Louisiana MPJE Review
Save
Terms in this set (330)
Food, Drug, and a batch process with instructions for
Cosmetic Act use and warnings for abuse.
(FDCA) notes
that certain
products
requires a ___ and
with ___.
FDCA requires SAFETY
___
documentation
for drugs.
The FDCA is the primary federal law
the FDA's ______.
, 1. Need to document safety only
2. Created an Rx only class of
medications
Three major
3. Application to INTRASTATE
Limitations to the
commerce
FDCA?
also, created a loophole for current
products (i.e., levothyroxine)
Durham- prescription and pharmacist
Humfrey
Amendment of
1951 , which
served as an
update to the
FDCA, clarified
the role of ____
and ____.
,Durham- Rx (prescription) vs OTC
Humfrey
classified drugs oral and written (must write
into two immediately)
different
categories ___ vs
___. Prescriptions
were allowed in
both ____ forms
by authorized
personnel.
Kefauver-Harris 1. Extensive animal testing prior to
Amendement of use in humans
1962 required 2. EFFECTIVE
____. Drugs must
be proven ____, in
accordance to
safety.
____ requires Kefauver-Harris
submission of an IND (Investigational New Drug)
IND followed by NDA (New Drug Application)
a NDA.
, According to FTC (Federal Trade Commission)
Kefauver-Harris FDA
Amendment: (1) informed consent (2) reporting of
OTC SE (3) GMPs*
medications are
regulated by the
___.
Prescription
Medications are
regulated by the
____,
FDA trials
require
_________________
According to the 5 years
FDCA
prescriptions
need to be
stored for a
minimum of ___.
Save
Terms in this set (330)
Food, Drug, and a batch process with instructions for
Cosmetic Act use and warnings for abuse.
(FDCA) notes
that certain
products
requires a ___ and
with ___.
FDCA requires SAFETY
___
documentation
for drugs.
The FDCA is the primary federal law
the FDA's ______.
, 1. Need to document safety only
2. Created an Rx only class of
medications
Three major
3. Application to INTRASTATE
Limitations to the
commerce
FDCA?
also, created a loophole for current
products (i.e., levothyroxine)
Durham- prescription and pharmacist
Humfrey
Amendment of
1951 , which
served as an
update to the
FDCA, clarified
the role of ____
and ____.
,Durham- Rx (prescription) vs OTC
Humfrey
classified drugs oral and written (must write
into two immediately)
different
categories ___ vs
___. Prescriptions
were allowed in
both ____ forms
by authorized
personnel.
Kefauver-Harris 1. Extensive animal testing prior to
Amendement of use in humans
1962 required 2. EFFECTIVE
____. Drugs must
be proven ____, in
accordance to
safety.
____ requires Kefauver-Harris
submission of an IND (Investigational New Drug)
IND followed by NDA (New Drug Application)
a NDA.
, According to FTC (Federal Trade Commission)
Kefauver-Harris FDA
Amendment: (1) informed consent (2) reporting of
OTC SE (3) GMPs*
medications are
regulated by the
___.
Prescription
Medications are
regulated by the
____,
FDA trials
require
_________________
According to the 5 years
FDCA
prescriptions
need to be
stored for a
minimum of ___.
