SOLUTION MANUAL
Essentials of Pharmacology for Health Professions
BRUCE COLBERT, ADAM JAMES, ELIZABETH KATRANCHA
10TH Edition
, Solution and Answer Guide: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions, 10e,
2026, 9798214116068; Chapter 1: Consumer Safety and Drug Regulations
Solution and Answer Guide
COLBERT, JAMES & KATRANCHA, ESSENTIALS OF PHARMACOLOGY FOR HEALTH PROFESSIONS,
10E, 2026, 9798214116068; CHAPTER 1: CONSUMER SAFETY AND DRUG REGULATIONS
TABLE OF CONTENTS
Chapter Review Quiz Answers ................................................................................1
CHAPTER REVIEW QUIZ ANSWERS
1. The first major U.S. drug law was passed in the year and was called the
.
Answer: 1906; Pure Food and Drug Act
Feedback: The Pure Food and Drug Act was passed in the U.S. in 1906. It was
the first government attempt to establish consumer protection in the
manufacture of drugs and foods.
2. USP stands for
Answer: United States Pharmacopeia
Feedback: The United States Pharmacopeia (USP) is a reference that
specifies the official U.S. standards for making individual drugs.
3. NF stands for
Answer: National Formulary
Feedback: The National Formulary (NF) is a reference that specifies the
official U.S. standards for making individual drugs. It has been combined
with the United States Pharmacopeia (USP) into one reference book, the
USP/NF
4. Which drug law established the USP and NF (which are now one)?
Answer: The Pure Food and Drug Act
Feedback: The 1906 Pure Food and Drug Act established two references of
officially approved drugs: the USP and NP, which were subsequently combined
into one single reference source.
5. The agency that requires you to keep a record of each controlled
substance transaction is the
Answer: Drug Enforcement Administration (DEA)
© 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.
, Solution and Answer Guide: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions, 10e,
2026, 9798214116068; Chapter 1: Consumer Safety and Drug Regulations
Feedback: The Drug Enforcement Administration enforces security and
accountability related to controlled substances. Anyone who dispenses,
receives, sells, or destroys controlled substances must keep on hand special
DEA forms, indicating the exact current inventory and a two-year inventory of
every controlled substance transaction.
6. Schedule C- has the lowest potential for abuse.
Answer: Schedule C-V has the lowest potential for abuse
Feedback: The 1970 Controlled Substances Act classified abused and
addicting drugs into five levels, or schedules, according to their medical
value, harmfulness, and potential for abuse or addiction: C-I, C-II, C-III, C-
IV, and C-V, with class C-I being the highest potential for abuse, and C-V
with the lowest potential for abuse.
7. How long must you keep an inventory record of each controlled substance
transaction at your office?
Answer: Two years
Feedback: The Drug Enforcement Administration (DEA) enforces security
and accountability related to controlled substances, including a two-year
inventory of every controlled substance transaction (see also feedback to
question 5).
8. Three responsibilities of the FDA include:
Answer: Three responsibilities of the FDA include any of the following:
Overseeing testing of all proposed new drugs before they are released into
the
U.S. market
Inspecting plants where foods, drugs, medical devices, or cosmetics are
made
Reviewing new drug applications and petitions for food additives
Investigating and removing unsafe drugs from the market
Ensuring proper labeling of foods, cosmetics, and drugs
Feedback: The increase in the number of drugs produced for marketing
brought dangers to the public. The federal FDA was established to ensure
that some basic standards would be followed. Its responsibilities include the
five listed in the answer above.
9. What types of drugs are listed in the C-V schedule?
Answer: Drugs that have the lowest abuse potential among the five classes
or schedules of controlled substance; these consist primarily of cough
suppressants containing codeine and antidiarrheal preparations such as
diphenoxylate
Feedback: Schedule C-V consists primarily of preparations for cough
suppressants containing codeine and preparations for diarrhea (e.g.,
diphenoxylate). Examples include promethazine with codeine, Cheratussin
AC, and Lomotil.
© 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.
, Solution and Answer Guide: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions, 10e,
2026, 9798214116068; Chapter 1: Consumer Safety and Drug Regulations
10. What method is recommended for securing the controlled substances at your
office?
