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37 Cards in this Set

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What did the Food and Drug Act require and when did it pass?
States that government pre-approval of drugs is required and was passed in 1906.
What did the Shirley Amendment do and when was it passed?
Prohibits false and misleading claims about the therapeutic effects of a drug and was passed in 1911.
What does the Food, Drug and Cosmetic (FDC) Act require and when did it pass?
Requires new drugs be shown to be safe before they are marketed and was passed in 1938.
What happened in Alberty Food Products vs US and when did this take place?
In 1950, the US Court of Appeals ruled that the purpose for which a drug is to be used must be included on the label.
What did the Durham-Humphrey Amendment do and when did this happen?
Defines what drugs require a prescription by a licensed practitioner and requires a caution label, was passed in 1951.
What does the Kefauver-Harris Amendment state and when was it passed?
States that drugs would have to be shown to be both safe and effective before they could be marketed in the US, passed in 1962.
What year was an ingredient found in sleeping pills shown to harm a growing fetus, what was the ingredient, and what is it used to treat today?
1962, thalidomide, and is used to treat multiple myeloma.
What does the Fair Packaging and Labeling Act require and when was it passed?
1966, requires that all consumer products in interstate commerce be honestly and informatively labeled
What does the Controlled Substance Act do and when was it passed?
1970, classifies drugs that may be easily abused and restricts their distibution
What does the Poison Prevention Packaging Act require and when was this passed?
1970, requires child-proof packaging on all controlled drugs and on most prescription drugs
What does the Medical Device Amendment require and when was it passed?
1976, requires pre-market approval for safety and effectiveness of life-sustaining and life-supporting medical devices
What does the Orphan Drug Act provide and when was it passed?
Provides incentives to promote the research, approval and marketing of drugs needed for the treatment of rare diseases and was passed in 1983.
What does the Prescription Drug Marketing Act do and when was it passed?
Restricts the distribution of prescription drugs to legitimate commercial channels and requires drug wholesalers to be licensed by the states and was passed in 1987.
Which act required drug manufacturers to provide proof of safety and efficacy?
The Kefauver-Harris Act (1962)
What does the Pediatric Labeling Rule require and when was this passed?
requires that all drugs have pediatric dosing and safety information on their labels if the drug has potential use for pediatric patients and was passed in 1994.
What is the purpose of Phase 2 in human testing, how long does this phase usually last and how many patients are involved?
Its purpose includes short-term safety, but is mainly effectiveness, it lasts several months up to 2 years and involves up to several hundred patients
What is the purpose of Phase 3 in human testing, how long does this phase usually last and how many patients are involved?
Its purpose is safety, dosage and effectiveness, it lasts 1-4 years and involves several hundred to several thousand patients.
What are the 3 options the FDA has if it determines that a marketed drug presents a risk?
They can seek an injunction, may seize the drug, or may issue a recall.
What does CDRH stand for?
The Center for Devices and Radiological Health
What is the CDRH responsible for?
Getting medical devices to meet FDA testing and approval requirements
What does the Hatch-Waxman Act provide?
Provides up to 5 year extensions of patent protection to patent holders
What is the reporting program that encourages health care professionals to report adverse side affects?
MedWatch
What does CBER stand for?
The Center for Biologics Evaluation and Research
What is the CBER responsible for?
For biological products made from living organisms to be FDA compliant
Who does a drug manufacturer have to prove that their drug is safe and effective to?
CDER, Center for Drug Evaluation and Research
Which state department is responsible for licensing all prescribers and dispensers?
The State Department of Professional Regulation
Which group monitors vaccines?
Vaccine Adverse Event Reporting System (VAERS)
What does ASCP stand for?
The American Society for Consultant Pharmacists
What is a "closed system"?
Only registered parties can distribute controlled substances
What does JCAHO stand for?
Joint Commission on Accreditation of Health Care Organizations
How does an FDA recall work?
1st - Reports of adverse effects
2nd - Manufacturer agrees to recall
3rd - Customers are contacted
4th - Recalls are listed publicly
What is the Food, Drug and Insecticide Administration and when was it formed?
1927, an agency that would be renamed in 1930 as the Food and Drug Administration
What was the date HIPAA required compliancy to met on?
April 14, 2003
How long is a drug patent in effect?
17 years from the date of the drug's discovery
How many controlled substance schedules are there?
5
Describe the 3 classes of drug recalls.
Class 1 - has a strong likelihood that the product will cause serious adverse effects or death
Class 2 - may cause temporary but reversible adverse effects
Class 3 - not likely to cause adverse effects
What must appear on prescriptions for Schedule II drugs?
The DEA number and the patients full street address