Fl Mpje

Front 1

adulteration, think..

Back 1

inside the pill
if a company does not follow c-GMP

Front 2

misbranded

Back 2

think outside the bottle
improperly labeled, improper advertising, not FDA registered establishment

Front 3

biologic drugs approved under?

Back 3

BLA not a NDA
reviewed for purity, potentcy, and safety

Front 4

what did the FDCA do

Back 4

established misbranding and adulteration
drug must be safe before maket
FDA can inspect distributers and manu

Front 5

what did public health service act do

Back 5

BLA for biologics

Front 6

what did the durham-humphrey amendment to FDCA do

Back 6

establishd RX and OTC categories
allows refills for Rx

Front 7

durham-humphrey labeling amendment
OTC drugs must be...

Back 7

labeled adequately- preg/breast feeding warnings
domestic contact info for ADR
OTC approved under OTC monograph or NDA

Front 8

durham-humphrey labeling amendment
Rx must be

Back 8

labeled adequately (PPI)
approved under NDA or grandfathered in
preg categorizzed

Front 9

peg categories
ABCDX

Back 9

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

Front 10

unit dose drugs labeling requirments

Back 10

gen or brand name (NOT BOTH)
strength, dosage, xpiration date, lot number
name of packager

DIRECTIONS NOT REQUIRED ON DOSE-STORED FOR RETRIEVABILITY

Front 11

Kefauver haris drug efficacy amendment to FDCA
what must be done?
need what..

Back 11

must be proven effective before marketing
creates NDA and SNDA- phase 1-3 research

need informed consent and IRB approval

Front 12

whats needed to test a drug in humans

Back 12

IND
FDA has 30 days to issued cinical hold

Front 13

Kefauver haris drug efficacy amendment to FDCA
ADR must be ...
who needs to/ doesn't need to report

Back 13

must be reported to FDA via medwatch (included clinical studies)

manu required to report, professionals/patients voluntarily report

Front 14

Kefauver haris drug efficacy amendment to FDCA
all drug labels need..
who regulates advertising for RX and OTC?

Back 14

brand and generic name
RX-FDA, OTC- FTC

Front 15

Kefauver haris drug efficacy amendment to FDCA
establishes what cGMP regulations

Back 15

manu mut register each facility w/ FDA + inspected q 2 years

Front 16

under cGMP
if facility is not registered with FDA and produces a drug
drug is considered?

Back 16

al drugs from that facility = misbranded

Front 17

under cGMP
if facility fails to comply w/ standards of purity, strength an quality and produces a drug, drug is considered?

Back 17

adulterated

Front 18

pharmacies that compound large amounts of RX NOT for individual basis must do what...

Back 18

register with FDA and cGMP

Front 19

pharmacy must dispense meds how..

Back 19

with child resistant containers
exceptions- nitro, chlestryamine, prednisone

Front 20

whos exempt from child-resistant caps

Back 20

hospital pharmacists

Front 21

exceptions of meds that do not require tamper resistant packaging

Back 21

insulin
lozenges
dermatologicals

Front 22

medicare whistleblowers befit how

Back 22

collect up to 25% of government award

Front 23

what kinds of things need to be reported when vaccinating

Back 23

any reports MUST be reported using VAERS- even conditions listed in package insert/clinically sig/unexpected events

Front 24

importation of drugs is ...
except for ...

Back 24

illegal
except for manufacturers

Front 25

what is prohibited with drug samples

Back 25

cannot sell, trade, or purchase samples

Front 26

fda allows samples for pt's personal use
in what quantity?
pt must do what?

Back 26

90 or less
pt must affirm in writing it is for pt's own use

Front 27

importing of active pharmaceutical ingredients (bulk) is legal only if...

Back 27

intended for compounding and meets 503A FDCA or has an approved drug app (ANDA, NDA) or
used in approved OTC monograph

Front 28

prescription drugs must display what

if not, considered?

Back 28

RX only

if not considered misbranded

Front 29

any drug without a legend is...

Back 29

mibranded

Front 30

dietary supplements are not required to be..

Back 30

safe and effective
must follow cGMP

Front 31

detary supplements must be in what form
any disease claims made make it...

Back 31

must be orally

disease claims, make it a drug and need FDA approval

Front 32

API-active pharm. ingredients may be imported under what circumstances

Back 32

if part of an FDA approved application or used for compounding (no bulk manu)

Front 33

who is pharmacy must be HIPPA trained

Back 33

all pharm personel

Front 34

how many refills on CIII-CV

Back 34

5 within 6 months

Front 35

what forms are needed for transfering (bulk) c2 within pharmacies

Back 35

222

for c3-c5 requires complete invoice

Front 36

can a c2 be called in?
can a c3- c5 be called in

Back 36

c2- in case of emergency

c3-c5- yes

Front 37

partial fills allowed for c2

for c3-5

Back 37

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

Front 38

whats the 5% rule

Back 38

if pharmacy ships 5 % of its inventory- must register as distributor

Front 39

what form is needed to report loss or theft
c2?
c3-5?

Back 39

c2- 106
c3-5: 106

Front 40

what form is required for destruction of scheduled drugs

Back 40

41

Front 41

what is dea form 224 used for

Back 41

new application for retail pharmacy, hospital, clinic, teaching institution, mid-level practitoner

Front 42

what is dea form 224a used for

Back 42

renewal of the app (224)

done every 3 years

Front 43

224b dea form used for?

Back 43

affadavit for chain renewal
renewal license for chain pharmacy operating under single registeration

Front 44

what is 224c form

Back 44

app for modification of registration for online pharmacies

Front 45

what is 225 form

Back 45

new app for manu, distrib, researcher, importer, exporter
(Mckesson, Ortho)
valid for 12 months

Front 46

what is 363 form

Back 46

new app for narcotic treatment programs

for methadone maint and detoxification programs

Front 47

what is 510 dea form

Back 47

new app for domestric chemical

business involved in precursosr chemicals for manu controls

Front 48

examples for C1

Back 48

marijuana, ecstacy, peyote, salvia, LSD, heroin

Front 49

examples for c2

Back 49

cocaine, hydrocodone (plain) codeine (straight), tylox, sublimaze, pentobarb

Front 50

examples of c3

Back 50

buprenoprhine, vicodin, steroids, suboxone, fiorinal

**NOT FIORICET

strengths usually divisible by 3

Front 51

c4 examples

Back 51

benzo, sonata, lunesta, soma
ZZZZ

Front 52

c5 examples

Back 52

lyrica, phenergan w/ codeine

strengths usually divisable by 5

Front 53

permit types
community pharm (chains)

Back 53

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

Front 54

class I is what type of pharmacy

describe the dispensing role

Back 54

class 1 institutional pharm is nursing home

meds are administred from individual prescription bottles to pt- meds are not dispensed on site

Front 55

nursing facility is required to have what on hand

what dea form are nursing facilities required to registered with?

Back 55

emergency med kits

nursing facilities may have controls on hand, but do not have to be DEA-registered

Front 56

how many controlled meds can a nursing home have

Back 56

UP TO 5 drugs

Front 57

class 2 insitutional pharmacy
what setting?
drugs must be dispensed how

Back 57

hospital

must be in unit-dose packaging

Front 58

er prescribers can dispense for outpt use if

Back 58

smallest duration or less than 24H

if drug is warranted + community pharm not available

drug must be properly labeled
-control meds ok to dispense