Instructor Manual: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions, 10e, 2026, 9798214116068; Chapter 1:
Consumer Safety and Drug Regulations
Instructor Manual
Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions,
10e, 2026, 9798214116068; Chapter 1: Consumer Safety and Drug Regulations
TABLE OF CONTENTS
Purpose and Perspective of the Chapter......................................................................2
Chapter Objectives........................................................................................................2
Chapter Outline.............................................................................................................3
Discussion Questions....................................................................................................7
© 2026 Cengage Learning, Inc. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly 1
accessible website, in whole or in part.
, Instructor Manual: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions, 10e, 2026, 9798214116068; Chapter 1:
Consumer Safety and Drug Regulations
PURPOSE AND PERSPECTIVE OF THE CHAPTER
The purpose of this chapter is to provide a comprehensive overview of key concepts and regulations in
pharmacology, including drug standards, historical milestones, and the evolution of drug laws in the
United States. It begins by explaining drug standards and tracing the historical development of
pharmacology. This chapter outlines significant legislation, such as the Federal Food, Drug, and Cosmetic
act of 1938—the first U.S. drug law for consumer safety—and the Controlled Substances Act of 1970,
clarifying their provisions and impact. It explains the roles of the FDA and DEA, the meaning of
USP/NF, and the classification of controlled substance schedules (C-I through C-V). Additionally, it
addresses orphan drugs and emphasizes the responsibilities associated with administering medications
under these laws.
CHAPTER OBJECTIVES
The following objectives are addressed in this chapter:
1. Explain what is meant by drug standards.
2. Summarize the historical development of pharmacology.
3. Name the first drug law passed in the United States for consumer safety and give the year it was
passed.
4. Summarize the provisions of the Federal Food, Drug, and Cosmetic Act of 1938 and its amendments.
5. Interpret what is meant by USP/NF.
6. Summarize the provisions of the Controlled Substances Act of 1970.
7. Contrast the responsibilities of the FDA and DEA.
8. Define orphan drug.
9. Differentiate between controlled substance schedules C-I through C-V.
10. State several responsibilities you have in administering medications as a direct result of the three
major drug laws described in this chapter.
[return to top]
© 2026 Cengage Learning, Inc. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly 2
accessible website, in whole or in part.
, Instructor Manual: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions, 10e, 2026, 9798214116068; Chapter 1:
Consumer Safety and Drug Regulations
CHAPTER OUTLINE
I. Drug History (LO 2, PPT Slides 5–8)
i. From the very first documented use of “pharmacology” in ancient Egypt, where
they used substances such as berries, beer, poppies, salt, and even crushed
precious stones to treat ailments, it was clear that humans were determined to
overcome diseases by any means necessary.
II. Pharmacology Timeline (LO 2, PPT Slides 9–14)
i. 16th century BCE: Earliest documented pharmacologic examples found recorded
on papyri from ancient Egypt.
ii. 2nd century BCE: Earliest evidence of actual “prescriptions”
iii. 1st century BCE: Greek physician Dioscorides writes the De Materia Medica,
which is considered the most influential work in the history of Western
pharmacology.
iv. 1885
a) Pasteur develops precursor to rabies vaccine.
b) Oswald Schmiedeberg, known as the founder of modern
pharmacology, publishes Outline of Pharmacology.
v. 1897–1899: Aspirin discovered and first marketed for use.
vi. 1905: German chemist Alfred Einhorn discovers procaine, giving it the trade
name Novocaine (aka Novocain).
vii. 1906: The Pure Food and Drug Act passed in United States.
viii. 1922: Insulin first used to treat diabetes.
ix. 1928: Alexander Fleming discovers penicillin.
x. 1936: Chemotherapy first used to treat cancer.
xi. 1937: Over 100 people die in the United States of a sulphanilamide elixir,
leading to passage of the Federal Food, Drug, and Cosmetic Act in 1938.
xii. 1953: Watson and Crick describe the structure of DNA.
xiii. 1960: First contraceptive pill.
xiv. 1958–1960 Thalidomide crisis where approximately 10,000 babies were born
with deformities after thalidomide was used to treat morning sickness; this led to
passage of a drug amendment act establishing the Food and Drug Administration
in 1962.
xv. 1969: Ibuprofen developed in Great Britain.
xvi. 1991: FDA approves the first-ever treatment for hepatitis C (interferon alpha-2b).
xvii. 2000: First draft of the human genome released to public; this sets the stage for
genetically targeted drugs.
xviii. 2017: Shingrix, the vaccine to treat shingles, approved.
xix. 2020–2021: Several vaccines developed in an attempt to mitigate the COVID-19
global pandemic.
xx. 2023–2024: First respiratory syncytial virus (RSV) vaccine approved.
