Missed law questions Flashcards
Before the FDA may classify a medication as a prescription drug, it must show which of the following?
It could harm the patient if not taken under the direction of a physician AND a patient who takes the drug for a condition that the drug cannot cure will suffer harm because of the delay in seeing a physician in reliance on the drug.
Which of the following must be packaged with tamper-evident packaging?
A ) Contact lens solution
B ) Toothpaste
C ) Cough lozenges
D ) Secobarbital
A ) Contact lens solution
Under what policy or law does the FDA permit the personal importation from any country of drugs that have not been approved by the FDA as long as certain criteria have been met?
A ) Department of Homeland Security Appropriations Act
B ) Compassionate Use Policy
B ) Compassionate Use Policy
Which of the following statements, if any, are FALSE in describing drugs that are permitted to be imported from Canada for personal use under the Department of Homeland Security Appropriations Act of 2007?
A ) It is an FDA-approved prescription drug.
B ) The drug must be transported on the individual’s person.
C ) The quantity may not exceed a 90-day supply.
D ) The drug may be a controlled substance.
E ) All of the above are true statements.
D ) The drug may be a controlled substance.
Under the Controlled Substances Act, which scenario is within the bounds of the law when a U.S. resident obtains a controlled substance in a foreign country?
A ) Patient personally carries a 90-day supply of oxycodone over the Canadian border into the U.S.
B ) Patient personally transports 10 dosage units of Fiorinal in a small travel-sized bottle and declares it in customs as Patient enters the U.S. from Mexico.
C ) Patient personally transports 50 dosage units of Fiorinal in the original container and declares it in customs as Patient enters the U.S. from Mexico.
D ) Patient mails 90 dosage units of oxycodone from Canada to his home address in the United States.
C ) Patient personally transports 50 dosage units of Fiorinal in the original container and declares it in customs as Patient enters the U.S. from Mexico.
The selling of drug samples in pharmacies is prohibited by which of the following federal laws?
A ) Drug Price Competition Act B ) DSHEA C ) Durham-Humphrey Amendment D ) The Sherman Act E ) Prescription Drug Marketing Act
E ) Prescription Drug Marketing Act
Which of the following laws streamlined the generic approval process but also provided incentives for manufacturers to develop new drugs?
A ) Orphan Drug Act
E ) Waxman-Hatch Amendment
E ) Waxman-Hatch Amendment
Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Waxman-Hatch Amendment.
Which of the following was the first to require that pharmaceutical manufacturers prove the efficacy of prescription drugs before marketing?
A ) Durham-Humphrey Amendment B ) FDCA of 1938 C ) Prescription Drug Marketing Act D ) Pure Drug and Food Act of 1906 E ) Kefauver-Harris Amendment
E ) Kefauver-Harris Amendment
Don’t confuse this with the FDCA of 1938 which was the first law to require pharmaceutical manufacturers to prove the safety of prescription drugs before marketing.
How many phases of clinical testing must be conducted before a new drug application may be submitted to the FDA?
A ) 8 B ) 2 C ) 3 D ) 5 E ) 4
C ) 3
The primary purpose of Phase I clinical trials is to evaluate the drug’s _______.
A ) Adverse effects in diseased patients B ) Therapeutic index C ) Efficacy in diseased patients D ) Safety E ) Marketability
D ) Safety
A clinical pharmacist in a hospital setting is most likely to participate in which phase of premarketing testing?
A ) 4 B ) 1 C ) 3 D ) 2 E ) 5
C ) 3
A Phase III clinical trial involves large groups of subjects. The purpose of this phase is to collect data concerning the drug’s effectiveness
Post-marketing surveillance of a new drug product is referred to as the Phase ____ clinical trial.
A ) 3 B ) 1 C ) 4 D ) 5 E ) 2
C ) 4
The FDA uses Phase 4 to determine whether the new drug or product should stay on the market.
A pharmaceutical company that originally developed a drug wants to lengthen the expiration date based upon additional stability data. The company must submit to the FDA a(n):
A ) NDA
B ) IND
C ) SNDA
D ) ANDA
C ) SNDA
An easy way to remember this is to know that if the Same company that original drug is submitting the application, a Supplemental New Drug Application is required. On the other hand, if Another company is submitting an application, it must be an Abbreviated New Drug Application.
