1. Chapter 3
Drug Products and
Their Regulations
© 2011 McGraw-Hill Higher Education. All rights reserved.

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
© 2011 McGraw-Hill Higher Education. All rights reserved.

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
© 2011 McGraw-Hill Higher Education. All rights reserved.

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
© 2011 McGraw-Hill Higher Education. All rights reserved.

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
© 2011 McGraw-Hill Higher Education. All rights reserved.

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
© 2011 McGraw-Hill Higher Education. All rights reserved.

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
© 2011 McGraw-Hill Higher Education. All rights reserved.