Use LEFT and RIGHT arrow keys to navigate between flashcards;
Use UP and DOWN arrow keys to flip the card;
H to show hint;
A reads text to speech;
58 Cards in this Set
- Front
- Back
adulteration, think..
|
inside the pill
if a company does not follow c-GMP |
|
misbranded
|
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
ABCDX |
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 DIRECTIONS NOT REQUIRED ON DOSE-STORED FOR RETRIEVABILITY |
|
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
|
IND
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
RX-FDA, OTC- FTC |
|
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? |
adulterated
|
|
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
|
insulin
lozenges dermatologicals |
|
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 ... |
illegal
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...
|
mibranded
|
|
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
|
222
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? c3-5? |
c2- 106
c3-5: 106 |
|
what form is required for destruction of scheduled drugs
|
41
|
|
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
**NOT FIORICET strengths usually divisible by 3 |
|
c4 examples
|
benzo, sonata, lunesta, soma
ZZZZ |
|
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 |
hospital
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 |