Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

MPJE > Federal > Flashcards

Federal Flashcards

1
Q

how to cite federal law or rules/regulations

A

T USC &S(Ss)
T - title
S - section
Ss - subsection

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

how to cite Indiana laws

A

IC T-A-C-S
T - title
A - article
C - chapter
S - section

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

how to cite Indiana rules/regulations

A

T IAC A-C-S

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

what is the definition of a drug - 4 factors

A

1 - article recognized in the official compendium
2 - article intended for use in dx, cure, tx
3 - article intended to affect body
4 - articles for use as component

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

what components constitute the official compendium

A

USP, NF, HPUS

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

what is an orphan drug

A

used for a condition that affects <200,000 in the US OR affects >200,000 in the US with no expectation that the cost of developing the drug will be recovered from sales

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

who is responsible for naming generic drugs

A

USAN

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

who is included in USAN

A

FDA liaison, at-large member, AMA, USP, APhA representative

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

what is considered adulteration - 8 factors

A

1 - consists of filthy, putrid, decomposed
2 - prepared in unsanitary conditions
3 - don’t follow cGMP if manufactured
4 - container is poisonous
5 - unsafe color additive
6 - quality or purity falls below standard
7 - strength differs from compendium
8 - been in a place that denies inspection

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

what is cGMP and the requirements

A

minimum manufacturing requirements
manufacturers MUST be registered with the FDA - failure to register = adulteration AND misbranding

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

how often do manufacturers have to be inspected by the FDA for cGMP

A

2 years

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

what is considered misbranding - 10 factors

A

1 - labeling is false
2 - in package UNLESS contains labeling
3 - required information is missing
4 - if not recognized by official compendium
5 - not adequate directions
6 - container is misleading
7 - dose is dangerous to health
8 - color additive isn’t on label
9 - violates PPPA
10 - REMS not followed

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

what is excluded from cGMP

A

compounded drugs
pharmacies

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

what factors do compounded drugs need to be exempt from cGMP, misbranding, and new drug requirements - 3 factors

A

for an individual patient
based on prescription
compounded by licensed pharmacist or physician

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

when will a pharmacy be considered an outsourcing facility (have to register)

A

compound and distribute out of state >5% of total prescriptions and have to follow cGMP

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

outsourcing facilities (503b) labeling requirements

A

“compounded drug”
outsourcing facility information
batch number
expiration date
storage list of ingredients

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

what are the medical devices and examples of each

A

class I - simple (stethoscope)
class II - need surveillance (syringe, tampon, A1C)
class III - sustain human life (pacemaker, soft contact lenses)
restricted - requires prescription due to harm (contact lenses, diaphragms)
custom - orthopedic footwear
banned - not on US market (prosthetic hair fibers, powdered gloves)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

If a new device is marketed, what class would it fall under

A

class III automatically unless the FDA determines it is equivalent to a different class

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

what are the classes of recalls

A

class I - serious consequence and death
class II - temporary, reversible harm
class III - no harm

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

what recalls are mandatory vs voluntary

A

biologics, devices, food are MANDATORY
drugs are VOLUNTARY

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

what is the durham-humphrey amendment of 1951

A

established qualities to make a drug prescription, who can prescribe, labeling requirements, refills

22
Q

who has authority to prescribe & who are the BIG FOUR

A

BIG FOUR - physician, dentist, veterinarian, podiatrist
NP
PA
pharmacist
OD

23
Q

prescription label requirements for FEDERAL

A

1 - name and address of dispenser
2 - serial number
3 - date filled
4 - name of prescriber
5 - name, directions, statements IF STATED

24
Q

how to decipher an NDC

A

XXXXX-XXXX-XX
first 5 = manufacturer
middle 4 = drug
last 1-2 = package size

25
Q

what is the Poison Prevention Packaging Act of 1970

A

requires special packaging (CRC)

26
Q

what is required to be considered CRC

A

at least 90% of adults can open
at least 85% of children UNDER 5 cannot open
at least 80% of children UNDNER 5 cannot open within 5 minutes after an adult showing them

27
Q

what drugs require CRC - only required for OUTPATIENT

A

PO legend drugs
Rx to OTC drugs
PO OTC drugs
sample packages for medications that require special packaging

