Fed Pharm Law & Regs QB Flashcards
Which of the following laws established the difference between prescription and over-the-counter drugs?
○ A. Pure Food and Drug Act
○ B. Kefauver-Harris Amendment
○ C. Durham-Humphrey Amendment
○ D. Poison Prevention Packaging Act
○ E. Drug Quality and Security Act
○ C. Durham-Humphrey Amendment
The drug labeling information requirements for pregnancy and nursing were changed in 2015. The previous pregnancy categories of A, B, C, D, and X are being phased out. What are the names of the sections that must be included in the new labeling? (Select ALL that apply.)
☐ A. Pregnancy
☐ B. Lactation
☐ C. Nursing Mothers
☐ D. Females and Males of Reproductive Potential
☐ E. Labor and Delivery
☐ A. Pregnancy
☐ B. Lactation
☐ D. Females and Males of Reproductive Potential
The Drug Quality and Security Act of 2013 differentiated between these two areas:
○ A. Prescription versus over-the-counter drugs
○ B. Traditional compounding pharmacies versus outsourcing facilities
○ C. Prescription versus medication orders
○ D. Small molecule drugs versus biologics
○ E. Controlled substances versus non-controlled substances
○ B. Traditional compounding pharmacies versus outsourcing facilities
What criteria does the drug need to meet in order to be considered an orphan drug? (Select ALL that apply.)
A. The targeted disease must affect less than 200,000 people.
B. A drug in which there is no reasonable expectation that the sales will make up for the development costs.
C. The targeted disease affects less than 1% of the U.S. population.
D. The targeted disease is not curative, even with treatment.
E. The targeted disease only affects females or children.
A. The targeted disease must affect less than 200,000 people.
B. A drug in which there is no reasonable expectation that the sales will make up for the development costs.
The Poison Prevention Packaging Act was enacted in order to (primarily) protect this group from an accidental drug overdose:
A. Elderly
B. Young children
C. Blind patients
D. Teenagers who are likely to abuse drugs
E. Patients with cognitive impairment
B. Young children
Which of the following drugs are misbranded? (Select ALL that apply.)
A. The manufacturer’s container states the brand name of the drug but does not state the established (generic) name of the active drug.
B. Motrin dispensed without a MedGuide.
C. The manufacturer’s label states that the container has Hysingla ER 40 mg when it actually contains Hysingla ER 20 mg.
D. The manufacturer’s label on a container of metformin is missing the statement “Rx only.”
E. Insulin shipped in an unrefrigerated container.
A. The manufacturer’s container states the brand name of the drug but does not state the established (generic) name of the active drug.
B. Motrin dispensed without a MedGuide.
C. The manufacturer’s label states that the container has Hysingla ER 40 mg when it actually contains Hysingla ER 20 mg.
D. The manufacturer’s label on a container of metformin is missing the statement “Rx only.”
Which clinical trial phase is the first to be conducted on human subjects?
A. Pre-clinical
B. Phase I
C. Phase II
D. Phase III
E. Phase IV
B. Phase I
Which of the following is considered a cosmetic?
A. Soaps that make a person sweat less.
B. Items that can be used to increase the caloric content in order to improve a person’s weight.
C. Soaps that treat acne.
D. Items that can be sprayed on the body to alter the appearance.
E. Products that can be swallowed to improve joint health.
D. Items that can be sprayed on the body to alter the appearance.
A manufacturer’s container of Soma has an NDC of 62756-446-05, what do the numbers “446” represent?
A. Manufacturer
B. Drug
C. Packaging
D. Price
E. Expiration date
B. Drug
Which of the following statements is true for the package insert of a legend drug? (Select ALL that apply.)
A. It should include safety information on any known health risks if taken during pregnancy.
B. It is prohibited from being given to a patient upon request.
C. It is intended for the healthcare provider.
D. It should be written at approximately an eighth-grade comprehension level.
E. It must be approved by the FDA.
A. It should include safety information on any known health risks if taken during pregnancy.
C. It is intended for the healthcare provider.
E. It must be approved by the FDA.
Which of the following drugs is misbranded?
A. The manufacturer’s container is labeled as containing 100 tablets, but only contains 80 tablets.
B. An insulin vial is stored at room temperature for over 60 days and the contents appeared discolored.
C. Humira stored at room temperature for 30 days.
D. A compounded drug prepared in a pharmacy with rat droppings on the floor.
E. Filling a drug in a dirty vial.
A. The manufacturer’s container is labeled as containing 100 tablets, but only contains 80 tablets.
A pharmaceutical company would like to market a new dosage for a drug. Which type of application must the pharmaceutical company submit to the Food and Drug Administration?
