FLORIDA CDR EXAM QUESTIONS AND ANSWERS
The department can, on the power of its own initiative, administer oaths, take
depositions, issue and serve Subpoenas, and compel the attendance of a witness and
the production of books, paper, documents, or other evidence. - Answers :True
In order to transport prescription drugs, which of the following entities must obtain a
permit from the department of business and professional regulation's (DBPR)? -
Answers :Freight forwarders
A Director, officer, trustee, partner or committee member of an applicant or at subsidiary
is known as? - Answers :And affiliated party and someone requires to file a personal
information statement
Who would be considered an " authorized recipient of prescription drugs on an ocean
going vessel"? - Answers :A license ship captain and first officer of the ship
A broker only prescription drug wholesale distributor can only possess the following
prescription drugs: - Answers :They can never possess prescription drugs
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 charge of ownership by the department? - Answers :50%
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?
- Answers :Retrievable in minutes
The following alterations to a container would be repackaging under Florida laws and
rules: - Answers :Changing the label on the bottle, changing the labeling insert
contained in the packaging, breaking a multi unit pack and selling an individual fully
labeled unit.
It is unlawful to perform which of the following acts in Florida? - Answers :Adulterating or
this branding a drug, device or cosmetic. Constructive refusal to allow the department to
inspect your car if it is transports drugs or devices or cosmetics. Not allow a department
agent to take samples of drugs devices or cosmetics
Who must allow inspection of any record of the establishment and allow a department
inspector to enter and inspect during operating hours even in the absence of the owner
and/or the CDR. - Answers :The Establishment that manufactures, processes,
packages, repackages, sells, brokers drugs devices or cosmetics.
, Prescription drugs can be purchased properly by a licensed entity using which of the
following methods? - Answers :Credit card and check
What does authorized trading partner mean? - Answers :The entity is properly permitted
or licensed.
When must a T3 be received? - Answers :T3 must be received and transmitted at the
time of the transaction
What does F. S. = - Answers :Florida statutes or Florida state
The department and it's own initiative without judicial or police action can: - Answers
:Inspect, take statement, and conduct inspections
What is the purpose of the Florida drug and cosmetic act 499? - Answers :To safeguard
the public health and promote public welfare by protecting the public from injury by
product used in merchandising deceit involving drugs, devices and cosmetics
What is ARI also known as? - Answers :Active Pharmaceutical ingredients
The five largest natural shareholders must own at least ___________% of the
applicants to meet the definition of an "affiliated party" - Answers :5%
If a drug has a label, identifying mark or imprint that was not authorized by the
manufacturer, the drug would be considered: - Answers :Contraband and counterfeit
If one license wholesaler A, transfer a prescription drug to another wholesaler B, at no
charge, this transaction would be best known as? - Answers :A wholesale distribution
Which of the following entities could be considered a Manufacturer as defined by
Chapter 499? - Answers :A person who owns the ANDA or NDA, And an affiliate of the
person who owns the ANDA or NDA and An entity that manufactures the product
If a certified designated representative is to have an " authorized absence ", he/she
must meet the following requirements: - Answers :
What is an active pharmaceutical ingredient? - Answers :Any substance or mixture of,
intended, represented or labeled
Adulterated, counterfeit - Transaction history, info & statement do not exist or has been
forged, counterfeited, falsely created or contains altered or falsely misrepresented
matter - Answers :Contraband
Contains seal/labeling of which without authorization bears the trademark, tradename or
other identifying marks, imprint or any likeness therefore falsely represents to be the
product - Answers :Counterfeit
The department can, on the power of its own initiative, administer oaths, take
depositions, issue and serve Subpoenas, and compel the attendance of a witness and
the production of books, paper, documents, or other evidence. - Answers :True
In order to transport prescription drugs, which of the following entities must obtain a
permit from the department of business and professional regulation's (DBPR)? -
Answers :Freight forwarders
A Director, officer, trustee, partner or committee member of an applicant or at subsidiary
is known as? - Answers :And affiliated party and someone requires to file a personal
information statement
Who would be considered an " authorized recipient of prescription drugs on an ocean
going vessel"? - Answers :A license ship captain and first officer of the ship
A broker only prescription drug wholesale distributor can only possess the following
prescription drugs: - Answers :They can never possess prescription drugs
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 charge of ownership by the department? - Answers :50%
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?
- Answers :Retrievable in minutes
The following alterations to a container would be repackaging under Florida laws and
rules: - Answers :Changing the label on the bottle, changing the labeling insert
contained in the packaging, breaking a multi unit pack and selling an individual fully
labeled unit.
It is unlawful to perform which of the following acts in Florida? - Answers :Adulterating or
this branding a drug, device or cosmetic. Constructive refusal to allow the department to
inspect your car if it is transports drugs or devices or cosmetics. Not allow a department
agent to take samples of drugs devices or cosmetics
Who must allow inspection of any record of the establishment and allow a department
inspector to enter and inspect during operating hours even in the absence of the owner
and/or the CDR. - Answers :The Establishment that manufactures, processes,
packages, repackages, sells, brokers drugs devices or cosmetics.
, Prescription drugs can be purchased properly by a licensed entity using which of the
following methods? - Answers :Credit card and check
What does authorized trading partner mean? - Answers :The entity is properly permitted
or licensed.
When must a T3 be received? - Answers :T3 must be received and transmitted at the
time of the transaction
What does F. S. = - Answers :Florida statutes or Florida state
The department and it's own initiative without judicial or police action can: - Answers
:Inspect, take statement, and conduct inspections
What is the purpose of the Florida drug and cosmetic act 499? - Answers :To safeguard
the public health and promote public welfare by protecting the public from injury by
product used in merchandising deceit involving drugs, devices and cosmetics
What is ARI also known as? - Answers :Active Pharmaceutical ingredients
The five largest natural shareholders must own at least ___________% of the
applicants to meet the definition of an "affiliated party" - Answers :5%
If a drug has a label, identifying mark or imprint that was not authorized by the
manufacturer, the drug would be considered: - Answers :Contraband and counterfeit
If one license wholesaler A, transfer a prescription drug to another wholesaler B, at no
charge, this transaction would be best known as? - Answers :A wholesale distribution
Which of the following entities could be considered a Manufacturer as defined by
Chapter 499? - Answers :A person who owns the ANDA or NDA, And an affiliate of the
person who owns the ANDA or NDA and An entity that manufactures the product
If a certified designated representative is to have an " authorized absence ", he/she
must meet the following requirements: - Answers :
What is an active pharmaceutical ingredient? - Answers :Any substance or mixture of,
intended, represented or labeled
Adulterated, counterfeit - Transaction history, info & statement do not exist or has been
forged, counterfeited, falsely created or contains altered or falsely misrepresented
matter - Answers :Contraband
Contains seal/labeling of which without authorization bears the trademark, tradename or
other identifying marks, imprint or any likeness therefore falsely represents to be the
product - Answers :Counterfeit
