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37 Cards in this Set
- Front
- Back
What did the Food and Drug Act require and when did it pass?
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States that government pre-approval of drugs is required and was passed in 1906.
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What did the Shirley Amendment do and when was it passed?
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Prohibits false and misleading claims about the therapeutic effects of a drug and was passed in 1911.
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What does the Food, Drug and Cosmetic (FDC) Act require and when did it pass?
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Requires new drugs be shown to be safe before they are marketed and was passed in 1938.
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What happened in Alberty Food Products vs US and when did this take place?
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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.
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What did the Durham-Humphrey Amendment do and when did this happen?
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Defines what drugs require a prescription by a licensed practitioner and requires a caution label, was passed in 1951.
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What does the Kefauver-Harris Amendment state and when was it passed?
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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.
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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?
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1962, thalidomide, and is used to treat multiple myeloma.
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What does the Fair Packaging and Labeling Act require and when was it passed?
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1966, requires that all consumer products in interstate commerce be honestly and informatively labeled
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What does the Controlled Substance Act do and when was it passed?
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1970, classifies drugs that may be easily abused and restricts their distibution
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What does the Poison Prevention Packaging Act require and when was this passed?
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1970, requires child-proof packaging on all controlled drugs and on most prescription drugs
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What does the Medical Device Amendment require and when was it passed?
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1976, requires pre-market approval for safety and effectiveness of life-sustaining and life-supporting medical devices
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What does the Orphan Drug Act provide and when was it passed?
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Provides incentives to promote the research, approval and marketing of drugs needed for the treatment of rare diseases and was passed in 1983.
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What does the Prescription Drug Marketing Act do and when was it passed?
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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.
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Which act required drug manufacturers to provide proof of safety and efficacy?
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The Kefauver-Harris Act (1962)
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What does the Pediatric Labeling Rule require and when was this passed?
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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.
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What is the purpose of Phase 2 in human testing, how long does this phase usually last and how many patients are involved?
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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
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What is the purpose of Phase 3 in human testing, how long does this phase usually last and how many patients are involved?
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Its purpose is safety, dosage and effectiveness, it lasts 1-4 years and involves several hundred to several thousand patients.
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What are the 3 options the FDA has if it determines that a marketed drug presents a risk?
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They can seek an injunction, may seize the drug, or may issue a recall.
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What does CDRH stand for?
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The Center for Devices and Radiological Health
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What is the CDRH responsible for?
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Getting medical devices to meet FDA testing and approval requirements
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What does the Hatch-Waxman Act provide?
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Provides up to 5 year extensions of patent protection to patent holders
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What is the reporting program that encourages health care professionals to report adverse side affects?
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MedWatch
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What does CBER stand for?
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The Center for Biologics Evaluation and Research
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What is the CBER responsible for?
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For biological products made from living organisms to be FDA compliant
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Who does a drug manufacturer have to prove that their drug is safe and effective to?
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CDER, Center for Drug Evaluation and Research
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Which state department is responsible for licensing all prescribers and dispensers?
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The State Department of Professional Regulation
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Which group monitors vaccines?
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Vaccine Adverse Event Reporting System (VAERS)
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What does ASCP stand for?
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The American Society for Consultant Pharmacists
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What is a "closed system"?
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Only registered parties can distribute controlled substances
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What does JCAHO stand for?
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Joint Commission on Accreditation of Health Care Organizations
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How does an FDA recall work?
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1st - Reports of adverse effects
2nd - Manufacturer agrees to recall 3rd - Customers are contacted 4th - Recalls are listed publicly |
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What is the Food, Drug and Insecticide Administration and when was it formed?
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1927, an agency that would be renamed in 1930 as the Food and Drug Administration
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What was the date HIPAA required compliancy to met on?
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April 14, 2003
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How long is a drug patent in effect?
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17 years from the date of the drug's discovery
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How many controlled substance schedules are there?
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5
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Describe the 3 classes of drug recalls.
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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 |
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What must appear on prescriptions for Schedule II drugs?
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The DEA number and the patients full street address
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