20 FL X Certified Designated Representative Exam
(Florida Board of Pharmacy – Designated
Representative for Prescription Drug Distributors|Just
Released!!
"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
safety and effectiveness for use under certain conditions,
has been recognized for use under such conditions, but
which drug has not, other than in those investigations,
been used to a material extent or for a material time under
such conditions.
(Florida Board of Pharmacy – Designated
Representative for Prescription Drug Distributors|Just
Released!!
"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
safety and effectiveness for use under certain conditions,
has been recognized for use under such conditions, but
which drug has not, other than in those investigations,
been used to a material extent or for a material time under
such conditions.