III. Drug Laws (LOs 1, 2, 4, 5, 6, 8, 9; PPT Slides 15–29)
© 2026 Cengage Learning, Inc. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly 3
accessible website, in whole or in part.
, Instructor Manual: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions, 10e, 2026, 9798214116068; Chapter 1:
Consumer Safety and Drug Regulations
i. During the 1900s, laws were passed that specifically addressed the matter of
safely dispensing drugs in the United States.
ii. Drug standards are rules set to assure consumers that they get what they pay for.
The law says that all preparations called by the same drug name must be of
uniform strength, quality, and purity.
a. 1906 Pure Food and Drug Act
i. First government attempt to establish consumer protection in the manufacture of
drugs and foods.
ii. Required all drugs marketed in the United States to meet minimal standards of
strength, purity, and quality.
iii. Demanded that drug preparations containing dangerous ingredients have a
labeled container indicating the ingredient.
iv. Established two references of officially approved drugs:
a) United States Pharmacopeia (USP)
b) National Formulary (NF)
b. 1938 Federal Food, Drug, and Cosmetic Act and Amendments of 1951, 1962, and 1972
i. Established the Food and Drug Administration (FDA) under the Department of
Health and Human Services to enforce the provisions of the Act.
a) All labels must be accurate and must include a listing of all
active and inactive ingredients.
b) All new products must be approved by the FDA before public
release.
c) “Warning” labels must be present on certain preparations.
d) Legend drugs must be labeled as “Caution—federal law
prohibits dispensing without a prescription.”
e) Certain drugs must be labeled with the legend (inscription)
“Caution—federal law prohibits dispensing without a
prescription.” Thus, the term legend drug refers to such
preparations. The act also designated which drugs can be sold
without a prescription.
f) Prescription and nonprescription drugs must be shown to be
effective as well as safe.
g) In 1972, the National Drug Code (NDC) Directory was
established. This provided the FDA with a list of all drugs
manufactured for commercial distribution.
1. The first part is five numbers and identifies the
manufacturer.
2. The second part is four numbers and identifies the
drug.
3. The third part is two digits and identifies the package
size.
ii. The five schedules of controlled substances are arranged with those with the
highest potential for abuse at level I and those with the lowest abuse potential at
level V (Refer to Table 1-1 in the text.).
c. 1970 Controlled Substances Act
© 2026 Cengage Learning, Inc. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly 4
accessible website, in whole or in part.
Consumer Safety and Drug Regulations
Instructor Manual
Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions,
10e, 2026, 9798214116068; Chapter 1: Consumer Safety and Drug Regulations
TABLE OF CONTENTS
Purpose and Perspective of the Chapter......................................................................2
Chapter Objectives........................................................................................................2
Chapter Outline.............................................................................................................3
Discussion Questions....................................................................................................7
© 2026 Cengage Learning, Inc. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly 1
accessible website, in whole or in part.
, Instructor Manual: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions, 10e, 2026, 9798214116068; Chapter 1:
Consumer Safety and Drug Regulations
PURPOSE AND PERSPECTIVE OF THE CHAPTER
The purpose of this chapter is to provide a comprehensive overview of key concepts and regulations in
pharmacology, including drug standards, historical milestones, and the evolution of drug laws in the
United States. It begins by explaining drug standards and tracing the historical development of
pharmacology. This chapter outlines significant legislation, such as the Federal Food, Drug, and Cosmetic
act of 1938—the first U.S. drug law for consumer safety—and the Controlled Substances Act of 1970,
clarifying their provisions and impact. It explains the roles of the FDA and DEA, the meaning of
USP/NF, and the classification of controlled substance schedules (C-I through C-V). Additionally, it
addresses orphan drugs and emphasizes the responsibilities associated with administering medications
under these laws.
CHAPTER OBJECTIVES
The following objectives are addressed in this chapter:
1. Explain what is meant by drug standards.
2. Summarize the historical development of pharmacology.
3. Name the first drug law passed in the United States for consumer safety and give the year it was
passed.
4. Summarize the provisions of the Federal Food, Drug, and Cosmetic Act of 1938 and its amendments.
5. Interpret what is meant by USP/NF.
6. Summarize the provisions of the Controlled Substances Act of 1970.
7. Contrast the responsibilities of the FDA and DEA.
8. Define orphan drug.
9. Differentiate between controlled substance schedules C-I through C-V.
10. State several responsibilities you have in administering medications as a direct result of the three
major drug laws described in this chapter.
[return to top]
© 2026 Cengage Learning, Inc. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly 2
accessible website, in whole or in part.
