Chapter 3: Drug Use, Regulation, and the Law
- Michigan State University
- Exceptionality Programs
- Exceptionality Programs 261
- Chapter 3: Drug Use, Regulation, and the Law
Last Modified: 2011-07-03
The 1906 Pure Food and Drug Act
-Required manufacturers to include on labels the amounts of alcohol, morphine, opium, cocaine, heroin, or marijuana extract in each product
-Marked the beginning of involvement by the government in drug manufacturing
-Did not prohibit distribution of dangerous preparations
The Sherley Amendment in 1912
Passed to strengthen existing laws and required that labels should not contain “any statement...regarding the curative or therapeutic effect...which is false and fraudulent.”
Food, Drug, and Cosmetic Act
-Companies were required to file applications with the government showing that new drugs were safe.
-Defined drugs to include products that affect bodily structure or function even in the absence of disease
-Drug label had to list all ingredients, as well as provide instructions regarding correct use and warnings about its dangers
-Made formal distinction between prescription and nonprescription drugs
-Prescription drugs fall into one of the following categories:
Drug is habit forming
Drug is not safe for self-medication
Drug is a new drug and not shown to be completely safe
-Drug manufacturers had to demonstrate the efficacy and safety of drugs
-The FDA was empowered to withdraw approval of a drug that was already being marketed
-The FDA regulated and evaluated drug testing by pharmaceutical companies
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