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58 Cards in this Set

  • Front
  • Back
adulteration, think..
inside the pill
if a company does not follow c-GMP
think outside the bottle
improperly labeled, improper advertising, not FDA registered establishment
biologic drugs approved under?
BLA not a NDA
reviewed for purity, potentcy, and safety
what did the FDCA do
established misbranding and adulteration
drug must be safe before maket
FDA can inspect distributers and manu
what did public health service act do
BLA for biologics
what did the durham-humphrey amendment to FDCA do
establishd RX and OTC categories
allows refills for Rx
durham-humphrey labeling amendment
OTC drugs must be...
labeled adequately- preg/breast feeding warnings
domestic contact info for ADR
OTC approved under OTC monograph or NDA
durham-humphrey labeling amendment
Rx must be
labeled adequately (PPI)
approved under NDA or grandfathered in
preg categorizzed
peg categories
A- safe in humans
B- safe in animals/ no human data
C- unknown safety in humans
D- unsafe, but benefit may be > risk
X- teratogenic, risk>benefit
unit dose drugs labeling requirments
gen or brand name (NOT BOTH)
strength, dosage, xpiration date, lot number
name of packager

Kefauver haris drug efficacy amendment to FDCA
what must be done?
need what..
must be proven effective before marketing
creates NDA and SNDA- phase 1-3 research

need informed consent and IRB approval
whats needed to test a drug in humans
FDA has 30 days to issued cinical hold
Kefauver haris drug efficacy amendment to FDCA
ADR must be ...
who needs to/ doesn't need to report
must be reported to FDA via medwatch (included clinical studies)

manu required to report, professionals/patients voluntarily report
Kefauver haris drug efficacy amendment to FDCA
all drug labels need..
who regulates advertising for RX and OTC?
brand and generic name
Kefauver haris drug efficacy amendment to FDCA
establishes what cGMP regulations
manu mut register each facility w/ FDA + inspected q 2 years
under cGMP
if facility is not registered with FDA and produces a drug
drug is considered?
al drugs from that facility = misbranded
under cGMP
if facility fails to comply w/ standards of purity, strength an quality and produces a drug, drug is considered?
pharmacies that compound large amounts of RX NOT for individual basis must do what...
register with FDA and cGMP
pharmacy must dispense meds how..
with child resistant containers
exceptions- nitro, chlestryamine, prednisone
whos exempt from child-resistant caps
hospital pharmacists
exceptions of meds that do not require tamper resistant packaging
medicare whistleblowers befit how
collect up to 25% of government award
what kinds of things need to be reported when vaccinating
any reports MUST be reported using VAERS- even conditions listed in package insert/clinically sig/unexpected events
importation of drugs is ...
except for ...
except for manufacturers
what is prohibited with drug samples
cannot sell, trade, or purchase samples
fda allows samples for pt's personal use
in what quantity?
pt must do what?
90 or less
pt must affirm in writing it is for pt's own use
importing of active pharmaceutical ingredients (bulk) is legal only if...
intended for compounding and meets 503A FDCA or has an approved drug app (ANDA, NDA) or
used in approved OTC monograph
prescription drugs must display what

if not, considered?
RX only

if not considered misbranded
any drug without a legend is...
dietary supplements are not required to be..
safe and effective
must follow cGMP
detary supplements must be in what form
any disease claims made make it...
must be orally

disease claims, make it a drug and need FDA approval
API-active pharm. ingredients may be imported under what circumstances
if part of an FDA approved application or used for compounding (no bulk manu)
who is pharmacy must be HIPPA trained
all pharm personel
how many refills on CIII-CV
5 within 6 months
what forms are needed for transfering (bulk) c2 within pharmacies

for c3-c5 requires complete invoice
can a c2 be called in?
can a c3- c5 be called in
c2- in case of emergency

c3-c5- yes
partial fills allowed for c2

for c3-5
c2- gen no , but yes if unable to fill ( remainder must be in w/i 72H

yes for LTCF, must write term. ill or LTCF PT on script

c3-5: yes within limited 6 month period
whats the 5% rule
if pharmacy ships 5 % of its inventory- must register as distributor
what form is needed to report loss or theft
c2- 106
c3-5: 106
what form is required for destruction of scheduled drugs
what is dea form 224 used for
new application for retail pharmacy, hospital, clinic, teaching institution, mid-level practitoner
what is dea form 224a used for
renewal of the app (224)

done every 3 years
224b dea form used for?
affadavit for chain renewal
renewal license for chain pharmacy operating under single registeration
what is 224c form
app for modification of registration for online pharmacies
what is 225 form
new app for manu, distrib, researcher, importer, exporter
(Mckesson, Ortho)
valid for 12 months
what is 363 form
new app for narcotic treatment programs

for methadone maint and detoxification programs
what is 510 dea form
new app for domestric chemical

business involved in precursosr chemicals for manu controls
examples for C1
marijuana, ecstacy, peyote, salvia, LSD, heroin
examples for c2
cocaine, hydrocodone (plain) codeine (straight), tylox, sublimaze, pentobarb
examples of c3
buprenoprhine, vicodin, steroids, suboxone, fiorinal


strengths usually divisible by 3
c4 examples
benzo, sonata, lunesta, soma
c5 examples
lyrica, phenergan w/ codeine

strengths usually divisable by 5
permit types
community pharm (chains)
each store must have its own permit (for chains)
MUST have a PDM on record
can only be manager of one pharm at a time (some exceptions)
must give 10days notice of quiting
class I is what type of pharmacy

describe the dispensing role
class 1 institutional pharm is nursing home

meds are administred from individual prescription bottles to pt- meds are not dispensed on site
nursing facility is required to have what on hand

what dea form are nursing facilities required to registered with?
emergency med kits

nursing facilities may have controls on hand, but do not have to be DEA-registered
how many controlled meds can a nursing home have
UP TO 5 drugs
class 2 insitutional pharmacy
what setting?
drugs must be dispensed how

must be in unit-dose packaging
er prescribers can dispense for outpt use if
smallest duration or less than 24H

if drug is warranted + community pharm not available

drug must be properly labeled
-control meds ok to dispense