Federal Pharmacy Laws & Regulations Video Flashcards
Which of the following scenarios is considered adulteration?
A. A dietary supplement advertisement states that it treats migraines
B. A drug label does not contain the manufacturer’s address
C. An IV solution prepared in a cleanroom where mold was found
D. A prescription bottle contains Lipitor, but is labeled as Crestor
E. A Procrit vial stored at refrigerated temperature
C. An IV solution prepared in a cleanroom where mold was found.
Kefauver-Harris Amendment
Safe and Effective
Durham-Humphrey
Established OTC
Which of the following was a key provision of the Kefauver-Harris Amendment of 1962?
A. Allowed generic substitution without prescriber approval
B. Required drugs to be proven safe and effective before marketing
C. Established the DEA for drug enforcement
D. Allowed the FDA to schedule controlled substances
B. Required drugs to be proven safe and effective before marketing
Which federal agency was granted the authority to enforce Current Good Manufacturing Practices (CGMPs) under the Kefauver-Harris Amendment?
A. DEA
B. FTC
C. FDA
D. NIH
C. FDA
What regulatory change resulted from the Kefauver-Harris Amendment?
A. Required informed consent for clinical trials
B. Allowed drug manufacturers to promote off-label use
C. Removed FDA authority over prescription drug advertising
D. Required patents on all prescription drugs
A. Required informed consent for clinical trials
Which of the following statements about the Kefauver-Harris Amendment are correct?
I. It required pharmaceutical manufacturers to report adverse drug events.
II. It allowed prescription drug advertisements to be regulated by the FDA.
III. It eliminated the need for drug efficacy studies.
A. I only
B. I and II only
C. II and III only
D. I, II, and III
B. I and II only
The Kefauver-Harris Amendment was passed in response to the Thalidomide tragedy.
True
Prior to the Kefauver-Harris Amendment, drug manufacturers only needed to prove the safety of their products, not efficacy.
True
The Kefauver-Harris Amendment transferred prescription drug advertising regulation from the FDA to the Federal Trade Commission (FTC).
False (It actually granted the FDA authority over prescription drug advertising.)
Which pharmacy law created a distinction between prescription and over-the-counter drugs?
A. Drug Listing Act
B. Durham-Humphrey Amendment
C. Food, Drug and Cosmetic Act
D. Hatch-Waxman Act
E. Kefauver-Harris Amendment
B. Durham-Humphrey Amendment
What is the correct format of an NDC number?
A. 5-5-1
B. 5-4-2
C. 5-3-3
D. 4-4-3
B. 5-4-2
Which part of the NDC number identifies the manufacturer or labeler(00641-4580-30)?
A. First segment (00641)
B. Second segment (4580)
C. Third segment (30)
D. None of the above
A. First segment (00641)
The last segment of an NDC number represents which of the following?
A. Labeler (Manufacturer)
B. Product (Strength, Dosage, Formulation)
C. Package Size and Type
D. National Registry Number
C. Package Size and Type
Which of the following statements about the National Drug Code (NDC) are correct?
I. The NDC consists of three segments: Labeler, Product, and Package.
II. The NDC is assigned by the FDA and is a permanent code for each drug.
III. The NDC must be present on all drug packaging for prescription and OTC drugs.
A. I only
B. I and II only
C. I and III only
D. I, II, and III
C. I and III only
What is the primary purpose of the Orphan Drug Act?
A. To increase the availability of generic drugs
B. To encourage the development of drugs for rare diseases
C. To regulate the pricing of specialty medications
D. To reduce the approval time for over-the-counter drugs
B. To encourage the development of drugs for rare diseases
A drug qualifies as an “orphan drug” if it is intended to treat a disease affecting how many people in the U.S.?
A. Fewer than 100,000
B. Fewer than 200,000
C. Fewer than 500,000
D. Fewer than 1,000,000
B. Fewer than 200,000
What incentive is NOT provided under the Orphan Drug Act?
A. Tax credits for clinical trial costs
B. Market exclusivity for 7 years
C. Government-funded advertising for the drug
D. FDA assistance with drug development
C. Government-funded advertising for the drug
Which of the following statements about the Orphan Drug Act are correct?
