ch 2 practice
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| The amendment that required labeling "CAUTION federal law prohibits dispensing without a prescription | Durham-Humphrey amendment
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| what does the orphan drug act do? | allows drug companies to bypass lengthy testing to treat people who have a rare disease
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| The law that requires pharmacist to counsel patientson new medication | OBRA 90
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| The main purpose of the fda is? | ensure that safety and effectiveness of medications is met by manufacturers
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| A pharmacy that will be dispensing controlled drugs must have which of the following forms on file with the DEA | form 224
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| All adverse reactions should be reported to the | FDA
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| the five caterigories of controlled substances are rated based on? | potential for abuse
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| DEA form 222 is used to obtain controlled substances form the manufacturer or distributor | true
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| repackiging: any medication taken from bulk package and placed in blister packs must have what information on each individual label? | drug name, strength, dosage form, manufacturer, lot number, and expiration date.
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| The two necessary components for a prescription label are? | pharmacy information and patient information
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| pharmaacy information includes | name of pharmacy, address of pharmacy, name of prescriber, date prescription was filled
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| patient information includes | name of patient, directions, any cautions described or provided on auxilary labels, refill information
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| The main functions of the FDA is? | to enforce guidlines for manufacturers and to ensure the safety and effectiveness of medications
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| The DEA was created under the Department of Justice and its functions are | prevent illegal distribution and misuse of controlled substances also issues licenses to practitioners, pharmacies, and manufacturers of controlled substances
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| to manufacture or distribute controlled substances what form is needed? | form 225
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| to run a controlled substance treatment program or compound controlled substance what form is needed? | form 363
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| to dispense controlled substances what form is needed? | form 224
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| to obtain a schedule 11 controlled substance from a distributer what form is needed? | form 222
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