FLORIDA CDR. Exam Review Question
and Answer.
A retail pharmacy wholesaler permittee Can wholesale distribute which of the following
products to which entities? - Answer Prescription drugs to a licensed retail pharmacy in
this state. Prescription drugs to a modified class to institutional pharmacy in the state.
Prescription drugs to a licensed healthcare practitioner in this state.
And licensed prescription drug wholesale distributor can buy prescription drugs from
which of the following entities? - Answer A prescription drug repackage your permit
The bond required to apply for prescription drug wholesaler permit can be in the form
of? - Answer A cash deposit in a trust account payable to the Florida professional
regulatory trust fund.
A prescription drug wholesaler distributor cannot be issued to the same address as a : -
Answer Healthcare entity, a pharmacy licensed under chapter 465FS with the exception
of a nuclear pharmacy and a personal residence.
The following conditions require pre-notification to the department? - Answer Change of
address
When a permitteeCloses, the following process must be observed - Answer A) The
permit he must notify the department in writing prior to closure.
B) The permit must be returned to the department.
C) If RX drugs are present, the permittee must notify the department of the disposition
of the drugs.
D) The permittee must provide the name and address of the person to contact for
records.
All of the above are correct.
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. - Answer 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)? - Answer
Freight forwarders
A Director, officer, trustee, partner or committee member of an applicant or at subsidiary
is known as? - Answer And affiliated party and someone requires to file a personal
information statement
, The five largest natural shareholders must own at least ___________% of the
applicants to meet the definition of an "affiliated party" - Answer 5%
If a drug has a label, identifying mark or imprint that was not authorized by the
manufacturer, the drug would be considered: - Answer 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? - Answer A wholesale distribution
Which of the following entities could be considered a Manufacturer as defined by
Chapter 499? - Answer 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: - Answer
Who would be considered an " authorized recipient of prescription drugs on an ocean
going vessel"? - Answer A license ship captain and first officer of the ship
A broker only prescription drug wholesale distributor can only possess the following
prescription drugs: - Answer 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? - Answer 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?
- Answer Retrievable in minutes
The following alterations to a container would be repackaging under Florida laws and
rules: - Answer 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? - Answer 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. - Answer The Establishment that manufactures, processes, packages,
repackages, sells, brokers drugs devices or cosmetics.
and Answer.
A retail pharmacy wholesaler permittee Can wholesale distribute which of the following
products to which entities? - Answer Prescription drugs to a licensed retail pharmacy in
this state. Prescription drugs to a modified class to institutional pharmacy in the state.
Prescription drugs to a licensed healthcare practitioner in this state.
And licensed prescription drug wholesale distributor can buy prescription drugs from
which of the following entities? - Answer A prescription drug repackage your permit
The bond required to apply for prescription drug wholesaler permit can be in the form
of? - Answer A cash deposit in a trust account payable to the Florida professional
regulatory trust fund.
A prescription drug wholesaler distributor cannot be issued to the same address as a : -
Answer Healthcare entity, a pharmacy licensed under chapter 465FS with the exception
of a nuclear pharmacy and a personal residence.
The following conditions require pre-notification to the department? - Answer Change of
address
When a permitteeCloses, the following process must be observed - Answer A) The
permit he must notify the department in writing prior to closure.
B) The permit must be returned to the department.
C) If RX drugs are present, the permittee must notify the department of the disposition
of the drugs.
D) The permittee must provide the name and address of the person to contact for
records.
All of the above are correct.
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. - Answer 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)? - Answer
Freight forwarders
A Director, officer, trustee, partner or committee member of an applicant or at subsidiary
is known as? - Answer And affiliated party and someone requires to file a personal
information statement
, The five largest natural shareholders must own at least ___________% of the
applicants to meet the definition of an "affiliated party" - Answer 5%
If a drug has a label, identifying mark or imprint that was not authorized by the
manufacturer, the drug would be considered: - Answer 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? - Answer A wholesale distribution
Which of the following entities could be considered a Manufacturer as defined by
Chapter 499? - Answer 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: - Answer
Who would be considered an " authorized recipient of prescription drugs on an ocean
going vessel"? - Answer A license ship captain and first officer of the ship
A broker only prescription drug wholesale distributor can only possess the following
prescription drugs: - Answer 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? - Answer 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?
- Answer Retrievable in minutes
The following alterations to a container would be repackaging under Florida laws and
rules: - Answer 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? - Answer 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. - Answer The Establishment that manufactures, processes, packages,
repackages, sells, brokers drugs devices or cosmetics.
