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FREE AND STUDY GAMES ABOUT ARLEN REVIEW CH 3
EXAM QUESTIONS
Actual Qs and Ans Expert-Verified Explanation
This Exam contains:
-Guarantee passing score -55 Questions and Answers -format set of multiple-choice -Expert-Verified Explanation
Question 1: Federal agency that enforces regulations concerning drug products
Answer:
FDA Question 2: the logo which indicates the control schedule of a drug with potential for abuse
Answer:
controlled substance mark
Question 3: in each state, pharmacists are licensed by
Answer:
the state board of pharmacy Question 4: schedule of drugs with a high potential for abuse leading to physical or psychological dependence
Answer:
C-II
Question 5: any drug which requires a prescription and Rx only on the label
Answer:
legend drug
Question 6: a number all prescribers of controlled substances are assigned
Answer:
DEA number
Question 7: number of refills for C-II
Answer:
none Question 8: Law that requires child-proof packaging on all controlled and most Rx drugs dispensed by pharmacies.
Answer:
Poison Prevention Packaging Act of 1970 Question 9: A drug which has the potential to be abused and appears on one of five schedules.
Answer:
controlled substance
Question 10: A drug patent is in effect for ___ years after its discovery.
Answer:
17
Question 11: second letter of Orange Book code
Answer:
additional information on the basis of FDA's evaluation Question 12: schedule with a low potential for abuse relative to C-IV, but abuse may lead to limited physical or psychological dependence.
Answer:
C-V
Question 13: Law that prohibited adulterated or misbranded food, drinks, and drugs.
Answer:
Food and Drug Act of 1906 Question 14: Law that defines legend drugs and requires the labeling "Caution: Federal Law prohibits dispensing without a prescription."
Answer:
Durham-Humphrey Amendment of 1951
Question 15: the NDC is assigned by the
Answer:
manufacturer
Question 16: The main purpose of phase I clinical trials is
Answer:
safety
Question 17: Recall where it is not likely that there will be adverse effects
Answer:
class 3 recall
Question 18: Recall where there may be temporary but reversible side effects
Answer:
class 2 recall
Question 19: Orange Book published by
Answer:
FDA Question 20: Law that classifies drugs that may be easily abused and restricts their distribution
- enforced by the DEA within the Justice Department
Answer:
Controlled Substances Act of 1970
Question 21: Law that provides broad and stringent regulations to protect patient privacy
Answer:
Health Insurance Portability and Accountability Act (HIPAA) of 1996 Question 22: schedule of drugs with a low potential for abuse relative to C-III and abuse may lead to low physical or psychological dependence.
Answer:
C-IV Question 23: Laws that require drug manufacturers to provide proof of safety and effectiveness before marketing.
Answer:
Kefauver-Harris Amendments of 1962 Question 24: Legend drugs should have the legend ____ on the manufacturer's label.
Answer:
Rx only Question 25: A comprehensive law enacted after the fatal poisoning of 107 people that requires new drugs be shown to be safe before marketing
Answer:
Food, Drug and Cosmetic Act of 1938
Question 26: serving to cure or heal
Answer:
therapeutic
Question 27: an inactive substance given in place of a medication
Answer:
placebo
Question 28: a court order preventing a specific action
Answer:
injunction