I. It encourages pharmaceutical companies to develop drugs for rare diseases.
II. It provides tax incentives to drug manufacturers.
III. It guarantees that orphan drugs will be FDA-approved.
A. I only
B. I and II only
C. II and III only
D. I, II, and III
B. I and II only
Which statement regarding NDC numbers is correct?
A. An NDC number must be listed on the label of every drug
B. NDC numbers are assigned to OTC products by the FTC
C. The first segment of the NDC number represents the product code
D. The second segment of the NDC number represents the manufacturer
E. The third segment of the NDC number represents the package code
E. The third segment of the NDC number represents the package code
“package code” is size and quantity
Only required on Prescription but requested to be placed on OTC
What was the primary purpose of the Hatch-Waxman Act?
A. To regulate the advertisement of prescription drugs
B. To streamline the approval process for generic drugs
C. To require all drugs to be tested on pediatric patients
D. To increase the cost of generic medications
B. To streamline the approval process for generic drugs
Which regulatory book lists FDA-approved interchangeable generic drugs?
A. Purple Book
B. Orange Book
C. Red Book
D. Blue Book
B. Orange Book
Under the Hatch-Waxman Act, how many years of market exclusivity is granted to brand-name drugs before a generic can be approved?
A. 3 years
B. 5 years
C. 7 years
D. 10 years
B. 5 years
Which of the following best describes how the Hatch-Waxman Act impacted generic drugs?
A. Allowed them to be marketed without FDA approval
B. Required extensive clinical trials for every generic drug
C. Created the Abbreviated New Drug Application (ANDA) process
D. Limited generic drug production to a single manufacturer
C. Created the Abbreviated New Drug Application (ANDA) process
Which of the following are true about the Hatch-Waxman Act?
I. It allows for an Abbreviated New Drug Application (ANDA) for generics.
II. It provides brand-name drugs with 5 years of market exclusivity.
III. It prevents pharmacists from substituting generic drugs for brand-name drugs.
A. I only
B. I and II only
C. II and III only
D. I, II, and III
B. I and II only
Which of the following best describes U.S. regulations on drug reimportation?
A. Patients can reimport drugs for personal use without restrictions.
B. Only the original manufacturer is allowed to reimport prescription drugs.
C. Any licensed pharmacist can reimport drugs into the U.S. if they are FDA-approved.
D. Reimportation is only allowed for drugs that have been on the market for over 10 years.
B. Only the original manufacturer is allowed to reimport prescription drugs.
Which of the following conditions must be met for a patient to bring a drug from another country into the U.S.?
A. The drug must be approved by the European Medicines Agency (EMA).
B. The patient must have a prescription from a foreign doctor.
C. The drug must be for personal use, in a ≤90-day supply, and treat a serious condition with no available U.S. treatment.
D. The drug must be labeled in English and comply with U.S. packaging regulations.
C. The drug must be for personal use, in a ≤90-day supply, and treat a serious condition with no available U.S. treatment.
Which of the following statements about personal drug importation into the U.S. are correct?
I. The drug must be for personal use and not resale.
II. The drug must not pose an unreasonable risk to the patient.
III. The patient may import up to a 180-day supply if they have a foreign prescription.
A. I only
B. I and II only
C. II and III only
D. I, II, and III
B. I and II only
What does OBRA require pharmacists to perform before dispensing Medicaid prescriptions?
A. Inventory checks
B. Prospective Drug Utilization Review (DUR)
C. Prescription cost adjustments
D. Notification to the prescriber for all refills
B. Prospective Drug Utilization Review (DUR)
Which patient population must be offered counseling under OBRA?
A. All patients
B. Only elderly patients
C. Medicaid beneficiaries
D. Patients receiving controlled substances
C. Medicaid beneficiaries
Which of the following statements about OBRA are correct?
I. Pharmacists must conduct a Prospective Drug Utilization Review (DUR) before dispensing Medicaid prescriptions.
II. Pharmacists are required to counsel all patients regardless of insurance status.
III. States must establish retrospective DUR programs to monitor prescribing trends.
A. I only
B. I and II only
C. I and III only
D. I, II, and III
C. I and III only