A. IND
B. NDA
C. ANDA
D. sNDA
E. BLA
D. sNDA
Supplemental New Drug Application
The drug approval process begins with pre-clinical testing with animals. If the pre-clinical testing on animals is promising, the next step would be to file an investigational new drug (IND) application. Who files the IND?
A. The manufacturer
B. The wholesaler
C. The outsourcing facility
D. The FDA
A. The manufacturer
The definitions for food, drugs, dietary supplements, and devices were each initially defined under this act:
A. The Federal False Claims Act (FFCA)
B. The Omnibus Budget Reconciliation Act of 1990 (OBRA ‘90)
C. The Prescription Drug Marketing Act (PDMA)
D. The Controlled Substances Act (CSA)
E. The Food, Drugs, and Cosmetics Act (FDCA)
E. The Food, Drugs, and Cosmetics Act (FDCA)
The FDA is responsible for approving prescription drugs before a drug is available on the market. When must a new drug application (NDA) be submitted to the FDA?
A. After phase III drug studies show promising results
B. After a phase II trial for a biologic shows promising results
C. When a pharmacy prepares a compounded product for distribution under Section 503B
D. Before a drug manufacturer begins manufacturing generic drugs
E. None of the answer choices are correct
A. After phase III drug studies show promising results
A drug company is marketing an over-the-counter drug as a product that will prevent colds. Which regulatory body is responsible for enforcing the accuracy of this claim?
A. Food and Drug Administration
B. Federal Trade Commission
C. Drug Enforcement Administration
D. Joint Commission on Accreditation of Healthcare Organizations
E. Board of Pharmacy
B. Federal Trade Commission
ML hears about a new and effective drug in Canada that treats her rare disease. She is planning to travel to Canada to pick up a 6-month supply. ML tells her friend JP, who has the same disease, about the new drug. JP asks if she can buy some of the medication from ML when she returns from Canada with a 6-month drug supply. Which of the following is correct?
A. ML can bring the 6-month supply into the US but cannot resell it to JP.
B. ML can bring the 6-month supply into the US and can resell it to JP.
C. ML can bring the 6-month supply into the US and sell it to JP if she has a letter from JP’s doctor approving the Canadian drug.
D. ML cannot bring the 6-month supply into the US or sell to JP.
E. ML cannot buy drugs from other countries and bring them into the US under any circumstances.
D. ML cannot bring the 6-month supply into the US or sell to JP.
Which of the following drugs are considered “misbranded?” (Select ALL that apply.)
A. If a prescription drug label does not contain dosage and administration information.
B. If an OTC drug label does not contain adequate directions for use.
C. When a prescription container label claims to contain a brand name drug but the contents are generic.
D. When the contents have decomposed due to moisture exposure.
E. When they contain filthy or putrid substances that have been held under unsanitary conditions.
A. If a prescription drug label does not contain dosage and administration information.
B. If an OTC drug label does not contain adequate directions for use.
C. When a prescription container label claims to contain a brand name drug but the contents are generic
What was the first law that required new drugs to be proven safe (if used as directed) before being marketed?
A. Pure Food and Drug Act
B. Food, Drug and Cosmetic Act
C. FDA Modernization Act
D. Poison Prevention Packaging Act
E. Drug Quality and Security Act
B. Food, Drug and Cosmetic Act
What must be included on the label by manufacturers of legend drugs?
A. “Rx Only” or “Caution: Federal law prohibits dispensing this drug without a prescription”
B. “Rx Only” or “Legend Only”
C. “Caution: Federal law prohibits transfer of this medicine to anyone not authorized”
D. “Caution: Dangerous Contents. Dispose of Properly”
E. “This product contains a legend drug. Do not share the contents with anyone except the person for whom it was prescribed”
A. “Rx Only” or “Caution: Federal law prohibits dispensing this drug without a prescription”
Which of the following was the first law that required drugs to be proven effective (if used as directed) before being marketed?
A. Pure Food and Drug Act
B. Kefauver-Harris Amendment
C. Durham-Humphrey Amendment
D. Poison Prevention Packaging Act
E. Drug Quality and Security Act
B. Kefauver-Harris Amendment
Which of the following products are adulterated? (Select ALL that apply.)
A. A prescription drug dispensed without a valid prescription.
B. Drugs stored in a container that may contaminate the drug.
C. A drug labeled with an incorrect generic name.
D. A drug that contains an excipient that has decomposed to cyanide.
E. Tablets that are found to contain 2.5 times the stated strength listed in the official compendia.
B. Drugs stored in a container that may contaminate the drug.
D. A drug that contains an excipient that has decomposed to cyanide.
E. Tablets that are found to contain 2.5 times the stated strength listed in the official compendia
A drug company is advertising a new prescription pain medication. Which of the following agencies will regulate the advertising?
