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ch3 drugreg/control

drug regulation and control

QuestionAnswer
medications with habit-forming ingredients that can be dispensed by a pharmacist without a prescription to persons at least 18 years of age exempt narcotics
any drug which requires a prescription and this "legend" on the label: Rx only legend drug
failing to do something you should have done neligence
important associated information that is not on the label of a drug product itself product labeling
legal responsibility for costs or damages arising from misconduct or negligence liability
status of medications like Plan B that are classified as both prescription and OTC drugs dual marketing
the action taken to remove a drug from the market and have it returned to the manufacturer recall
the mark (CII-CV) which indicates the control category of a drug with a potential for abuse controlled substance mark
the number on a manufacturer's label indicating the manufacturer and product information NDC (national drug code)
Federal law that sets daily and monthly limits on OTC sale of pseudoephedrine and ephedrine CMEA (combat methamphetamine epidemic act)
Both domestic and imported drugs require approval by the ___ before they can be marketed in the United States. FDA
The _____ probibited interstate commerce in aduterated or misbranded food, drinks, and drugs. Food and Drug Act of 1906
In response to growing addiction to opiates and cocaine-containing medicines, the Harrison Narcotic Act of 1914 required that all manufacturers, importers and physicians prescribing narcotics be licensed and taxed
Because of fatal poisoning from liquid sulfanilamide, the _____ required new drugs be shown to be safe before marketing. 1938 Food, Drug and Cosmetic Act
The _____ required child-proof packaging for most prescription drugs. Poison Prevention Packaging Act
The 1984 Hatch-Watchman Act allowed for quicker introduction of drugs and extension of drug patent terms
Pharmacists were required to offer counseling to Medicaid patients by the 1990 Omnibus Budget Reconciliation Act (OBRA)
Drugs that require priscriptions are _______ legend drugs
An inactive substance given in place of a medication during clinical trials is a placebo
The FDA requires ____ phases of testing in humans three
The main purpose of phase 2 clinical trials is effectiveness
Phase 3 clinical trials generally have _____ participants several hundred to several thousand
After a patent has expired for a medication, other manufacturers may copy the drug and release it under the ____ name generic
Drugs that do not require a prescription are ___ drugs OTC
The CMEA requires that OTC cold and allergy medications that contain which of the following drugs be kept behind the counter? ephedrine and pseudoephedrine
Pharmacy technicians may sell exempt narcotics only after the pharmacist has approved and documented the sale in a record book
A prescription to dispense Plan B is required for patients 17 years of age and under unless otherwise allowed by state law
Which Schedule of drugs deals with drugs that have no accepted medical use in the United States Schedule I
Amphetamines, opium, cocaine, and methadone are in DEA Schedule ___ because they have acceptted medical use, bu have a high potential for abuse and may lead to physical or psychological dependence II
The FDA reporting system for adverse effects that occur from use of approved drugs is called MedWatch
Class ___ drug recalls are issued by manufacturers when there is a strong likelihood that the product will cause serious adverse effects or death I
A technician could be prosecuted for misconduct called ____ if s/he incorrectly labeled a prescription negligence
Pharmacies located in the health care institutions (hospitals, etc.)are required to follow regulations of this organization JCAHO
Created by: iaespinoza
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