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 1
, 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 2
, 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 3
, 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 National Drug Code (NDC) is a directory of numerical codes that allow
identification of a drug, as well as the package size and the manufacturer. This
directory provides a list of all drugs manufactured for commercial distribution. The
NDC is comprised of three parts: the first part is five numbers and identifies the
manufacturer, the second part is four numbers and identifies the drug, and the third
part is two digits and identifies the package size.
15. Answer the questions concerning the following three drug labels:
a. Which drug(s) requires a prescription?
Answer: Morphine Sulfate and Procardia (nifedipine)
Feedback: Both Morphine and Procardia (nifedipine) require a prescription and cannot
be purchased over the counter.
b. Which drug(s) can be bought without a prescription?
Answer: Acetaminophen
Feedback: Acetaminophen can be obtained over the counter from any pharmacy
without a prescription.
c. Which drug(s) require(s) a DEA number?
Answer: Morphine Sulfate
Feedback: Morphine is a controlled substance that requires not only a prescription but
also that the ordering and dispensing, respectively, needs to be by a physician and a
pharmacist that have a DEA number indicating their proper registration with the
agency.
16. Drug standards ensure consistency in all the areas EXCEPT
a. strength
b. purity
c. quality
d. size
Answer: d
Feedback: Drug standards assure consumers that the drugs they take are of uniform
strength, purity, and quality.
17. The Federal Food, Drug, and Cosmetic Act of 1938 established which agency?
a. NDC
b. DEA
c. FDA
d. USP
Answer: c
Feedback: The Federal Food, Drug, and Cosmetic Act of 1938 established the Food and
Drug Administration (FDA) under the Department of Health and Human Services to
enforce the provisions of the Act.
© 2026 4
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 1
, 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 2
, 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 3
, 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 National Drug Code (NDC) is a directory of numerical codes that allow
identification of a drug, as well as the package size and the manufacturer. This
directory provides a list of all drugs manufactured for commercial distribution. The
NDC is comprised of three parts: the first part is five numbers and identifies the
manufacturer, the second part is four numbers and identifies the drug, and the third
part is two digits and identifies the package size.
15. Answer the questions concerning the following three drug labels:
a. Which drug(s) requires a prescription?
Answer: Morphine Sulfate and Procardia (nifedipine)
Feedback: Both Morphine and Procardia (nifedipine) require a prescription and cannot
be purchased over the counter.
b. Which drug(s) can be bought without a prescription?
Answer: Acetaminophen
Feedback: Acetaminophen can be obtained over the counter from any pharmacy
without a prescription.
c. Which drug(s) require(s) a DEA number?
Answer: Morphine Sulfate
Feedback: Morphine is a controlled substance that requires not only a prescription but
also that the ordering and dispensing, respectively, needs to be by a physician and a
pharmacist that have a DEA number indicating their proper registration with the
agency.
16. Drug standards ensure consistency in all the areas EXCEPT
a. strength
b. purity
c. quality
d. size
Answer: d
Feedback: Drug standards assure consumers that the drugs they take are of uniform
strength, purity, and quality.
17. The Federal Food, Drug, and Cosmetic Act of 1938 established which agency?
a. NDC
b. DEA
c. FDA
d. USP
Answer: c
Feedback: The Federal Food, Drug, and Cosmetic Act of 1938 established the Food and
Drug Administration (FDA) under the Department of Health and Human Services to
enforce the provisions of the Act.
© 2026 4
