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Pharmacy Law: Exam 1

Terms in this set (113)

Law
Requirements for human conduct applying to all persons within their jurisdiction.
Public Goods
Necessary and beneficial commodities that private entities will not supply because there is no incentive in providing them.
Externality
When the production or consumption of a good affects someone who does not fully consent to the effect and when the costs of the good are not fully incorporated in the price of the good.
Monopoly
When the fixed costs of providing a good are high relative to the variable costs of producing the good.
Public goods, externalities, monopolies, information asymmetry
What are the four market failures that apply to drug use?
Market failure
What justifies government agencies to interfere with private choice?
Public Goods
Orphan drugs and vaccines are an example of what market failure?
Externality
Overuse of antibiotics and air pollution are an example of what market failure?
Monopoly
Government incentives on creating new drugs help regulate what market failure?
Information Asymmetry
When the consumer is uniformed about the true value of a good.
Information Asymmetry
When consumers cannot determine the benefits or detriments of a drug, it could lead to what market failure?
Young v. Board of Pharmacy
What legal case was overruled by the New Mexico Supreme Court in 1969 because the court did not find inadequate record keeping to be a reliable judgement of professionalism?
Legislative Branch
What branch of the US government "makes" the law?
Executive Branch
What branch of the US government "enforces" the law?
Judicial Branch
What branch of the US government "interprets" the law?
The Constitution
What is the supreme law of the US?
16
How many amendments, in addition to the Bill of Rights, have there been to the Constitution since 1787?
Legislature
An elected body of persons with the primary responsibility to enact laws or statutes.
Legislature
Who makes administrative agencies to administer a body of substantive law?
De Novo
What is it called when a court demands a new trial due to insufficient evidence in an administrative agency judicial trial?
Code of Federal Regulations
What is the compilation of final regulations divided and indexed by subject matter?
Title 21
What title contains all of the FDA regulations in the CFR?
50
How many titles make up the CFR?
Common Law
What is the law that is made by judges through decisions of courts and similar tribunals rather than through legislative statutes or executive branch action?
Stare Decisis
What is the legal principle by which judges are obliged to respect the precedents established by prior decisions?
535
How many members make up the Congress?
100
How many members are in the Senate?
435
How many members are in the House of Representatives?
Congress
The House of Representatives and Senate make up what?
With a 2/3 vote
How can Congress overturn the President's veto?
Pocket Veto
If the President does not return a law to Congress within 10 days, what happens?
Criminal
What type of trial is taking place if a case is Government v. Private Party?
Civil
What type of trial is taking place if a case if Private Party v. Private Party?
Administrative
What type of trial is taking place if a case is Agency v. Private Party?
Civil
What type of trial's objective is to obtain compensation for an injured party?
Criminal
What type of trial's objective is to deter, punish or rehabilitate the defendant?
9
How many justices comprise the US Supreme Court?
Writ of certiorari
What is an order by a higher court directing a lower court, tribunal, or public authority to send the record in a given case for review?
12
How many judicial circuits comprise the US Court of Appeals?
True
True or false: Each US State has only one State Supreme Court but can have multiple Intermediate Appellate Courts.
False
True or false: Trial courts have very limited jurisdiction.
False
True of false: A traffic court has more jurisdiction than a family court.
Federal court
Where would a case be sent if the two parties are from different states?
Plaintiff
In a trial, who is the person bringing the action?
Defendant
In a trial, who is the person the action is brought against?
Plaintiff
In a trial, which party's name appears first on the title of the case?
Statute of Limitations
What limits the period of time in which a case can
be filed?
Complaint
What contains all material facts of a case and the remedy requested?
Summons
What is issued by a court notifying the defendant of a lawsuit and commands the defendant to file an answer?
Answer
What is written admitting to or denying allegations of a summons and serves as basis on which the trial is built?
Deposition
In the discovery process of a case, what is the out of court testimony by a witness under oath?
Voir dire examination
During a jury selection process, what is the questioning by each side of potential jurors?
To determine questions of fact
What is the jury's role in a civil trial?
To determine questions of law
What is the judge's role in a civil trial?
False
True or false: Witnesses can never be subject to subpoena to appear in court.
Expert witness
Who is called to the stand when the factual material of a case is beyond the scope of jurors?
Motion for summary judgement
What happens when one party attempts to convince the judge that the other sides claims have no merit even if correct?
Motion for directed verdict
What happens when, after the introduction of evidence, the parties allege that the other lacks sufficient evidence?
Judgement notwithstanding the verdict
What is it called when the judge may rule contrary to the jury if the jury clearly reached the wrong verdict?
Indictment
In a criminal trial, what is issued by a grand jury when it determines that enough evidence exists for an arrest and trial?
Plea Bargain
In a criminal trial, what is it called when the defendant agrees to a lesser charge rather than face a trial?
False
True or false: As in State and Federal Appellate Courts, Trial Courts must report and cite court decisions.
