This document discusses the history and development of drug regulation in the United States. It notes that current drug laws trace back to the Pure Food and Drugs Act of 1906 and the Harrison Act of 1914. The 1906 act was intended to ensure drug purity and honest labeling under the Department of Agriculture. The 1914 act aimed to restrict opioid and cocaine commerce through taxation under the Treasury Department. Over time, laws and the FDA have imposed greater requirements for pre-market testing, approval, and proving drug safety and effectiveness.

1. Chapter 3
Drug Products and
Their Regulations
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2. Chapter 3: Regulation &
Legislation
 What is being targeted?
 Certain substances
 Recreational use
 Medicinal use
 Who is doing the regulating?
 U.S. Department of Agriculture/FDA
 U.S. Treasury Department
 Motives
 Public safety concerns?
 Revenue & trade status?
 Impact
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3. Reformism
 Current laws trace back to
two pieces of legislation
from the early 1900s
 Racist fears about deviant
behavior, including drug
misuse, played a role in the
development of drug
regulation
 Laws were developed to
regulate undesirable
behaviors
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4. 3 Issues Leading to
Legislation
 Fraud in patent medicines that were
sold directly to the public
 False therapeutic claims
 Habit-forming drug content
 Collier’s magazine series: Great
American Fraud
 Opium
 Sale of opium by merchants
 Reactions
 Cocaine
 Availability led to concerns of overuse
 Concerns of crime
© 2011 McGraw-Hill Higher Education. All rights reserved.

5. Two Bureaus, Two Types
of Regulation
 The Pure Food and Drugs Act (1906)
 U.S. Department of Agriculture
 Goal: drugs are pure and honestly labeled
 Foundation for modern laws
 Harrison Act (1914)
 U.S. Treasury Department
 Goal: taxation of drugs to restrict commerce in
opioids and cocaine to authorized physicians,
pharmacists, and legitimate manufacturers
 Question of motives
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6. From 1906 Act: Regulation of
Pharmaceuticals
1. Purity
 The contents of the product must be accurately listed on the label
 FDA encouraged voluntary cooperation and compliance
2. Safety
 Originally—no legal requirement that medications be safe
 1938 Food, Drug, and Cosmetic Act required pre-market testing for
toxicity
 Companies required to submit a New Drug Application (NDA) to the
FDA
 Directions must be included
 Adequate instructions for consumer OR
 Drug can be used only with physician prescription
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7. Regulation of
Pharmaceuticals
3. Effectiveness
 1962 Kefauver-Harris Amendments
 Pre-approval required before human testing
 Advertising for prescription drugs must include information about
adverse reactions
 Every new drug must be demonstrated to be effective for the
illnesses mentioned on label
 Steps
 Preclinical research and development
 Clinical research and development
 Permission to market
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8. From 1914 Act: Registration &
Taxation
 Early enforcement
 Dr. Webb
 1919 Volstead act & Bureau of Prohibition
 Prohibited sale of alcohol
 Penalties for production
 18th Amendment: Prohibition – 1920
 Repealed in 1933 by the 21st Amendment
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