FL CDR COMPREHENSIVE EXAM 2026 QUESTIONS AND
ANSWERS RATED A+
✔✔Active Pharmaceutical Ingredient (API) - ✔✔includes any substance or mixture of
substances intended, represented, or labeled for use in drug manufacturing that
furnishes or is intended to furnish, in a finished dosage form, any pharmacological
activity or other direct effect in the diagnosis, cure, mitigation, treatment, therapy, or
prevention of disease in humans or other animals, or to affect the structure or any
function of the body of humans or animals.
✔✔"Contraband prescription drug" - ✔✔means any adulterated drug, as defined in s.
499.006, any counterfeit drug, as defined in this section, and also means any
prescription drug for which a transaction history, transaction information, or transaction
statement does not exist, or for which the transaction history, transaction information, or
transaction statement in existence has been forged, counterfeited, falsely created, or
contains any altered, false, or misrepresented matter.
✔✔"Counterfeit drug" - ✔✔means a drug, device, or cosmetic which, or the container,
seal, or labeling of which, without authorization, bears the trademark, trade name, or
other identifying mark, imprint, or device, or any likeness thereof, of a drug, device, or
cosmetic manufacturer, processor, packer, or distributor other than the person that in
fact manufactured, processed, packed, or distributed that drug, device, or cosmetic and
which thereby falsely purports or is represented to be the product of, or to have been
packed or distributed by, that other drug, device, or cosmetic manufacturer, processor,
packer, or distributor.
✔✔True - ✔✔true/false - if an entity doesn't qualify to be the manufacturer under 29(a-
d) then they are a wholesaler and will need an additional permit as a wholesaler to
distribute those drugs
✔✔medical convenience kit EDITOR'S NOTE - ✔✔a medical convenience kit or just
"kit" contains non-Rx items and one Rx product, therefore, these kits are treated as
DRUGS even though they are technically devices under Federal law. We will learn that
permitting laws apply but these kits are exempt from the definition of "product" under
federal law and therefore no track and trace applies... but EVERYTHING ELSE
APPLIES
✔✔Medical gas - ✔✔means any liquefied or vaporized gas that is a prescription drug,
whether alone or in combination with other gases, as defined in the federal act.
EDITORS NOTE: we will learn more about medical oxygen. this is treated as a Rx drug.
✔✔New Drug - ✔✔(EDITORS NOTE: a new drug is an unapproved drug)
✔✔True - ✔✔T/F a wholesaler cannot repackage in any way
, ✔✔authorized absence - ✔✔means the physical absence of the designated rep from
the permitted establishment, for a cumulative 60 calendar days in any 365 calendar day
period for situations such as: the birth of the employee's child; the placement of a child
with the employee for adoption/foster care; the care of a family member with a health
condtion; or the employee's own serious health condition makes the employee unable to
perform the functions of the designated rep.
✔✔authorized recipient - ✔✔means a person permitted by or otherwise authorized by
Florida law, or by the law of the jurisdiction in which the person receives the prescription
drugs, to purchase, own, receive, or possess those prescription drugs.
DOES NOT include a Class 1 Institutional pharmacy since it is only authorized to
possess dispensed prescription drugs and medical oxygen for administration to it's
patients.
✔✔broker* - ✔✔means a person participating in the wholesale distribution of a
prescription drug by buying, purchasing, or OTHERWISE TAKING OWNERSHIP of or
title to the prescription drug and selling or transferring, or offering to sell or transfer,
ownership of or title to the prescription drug to a person other than the patient or the
patient's agent WITHOUT TAKING ANY PHYSICAL POSSESSION of the prescription
drug.
✔✔change in ownership - ✔✔meant that there has been a transfer or assignment of a
majority of direct ownership or controlling interest of a permitted establishment. when
someone new gains MORE THAN 50% OWNERSHIP
✔✔Intracompany transfer - ✔✔means a distribution of a specific unit of a prescription
drug between two establishments wholly owned and operated by the same business
entity. EDITOR'S NOTE: keep intracompany transfer in the back of your mind. It is an
exception to T3 and wholesale distribution. notes it's INTRA not INTER.
✔✔"readily available" or "readily retrievable - ✔✔records (hard or electronic) are
organized in a manner that they can quickly be retrieved within minutes during an
inspection (unless the permitted address is not within the state in which case a 48 hour
timeframe is available for producing records
✔✔the only time a wholesaler can repackage is... - ✔✔altering a package of multiple
units for sale if the individual unit is a fully labeled self-contained package that is
shipped by the manufacturer in multiple units; or by adding the package insert to a fully
labeled unit
✔✔sale - ✔✔includes any transfer of title or ownership whether by barter, exchange, or
gift.