Which of the following chemical classifications indicates that a new drug possesses significant advancement over present drug therapy?
A ) Type 1 B ) Type 6 C ) Type 2 D ) Type A E ) Type S
A ) Type 1
Type 1: New molecular entity (new molecular structure from existing drugs used for same therapeutic purpose. Not currently marketed in the U.S.)
Type 2: New ingredient
Type 3: New dosage form
Type 4: New combination of two or more drugs.
Type 5: New formulation or new manufacturer
Type 6: New therapeutic indicators for drug that is already approved.
Type 7: Drug is already marketed without an approved NDA
Type 8: OTC (over-the-counter) switch
Type 9 — New indication or claim, drug not to be marketed under Type 9 NDA after approval
Type 10: New indication submitted as distinct NDA (not consolidated)
Some new drug applications are granted a “Type P” status by the FDA. This status implies that the drug:
A ) Relates to pregnancy
B ) Is for parenteral use only
C ) Will receive a low priority or passive review
D ) Requires special packaging
E ) Will receive a priority review of the NDA
E ) Will receive a priority review of the NDA
Type P: unique, priority review
Type S: similar to other drugs on market, standard review.
A specific drug product has a NDC of 0137-0145-10. The “0137”represents:
A ) The trade name of the drug B ) The labelers code assigned by the FDA C ) The location of the manufacturer D ) The generic name of the drug E ) A unit dose package
B ) The labelers code assigned by the FDA
The “0137” is assigned by the FDA and identifies the manufacturer.
The “0145” is assigned by the manufacturer and identifies a specific strength, dosage form, and formulation for that particular manufacturer.
The “10” is also assigned by the manufacturer and identifies the trade package size and characteristics
The USP/NF is published by:
A ) A coalition of pharmaceutical companies
B ) A private, independent organization
C ) The Department of Health and Human Services
D ) The FDA
B ) A private, independent organization
A product that prevents pregnancy is:
A ) a drug because it is used in the diagnosis, cure, mitigation, treatment, or prevention of disease.
B ) not a drug because pregnancy is not a disease.
C ) a drug because it affects the structure or function of the human body.
D ) a drug if it is recognized in the official USP/NF.
C ) a drug because it affects the structure or function of the human body.
D ) a drug if it is recognized in the official USP/NF.
Dietary supplements are treated more like which of the following under the FDCA?
A ) Devices
B ) Cosmetics
C ) Drugs
D ) Foods
D ) Foods
The primary goal of the Prescription Drug Marketing Act of 1987 was which of the following?
B ) To prevent drug diversion from normal channels of distribution
D ) To prevent unsubstantiated health claims on prescription drug advertising.
B ) To prevent drug diversion from normal channels of distribution
A prescriber who requests drug samples from a manufacturer’s representative must keep records regarding the drug samples for how many years?
B ) 3
C ) 2
B ) 3
A moisturizer that claims sun protection is which of the following?
A ) Soap B ) Cosmeceutical C ) Cosmetic D ) Cosmetic/Drug combination E ) Drug
D ) Cosmetic/Drug combination
Insulin syringes, infusion pumps, and diagnostic reagents are classified by the FDA as which of the following:
A ) Medical Devices – Class II
B ) Medical Devices – Class III
C ) Medical Devices – Class I
D ) Drugs
A ) Medical Devices – Class II
Medical Devices Class I include: needles, scissors, examination gloves, stethoscopes, and toothbrushes. The pose the least potential harm to users, and general controls are adequate to ensure safety and effectiveness.
Medical Devices Class II include: insulin syringes, infusion pumps, thermometers, diagnostic reagents; tampons, and electric heating pads. General controls are insufficient to ensure general safety and effectiveness, and these devices must meet performance standards established by the FDA.
Medical Devices Class III include: pacemakers, soft contact lenses, and replacement heart valves. These devices are life supporting or life-sustaining, and they present a potential unreasonable risk of illness or injury. The require premarket approval.
