Pharmacy Practice Chapter 2 Exam
UPDATED Study Guide QUESTIONS
AND CORRECT ANSWERS
Prior to the 20th centry, many pharmaceuticals products contained _____ as a miracle cure -
CORRECT ANSWER opium and alcohol
In 1937, moe than 100 individuals died as the result of poisoning from a sulfa drug product that
contained diethylene glycol. This tragedy led to the passing of the - CORRECT ANSWER
Food, Drug and Cosmetic Act
Which of the following would be a violation of the Drug Enforcement Administration's rule regarding
filling a prescription? - CORRECT ANSWER refilling a Schedule II drug
The Food and Drug Administration was created by the Food, Drug and Cosmetic Act in 1938 to -
CORRECT ANSWER Evaluate safety data to show that drug products are safe in humans
Which of the following statements about adulterated drug products is correct? - CORRECT ANSWER
They differ in quality,purity, and standards from the original
What modification did the Durham- Humphrey Amendment make to the Food Drug and Cosmetic
Act? - CORRECT ANSWER Defined a difference between legend (Rx) drugs and OTC drygs
Since the 1900s, many laws, regulatory agencies, and professional organizations have been developed
to protect United States citizens from dangerous drugs and other public health issues. Which of these
is a government agency rather than a professional organization? - CORRECT ANSWER
Centers for Disease Control and Prevention
Drug manufacturers were not required to prove drug efficacy until the - CORRECT ANSWER
Kefauver-Harris Amendment of 1962
What role did the FDA adopt after the occurrence of birth defects due to thalidomide and the passing
of the Kefauver- Harris Amendment of 1962? - CORRECT ANSWER moitoring animal drug
studies data of the Investigational New Drug Application (INDA) for safety
UPDATED Study Guide QUESTIONS
AND CORRECT ANSWERS
Prior to the 20th centry, many pharmaceuticals products contained _____ as a miracle cure -
CORRECT ANSWER opium and alcohol
In 1937, moe than 100 individuals died as the result of poisoning from a sulfa drug product that
contained diethylene glycol. This tragedy led to the passing of the - CORRECT ANSWER
Food, Drug and Cosmetic Act
Which of the following would be a violation of the Drug Enforcement Administration's rule regarding
filling a prescription? - CORRECT ANSWER refilling a Schedule II drug
The Food and Drug Administration was created by the Food, Drug and Cosmetic Act in 1938 to -
CORRECT ANSWER Evaluate safety data to show that drug products are safe in humans
Which of the following statements about adulterated drug products is correct? - CORRECT ANSWER
They differ in quality,purity, and standards from the original
What modification did the Durham- Humphrey Amendment make to the Food Drug and Cosmetic
Act? - CORRECT ANSWER Defined a difference between legend (Rx) drugs and OTC drygs
Since the 1900s, many laws, regulatory agencies, and professional organizations have been developed
to protect United States citizens from dangerous drugs and other public health issues. Which of these
is a government agency rather than a professional organization? - CORRECT ANSWER
Centers for Disease Control and Prevention
Drug manufacturers were not required to prove drug efficacy until the - CORRECT ANSWER
Kefauver-Harris Amendment of 1962
What role did the FDA adopt after the occurrence of birth defects due to thalidomide and the passing
of the Kefauver- Harris Amendment of 1962? - CORRECT ANSWER moitoring animal drug
studies data of the Investigational New Drug Application (INDA) for safety
