All Chapters 1-27 With Comprehensive Exam Part 1, Part 2: Colbert, Essentials of Pharmacology, 9e, © 2023, 9780357618301; Chapter 1: Consumer
Safety and Drug Regulations
All Chapters 1-27 With Comprehensive
Exam Part 1, Part 2
Solution and Answer Guide
Colbert, Essentials of Pharmacology, 9e, © 2023, 9780357618301; 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 is the first drug law passed in 1906 to ensure
consumer safety.
2. USP stands for
______________________________________________________________________
Answer: United States Pharmacopeia
Feedback: The United States Pharmacopeia 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 another 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.
© 2023 Cengage. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly accessible 1
website, in whole or in part.
, Solution and Answer Guide: Colbert, Essentials of Pharmacology, 9e, © 2023, 9780357618301; Chapter 1: Consumer Safety and Drug Regulations
5. The agency that requires you to keep a record of each controlled substance transaction
is the __________
Answer: Drug Enforcement Agency
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-1 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 enforces security and accountability
related to controlled substances, including a two-year inventory of every controlled
substance transaction (also see feedback to question 5).
8. Three responsibilities of the FDA include:
_________________________________________________
Answer: Three responsibilities of the FDA may include any of the following:
Oversee testing of all proposed new drugs before they are approved for marketing
Investigate and remove unsafe drugs from the market
Ensure proper labeling of drugs, foods, and cosmetics
Review new drug applications and petitions for food additives
Inspect plants where foods, drugs, medical devices, or cosmetics are made
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 answers
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, and primarily consist of cough suppressants
containing codeine and antidiarrheal preparations such as diphenoxylate
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, and drugs with the C-V
classification have the lowest potential for abuse.
© 2023 Cengage. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly accessible 2
website, in whole or in part.
, Solution and Answer Guide: Colbert, Essentials of Pharmacology, 9e, © 2023, 9780357618301; 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, including that all controlled substances must be kept
inside a locked safety box, which is then placed within in 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 as to which schedules
prescriptions may be phoned in to the pharmacy. A refill for a C-II substance cannot be
called into a pharmacy as a new prescription is required.
12. Dawn Vasquez has a rare disease that requires medication for only a small population of
patients. Which act has allowed her 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
he has been taking for six months. You bring up his chart and notice that he has been
requesting new prescriptions every 23 days, whereas the medication should last 30
days. Additionally, the patient also mentions that he feels that he is in need of a higher
dose and gets agitated and irritable when you tell him that he 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 s(he) can assess the real need of 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 that what is allowed by his physician for his medical condition. Given
the high potential of narcotic abuse, such request needs 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
© 2023 Cengage. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly accessible 3
website, in whole or in part.
, Solution and Answer Guide: Colbert, Essentials of Pharmacology, 9e, © 2023, 9780357618301; Chapter 1: Consumer Safety and Drug Regulations
Feedback: The National Drug Code (NDC) is a directory of numerical code that allows
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
that identifies the package size.
15. Drug standards insure consistency in all the areas EXCEPT
a. strength
b. purity
c. quality
d. size
Answer: d
Feedback: Drug standards assure consumers that the drug they take are of uniform
strength, purity, and quality
16. 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).
17. The earliest recorded use of drugs occurred during which civilization?
a. Egyptian
b. Roman
c. Greek
d. Aztec
Answer: a
Feedback: The first documented use of drug was in ancient Egypt.
18. 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) requires a DEA number?
Answer: Morphine Sulfate
© 2023 Cengage. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly accessible 4
website, in whole or in part.
Safety and Drug Regulations
All Chapters 1-27 With Comprehensive
Exam Part 1, Part 2
Solution and Answer Guide
Colbert, Essentials of Pharmacology, 9e, © 2023, 9780357618301; 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 is the first drug law passed in 1906 to ensure
consumer safety.
2. USP stands for
______________________________________________________________________
Answer: United States Pharmacopeia
Feedback: The United States Pharmacopeia 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 another 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.
© 2023 Cengage. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly accessible 1
website, in whole or in part.
, Solution and Answer Guide: Colbert, Essentials of Pharmacology, 9e, © 2023, 9780357618301; Chapter 1: Consumer Safety and Drug Regulations
5. The agency that requires you to keep a record of each controlled substance transaction
is the __________
Answer: Drug Enforcement Agency
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-1 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 enforces security and accountability
related to controlled substances, including a two-year inventory of every controlled
substance transaction (also see feedback to question 5).
8. Three responsibilities of the FDA include:
_________________________________________________
Answer: Three responsibilities of the FDA may include any of the following:
Oversee testing of all proposed new drugs before they are approved for marketing
Investigate and remove unsafe drugs from the market
Ensure proper labeling of drugs, foods, and cosmetics
Review new drug applications and petitions for food additives
Inspect plants where foods, drugs, medical devices, or cosmetics are made
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 answers
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, and primarily consist of cough suppressants
containing codeine and antidiarrheal preparations such as diphenoxylate
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, and drugs with the C-V
classification have the lowest potential for abuse.
© 2023 Cengage. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly accessible 2
website, in whole or in part.
, Solution and Answer Guide: Colbert, Essentials of Pharmacology, 9e, © 2023, 9780357618301; 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, including that all controlled substances must be kept
inside a locked safety box, which is then placed within in 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 as to which schedules
prescriptions may be phoned in to the pharmacy. A refill for a C-II substance cannot be
called into a pharmacy as a new prescription is required.
12. Dawn Vasquez has a rare disease that requires medication for only a small population of
patients. Which act has allowed her 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
he has been taking for six months. You bring up his chart and notice that he has been
requesting new prescriptions every 23 days, whereas the medication should last 30
days. Additionally, the patient also mentions that he feels that he is in need of a higher
dose and gets agitated and irritable when you tell him that he 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 s(he) can assess the real need of 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 that what is allowed by his physician for his medical condition. Given
the high potential of narcotic abuse, such request needs 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
© 2023 Cengage. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly accessible 3
website, in whole or in part.
, Solution and Answer Guide: Colbert, Essentials of Pharmacology, 9e, © 2023, 9780357618301; Chapter 1: Consumer Safety and Drug Regulations
Feedback: The National Drug Code (NDC) is a directory of numerical code that allows
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
that identifies the package size.
15. Drug standards insure consistency in all the areas EXCEPT
a. strength
b. purity
c. quality
d. size
Answer: d
Feedback: Drug standards assure consumers that the drug they take are of uniform
strength, purity, and quality
16. 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).
17. The earliest recorded use of drugs occurred during which civilization?
a. Egyptian
b. Roman
c. Greek
d. Aztec
Answer: a
Feedback: The first documented use of drug was in ancient Egypt.
18. 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) requires a DEA number?
Answer: Morphine Sulfate
© 2023 Cengage. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly accessible 4
website, in whole or in part.
