FL CDR Sample questions module 9-15: Sample
Questions & Answers | A+ Score Solution
/Which of the following entities could be considered a Manufacturer as defined by
Chapter 499? - 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? - 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? - 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: - 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*
/.If a Certified Designated Representative is to have an "authorized absence", he/she
must meet the following requirements: - 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 - 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: - 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. - 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? - Answer-A) 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? - Answer-A) 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: - Answer-A) 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
Questions & Answers | A+ Score Solution
/Which of the following entities could be considered a Manufacturer as defined by
Chapter 499? - 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? - 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? - 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: - 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*
/.If a Certified Designated Representative is to have an "authorized absence", he/she
must meet the following requirements: - 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 - 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: - 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. - 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? - Answer-A) 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? - Answer-A) 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: - Answer-A) 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
