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Morton's Chapter 3 Part 1

True/False
Indicate whether the statement is true or false.
 

 1. 
Thalidomide, although causing severe birth defects, can be legally prescribed in the United States today.
 

 2. 
Medications developed outside the United States do not have to meet Federal standards to be dispensed in America.
 

 3. 
Motrin (ibuprofen) has dual marketing status.
 

 4. 
Becuase it is the active ingredient in Crystal Meth, You now need a prescription to purchase pseudoephrine (Sudafed®).
 

 5. 
Exempt narcotics are habit forming drugs that can be purchased OTC.
 

Multiple Choice
Identify the choice that best completes the statement or answers the question.
 

 6. 
This law was designed to prevent mislabeling of products but was unenforceable.
A.
1906 Food and Drug Act
B.
1914 Harrison Narcotic Tax Act
C.
1938 Food , Drug and Cosmetic Act
D.
1951 Durham-Humphrey Amendment
E.
1962 Kefauver-Harris Amendment
 

 7. 
Which law requires you to have a prescription for all opium products?
A.
1906 Food and Drug Act
B.
1914 Harrison Narcotic Tax Act
C.
1938 Food , Drug and Cosmetic Act
D.
1951 Durham-Humphrey Amendment
E.
1962 Kefauver-Harris Amendment
 

 8. 
The FDA’s goal is
A.
 to prevent over pricing of medications.
B.
make sure all medications are safe.
C.
make sure all medicaions are effective.
D.
both B and C
E.
A, B, and C are all true.
 

 9. 
FDA stands for
A.
Federal Drug Development Agency
B.
Federal Drug Agency
C.
Food and Drug Administration
D.
Food and Drug Act
 

 10. 
This law created a distinction between legend drugs and OTC medications.
A.
1906 Food and Drug Act
D.
1951 Durham-Humphrey Amendment
B.
1914 Harrison Narcotic Tax Act
E.
1962 Kefauver-Harris Amendment
C.
1938 Food , Drug and Cosmetic Act
 

 11. 
Warning label that states “Caution:  May be Habit Forming” was required on all narcotics following the law.
A.
1906 Food and Drug Act
D.
1951 Durham-Humphrey Amendment
B.
1914 Harrison Narcotic Tax Act
E.
1962 Kefauver-Harris Amendment
C.
1938 Food , Drug and Cosmetic Act
 

 12. 
This law required the label  “Caution: Federal prohibits dispensing without a presciption” or “Rx Only.”
A.
1906 Food and Drug Act
D.
1951 Durham-Humphrey Amendment
B.
1914 Harrison Narcotic Tax Act
E.
1962 Kefauver-Harris Amendment
C.
1938 Food , Drug and Cosmetic Act
 

 13. 
Term used where individuals are not given real medications during testing.
A.
legend
C.
“controlled”
B.
placebo
D.
therapuetically equivalent
 

 14. 
Medication that can have both a precription drug status and over-the-counter status and be the same dosage is
A.
exempt narcotics.
B.
placebo.
C.
legend.
D.
dual marketing.
 

 15. 
This law enacted in response to Sulfa poisonings.
A.
1906 Food and Drug Act
D.
1951 Durham-Humphrey Amendment
B.
1914 Harrison Narcotic Tax Act
E.
1962 Kefauver-Harris Amendment
C.
1938 Food , Drug and Cosmetic Act
 

Matching
 
 
Match the drug testing phase with each statement.  (Some maybe used more than once)
A.
Phase 1
B.
Phase 2
C.
Phase 3
 

 16. 

 Several hundred patients are tested.
 

 17. 

 This phase last several months.
 

 18. 

 20-100 patients are tested.
 

 19. 

 The Purpose of this phase is mainly to determine the safety of the drug.
 

 20. 

 This phase last several months to 2 years.
 

 21. 

 Sevveral hundred to several thousand patients are tested.
 

 22. 

 Purpose of this phase is to determine safety, dosage and effectivenss of the medication.
 

Short Answer
 

 23. 
Whose responisblity is it to provide proof that a drug is safe and effective?  ________________________
 

 24. 
Give 4 rules that apply to the sale of exempt narcotics:
1.  __________________________________________________________________
2.  __________________________________________________________________
3.  __________________________________________________________________
4.  __________________________________________________________________
 

 25. 
What does the abbrevation IND mean?  ______________________________________________________
 



 
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