Chapter 3 Laws and Regulations: The Road to Regulation

 

  1. Explain some of the problems arising in the USA in the early 1900’s with patent medicines.

 

  1. What are the main components of the Pure Food and Drug Act of 1906? How was this law attempting to protect the public?

 

  1. What are the main components of the Sherley Amendment: How was this law attempting to protect the public?

 

  1. How did the 1938 Food, Drug and Cosmetic Act improve the 1906 Food and Drug Act?

 

  1. What are the main components of the 1952 Durham Humphrey Act? How was this law attempting to protect the public?

 

  1. What are the main purpose and influence of the Kefauver-Harris Amendment of 1962? How was this law attempting to protect the public?

 

  1. What is the main purpose of the Comprehensive Drug Abuse Prevention and Control Act of 1970?

 

  1. List and briefly describe the 5 levels of drug scheduling under the controlled substances, schedule I-V”

 

  1. What are the 3 main steps in regulating the development of new pharmaceutical drugs?

 

  1. Define and describe the 2 main drug prevention strategies: Supply Reduction and Demand Reduction

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