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MPJE > Laws and Regulations module > Flashcards

Laws and Regulations module Flashcards

1
Q

What is a required for a drug to be marketed through the drug monograph process?

A 
An approved dose
An approved indication
Non-adulterated
Non-misbranded
CGMP compliant
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2
Q

Durham-Humphrey Amendment of 1951

A

Separated Rx from OTC

Rx-only if:

  • Habit-forming
  • Unsafe w/out monitoring
  • Limited to Rx per manufacturer’s NDA
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3
Q

Exemptions from PPFA

A

Patient blanket waiver

Prescriber single Rx waiver

Pharmacists CANNOT do this

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4
Q

Definition of diseases that qualify for orphan drug development:

A

Affect < 200k in US

No reasonable expectation to make your money back on the drug

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5
Q

Generic drugs have to have the same what as brands?

A

Active ingredient
Route
Dosage
Formulation

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6
Q

Pure Food and Drug Act of 1906

A

Labels are required

ingredients must meet USP/NF standards

The label must be true to what is in the product

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7
Q

Dietary supplements are…?

A

Foods.

They cannot make health claims.

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8
Q

Federal Anti-Tampering Act of 1982

A

Preceded by the cyanide in Tylenol OTC

OTC tamper resistance packaging

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9
Q

What does a IND allow for?

A

Testing in humans

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10
Q

OTC Drug approval

A 
NDA
or 
Drug Monograph
- Rare
- Caffeine is an example
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11
Q

Food, Drug, and Cosmetic Act (FDCA) of 19383

A

Drugs must be proven safe

No alduteration/misbranding

Ingredients must be on label

FDA can inspect manufacturers/distributers

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12
Q

Hatch-Waxman (Price and Patent) 1984

A

Established ANDA for development of generics

Designated originators as RLDs

Gave patent patent protection rights to brands though?

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13
Q

Phase II testing

A 
Humans - about 200
Relatively clean patients
Main concerns are:
- Safety
- Efficacy especially
- Dose ranging
Usually 2-5 years long
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14
Q

Drug Listing Act of 1972

A

Required NDC numbers

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15
Q

Phase IV

A

In conjunction with FDA
Mass data
Can be used to revise indications, safety warnings, etc.

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16
Q

Phase III testing

A 
Humans - about 2,000
Slightly more diverse population
May be multicenter and multinational
Can really nail down efficacy here and continue to assess safety and dosing
Usually 3-5 years
Submitted as part of the NDA
17
Q

sNDA are for:

A

New labels, formulations, packages, manufacturers, or indications

18
Q

NDA are for:

A

Brand drugs

19
Q

NADA are for:

A

Animal drugs

20
Q

Orphan Drug Act of 1983

A

Incentivized drug development for orphan-disease states by providing:

  • Tax credits
  • Extended exclusivity
  • Facilitated approval process
21
Q

OBRA ‘90

A

Required offer to counsel to Medicaid patient’s
- Has spread really to all states and prescriptions

Required a DUR record

22
Q

ANDA are for:

A

Generics drugs

23
Q

BLA are for:

A

Biologics

24
Q

NDC components

A

10 digits, three segments

  • Manufacturer
  • Drug/strength
  • Pack size
25
Q

Pre-clinical testing

A

Animals - 2 species

Pharmacology 
Toxicity
- Carcinogenicity
- Teratogenicity
- Mutagenicity
Dose estimation
26
Q

ANADA are for:

A

Animal generic drugs?

27
Q

Prescription Drug Marketing Act of 1987

A

You can’t buy drugs outside of the US and bring that back unless:

  • 90 day supply
  • For you only
  • They really need it or we don’t have it…

Wholesalers have to register with state they operate in

Hosptial drug sale restrictions
Can’t sell samples
Can’t sell coupons

28
Q

Kefauver-Harris Amendment of 1962

A

Preceded by thalidomide:

Safety AND efficacy

Adverse rxn’s from trials must be reported to FDA

Created NDA and sNDA

Created IND and role of the IRB

29
Q

Poison Prevention and Packaging Act (PPFA) of 1970

A

Applies to Rx drugs

CR-packaging; originally meant to target children 5 and younger

Think about that Rx drugs don’t have air-tight seals on them; that is for OTC’s.

Not a part of the FDCA

30
Q

DSHEA 1994

A

Now supplement Manufacturers can make some sort of claims about their products

“This product will make you feel great in the morning”

31
Q

Phase I testing

A

Humans - about 20
Healthy male volunteers
Main concern here is safety
Usually 1 year long

32
Q

Bioequivalence is based on what?

A

Cross-over studies b/w generic and brand

MPJE (11 decks)

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