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MPJE Prep > Federal Law > Flashcards

Federal Law Flashcards

1
Q

food drug and cosmetic act of 1938

A

drugs now require FDA approval based on safety (only) PLUS
adequate directions for use on consumer label = OTC

“if we cannot put directions for use then it cannot be an OTC product”

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2
Q

Durham Humphrey (“Rx Drug Amendment”) 1951

A

distinguished rx from otc; adequate directions for use requierd on OTC label
require RX only phrase on rx meds

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3
Q

Kefauver-Harris (Drug Efficacy Amendment) of 1961

A

NDA process, proof of efficacy (not just safety), informed consent required in clinical trials, DESI
manufacturing: CGMPs, FDA authority to inspect

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4
Q

orphan drug act of 1983

A

gave manufacturers financial incentives to bring drugs to market for rare diseases (<200,000 americans)

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5
Q

Waxman Hatch Law 1984 (Drug Price Competition Act)

A

abbreviated new drug application (NDA) for generics

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6
Q

Rx drug marketing act (1987)

A

samples
wholesaler licensing

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7
Q

Drug Quality and Security Act 2013

A

compounding and outsourcing facilities
drug supply chain security

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8
Q

FDA main functions are to

A

safety of med supply in US
drug approval and surveillance
regulation of profession
- compounding (503a)
- 795, 797, 800
- outsourcing (503b)
REMS
med guides
package inserts
poison prevention
etc.

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9
Q

what created the FDA

A

the US constitution under the interstate commerce power

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10
Q

what is a class I recall

A

reasonable probability of adverse health events

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11
Q

what is a class II recall

A

temporary or medically reversible

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12
Q

what is a class III recall

A

not likely to cause harm

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13
Q

definition of dietary supplement
examples?

A

intended to supplement the diet via ORAL ingestion that bears or contains one or more of the following

vitamin
mineral
herb
botanical
amino acid
dietary substance

and is therefore removed from FDA regulations

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14
Q

adulteration definition

A

filthy, putrid, decomposed, insanitary etc.

inappropriate container or conditions

if strength, quality or purity differ from the standard

reduced quality or strength

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15
Q

misbranding

A

always about label/labeling

false or misleading
name and place of business, packer, distributor, etc not prominently placed

OTC without adequate directions for use

imitation of another drug

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16
Q

misbranding examples

A

child resistant packaging when required

tamper resistant/evident (seal, wrap etc.)

OTC without directions for use

rx products without accurate information for use (not directions)

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17
Q

what is drug labeling and label tied to (law wise)

A

Durham Humphrey

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18
Q

label vs labeling

A

labeling is label plus supplemental info (med guide, package insert, etc.)

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19
Q

what does adequate directions for use include on an OTC drug

A

normal dose
freq
duration
route
preparation
admin tips (onset, meals etc.)
drug facts (purpose, uses, warnings, directions)

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20
Q

what is required on an stock bottle (rx)

A

mfr name and address
quantity of active ingredients
generic and proprietary names
“rx only”
route (if NOT oral)
NDC
lot
exp date
type of container (“light resistant”)

21
Q

what is required on a unit dose label

A

name
quantity
lot
exp date
bar code

22
Q

what should a package insert include

A

BBW
adequate info for use
pregnancy warnings
brief summary
etc.

23
Q

what is a new drug

A

never been FDA approved
crime to distribute in interstate commerce
not generally recognized as safe and effective

24
Q

what does the FDA have the authority to do if they determine an adulterated drug or unapproved new drug is in possession

A

injunction
criminal proceedings
warning letters
recalls

25
Q

what is the 505b1 process

A

NDA (new drug application) process
kicks of clinical trials

26
Q

who is responsible for surveilling drugs after they are on the market

A

FDA

27
Q

IND definition

A

investigational new drug
filed by manufacturer to FDA
FDA approves and allows manufacturer to distribute drug via interstate commerce and be exempt from the NDA process

28
Q

what does an NDA involve

A

clinical trials
components and composition
sample
proposed labeling/package insert
manufacturing details

approved when substantial evidence of safety and efficacy for intended use is est

29
Q

what is non malifecance

A

minimizing harm and risk

30
Q

supplemental NDA

A

SNDA
supports manufacturers interest in changing dosage form, production, manufacturing, indication etc.
if new indication this will include clinical trials

31
Q

what allowed the FDA to require new clinical trials after approval of

A

2007 Amendments

32
Q

505b2 application

A

for improved generics of drugs that no longer have patent protection

same substances with Phamaceutical or therapeutic differences
hybrid between NDA and abbreviated-NDA (ANDA)

new dosage form, new indication, new delivery mechanism

33
Q

if a generic is approved how long do they have market exclusivity

A

3 years!

34
Q

what is used for generic drug approval following a brand

A

ANDA

35
Q

orphan drug act of 1983

A

</= 200,000 americans
tax incentives
7 years exclusivity
assistance with clinical trial design
facilitated review

36
Q

what restricts dispensing of OTC plan B

A

none
additional restrictions are not allowed

37
Q

what is done if a pharmacist refuses to dispense a medication based on moral/religious etc. beliefs

A

pharmacist should alert employer and tell them they do not want to
employer will ensure pharmacist will hand off to another pharmacist so as to avoid patient abandonment

38
Q

are patient package inserts required to be dispensed in hospitals

A

yes

39
Q

when are patient package inserts and med guides required

A

w every dispense!
med guide not required in hospital

40
Q

are off label uses allowed

A

yes
promotes innovation in profession
called ‘practice of medicine’

41
Q

FDAs orange book

A

reference guide for therapeutic equivalents
equivalence ratings
now strictly a database

42
Q

what qualifies a drug to be pharmaceutically equivalent to another

A

same
active ingredients, dosage form, strengthq

43
Q

what qualifies a drug to be bio equivalent to another

A

rate and extent of absorption (PK) do not show a significant difference from listed drug

44
Q

does substituting a B rated drug violate federal law

A

nope

45
Q

what did the generic drug substitution act of 1977 do

A

‘less expensive drug equivalent shall be dispensed unless DAW written’

46
Q

if brand only available, how does this work

A

depends if emergency

no emergency: dispense brand, charge generic

emergency (think ER): dispense brand, charge brand

47
Q

are biosimilar products always interchangeable with reference products

A

no

48
Q

who decides how pharmacists substitute biosimilars

A

the individual state

49
Q
A

MPJE Prep (6 decks)

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