Pharmacist receives a prescription for a brand name drug. The patient requests the brand name drug, but indicates she expects to pay no more than she would pay for the generic drug. Under state law, pharmacist may legally substitute the generic drug for the brand name drug. However, to placate the patient and mislead her into believing that she is receiving the brand name drug, Pharmacist labels the dispensed generic drug with the brand name drug. What penalties, if any, may pharmacist incur as a result of this action?
A ) None. Pharmacist has not violated the FDCA.
B ) Up to 3 years in prison, and up to a $10,000 fine.
C ) Up to 5 years in prison, and up to a $25,000 fine.
D ) Up to 1 year in prison, and up to a $1000 fine.
B ) Up to 3 years in prison, and up to a $10,000 fine.
may be imprisoned for not more than 1 year, and fined not more than $1000. However, for a second offense, or for an offense committed with the intent to defraud or mislead, a violator may be imprisoned up to 3 years and fined up to $10,000.
For FDA approval, a brand name drug company must complete applications and clinical trials in this order:
A ) IND; NDA; clinical trial phases I, II, III and IV
B ) IND; clinical trial phases I, II, III and IV; NDA
C ) NDA; clinical trial phases I, II and III; IND; phase IV
D ) IND; clinical trial phases I, II and III; NDA; phase IV
D ) IND; clinical trial phases I, II and III; NDA; phase IV
Investigational New Drug Application (IND) must be filed with the FDA first. If the FDA does not reject the application within 30 days, the brand name drug company begin clinical trials, Phase I, Phase II, and Phase III. Assuming the clinical trials prove that the drug is safe and effective, the company may file a New Drug Application (NDA). After the FDA approves the NDA, the company may market the drug to the public, subject to Phase IV (post market surveillance).
Adequate information for use in a drug’s labeling means that the:
A ) directions are adequate for a patient to take the drug safely and for the purposes intended.
D ) directions are adequate for a health care professional, not the patient.
D ) directions are adequate for a health care professional, not the patient.
If the labeling requires “adequate information for use” it means that the drug is a prescription drug and the information in the labeling is for the health care provider.
Over the counter drugs require “adequate directions for use” and it means that the information is adequate for a patient to take the drug safely and for the purposes intended.
A physician wants to treat a patient who has a life threatening disease with an investigational new drug currently in Phase I. Under federal law, the physician:
A ) may use the drug if patient has no other treatment options.
C ) must enroll the patient in the clinical trial.
A ) may use the drug if patient has no other treatment options.
Under the Canadian Personal Use Exemption, an individual patient may obtain a prescription drug in Canada and bring it into the United States if Patient personally carries:
A ) 50 dosage units of Fiorinal in the original container and declares it in customs as Patient enters the U.S.
B ) 50 dosage units of a drug currently in a phase III clinical trial.
C ) a 90-day supply of hydrocodone.
D ) a 90-day supply of amlodipine.
D ) a 90-day supply of amlodipine.
The Canadian Personal Use Exemption was created under the Department of Homeland Security Appropriations Act of 2007. It allows an individual patient to import an FDA-approved prescription drug into the U.S. from Canada on his or her person in a quantity not to exceed a 90-day supply. It cannot be a controlled substance or a biological product.
A pharmaceutical company that wants to market a drug after the innovator company’s patent expires must submit to the FDA a(n):
B ) ANDA
D ) SNDA
B ) ANDA
Another company is submitting an application, and it must submit an Abbreviated New Drug Application. An easy way to remember this is to know that if it is Another company, it must submit an ANDA. On the other hand, if the Same company that marketed the original drug is submitting the application, a Supplemental New Drug Application is required.
Pharmacist finds out that her husband is having a romantic affair with one of the pharmacy’s patients. Pharmacist accesses the patient’s prescription records and patient profile and finds information that would embarrass and humiliate the patient if made public. Pharmacist maliciously posts the information on Facebook and posts flyers around the patient’s workplace. Under HIPAA, Pharmacist may be subject to a maximum penalty of:
A ) up to a $100,000 fine and up to 5 years in prison.
B ) up to a $250,000 fine and up to 10 years in prison.
C ) up to a $50,000 fine and up to 1 year in prison.
D ) $100 fine per violation, up to $25,000.
B ) up to a $250,000 fine and up to 10 years in prison.