.
Answer: The drugs should be kept inside a locked safety box, which is then
placed within in a cupboard that is also locked.
Feedback: The Drug Enforcement Administration enforces security and
accountability related to controlled substances; this includes keeping all
controlled substances inside a locked safety box, which is then placed
within a cupboard that is also locked.
11. If a patient calls to request a refill of a Percocet (C-II) prescription, how
would you reply?
Answer: A refill for a C-II substance cannot be called into a pharmacy as a new
prescription is required by law.
Feedback: The 1970 Controlled Substances Act set regulations governing which
schedules may have prescriptions phoned in to the pharmacy. A refill for a C-II
substance cannot be called into a pharmacy; a new written prescription is
required.
12. A patient has a rare disease that requires medication for only a small
population of patients. Which act has allowed their drug to be produced
even though it is not profitable to the pharmaceutical industry?
Answer: The Orphan Drug Act of 1983
Feedback: The 1983 Orphan Drug Act provides pharmaceutical companies
financial incentives to develop medications for diseases that affect only a
small number of people, so that orphan drugs that would otherwise be of low
profitability would be available to patients with rare diseases.
13. A patient calls into the office asking for a new prescription for a narcotic
medication that they have been taking for six months. You bring up their
chart and notice that whereas they have been requesting new prescriptions
every 23 days, the medication should last 30 days. Additionally, the patient
also mentions that they feel that they are in need of a higher dose, and
they become agitated and irritable when you tell them that they will need
an appointment. What do you think of this? What should you do?
Answer: The medication taking behavior suggests a potential pattern of
drug abuse. Nevertheless, the most appropriate action should be to notify
the patient’s physician so that they can assess the real need for an increase
in the dose and/or frequency of administration.
Feedback: The prescription fill record indicated that the patient is getting the
narcotic more frequently than what is allowed by their physician for their medical
condition. Given the high potential of narcotic abuse, such requests need to be
addressed by the physician.
14. Each drug is given a number to identify the manufacturer, the
drug, and the package size.
a. FDA
b. USP
c. DEA
d. NDC
Answer: d
© 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.
Essentials of Pharmacology for Health Professions
BRUCE COLBERT, ADAM JAMES, ELIZABETH KATRANCHA
10TH Edition
, Solution and Answer Guide: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions, 10e,
2026, 9798214116068; Chapter 1: Consumer Safety and Drug Regulations
Solution and Answer Guide
COLBERT, JAMES & KATRANCHA, ESSENTIALS OF PHARMACOLOGY FOR HEALTH PROFESSIONS,
10E, 2026, 9798214116068; CHAPTER 1: CONSUMER SAFETY AND DRUG REGULATIONS
TABLE OF CONTENTS
Chapter Review Quiz Answers ................................................................................1
CHAPTER REVIEW QUIZ ANSWERS
1. The first major U.S. drug law was passed in the year and was called the
.
Answer: 1906; Pure Food and Drug Act
Feedback: The Pure Food and Drug Act was passed in the U.S. in 1906. It was
the first government attempt to establish consumer protection in the
manufacture of drugs and foods.
2. USP stands for
Answer: United States Pharmacopeia
Feedback: The United States Pharmacopeia (USP) is a reference that
specifies the official U.S. standards for making individual drugs.
3. NF stands for
Answer: National Formulary
Feedback: The National Formulary (NF) is a reference that specifies the
official U.S. standards for making individual drugs. It has been combined
with the United States Pharmacopeia (USP) into one reference book, the
USP/NF
4. Which drug law established the USP and NF (which are now one)?
Answer: The Pure Food and Drug Act
Feedback: The 1906 Pure Food and Drug Act established two references of
officially approved drugs: the USP and NP, which were subsequently combined
into one single reference source.
5. The agency that requires you to keep a record of each controlled
substance transaction is the
Answer: Drug Enforcement Administration (DEA)
© 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.
, Solution and Answer Guide: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions, 10e,
2026, 9798214116068; Chapter 1: Consumer Safety and Drug Regulations
Feedback: The Drug Enforcement Administration enforces security and
accountability related to controlled substances. Anyone who dispenses,
receives, sells, or destroys controlled substances must keep on hand special
DEA forms, indicating the exact current inventory and a two-year inventory of
every controlled substance transaction.
