Section 3: Federal Pharmacy Law

Front 1

it prohibits the distribution or sale of adulterated or misbranded foods and drugs.When was it enacted?

Back 1

Food, Drug, and Cosmetic Act(FDCA) - 1938

Front 2

This legislation oversees the marketing of all new drugs.

Back 2

Food, Drug, and Cosmetic Act(FDCA) - 1906

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the presence of any decomposed substance, packaging under unsanitary conditions, or if the product's strength, quality, or purity is different from what is indicated on the label.

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Adulteration

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a drug monograph is

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literature on a drug

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a trot

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causing injury to a person intentionally or through negligence

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both the DEA and the FDA were created under the department of justice

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false

Front 7

combat methamphetamine epidemic act (CMEA) OF 2005

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addresses al areas related to manufactuer of, enforcement of laws pertaining to and sale of pseudoephedrine, which can be used to create methamphetamines

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Controlled substance

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any drug or substance that is scheduled I through V and is regulated by the DEA

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drug diversion

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intentional misuse of a drug intended for medical purposes

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drug utilization evaluation (DUE)

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a process used to ensure that prescription drugs are utilized appropriately

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Durham-Humphrey amendment

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made the initial distinction between a legend drug and an over the counter drug; required legend drugs to carry the label " caution: federal law prohibits dispensing without prescription"

Front 12

federal food and drug act of 1906

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enacted to stop the sale of inaccurately labeled drugs

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food, drug, and cosmetic act of 1938

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required drugs companies to include consumer directions for use on drug products; required the marketing "warning may be habit forming" for all controlled substances

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Harrison narcotic act of 1914

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enacted because of excessive opium addiction across the U.S

Front 15

HIPAA is a federal law hat protects patients health information

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true

Front 16

invoices for a C-II must be kept for up to how many years

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7 years

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not all controlled substances are addictive

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false

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not all prescription must not be registered with the DEA to write prescription for narcotics

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false

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omnibus budget reconciliation act (OBRA 90)

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states that a pharmacist must counsel at the time of purchase all Medicare patients who receive new prescriptions

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prescription drug marketing act of 1987

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addressed issues related to the distribution and wholesale pedigree of human prescription drugs

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protected health information (PHI)

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term used to describe a patients personal health data

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technicians' will not be held liable if they do not know all the new upcoming changes related to HIPAA

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false

Front 23

thalidomide, a drug prescribed to help people sleep, caused children to be born without limbs and with severe defects; this was a widespread problem throughout the U.S

Back 23

true

Front 24

the FDA regulates the manufacture and safeguarding of medicines

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true

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the health insurance portability and accountability act (HIPAA)

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federal act adopted to protect patients rights to establish national standards for electronic health care communication and to ensure the security and privacy of health data

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the highest level of recall is

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class 1 recall

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the orphan drug act was passed to promote the development of new treatments for rare diseases that affect fewer then 200,000 persons in the U.S

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false

Front 28

the strictest law (federal vs. state) is the that employees of the pharmacy must follow

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true

Front 29

to destroy a controlled substance what from must you fill out

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form 41

Front 30

what DEA form must be filled out to get a schedule II

Back 30

FROM 222

Front 31

what schedule can you get without a perscription

Back 31

C-V

Front 32

when state require counseling of patients under OBRA guidelines, patients must be given information on the drugs they are taking, such as the drug's name, when to take it, and any associated side effects or possible interactions

Back 32

true

Front 33

who has the authority to decide under what schedule a drug should be placed

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attorney general