28
Q

what drugs do NOT need special packaging - generally & 19 specific drugs

A

drugs not for PO administration (including topical application to teeth or inhalation)
1 - SL nitroglycerin
2 - SL isosorbide dinitrate <10mg
3 - erythromycin ethylsuccinate oral suspension <8g
4 - erythromycin ethylsuccinate tablets <16g
5 - anhydrous cholestyramine packets
6 - potassium supplements <50 mEq
7 - sodium fluoride liquid and tablets <264mg
8 - betamethasone tablets <12.6mg
9 - mebendazole tablet <600mg
10 - methylprednisolone tablet <84mg
11 - colestipol powder <5g
12 - pancrelipase tablet, capsule, powder
13 - ORAL contraceptives
14 - prednisone tablets <105mg
15 - conjugated estrogen tablets <32mg
16 - norethindrone tablets <50mg
17 - medroxyprogesterone tablets
18 - sacrosidase (sucrase) in glycerol and water
19 - hormone replacement therapy

29
Q

when can special packaging NOT be used if required

A

patient makes blanket waiver
prescriber provides waiver each rx basis

30
Q

which drugs require PPI and who gets them - each new rx and refill

A

INPATIENT AND OUTPATIENT
estrogen and PO contraceptives

31
Q

which drugs require MedGuides and who gets them - each new rx and refill

A

OUTPATIENT
NSAIDs, amphetamines, PPIs, mood stabilizers, opioids

32
Q

what is the Prescription Drug Marketing Act of 1987

A

to protect public health against drug diversion
prohibits drug reimportation and bans sale or trade of drugs and samples

33
Q

when can a drug be reimported into the US

A

reimported by the manufacturer
emergency use after FDA review

34
Q

how can drug samples be given

A

prescribers asks in writing to the manufacturer
hospital/clinic pharmacies can have samples for providers after the provider requests
NOT OTC

35
Q

PDMA recordkeeping and violations

A

records must be kept for 3 years
whistleblowers can get 1/2 criminal fine in rewards

36
Q

what is the federal anti-tampering act

A

for OTC
MUST have one or more barriers to entry

37
Q

what are the 5 crimes to the federal anti-tampering act

A

tampering or attempting to tamper
tainting
communicating false information that a product is tainted
threatening to tamper
conspiring to tamper

38
Q

what is the DSHEA

A

manufacturers can make claims relating to supplement’s effect on structure or function in the body if:
- related to nutrient deficiency
- describes the role of a nutrient
- characterizes mechanism
- describes general well-being

39
Q

what are the requirements for the manufacturer to market a supplement under DSHEA

A

“this has not been evaluated by the FDA”
notify FDA within 30 days of first marketing product

40
Q

is it mandatory for all drugs to use the new pregnancy categories

A

NO - drugs before June 2001 can choose which one follow. after 2001 is required in the new form

41
Q

what happens during an FDA inspection

A

for anyone that manufactures, compounds
request entry with NOI (form 482) and credentials
CAN refuse

42
Q

what happens during a DEA inspection

A

for controls
provide NOI (form 82)
if refused - will get AIW or search warrant

43
Q

what happens during BOP inspection

A

inspect without warrant and CANNOT refuse

44
Q

what are the ratings for generic substitutions

A

AA - can substitute
BX - not sufficient data CANNOT substitute
AN - bioequivalent solutions and powders for aerosolization

A can substitute
B cannot substitute

45
Q

INDA process

A

submit for each clinical trial phase - can start 30 days after submission unless denied
MUST submit annual reports to FDA

46
Q

what are the different phases in human trials

A

phase I - <100 patients without disease
phase II - <1000 patients with disease
phase III - 1000s of patients

47
Q

NDA process

A

send INDA information and FDA has 180 days to respond

48
Q

ANDA process

A

to show the drug is bioequivalent (generic drugs)

49
Q

what are the four types of REMS

A

MedGuide
communication plans
ETASU (iPLEDGE)
implementation system - review ETASU

50
Q

what is excluded from cGMP

A

compounded drugs
pharmacies

50
Q

what is the max quantity of isotretinoin prescribed for patients

A

7 days for people that can get pregnant
30 days for people that can’t get pregnant
NO REFILLS

MPJE (4 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2025 Bold Learning Solutions. Terms and Conditions