, Instructor Manual: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions, 10e, 2026, 9798214116068; Chapter 1:
Consumer Safety and Drug Regulations
CHAPTER OUTLINE
I. Drug History (LO 2, PPT Slides 5–8)
i. From the very first documented use of “pharmacology” in ancient Egypt, where
they used substances such as berries, beer, poppies, salt, and even crushed
precious stones to treat ailments, it was clear that humans were determined to
overcome diseases by any means necessary.
II. Pharmacology Timeline (LO 2, PPT Slides 9–14)
i. 16th century BCE: Earliest documented pharmacologic examples found recorded
on papyri from ancient Egypt.
ii. 2nd century BCE: Earliest evidence of actual “prescriptions”
iii. 1st century BCE: Greek physician Dioscorides writes the De Materia Medica,
which is considered the most influential work in the history of Western
pharmacology.
iv. 1885
a) Pasteur develops precursor to rabies vaccine.
b) Oswald Schmiedeberg, known as the founder of modern
pharmacology, publishes Outline of Pharmacology.
v. 1897–1899: Aspirin discovered and first marketed for use.
vi. 1905: German chemist Alfred Einhorn discovers procaine, giving it the trade
name Novocaine (aka Novocain).
vii. 1906: The Pure Food and Drug Act passed in United States.
viii. 1922: Insulin first used to treat diabetes.
ix. 1928: Alexander Fleming discovers penicillin.
x. 1936: Chemotherapy first used to treat cancer.
xi. 1937: Over 100 people die in the United States of a sulphanilamide elixir,
leading to passage of the Federal Food, Drug, and Cosmetic Act in 1938.
xii. 1953: Watson and Crick describe the structure of DNA.
xiii. 1960: First contraceptive pill.
xiv. 1958–1960 Thalidomide crisis where approximately 10,000 babies were born
with deformities after thalidomide was used to treat morning sickness; this led to
passage of a drug amendment act establishing the Food and Drug Administration
in 1962.
xv. 1969: Ibuprofen developed in Great Britain.
xvi. 1991: FDA approves the first-ever treatment for hepatitis C (interferon alpha-2b).
xvii. 2000: First draft of the human genome released to public; this sets the stage for
genetically targeted drugs.
xviii. 2017: Shingrix, the vaccine to treat shingles, approved.
xix. 2020–2021: Several vaccines developed in an attempt to mitigate the COVID-19
global pandemic.
xx. 2023–2024: First respiratory syncytial virus (RSV) vaccine approved.
III. Drug Laws (LOs 1, 2, 4, 5, 6, 8, 9; PPT Slides 15–29)
© 2026 Cengage Learning, Inc. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly 3
accessible website, in whole or in part.
, Instructor Manual: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions, 10e, 2026, 9798214116068; Chapter 1:
Consumer Safety and Drug Regulations
i. During the 1900s, laws were passed that specifically addressed the matter of
safely dispensing drugs in the United States.
ii. Drug standards are rules set to assure consumers that they get what they pay for.
The law says that all preparations called by the same drug name must be of
uniform strength, quality, and purity.
a. 1906 Pure Food and Drug Act
i. First government attempt to establish consumer protection in the manufacture of
drugs and foods.
ii. Required all drugs marketed in the United States to meet minimal standards of
strength, purity, and quality.
iii. Demanded that drug preparations containing dangerous ingredients have a
labeled container indicating the ingredient.
iv. Established two references of officially approved drugs:
a) United States Pharmacopeia (USP)
b) National Formulary (NF)
b. 1938 Federal Food, Drug, and Cosmetic Act and Amendments of 1951, 1962, and 1972
i. Established the Food and Drug Administration (FDA) under the Department of
Health and Human Services to enforce the provisions of the Act.
a) All labels must be accurate and must include a listing of all
active and inactive ingredients.
b) All new products must be approved by the FDA before public
release.
c) “Warning” labels must be present on certain preparations.
d) Legend drugs must be labeled as “Caution—federal law
prohibits dispensing without a prescription.”
e) Certain drugs must be labeled with the legend (inscription)
“Caution—federal law prohibits dispensing without a
prescription.” Thus, the term legend drug refers to such
preparations. The act also designated which drugs can be sold
without a prescription.
f) Prescription and nonprescription drugs must be shown to be
effective as well as safe.
g) In 1972, the National Drug Code (NDC) Directory was
established. This provided the FDA with a list of all drugs
manufactured for commercial distribution.
1. The first part is five numbers and identifies the
manufacturer.
2. The second part is four numbers and identifies the
drug.
3. The third part is two digits and identifies the package
size.
ii. The five schedules of controlled substances are arranged with those with the
highest potential for abuse at level I and those with the lowest abuse potential at
level V (Refer to Table 1-1 in the text.).
c. 1970 Controlled Substances Act
© 2026 Cengage Learning, Inc. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly 4
accessible website, in whole or in part.
