Exam 2: Parts of Laws Flashcards
Which law established standards for vaccines and anti-toxins
biologics control act
Which law prohibited the manufacture, sale, or transportation of adulterated or misbranded/poisonous food, drug, medicine, or liquors
Food and Drug Act
Which law prohibited labeling medicines with false claims to defraud the purchaser
Sherley Amendment
What are the requirements of fraud
a false statement
knowledge that it is false
intent to deceive
reliance on the statement by the consumer
injury as a result
what law required manufacturers, importers, pharmacists, and physicians to be licensed and taxed to produce or write prescriptions for narcotics
Harrison Narcotic Tax Act
what law established the pharmacy as the sole legal outlet for liquor
Volstead act
what law created the liquor license
Volstead act
what law causes a massive walgreens expansion
Volstead act
what law required drugs to be safe.
food, drug, and cosmetic act
what law extended the FDA control to cosmetics and devices
food, drug, and cosmetic act
what law identified that drugs that are habit forming or unsafe unless monitored by a practitioner require an Rx
food, drug, and cosmetic act
what law removed the Sherley requirement of fraud for misbranding
Food, drug, and cosmetic act
what law authorized factory inspections
food, drug, and cosmetic act
what law officially created the prescription only category of drugs (drug legend)
Durham Humphrey
what law required Rxs to label “Federal Law prohibits dispensing w/out a prescription”
Durham Humphrey
what law required non-rx drugs require adequate directions and warnings
Durham Humphrey
what law created the minimum label requirements on an Rx
Durham Humphrey
what law required drugs be safe and effective and it be proven to the FDA
Kefauver-Harris Amendment
what law required adverse events be reported to the FDA
Kefauver Harris Amendment
what law required advertisements to physicians must balance risks and benefits
Kefauver-Harris Amendment
what law gave FDA jurisdiction over Rx drug advertising
Kefauver-Harris Amendment
what law created the modern day drug approval process
Kefauver-Harris Amendment
what law created the schedule of controlled substances
The controlled substances act/comprehensive drug abuse prevention and control act
what law required that schedule II drugs must be ordered using the DEA form 222
The controlled substances act/comprehensive drug abuse prevention and control act
what law set additional specific requirements for schedule drug prescriptions, fax, e-prescribing, transfer, and partial fills
The controlled substances act/comprehensive drug abuse prevention and control act
what law required special packaging of household products
poison prevention packaging act
what law created incentive specific in R & D areas by giving
additional tax deductions
extended exclusivity
subsidized research through funding to universities and companies
Orphan Drug Act
what law removed clinical requirements for generic drugs so long as bio-equivalence could be proven
Hatchwaxman act
Drug price competition and patent-term restoration act
what law allowed up to 5 years to be added to a patent exclusivity to make up for R & D time
Hatchwaxman act
Drug price competition and patent-term restoration act
what law granted 180 day market exclusivity to first generic drug
Hatchwaxman act
Drug price competition and patent-term restoration act
