FL CDR Sample questions module 1-8
Which of the following entities could be considered a Manufacturer as defined by Chapter 499?
- ANSa. 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? -
ANSA) 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? - ANSA) 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: -
ANSA) 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*
If a Certified Designated Representative is to have an "authorized absence", he/she must meet
the following requirements: - ANSA) 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 - ANSA) 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: - ANSA) 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. - ANSA) 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? -
ANSA) Retrievable within minutes.*
B) Retrievable within a reasonable amount of time.
C) Retrievable within the same day.
D) Retrievable within 24 hours.
It is unlawful to perform which of the following acts in Florida? - ANSA) Adulterating or
misbranding a drug, device or cosmetic.
B) Constructive refusal to allow the department to inspect your car if it transports drugs, devices
or cosmetics.
C) Not allow a Department Agent to take samples of drugs, devices or cosmetics.
D) Only A
E) All of the above*
The establishment that manufacturers, processes, packages, repackages, sells, brokers, drugs
devices or cosmetics must: - ANSA) Allow inspection of ANY record of the establishment.
B) Allow a Department inspector to enter and inspect during operating hours even in the
absence of the owner and/or CDR.
C) Both of the above*
D) Neither of the above
Prescription drugs can be purchased by a properly licensed entity using which of the following
methods? - ANSA) Cash
Which of the following entities could be considered a Manufacturer as defined by Chapter 499?
- ANSa. 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? -
ANSA) 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? - ANSA) 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: -
ANSA) 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*
If a Certified Designated Representative is to have an "authorized absence", he/she must meet
the following requirements: - ANSA) 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 - ANSA) 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: - ANSA) 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. - ANSA) 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? -
ANSA) Retrievable within minutes.*
B) Retrievable within a reasonable amount of time.
C) Retrievable within the same day.
D) Retrievable within 24 hours.
It is unlawful to perform which of the following acts in Florida? - ANSA) Adulterating or
misbranding a drug, device or cosmetic.
B) Constructive refusal to allow the department to inspect your car if it transports drugs, devices
or cosmetics.
C) Not allow a Department Agent to take samples of drugs, devices or cosmetics.
D) Only A
E) All of the above*
The establishment that manufacturers, processes, packages, repackages, sells, brokers, drugs
devices or cosmetics must: - ANSA) Allow inspection of ANY record of the establishment.
B) Allow a Department inspector to enter and inspect during operating hours even in the
absence of the owner and/or CDR.
C) Both of the above*
D) Neither of the above
Prescription drugs can be purchased by a properly licensed entity using which of the following
methods? - ANSA) Cash