A. Centers for Disease Control and Prevention
B. Food and Drug Administration
C. Federal Trade Commission
D. Drug Enforcement Administration
E. State Boards of Pharmacy
B. Food and Drug Administration
Which clinical trial phase is conducted after the drug is already approved by the FDA?
A. Pre-clinical
B. Phase I
C. Phase II
D. Phase III
E. Phase IV
E. Phase IV
A manufacturer’s container of simvastatin 20 mg has an NDC of 68180-479-02, what do the numbers “68180” represent?
A. Manufacturer
B. Drug
C. Packaging
D. Price
E. Expiration date
A. Manufacturer
All of the following would be considered misbranding EXCEPT:
A. Drugs that contain unsafe color additives.
B. Drugs dispensed without a MedGuide.
C. Drugs that do not comply with the Poison Prevention Packaging Act.
D. Nonprescription drugs that do not contain adequate directions for use.
E. Drug manufacturer’s container that does not contain an expiration date.
A. Drugs that contain unsafe color additives.
Which of the following over-the-counter products must be packaged in tamper-resistant containers according to the Federal Anti-Tampering Act? (Select ALL that apply.)
A. Short-acting insulin
B. Tylenol
C. Multivitamin tablets
D. Pepcid AC
E. Cepacol lozenges
B. Tylenol
C. Multivitamin tablets
D. Pepcid AC
A drug company would like to make a generic version of a prescription drug product with an expired exclusivity period. Which type of application must the company submit to the Food and Drug Administration?
A. IND
B. NDA
C. ANDA
D. sNDA
E. gNDA
C. ANDA
Abbreviated New Drug Application
In which of the following scenarios is the drug adulterated?
A. The retail pharmacist dispenses Ortho Tri-Cyclen without the patient package insert.
B. The air conditioning is broken and the drug stock in the pharmacy is exposed to a temperature of 98°F.
C. The manufacturer’s container does not indicate the amount of dosage units it contains.
D. The manufacturer label is illegible.
E. The manufacturer label does not have the name of the manufacturer.
B. The air conditioning is broken and the drug stock in the pharmacy is exposed to a temperature of 98°F.
Which of the following medications is misbranded?
A. A unit dose label for Invokana does not have a beyond-use date on it.
B. A Pepcid tablet containing glass shards in the tablet.
C. An elixir manufactured with a toxic, unapproved ingredient.
D. A methylprednisolone injection found to be growing mold.
E. None of the answers are correct.
A. A unit dose label for Invokana does not have a beyond-use date on it.
A female patient with a rare genetic disease has tried all the currently available products in the United States, but nothing has helped her so far. She is planning a trip to a Canadian pharmacy to purchase a new, safe Canadian drug to treat her disease. She plans to bring back a 30-day supply. Choose the correct statement:
A. She cannot bring the drug into the United States, but her retail pharmacy can import it for her.
B. The quantity of drugs she wants to bring back to the United States exceeds the legal amount.
C. She can bring the drug into the United States since an effective treatment is not available in the United States.
D. The day supply she wants to bring back to the United States exceeds the legal amount.
E. She cannot buy drugs from other countries and bring them back into the United States under any circumstances.
C. She can bring the drug into the United States since an effective treatment is not available in the United States.
Which of the following items is considered a dietary supplement according to the FDA?
A. Chewing tobacco
B. Smokeless tobacco
C. Patchouli oil used for massage purposes
D. L-Lysine
E. Meal replacement protein shakes
D. L-Lysine
A pharmaceutical company has conducted animal and human clinical trials for a new biological drug to treat Alzheimer’s Disease. Which type of application must the pharmaceutical company submit to the Food and Drug Administration?
A. IND
B. NDA
C. BDA
D. sBDA
E. BLA
E. BLA
Biologic Licensing Application
A drug has the following National Drug Code: 0085-1264-02. What do the numbers “02” represent?
A. Manufacturer
B. Drug
C. Packaging
D. Price
E. Expiration date
C. Packaging
Each of the following statements about NDC numbers are correct EXCEPT:
A. The first segment identifies the company that prepared the drug or packaged it.
B. NDCs identify prescription drugs only; OTC drugs do not contain NDC numbers.
C. The second segment identifies the strength, dosage, and formulation of the drug.
D. The third segment identifies the package size of the drug.
E. NDC stands for National Drug Code.
B. NDCs identify prescription drugs only; OTC drugs do not contain NDC numbers.
