FL CDR Final Examination Question and
Answer
"Drug" - Answer means an article that is: (a) Recognized in the current edition of the
United States Pharmacopoeia and National Formulary, official Homeopathic
Pharmacopoeia of the United States, or any supplement to any of those publications;
(b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention
of disease in humans or other animals; (c) Intended to affect the structure or any
function of the body of humans or other animals; or (d) Intended for use as a component
of any article specified in paragraph (a), paragraph (b), or paragraph (c), and includes
active pharmaceutical ingredients, but does not include devices or their nondrug
components, parts, or accessories.
"Establishment" - Answer means a place of business which is at one general physical
location and may extend to one or more contiguous suites, units, floors, or buildings
operated and controlled exclusively by entities under common operation and control.
Where multiple buildings are under common exclusive ownership, operation, and
control, an intervening thoroughfare does not affect the contiguous nature of the
buildings. For purposes of permitting, each suite, unit, floor, or building must be
identified in the most recent permit application.
"Federal act" - Answer means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. ss.
301 et seq.; 52 Stat. 1040 et seq.
"Freight forwarder" - Answer means a person who receives prescription drugs which are
owned by another person and designated by that person for export, and exports those
prescription drugs.
EDITORS NOTE: you must know the definition of freight forwarder and understand
when you use a freight forwarder vs a 3PL vs a common carrier
"Health care entity" - Answer means a closed pharmacy or any person, organization, or
business entity that provides diagnostic, medical, surgical, or dental treatment or care,
or chronic or rehabilitative care, but does not include any wholesale distributor or retail
pharmacy licensed under state law to deal in prescription drugs. However, a blood
establishment is a health care entity that may engage in the wholesale distribution of
prescription drugs under s. 499.01(2)(h)1.c.
"Health care facility" - Answer means a health care facility licensed under chapter 395.
"Hospice" - Answer means a corporation licensed under part IV of chapter 400.
, "Hospital" - Answer means a facility as defined in s. 395.002 and licensed under chapter
395.
"Immediate container" - Answer does not include package liners.
"Label" - Answer means a display of written, printed, or graphic matter upon the
immediate container of any drug, device, or cosmetic. A requirement made by or under
authority of this part or rules adopted under this part that any word, statement, or other
information appear on the label is not complied with unless such word, statement, or
other information also appears on the outside container or wrapper, if any, of the retail
package of such drug, device, or cosmetic or is easily legible through the outside
container or wrapper.
"Labeling" - Answer means all labels and other written, printed, or graphic matters: (a)
Upon a drug, device, or cosmetic, or any of its containers or wrappers; or (b)
Accompanying or related to such drug, device, or cosmetic.
"Manufacture" - Answer means the preparation, deriving, compounding, propagation,
processing, producing, or fabrication of any drug, device, or cosmetic.
"Manufacturer" - Answer means: (a) A person who holds a New Drug Application, an
Abbreviated New Drug Application, a Biologics License Application, or a New Animal
Drug Application approved under the federal act or a license issued under s. 351 of the
Public Health Service Act, 42 U.S.C. s. 262, for such drug or biologics, or if such drug or
biologics are not the subject of an approved application or license, the person who
manufactured the drug or biologics; (b) A co-licensed partner of the person described in
paragraph (a) who obtains the drug or biologics directly from a person described in
paragraph (a), paragraph (c), or this paragraph; (c) An affiliate of a person described in
paragraph (a), paragraph (b), or this paragraph that receives the drug or biologics
directly from a person described in paragraph (a), paragraph (b), or this paragraph; or
(d) A person who manufactures a device or a cosmetic. The term does not include a
pharmacy that is operating in compliance with pharmacy practice standards as defined
in chapter 465 and rules adopted under that chapter.
"Medical convenience kit" - Answer means packages or units that contain combination
products as defined in 21 C.F.R. s. 3.2(e)(2).
"Medical gas" - Answer means any liquefied or vaporized gas that is a prescription drug,
whether alone or in combination with other gases, and as defined in the federal act.
