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40 Cards in this Set
- Front
- Back
Define: legislative system
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passes bills into laws (statutes)
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Define: executive system
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enforces laws by creating regulations
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Define: judicial system
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interprets laws
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Define: constitutional law
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the interpretation and implementation of the United States Constitution
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Define: statutory law
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written law created by legislature
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Define: regulatory law
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law created by an executive branch agency under a delegation from a legislature
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Define: regulation
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A principle, rule, or law designed to control or govern conduct
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Define: judicial law
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laws resulting from judicial decisions
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Define: opinion
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a view or judgment formed about something
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Define: administrative law
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the body of law that governs the activities of administrative agencies of government
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Define: criminal law
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the body of law that relates to crime
- It regulates social conduct and proscribes threatening, harming, or otherwise endangering the health, safety, and moral welfare of people |
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Define: civil law
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non-criminal law
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Define: misdemeanor
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Offense lower than felonies and generally those punishable by fine, penalty, Forfeiture, or imprisonment other than in a penitentiary
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Define: felony
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A serious crime, characterized under federal law and many state statutes as any offense punishable by death or imprisonment in excess of one year
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What are the Federal Register and Wisconsin Register?
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Daily publications of the status of pending pharmacy legislation
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What is the CFR?
What chapter relates to pharmacy? |
Code of Federal Regulations
pharmacy = Chapter 21 |
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What are the three conditions needed for legislature to have authority over pharmacy regulations?
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1. Scope of Authority
2. Statutory basis 3. Public Health, Safety, and Welfare |
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What are the three types of legal action that can be taken against a pharmacist?
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1. Administrative
2. Criminal 3. Civil |
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What is the FDCA's focus on purity?
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focuses on how things are made, processed, etc.
adulteration is the crime of not meeting purity standards |
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Define: adulteration
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the crime of not meeting purity standards
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What is the FDCA's focus on labels?
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labels must specify:
- contents - directions for use - strength - quantity |
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Define: misbranding
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the crime of errors on a label
(i.e. the wrong label on a prescription) |
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Give examples of how the FDCA promotes public health safety directly vs. indirectly
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directly = preventing harm by removing a product from the market
indirectly = requiring information on the label to give consumers the knowledge to prevent harm |
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What is prohibited by the Pure Food and Drug Act of 1906?
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the adulteration and misbranding of foods and drugs in interstate commerce
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What is the significance of U.S. vs. Johnson in 1911
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led to the 1912 amendment to the Pure Food and Drug Act to prohibit false and fraudulent efficacy claims
Johnson falsely claimed on a label that a drug was effective against cancer The court ruled that misbranding prevented false statements only on a drugs identity, not its efficacy |
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What is the significance of the Elixir of Sulfanilamide Trajedy?
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led to passage of the FDCA (Food, Drug, and Cosmetic Act) of 1938
manufacturer used diethyl glycol as a solvent, leading to >100 deaths |
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What was the main provisions of the FDCA of 1938?
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1) no new drug could be marketed until proven safe for use under the conditions described on the label and approved by the FDA
2) expanded definition of misbranding and adulteration, requiring that labels contain adequate directions for use and warnings |
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What is the significance of U.S. vs. Sullivan
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determined that pharmacists who are not involved in interstate commerce are still subject to the federal regulations
- a GA pharmacist claimed he was exempt, but the courts disagreed (1948) |
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What was established by the Durham-Humphrey Amendment of 1951?
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required all drugs to be labeled with "adequate directions for use"
- because many drugs were not safe for use except under medical supervision, two classes of drugs were established: legend & non-legend |
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What prompted passage of the Kefauver-Harris Amendment of 1962?
What was its effects? |
experimental use of the sedative thalidomide caused birth defects in thousands of infants
aka the Drug Efficacy Amendment, it strengthened the new drug approval process by requiring that drugs be proven not only safe, but also effective It also placed FDA in charge of drug advertising (instead of FCC) the new law was made retroactive to all drugs marketed from 1938-1962 |
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Why was the Medical Device Amendment of 1976 necessary?
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previously, the FDA had no jurisdiction over medical devices unless it classified them as drugs
- numerous unsafe devices had been marketed and caused damage (Dalkon Shield) |
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How did the Orphan Drug Act of 1983 incentivize manufacture of orphan drugs?
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provided tax and exclusive licensing incentives for manufacturers to develop and market these drugs or biologicals
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What is the Waxman-Hatch Amendment?
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the Drug Price Competition and Patent Term Restoration Act of 1984
- streamlined generic drug approval process while giving patent extensions to certain innovator drugs |
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What is the Dietary Supplement Health and Education Act of 1994?
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permits manufacturers to make certain claims that otherwise would have been illegal under the FDCA
- forced the FDA t regulate dietary supplements more as foods than as drugs |
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How does the FDCA determine if a product is a drug?
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A. It is listed in the Official Compendia
B. It is used in the diagnosis, cure, mitigation, or treatment of disease C. It is intended to affect the structure or any function of the body D. any component of A, B, or C |
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Define: biologics
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medical products derived form living organisms
i.e. viruses, toxins, antitoxins, vaccines |
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How are medical devices divided into classes?
Give some examples of each class. |
Class is based on the degree of control necessary to assure the various types of devices are safe and effective
Class I: minimal potential for harm (toothbrushes, elastic bandages) Class II: most medical devices (syringes, infusion pumps, tampons) Class III: usually sustain or support life, are implanted, or present potential increased risk of illness or injury (pacemakers, contact lenses) |
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What are the conditions for a medical device to be exempt?
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must fall into an exempted category of Class I devices
- premarket notification application and FDA clearance are not required |
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What is a label vs. labeling?
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A label is the actual piece of paper stuck on the bottle and the info on it. A label is a component of the labeling.
The ppi is labeling, but is not part of the label. |
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What three publication make up the Official Compendia?
What is their purpose? |
1. US Pharmacopeia (USP)
2. National Formulary (NF) 3. Homeopathic Pharmacopeia of the US (HPUS) They are important books for standards of quality and purity. The FDA does not have Q&P standards written into the regulations, rather it refers to specific standards in the compendia. |