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Health-Care Systems > Exam 2: Parts of Laws > Flashcards

Exam 2: Parts of Laws Flashcards

1
Q

Which law established standards for vaccines and anti-toxins

A

biologics control act

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2
Q

Which law prohibited the manufacture, sale, or transportation of adulterated or misbranded/poisonous food, drug, medicine, or liquors

A

Food and Drug Act

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3
Q

Which law prohibited labeling medicines with false claims to defraud the purchaser

A

Sherley Amendment

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4
Q

What are the requirements of fraud

A

a false statement
knowledge that it is false
intent to deceive
reliance on the statement by the consumer
injury as a result

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5
Q

what law required manufacturers, importers, pharmacists, and physicians to be licensed and taxed to produce or write prescriptions for narcotics

A

Harrison Narcotic Tax Act

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6
Q

what law established the pharmacy as the sole legal outlet for liquor

A

Volstead act

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7
Q

what law created the liquor license

A

Volstead act

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8
Q

what law causes a massive walgreens expansion

A

Volstead act

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9
Q

what law required drugs to be safe.

A

food, drug, and cosmetic act

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10
Q

what law extended the FDA control to cosmetics and devices

A

food, drug, and cosmetic act

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11
Q

what law identified that drugs that are habit forming or unsafe unless monitored by a practitioner require an Rx

A

food, drug, and cosmetic act

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12
Q

what law removed the Sherley requirement of fraud for misbranding

A

Food, drug, and cosmetic act

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13
Q

what law authorized factory inspections

A

food, drug, and cosmetic act

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14
Q

what law officially created the prescription only category of drugs (drug legend)

A

Durham Humphrey

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15
Q

what law required Rxs to label “Federal Law prohibits dispensing w/out a prescription”

A

Durham Humphrey

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16
Q

what law required non-rx drugs require adequate directions and warnings

A

Durham Humphrey

17
Q

what law created the minimum label requirements on an Rx

A

Durham Humphrey

18
Q

what law required drugs be safe and effective and it be proven to the FDA

A

Kefauver-Harris Amendment

19
Q

what law required adverse events be reported to the FDA

A

Kefauver Harris Amendment

20
Q

what law required advertisements to physicians must balance risks and benefits

A

Kefauver-Harris Amendment

21
Q

what law gave FDA jurisdiction over Rx drug advertising

A

Kefauver-Harris Amendment

22
Q

what law created the modern day drug approval process

A

Kefauver-Harris Amendment

23
Q

what law created the schedule of controlled substances

A

The controlled substances act/comprehensive drug abuse prevention and control act

24
Q

what law required that schedule II drugs must be ordered using the DEA form 222

A

The controlled substances act/comprehensive drug abuse prevention and control act

25
Q

what law set additional specific requirements for schedule drug prescriptions, fax, e-prescribing, transfer, and partial fills

A

The controlled substances act/comprehensive drug abuse prevention and control act

26
Q

what law required special packaging of household products

A

poison prevention packaging act

27
Q

what law created incentive specific in R & D areas by giving
additional tax deductions
extended exclusivity
subsidized research through funding to universities and companies

A

Orphan Drug Act

28
Q

what law removed clinical requirements for generic drugs so long as bio-equivalence could be proven

A

Hatchwaxman act
Drug price competition and patent-term restoration act

29
Q

what law allowed up to 5 years to be added to a patent exclusivity to make up for R & D time

A

Hatchwaxman act
Drug price competition and patent-term restoration act

30
Q

what law granted 180 day market exclusivity to first generic drug

A

Hatchwaxman act
Drug price competition and patent-term restoration act

Health-Care Systems (3 decks)

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