"New drug" - Answer (EDITORS NOTE: a new drug is an unapproved drug) means: (a)
Any drug the composition of which is such that the drug is not generally recognized,
among experts qualified by scientific training and experience to evaluate the safety and
effectiveness of drugs, as safe and effective for use under the conditions prescribed,
recommended, or suggested in the labeling of that drug; or (b) Any drug the
composition of which is such that the drug, as a result of investigations to determine its
Answer
"Drug" - Answer means an article that is: (a) Recognized in the current edition of the
United States Pharmacopoeia and National Formulary, official Homeopathic
Pharmacopoeia of the United States, or any supplement to any of those publications;
(b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention
of disease in humans or other animals; (c) Intended to affect the structure or any
function of the body of humans or other animals; or (d) Intended for use as a component
of any article specified in paragraph (a), paragraph (b), or paragraph (c), and includes
active pharmaceutical ingredients, but does not include devices or their nondrug
components, parts, or accessories.
"Establishment" - Answer means a place of business which is at one general physical
location and may extend to one or more contiguous suites, units, floors, or buildings
operated and controlled exclusively by entities under common operation and control.
Where multiple buildings are under common exclusive ownership, operation, and
control, an intervening thoroughfare does not affect the contiguous nature of the
buildings. For purposes of permitting, each suite, unit, floor, or building must be
identified in the most recent permit application.
"Federal act" - Answer means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. ss.
301 et seq.; 52 Stat. 1040 et seq.
"Freight forwarder" - Answer means a person who receives prescription drugs which are
owned by another person and designated by that person for export, and exports those
prescription drugs.
EDITORS NOTE: you must know the definition of freight forwarder and understand
when you use a freight forwarder vs a 3PL vs a common carrier
"Health care entity" - Answer means a closed pharmacy or any person, organization, or
business entity that provides diagnostic, medical, surgical, or dental treatment or care,
or chronic or rehabilitative care, but does not include any wholesale distributor or retail
pharmacy licensed under state law to deal in prescription drugs. However, a blood
establishment is a health care entity that may engage in the wholesale distribution of
prescription drugs under s. 499.01(2)(h)1.c.
"Health care facility" - Answer means a health care facility licensed under chapter 395.
"Hospice" - Answer means a corporation licensed under part IV of chapter 400.
, "Hospital" - Answer means a facility as defined in s. 395.002 and licensed under chapter
395.
"Immediate container" - Answer does not include package liners.
"Label" - Answer means a display of written, printed, or graphic matter upon the
immediate container of any drug, device, or cosmetic. A requirement made by or under
authority of this part or rules adopted under this part that any word, statement, or other
information appear on the label is not complied with unless such word, statement, or
other information also appears on the outside container or wrapper, if any, of the retail
package of such drug, device, or cosmetic or is easily legible through the outside
container or wrapper.
"Labeling" - Answer means all labels and other written, printed, or graphic matters: (a)
Upon a drug, device, or cosmetic, or any of its containers or wrappers; or (b)
Accompanying or related to such drug, device, or cosmetic.
"Manufacture" - Answer means the preparation, deriving, compounding, propagation,
processing, producing, or fabrication of any drug, device, or cosmetic.
"Manufacturer" - Answer means: (a) A person who holds a New Drug Application, an
Abbreviated New Drug Application, a Biologics License Application, or a New Animal
Drug Application approved under the federal act or a license issued under s. 351 of the
Public Health Service Act, 42 U.S.C. s. 262, for such drug or biologics, or if such drug or
biologics are not the subject of an approved application or license, the person who
manufactured the drug or biologics; (b) A co-licensed partner of the person described in
paragraph (a) who obtains the drug or biologics directly from a person described in
paragraph (a), paragraph (c), or this paragraph; (c) An affiliate of a person described in
paragraph (a), paragraph (b), or this paragraph that receives the drug or biologics
directly from a person described in paragraph (a), paragraph (b), or this paragraph; or
(d) A person who manufactures a device or a cosmetic. The term does not include a
pharmacy that is operating in compliance with pharmacy practice standards as defined
in chapter 465 and rules adopted under that chapter.
"Medical convenience kit" - Answer means packages or units that contain combination
products as defined in 21 C.F.R. s. 3.2(e)(2).
"Medical gas" - Answer means any liquefied or vaporized gas that is a prescription drug,
whether alone or in combination with other gases, and as defined in the federal act.
"New drug" - Answer (EDITORS NOTE: a new drug is an unapproved drug) means: (a)
Any drug the composition of which is such that the drug is not generally recognized,
among experts qualified by scientific training and experience to evaluate the safety and
effectiveness of drugs, as safe and effective for use under the conditions prescribed,
recommended, or suggested in the labeling of that drug; or (b) Any drug the
composition of which is such that the drug, as a result of investigations to determine its
