%*
B) 30%
C) 40%
D) 60%
"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? - ✔✔ correct
answer A) Retrievable within minutes.*
