FL CDR Sample questions module 1-8: 55 Verified
Questions & 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. - ANSWERTrue
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)? -
ANSWERFreight forwarders
A Director, officer, trustee, partner or committee member of an applicant or at
subsidiary is known as? - ANSWERAnd 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" - ANSWER5%
If a drug has a label, identifying mark or imprint that was not authorized by the
manufacturer, the drug would be considered: - ANSWERContraband 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? - ANSWERA wholesale
distribution
Which of the following entities could be considered a Manufacturer as defined by
Chapter 499? - ANSWERA 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
Who would be considered an " authorized recipient of prescription drugs on an
ocean going vessel"? - ANSWERA license ship captain and first officer of the ship
A broker only prescription drug wholesale distributor can only possess the following
prescription drugs: - ANSWERThey 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? - ANSWER50%
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? - ANSWERRetrievable in minutes
The following alterations to a container would be repackaging under Florida laws and
rules: - ANSWERChanging 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? -
ANSWERAdulterating 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. - ANSWERThe 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? - ANSWERCredit card and check
What does authorized trading partner mean? - ANSWERThe entity is properly
permitted or licensed.
When must a T3 be received? - ANSWERT3 must be received and transmitted at the
time of the transaction
What does F. S. = - ANSWERFlorida statutes or Florida state
The department and it's own initiative without judicial or police action can: -
ANSWERInspect, take statement, and conduct inspections
What is the purpose of the Florida drug and cosmetic act 499? - ANSWERTo
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? - ANSWERActive Pharmaceutical ingredients
What is an active pharmaceutical ingredient? - ANSWERAny 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 - ANSWERContraband
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 - ANSWERCounterfeit
Questions & 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. - ANSWERTrue
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)? -
ANSWERFreight forwarders
A Director, officer, trustee, partner or committee member of an applicant or at
subsidiary is known as? - ANSWERAnd 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" - ANSWER5%
If a drug has a label, identifying mark or imprint that was not authorized by the
manufacturer, the drug would be considered: - ANSWERContraband 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? - ANSWERA wholesale
distribution
Which of the following entities could be considered a Manufacturer as defined by
Chapter 499? - ANSWERA 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
Who would be considered an " authorized recipient of prescription drugs on an
ocean going vessel"? - ANSWERA license ship captain and first officer of the ship
A broker only prescription drug wholesale distributor can only possess the following
prescription drugs: - ANSWERThey 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? - ANSWER50%
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? - ANSWERRetrievable in minutes
The following alterations to a container would be repackaging under Florida laws and
rules: - ANSWERChanging 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? -
ANSWERAdulterating 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. - ANSWERThe 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? - ANSWERCredit card and check
What does authorized trading partner mean? - ANSWERThe entity is properly
permitted or licensed.
When must a T3 be received? - ANSWERT3 must be received and transmitted at the
time of the transaction
What does F. S. = - ANSWERFlorida statutes or Florida state
The department and it's own initiative without judicial or police action can: -
ANSWERInspect, take statement, and conduct inspections
What is the purpose of the Florida drug and cosmetic act 499? - ANSWERTo
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? - ANSWERActive Pharmaceutical ingredients
What is an active pharmaceutical ingredient? - ANSWERAny 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 - ANSWERContraband
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 - ANSWERCounterfeit
