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WorksheetsLaw & Ethics E1
Total questions: 43
Worksheet time: 24mins
What best describes statutory law?
A law proposed by legislature and enacted by executive. Includes federal statutes, state constitutions, and ordinances
Created, administered, and enforced by an administrative agency, such as the SC LLR
Includes regulations
Published in the Federal Register
What best describes administrative law?
A law proposed by legislature and enacted by executive
Created, administered, and enforced by an administrative agency, such as the SC LLR
Includes state constitutions
Abides by Stare Decisis
What is Stare Decisis?
Removes flexibility of factual differences
The ignoring of judicial opinions and decision making
A principle of common law to abide by previously decided cases
Never becomes codified into statutes
Which term is incorrectly matched to its objective?
Criminal law - punishes those who break the law
Civil action - compensates for damages caused
Administrative action - process of developing legal action
Litigation - resolving legal disputes
The Interstate Commerce Clause regulates drug distribution in the US. What term describes this law?
Federal Law
Stare Decisis
State law
Administrative law
A pharmacist is under investigation for insulting a customer during a dispute. Which of the following types of actions are most likely to occur?
Criminal Law
Civil Action from the customer over mental distress, etc.
Administrative Action from the state board if regulations are broken
None, the customer probably deserved it
A pharmacy technician was negligent in their duties and lead to a patient injury. Which of the following could be involved in the following events?
Civil action from the patient for compensation of injury
Administrative action if state agency regulations were broken
None, the charges would be solely against the pharmacist
Tort law if the court proceedings result in a mistrial
What best describes the purpose of the Pure Food and Drug Act?
Creation of the FDA to monitor drugs and regulate drug approval
Standardization of labels for the use and warnings for drugs, alcohol, food, and other similar products
Creating a tiered system to evaluate the negative outcomes of a drug and how to regulate their availability to consumers
Prohibiting the manufacture, sale, or transport of adulterated, misbranded, etc. foods and drugs
Which of the 3 following characteristics are cons of the 1912 Sherley Amendment to the Pure Food and Drug Act?
Difficult to enforce
Required the government to prove fraudulent intent
Easily avoided by claiming ignorance
Referred only to drug identity
What statement about the Food, Drug, and Cosmetic Act of 1938 is true?
Provides a basis for civil action in pharmacy-related cases and defines the common law of the era
Fails to expand the definition of misbranding or adulteration
Attempts to prevent unsafe drugs from marketing but has no efficacy requirements
Established the differentiation of Rx and OTC at the time of its passing
The Durham-Humphrey Amendment to the Food, Drug, and Cosmetic Act includes what?
The differentiation of Rx and OTC drugs as well as proper instructions for OTC drugs
Requires food additives to have an FDA approval
Requires color additives to have an FDA approval before they can be marketed
Responds to the thalidomide tragedy of the late 1950s
Which amendment to the Food, Drug, and Cosmetic Act added the requirement of drugs to be both safe and effective, established cGMP, and allowed FDA inspections and oversight of Rx advertising?
Poison Prevention Packaging Act (1970)
Kefauver-Harris Amendment (1962)
Humphrey-Durham Amendment (1945)
Color and Foods Additives Amendment (1989)
Which act provides various incentives to manufacturers to develop and market drugs for rare diseases according to the NORD?
Kefauver-Harris Amendment (1989)
Orphan Drug Act (1983)
Hurham-Durham Act (1972)
Drug Price Competition and Patent Term Restoration Act (1984)
Which act created Abbreviated NDAs (ANDA) to streamline drug approval processes while also including incentives for generics and new drugs?
Drug Price Competition and Patent Term Restoration Act (1984)
Kefauver-Harris Amendment
Hatch-Harris Amendment
Prescription Drug Marketing Act (1987)
Which of the following acts is prohibited by the Prescription Drug Marketing Act (1987)?
Selling drugs wholesale with a license
A physician's office dispenses a week sample of a drug in exchange for cash
Drug manufacturers produce and ship bottles of acetaminophen without an inner tamper seal
Producing more than the allowed quota of a controlled substance per the guidelines
The _______ Act established application and supplement fees paid to the FDA during drug approval and clinical studies, which now consists of >25% of the FDA funding.
Arsenic Control Act (1642)
Dietary Supplement Health and Education Act (1990)
Prescription Drug User Fee Act (1992)
Omnibus Reconciliation Act (1990)
(True/False) The FDA is allowed to audit foreign drug manufacturers if they are selling in the US as well as implementing new fees for NDAs and medical devices.
True
False
Which act responding to the NECC incident clarified compounding pharmacies' roles and improved the FDA's oversight of the drug supply chain?
Kefauver-Harris Act
FDA Amendments Act (2007)
FDA Safety and Innovation Act (2012)
Drug Quality and Security Act (2013)
Select all of the following areas that the FDA has oversight for:
A stand in the mall selling e-cigarette cartridges
A Doctor of Veterinary Medicine (DVM) prescribing Cerenia for a dog
The sale and production of urinary catheters
The sale, distribution, and marketing of homeopathic products
What is the definition of a drug?