Supremacy Clause
When Federal and State Law conflict, what in the US Constitution determines that the Federal Law must be obeyed?
Interstate Commerce Clause
What clause in the US Constitution gives federal authority to regulate drugs?
Tenth Amendment
What in the US Constitution, gives states the authority to regulate?
Durham-Humphrey Amendment
What amendment establishes criteria for distinguishing
prescription drugs from OTC drugs and legally establishes oral prescriptions and refills?
Durham-Humphrey Amendment
What amendment specifies the minimum information that a dispensed Rx label must contain?
False
True of false: Expiration dates and/or beyond use dates are required on Rx labels per the Durham-Humphrey Amendment.
True
True or false: Adding or changing a drug monograph for OTC switch affects all products in its class.
False
True or false: Federal law determines who can prescribe drugs.
Conscientious Objection
What refers to whether a pharmacist has a right to refused to dispense prescriptions he or she has a moral or religious objection?
False
True or false: PPI requirements are only for community pharmacies.
FDCA
Off-label prescribing and dispensing is legal under what act?
FDAMA
In 1997, what stripped the FDA of authority to consider compounded drugs as "new drugs"?
True
True or false: The FDA still thinks of compounded drugs as new drugs.
False
True or false: It is legal for compounding pharmacies to compound a minoxidil cream according to the FDAMA.
Orange book
What book evaluates generic-brand substitution?
Narrow Therapeutic Index Drugs
What are drugs with less than a two-fold difference
between median lethal dose and median effective dose or two-fold difference between minimum toxic concentrations and minimum effective concentrations?
Prescription Drug Marketing Act
What act set up guidelines for drug samples, reimportation, resale and requires state licensing for wholesalers?
Prescription Drug Marketing Act
What act prohibits community pharmacies from receiving drug samples?
Pedigree
What is required for secondary wholesalers according to the prescription drug marketing act?
PDMA
What act generally prohibits reimportation of Rx drugs in attempt to prevent counterfeiting?
CSA
What act allows for limited personal importation of legal prescription drugs from other countries?
MMA
What would allow wholesale importation of Rx medications from Canada provided Secretary of HHS would approve?
False
True or false: The FDA cannot search a pharmacy without a warrant to determine if they are manufacturing or compounding.
Poison Prevention Packaging Act
What law establishes the standards for child resistant containers?
Narcotics
What are natural or synthetic opium or opiates or derivatives including cocaine?
Schedule I
Which schedule of drugs have no accepted medical use?
1.8 grams
What is the strength limit per 100 mL for codeine as a CIII?
Attorney General
Who, after advising from secretary of DHHS, has prescription scheduling authority?
Annually
How often do manufacturers and distributors of controlled drugs have to register with the DEA?
Every three years
How often do dispensers of controlled drugs have to register with the DEA?
20%
A pharmacy may manufacturer and distribute aqueous or oleaginous solution or solid dosage form of a narcotic not exceeding what percent narcotic concentration?
Form 224
What DEA form is used to be able to dispense controlled substances?
Form 222
What DEA form is used for distributors of controlled substances?
Code 841
What code establishes penalties for drug traffickers and is applicable to practitioners who prescribe and/or dispense outside of the ordinary course of professional practice?
Code 842
What code establishes penalties for practitioners for not conforming to the requirements of the CSA, such as record-keeping?
Fourth Amendment
What protects individuals from unreasonable searches and seizures and requires a search warrant for these searches?
Administrative Inspection Warrant
What allows an inspection or search without consent or notice of inspection?
Anabolic Steroids Act of 2004
What act maintains anabolic steroids as schedule III?
3.6
The law limits sale to no more than how many grams of ephedrine, PSE, or PPA base to a single purchaser per day?
9
The law limits sale to no more than how many grams of ephedrine, PSE or PPA base to a single purchaser per 30 days?
Combat Methamphetamine Epidemic Act of 2005
What act says ephedrine, PSE or PPA products must be stored behind counter or in a locked cabinet where customers do not have direct access?
Methamphetamine Production Prevention Act of 2008
What act was signed into law to further stop methamphetamine production by encouraging the use of electronic log books?
False
True or false: Controlled substances cannot be mailed.
patient's name, name of drug, prescriber's signature
What can a pharmacist not change on a control prescription?
True
True or false: Pharmacists cannot orally change CII prescriptions per the DEA.
Service ID number
For practitioners in the service, what must they use on a control prescription in place of a DEA number?
90 days
What is the maximum day supply for CII prescriptions?
Once
How many times can a CIII-CV be transferred to a different pharmacy?
Ryan Haight Act
Which law defines a valid Rx as one that has been issued for a legitimate medical purpose by a practitioner who has conducted at least one in-person medical evaluation of the patient?
Form 106
What form must be filed if there was a theft or loss of controlled substances from the pharmacy?
Form 222
Whenever registrants distribute CI or CII drugs among themselves, what form must be filed?
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