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.

9. Comprehensive Drug Abuse
Prevention and Control Act of 1970
 Replaced or updated all previous laws
 Drugs controlled by the Act are under federal
jurisdiction
 Prevention and treatment funding increased
 Direct control of drugs, not control through
taxation, is the goal
 Enforcement separated from scientific and
medical decisions
© 2011 McGraw-Hill Higher Education. All rights reserved.

10. Comprehensive Drug Abuse
Prevention and Control Act of 1970
 Drug Schedules
 I – No medical use; high potential for abuse
 II – Medical use; high potential for abuse
 III – Medical use; moderate potential for abuse
 IV – Medical use; mild potential for abuse
 V – Medical use; low potential for abuse
 Penalties for illegal manufacture, distribution or
possession were assigned by category
 Rules for prescribing physicians
 Amendments
 1984
 1986
 1988
 2010
© 2011 McGraw-Hill Higher Education. All rights reserved.

11. Impact of Drug Enforcement
 Early enforcement
 Prison vs. rehabilitation
 Punishment seemed not to be working
 “Narcotic farms”
 Current issues
 Bureau of Narcotics (Treasury Department)
 “Drug Czar”
 Mandatory minimum sentences (1951)
 1956 Narcotic Drug Control Act toughened penalties
 DEA formed
 State vs. federal law
 Drug screening
© 2011 McGraw-Hill Higher Education. All rights reserved.

12. Impact of Drug
Enforcement
 Budget
 Other costs
 Cost of prison population
 Crimes committed to purchase drugs
 Corruption in law enforcement
 Conflicting international policy goals
 Loss of individual freedom
 Effectiveness of control?
© 2011 McGraw-Hill Higher Education. All rights reserved.