A substance intended to aid in the treatment of a disease
A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of a disease
A substance intended to help prevent a disease
Includes vitamins and dietary supplements
What is the definition of a dietary supplement?
A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of a disease
A product intended for ingestion to supplement the diet and contains an amino acid, botanical, mineral, etc.
A product to supplement the diet and preventing a common disease
A product only intended for prescription use to supplement the diet containing an amino acid, botanical, etc.
A company plans to make a dietary supplement and include that it supports nutrition on the bottle. Is this acceptable?
Yes without any other restrictions
Yes if they include the statement hasn't been evaluated by the FDA and isn't for any drug uses
Yes if the manufacturing area has been evaluated by the FDA within 90 days of first shipping
No not under any conditions
(True/False) Dietary supplements, despite not being drugs, are required to follow cGMP to be able to market in the US.
True
False
You see a TV ad that claims chemical X, a dietary supplement, is a magic bullet cure for diabetes. What agency has oversight over this problem?
FDA Safety Reporting Portal
NIH
FTC
FBI
Select all of the factors that best describe Phase I Trials
Focuses on safety and PK/PD
May have 20-100 healthy volunteers
May have 100-300 patients with the intended disease
Estimates benefit to risk ratio
Which of the following descriptions best fit Phase 2 Trials?
Focuses on long term safety and efficacy
Can be used for dosing ranges
May have 100-300 patients with the intended disease
Used for short term safety
Phase 3 trials are described by which of the following?
Often has long follow up periods
Focuses on short term safety
May have 300-3000 patients with the intended disease
Used to evaluate benefits and risk
Novartis has developed a brand new molecule that they intend to use to treat a disease using a biochemical pathway unlike any other drug. They have just finished preclinical trials to establish that it is safe for humans. What is their next step?
File an investigator IND
File an emergency IND
File a treatment IND
File an SNDA
What is the equivalent of an NDA used for biologic agents according to both the Food, Drug and Cosmetic Act and the Public Health Service Act?
SNDA
BLA
INDA
Treament INDA
Eli Lily hopes to expand an indication and add a package label to an oral antidiabetic agent that is not a biologic agent. What application should they submit?
sBLA
NDA
sNDA
INDA
GSK made news the other year for making their Voltaren (diclofenac) gel for arthritis OTC instead of Rx-only. What application would they submit if they also wanted to make a generic version?
SNDA
ANDA
INDA
SBLA
Which of the following are included in the definition of adulteration?
The product of interest is prepared or stored in unsanitary conditions
The manufacturer isn't using proper quality controls, testing, or otherwise is not cGMP
The drug labels are not factual
The ingredients in the final product are different than USP standards
Which of the following are included in the definition of misbranding?
The final product has different ingredients than USP standards
The drug label has a printing error that makes it incomplete and illegible
The drug label is missing a warning
The drug was improperly stored
An overseas manufacturing company is found to have imported hand sanitizer to the US. The label states the active ingredient is 75% ethyl alcohol USP. Testing finds the bottles hold 35% ethyl alcohol and 37% methanol, a toxic substance not listed on the label. What does this situation count as?
Adulteration
Misbranding
Adulteration and Misbranding
Neither
A DVM at a veterinary hospital is found to have been injecting themself with a controlled substance meant for dispensing to patients and replacing the difference with saline or phenobarbital. What does this count as?
Adulteration
Misbranding
Adulteration and misbranding
Neither
Which of the following is an incorrect drug recall class?
Class 1 - reasonable probability to cause serious adverse reaction or death
Class 2 - might cause temporary/reversible adverse health consequence but serious event chance is remote
Class 3 - products unlikely to cause adverse health consequences
Class 4 - product is being voluntarily recalled by manufacturer due to a minor problem
(True/False) The patient package insert for estrogen products is required to be provided every time such a product is dispensed in the outpatient setting - regardless of how often it is dispensed or how long the patient has had the prescription.
True
False
An advertisement mentions a drug's name, an approved indication, and the most prevalent side effects. What kind of ad is this?
Product Claim advertisement
Reminder advertisement
Help-seeking advertisement
Promotional label
A drug advertisement mentions the name of a drug but doesn't mention or suggest indications, risk information, or any benefit/risk. What kind of ad is this?
Product Claim advertisement
Reminder advertisement
Help-Seeking advertisement
Promotional label
Which of the following are applicable statements for emergency kits?
Holds both controlled and non-controlled drugs
Must be sealed and is replaced when the seal is broken - even if nothing is used
Outside list with each name, strength, amount, expiration, and supplier info
Stored in a location easily accessible by patients and providers
Which of these medications requires child resistant packaging?
SL nitroglycerin dispensed for acute angina
Yaz dispensed in a weekly based package
Amoxicillin oral suspension
Effervescent acetaminophen tablets
What non-controlled drug is limited for purchase by the Combat Methamphetamine Epidemic Act (CMEA)?
ibuprofen
Heroin
Pseudoephedrine
Methamphetamine
What act requires the offering of oral counseling during prescription dispensing?
OBRA90
FDCA
HIPAA
K-H Amendment
