WV Pharmacy Law Exam Newest 2025/2026 With
Complete All Questions And Correct Answers
|Already Graded A+||Brand New Version!|
Manufacturers, located every 2 years
anywhere in the
world, must be registered with
the FDA and are normally
inspected by the FDA for
compliance with CGMP in a
period of once
________.
True or False: The monitoring True
of product
tampering is not associated
with the Poison Prevention
Packaging Act.
If a commercial container last day of the month
has an expiration date listed
of the month and year, it
expires on the...
the "Highlights" section boxed warnings, indications and usage, dosage and
of the PI must include... administration, and a list of all changes to the product
within the last year
Package insert laws were 5, June 30 2006
retroactive to ___ years on
______ _.
Where are the boxed the highlights section
warnings located within
the package insert?
A national drug code number 11 digits separated into 3 segments
consists of:
This segment of the NDC first segment
codes for the manufacturer
,or distributor
This segment of the NDC second segment
codes for the specific
strength, dosage form, and
formulation of the drug
This segment of the NDC third segment
codes for the package size
and type of drug
From discovery to 14
marketing, the drug approval
process takes approximately
__ years.
What phases of a clinical Phases I and II
trial must have written
consent from the
patient to
proceed?
A patent for a new drug is 20
granted for ___ years.
a status that a drug maker break-thru therapy status
can apply for if the drug
they wish to market is a
brand new therapy for an
established disease state
What is the period of 12 years
marketing exclusivity for
biosimilars?
What is the MedWatch 1-800-FDA-1088
telephone number?
regulates nonprescription FTC (federal trade commission)
drug advertising
What is the telephone 1-800-222-1222
number for the poison
center?
the official compendium for United States Pharmacopia (USP)
drug standards in the US
,one having an indicator or taper resistant packaging
barrier to entry which, if
breeched or missing, can
reasonably be expected to
provide visible evidence to
consumers that tampering
has occurred
How many years of 5 years
marketing exclusivity are
given to a new drug?
sheets of information printed consumer medication information
at the
pharmacy that are to be
handed out to each
patient. These are not
regulated by the FDA
formerly PPI; given only medication guide
with drugs posing a serious
and significant concern
Who is responsible for generic the states
substitution laws?
the therapeutic generic AA
category that is given this
rating when there is a
conventional dosage
form, no
bioequivalence
problems
the therapeutic generic AB
category that is given this
rating when actual or
potential bioequivalence
problems may have existed
but have since been
resolved by adequate
scientific evidence
, this is the therapeutic B
generic category of the
rating of generic
equivalents that
should not be on the market
defined as one where narrow therapeutic index (NTI) drug
there is less than a two-
fold difference between
the median lethal dose and
the median effective dose
Who enforces the Poison Consumer Product Safety Commission (CPSC)
Prevention Packaging
act?
promotional labeling for FDA
RX drugs is controlled
by ____.
The specific department the Office of RX Drug Promotion
within the FDA that
handles RX drug
advertising
set of regulations that CGMP
establishes minimum
requirements for the methods,
facilities, or controls, used in
the manufacture,
processing, packaging, or
holding of a drug product
True or False: The presence True
of an NDC does not
indicate that the drug has
received an approved
NDA.
the number of days the FDA 30 days
has to reject an INDA
How does a drug go from RX the manufacturer requests it
to OTC?
The book of generic the Orange book
substitution
Complete All Questions And Correct Answers
|Already Graded A+||Brand New Version!|
Manufacturers, located every 2 years
anywhere in the
world, must be registered with
the FDA and are normally
inspected by the FDA for
compliance with CGMP in a
period of once
________.
True or False: The monitoring True
of product
tampering is not associated
with the Poison Prevention
Packaging Act.
If a commercial container last day of the month
has an expiration date listed
of the month and year, it
expires on the...
the "Highlights" section boxed warnings, indications and usage, dosage and
of the PI must include... administration, and a list of all changes to the product
within the last year
Package insert laws were 5, June 30 2006
retroactive to ___ years on
______ _.
Where are the boxed the highlights section
warnings located within
the package insert?
A national drug code number 11 digits separated into 3 segments
consists of:
This segment of the NDC first segment
codes for the manufacturer
,or distributor
This segment of the NDC second segment
codes for the specific
strength, dosage form, and
formulation of the drug
This segment of the NDC third segment
codes for the package size
and type of drug
From discovery to 14
marketing, the drug approval
process takes approximately
__ years.
What phases of a clinical Phases I and II
trial must have written
consent from the
patient to
proceed?
A patent for a new drug is 20
granted for ___ years.
a status that a drug maker break-thru therapy status
can apply for if the drug
they wish to market is a
brand new therapy for an
established disease state
What is the period of 12 years
marketing exclusivity for
biosimilars?
What is the MedWatch 1-800-FDA-1088
telephone number?
regulates nonprescription FTC (federal trade commission)
drug advertising
What is the telephone 1-800-222-1222
number for the poison
center?
the official compendium for United States Pharmacopia (USP)
drug standards in the US
,one having an indicator or taper resistant packaging
barrier to entry which, if
breeched or missing, can
reasonably be expected to
provide visible evidence to
consumers that tampering
has occurred
How many years of 5 years
marketing exclusivity are
given to a new drug?
sheets of information printed consumer medication information
at the
pharmacy that are to be
handed out to each
patient. These are not
regulated by the FDA
formerly PPI; given only medication guide
with drugs posing a serious
and significant concern
Who is responsible for generic the states
substitution laws?
the therapeutic generic AA
category that is given this
rating when there is a
conventional dosage
form, no
bioequivalence
problems
the therapeutic generic AB
category that is given this
rating when actual or
potential bioequivalence
problems may have existed
but have since been
resolved by adequate
scientific evidence
, this is the therapeutic B
generic category of the
rating of generic
equivalents that
should not be on the market
defined as one where narrow therapeutic index (NTI) drug
there is less than a two-
fold difference between
the median lethal dose and
the median effective dose
Who enforces the Poison Consumer Product Safety Commission (CPSC)
Prevention Packaging
act?
promotional labeling for FDA
RX drugs is controlled
by ____.
The specific department the Office of RX Drug Promotion
within the FDA that
handles RX drug
advertising
set of regulations that CGMP
establishes minimum
requirements for the methods,
facilities, or controls, used in
the manufacture,
processing, packaging, or
holding of a drug product
True or False: The presence True
of an NDC does not
indicate that the drug has
received an approved
NDA.
the number of days the FDA 30 days
has to reject an INDA
How does a drug go from RX the manufacturer requests it
to OTC?
The book of generic the Orange book
substitution