6. Schedule C- has the lowest potential for abuse.
Answer: Schedule C-V has the lowest potential for abuse
Feedback: The 1970 Controlled Substances Act classified abused and
addicting drugs into five levels, or schedules, according to their medical
value, harmfulness, and potential for abuse or addiction: C-I, C-II, C-III, C-
IV, and C-V, with class C-I being the highest potential for abuse, and C-V
with the lowest potential for abuse.
7. How long must you keep an inventory record of each controlled substance
transaction at your office?
Answer: Two years
Feedback: The Drug Enforcement Administration (DEA) enforces security
and accountability related to controlled substances, including a two-year
inventory of every controlled substance transaction (see also feedback to
question 5).
8. Three responsibilities of the FDA include:
Answer: Three responsibilities of the FDA include any of the following:
Overseeing testing of all proposed new drugs before they are released into
the
U.S. market
Inspecting plants where foods, drugs, medical devices, or cosmetics are
made
Reviewing new drug applications and petitions for food additives
Investigating and removing unsafe drugs from the market
Ensuring proper labeling of foods, cosmetics, and drugs
Feedback: The increase in the number of drugs produced for marketing
brought dangers to the public. The federal FDA was established to ensure
that some basic standards would be followed. Its responsibilities include the
five listed in the answer above.
9. What types of drugs are listed in the C-V schedule?
Answer: Drugs that have the lowest abuse potential among the five classes
or schedules of controlled substance; these consist primarily of cough
suppressants containing codeine and antidiarrheal preparations such as
diphenoxylate
Feedback: Schedule C-V consists primarily of preparations for cough
suppressants containing codeine and preparations for diarrhea (e.g.,
diphenoxylate). Examples include promethazine with codeine, Cheratussin
AC, and Lomotil.
© 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.
, Solution and Answer Guide: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions, 10e,
2026, 9798214116068; Chapter 1: Consumer Safety and Drug Regulations
10. What method is recommended for securing the controlled substances at your
office?
.
Answer: The drugs should be kept inside a locked safety box, which is then
placed within in a cupboard that is also locked.
Feedback: The Drug Enforcement Administration enforces security and
accountability related to controlled substances; this includes keeping all
controlled substances inside a locked safety box, which is then placed
within a cupboard that is also locked.
11. If a patient calls to request a refill of a Percocet (C-II) prescription, how
would you reply?
Answer: A refill for a C-II substance cannot be called into a pharmacy as a new
prescription is required by law.
Feedback: The 1970 Controlled Substances Act set regulations governing which
schedules may have prescriptions phoned in to the pharmacy. A refill for a C-II
substance cannot be called into a pharmacy; a new written prescription is
required.
12. A patient has a rare disease that requires medication for only a small
population of patients. Which act has allowed their drug to be produced
even though it is not profitable to the pharmaceutical industry?
Answer: The Orphan Drug Act of 1983
Feedback: The 1983 Orphan Drug Act provides pharmaceutical companies
financial incentives to develop medications for diseases that affect only a
small number of people, so that orphan drugs that would otherwise be of low
profitability would be available to patients with rare diseases.
13. A patient calls into the office asking for a new prescription for a narcotic
medication that they have been taking for six months. You bring up their
chart and notice that whereas they have been requesting new prescriptions
every 23 days, the medication should last 30 days. Additionally, the patient
also mentions that they feel that they are in need of a higher dose, and
they become agitated and irritable when you tell them that they will need
an appointment. What do you think of this? What should you do?
Answer: The medication taking behavior suggests a potential pattern of
drug abuse. Nevertheless, the most appropriate action should be to notify
the patient’s physician so that they can assess the real need for an increase
in the dose and/or frequency of administration.
Feedback: The prescription fill record indicated that the patient is getting the
narcotic more frequently than what is allowed by their physician for their medical
condition. Given the high potential of narcotic abuse, such requests need to be
addressed by the physician.
14. Each drug is given a number to identify the manufacturer, the
drug, and the package size.
a. FDA
b. USP
c. DEA
d. NDC
Answer: d
© 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.