✔✔ Active pharmaceutical ingredient - ✔✔includes any substance or mixture of
substances intended, represented, or labeled for use in drug manufacturing that
ANSWERS RATED A+
✔✔Active Pharmaceutical Ingredient (API) - ✔✔includes any substance or mixture of
substances intended, represented, or labeled for use in drug manufacturing that
furnishes or is intended to furnish, in a finished dosage form, any pharmacological
activity or other direct effect in the diagnosis, cure, mitigation, treatment, therapy, or
prevention of disease in humans or other animals, or to affect the structure or any
function of the body of humans or animals.
✔✔"Contraband prescription drug" - ✔✔means any adulterated drug, as defined in s.
499.006, any counterfeit drug, as defined in this section, and also means any
prescription drug for which a transaction history, transaction information, or transaction
statement does not exist, or for which the transaction history, transaction information, or
transaction statement in existence has been forged, counterfeited, falsely created, or
contains any altered, false, or misrepresented matter.
✔✔"Counterfeit drug" - ✔✔means a drug, device, or cosmetic which, or the container,
seal, or labeling of which, without authorization, bears the trademark, trade name, or
other identifying mark, imprint, or device, or any likeness thereof, of a drug, device, or
cosmetic manufacturer, processor, packer, or distributor other than the person that in
fact manufactured, processed, packed, or distributed that drug, device, or cosmetic and
which thereby falsely purports or is represented to be the product of, or to have been
packed or distributed by, that other drug, device, or cosmetic manufacturer, processor,
packer, or distributor.
✔✔True - ✔✔true/false - if an entity doesn't qualify to be the manufacturer under 29(a-
d) then they are a wholesaler and will need an additional permit as a wholesaler to
distribute those drugs
✔✔medical convenience kit EDITOR'S NOTE - ✔✔a medical convenience kit or just
"kit" contains non-Rx items and one Rx product, therefore, these kits are treated as
DRUGS even though they are technically devices under Federal law. We will learn that
permitting laws apply but these kits are exempt from the definition of "product" under
federal law and therefore no track and trace applies... but EVERYTHING ELSE
APPLIES
✔✔Medical gas - ✔✔means any liquefied or vaporized gas that is a prescription drug,
whether alone or in combination with other gases, as defined in the federal act.
EDITORS NOTE: we will learn more about medical oxygen. this is treated as a Rx drug.
✔✔New Drug - ✔✔(EDITORS NOTE: a new drug is an unapproved drug)
✔✔True - ✔✔T/F a wholesaler cannot repackage in any way
, ✔✔authorized absence - ✔✔means the physical absence of the designated rep from
the permitted establishment, for a cumulative 60 calendar days in any 365 calendar day
period for situations such as: the birth of the employee's child; the placement of a child
with the employee for adoption/foster care; the care of a family member with a health
condtion; or the employee's own serious health condition makes the employee unable to
perform the functions of the designated rep.
✔✔authorized recipient - ✔✔means a person permitted by or otherwise authorized by
Florida law, or by the law of the jurisdiction in which the person receives the prescription
drugs, to purchase, own, receive, or possess those prescription drugs.
DOES NOT include a Class 1 Institutional pharmacy since it is only authorized to
possess dispensed prescription drugs and medical oxygen for administration to it's
patients.
✔✔broker* - ✔✔means a person participating in the wholesale distribution of a
prescription drug by buying, purchasing, or OTHERWISE TAKING OWNERSHIP of or
title to the prescription drug and selling or transferring, or offering to sell or transfer,
ownership of or title to the prescription drug to a person other than the patient or the
patient's agent WITHOUT TAKING ANY PHYSICAL POSSESSION of the prescription
drug.
✔✔change in ownership - ✔✔meant that there has been a transfer or assignment of a
majority of direct ownership or controlling interest of a permitted establishment. when
someone new gains MORE THAN 50% OWNERSHIP
✔✔Intracompany transfer - ✔✔means a distribution of a specific unit of a prescription
drug between two establishments wholly owned and operated by the same business
entity. EDITOR'S NOTE: keep intracompany transfer in the back of your mind. It is an
exception to T3 and wholesale distribution. notes it's INTRA not INTER.
✔✔"readily available" or "readily retrievable - ✔✔records (hard or electronic) are
organized in a manner that they can quickly be retrieved within minutes during an
inspection (unless the permitted address is not within the state in which case a 48 hour
timeframe is available for producing records
✔✔the only time a wholesaler can repackage is... - ✔✔altering a package of multiple
units for sale if the individual unit is a fully labeled self-contained package that is
shipped by the manufacturer in multiple units; or by adding the package insert to a fully
labeled unit
✔✔sale - ✔✔includes any transfer of title or ownership whether by barter, exchange, or
gift.
✔✔ Active pharmaceutical ingredient - ✔✔includes any substance or mixture of
substances intended, represented, or labeled for use in drug manufacturing that
