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.
, Solutiona 2 anda 2 Answera 2 Guide:a 2 Colbert,a 2 Jamesa 2 &a 2 Katrancha,a 2 Essentialsa 2 ofa 2 Pharmacologya 2 fora 2 H
ealtha 2 Professions,a 2 10e,
2026,a29798214116068;a2Chaptera21:a2 Consumera2Safetya2 anda2Druga2 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
©a22026a2Cengagea2Learning,a2Inc.a2Alla2Rightsa2Reserved.a2Maya2nota2bea2scanned,a2copieda2ora2duplicate
d,a2ora2posteda2toa2aa2publicly
3
accessiblea2website,a2ina2wholea2ora2ina2part.
, Solutiona 2 anda 2 Answera 2 Guide:a 2 Colbert,a 2 Jamesa 2 &a 2 Katrancha,a 2 Essentialsa 2 ofa 2 Pharmacologya 2 fora 2 H
ealtha 2 Professions,a 2 10e,
2026,a29798214116068;a2Chaptera21:a2 Consumera2Safetya2 anda2Druga2 Regulations
Feedback:a2Thea2Nationala2Druga2Codea2(NDC)a2isa2aa2directorya2ofa2numericala2code
sa2thata2allowa2identificationa2ofa2aa2drug,a2asa2wella2asa2thea2packagea2sizea2anda2t
hea2manufacturer.a2Thisa2directorya2providesa2aa2lista2ofa2alla2drugsa2manufactureda
2fora2commerciala2distribution. a2Thea2NDCa2isa2compriseda2ofa2threea2parts:a2thea2fi
rsta2parta2isa2fivea2numbersa2anda2identifies a2thea2manufacturer,a2thea2seconda2part
a2isa2foura2numbers a2anda2identifiesa2thea2drug,a2anda2thea2thirda2part a2isa2twoa2dig
itsa2anda2identifies a2thea2packagea2size.
15. Answera2thea2questions a2concerninga2thea2followinga2threea2druga2labels:
a. Whicha2drug(s)a2requiresa2aa2prescription?
Answer:a 2 Morphinea 2 Sulfatea 2 anda 2 Procardiaa 2 (nifedipine)
Feedback:a2Botha2Morphinea2anda2Procardiaa2(nifedipine)a2requirea2aa2prescriptiona2a
nda2cannota2bea2purchaseda2overa2thea2counter.
b. Whicha2drug(s)a2cana2bea2boughta2withouta2aa2prescription?
Answer:a2 Acetaminophen
Feedback:a2Acetaminophena2cana2bea2obtaineda2overa2thea2countera2froma2anya2phar
macya2withouta2aa2prescription.
c. Whicha2drug(s)a2require(s)a2aa2DEAa2number?
Answer:a2Morphinea2Sulfate
Feedback:a2Morphinea2isa2aa2controlleda2substancea2thata2requires a2nota2onlya2aa2pre
scriptiona2buta2alsoa2thata2thea2orderinga2anda2dispensing,a2respectively,a2needsa2toa
2bea2bya2aa2physician a2anda2aa2pharmacista2thata2havea2aa2DEAa2numbera2indicatinga
2theira2propera2registration a2witha2thea2agency.
16. Druga2standardsa2 ensurea2consistency a2ina2alla2thea2areasa2EXCEPT
a. strength
b. purity
c. quality
d. size
Answer:a2 d
Feedback:a2Druga2standardsa2assurea2consumers a2thata2thea2drugsa2theya2takea2area2ofa2
uniforma2strength,a2purity,a2anda2quality.
17. Thea2Federala2Food,a2Drug,a2anda2Cosmetica2Acta2ofa21938a2establisheda2whicha2agency?
a. NDC
b. DEA
c. FDA
d. USP
Answer:a2 c
Feedback:a2Thea2Federala2Food,a2Drug,a2anda2Cosmetica2Acta2ofa21938a2establisheda2t
hea2Fooda2anda2Druga2Administrationa2(FDA)a2undera2thea2Department a2ofa2Healtha2a
nda2Humana2Services a2toa2enforcea2thea2provisions a2ofa2thea2Act.
©a22026a2Cengagea2Learning,a2Inc.a2Alla2Rightsa2Reserved.a2Maya2nota2bea2scanned,a2copieda2ora2duplicate
d,a2ora2posteda2toa2aa2publicly
4
accessiblea2website,a2ina2wholea2ora2ina2part.
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.
, Solutiona 2 anda 2 Answera 2 Guide:a 2 Colbert,a 2 Jamesa 2 &a 2 Katrancha,a 2 Essentialsa 2 ofa 2 Pharmacologya 2 fora 2 H
ealtha 2 Professions,a 2 10e,
2026,a29798214116068;a2Chaptera21:a2 Consumera2Safetya2 anda2Druga2 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
©a22026a2Cengagea2Learning,a2Inc.a2Alla2Rightsa2Reserved.a2Maya2nota2bea2scanned,a2copieda2ora2duplicate
d,a2ora2posteda2toa2aa2publicly
3
accessiblea2website,a2ina2wholea2ora2ina2part.
, Solutiona 2 anda 2 Answera 2 Guide:a 2 Colbert,a 2 Jamesa 2 &a 2 Katrancha,a 2 Essentialsa 2 ofa 2 Pharmacologya 2 fora 2 H
ealtha 2 Professions,a 2 10e,
2026,a29798214116068;a2Chaptera21:a2 Consumera2Safetya2 anda2Druga2 Regulations
Feedback:a2Thea2Nationala2Druga2Codea2(NDC)a2isa2aa2directorya2ofa2numericala2code
sa2thata2allowa2identificationa2ofa2aa2drug,a2asa2wella2asa2thea2packagea2sizea2anda2t
hea2manufacturer.a2Thisa2directorya2providesa2aa2lista2ofa2alla2drugsa2manufactureda
2fora2commerciala2distribution. a2Thea2NDCa2isa2compriseda2ofa2threea2parts:a2thea2fi
rsta2parta2isa2fivea2numbersa2anda2identifies a2thea2manufacturer,a2thea2seconda2part
a2isa2foura2numbers a2anda2identifiesa2thea2drug,a2anda2thea2thirda2part a2isa2twoa2dig
itsa2anda2identifies a2thea2packagea2size.
15. Answera2thea2questions a2concerninga2thea2followinga2threea2druga2labels:
a. Whicha2drug(s)a2requiresa2aa2prescription?
Answer:a 2 Morphinea 2 Sulfatea 2 anda 2 Procardiaa 2 (nifedipine)
Feedback:a2Botha2Morphinea2anda2Procardiaa2(nifedipine)a2requirea2aa2prescriptiona2a
nda2cannota2bea2purchaseda2overa2thea2counter.
b. Whicha2drug(s)a2cana2bea2boughta2withouta2aa2prescription?
Answer:a2 Acetaminophen
Feedback:a2Acetaminophena2cana2bea2obtaineda2overa2thea2countera2froma2anya2phar
macya2withouta2aa2prescription.
c. Whicha2drug(s)a2require(s)a2aa2DEAa2number?
Answer:a2Morphinea2Sulfate
Feedback:a2Morphinea2isa2aa2controlleda2substancea2thata2requires a2nota2onlya2aa2pre
scriptiona2buta2alsoa2thata2thea2orderinga2anda2dispensing,a2respectively,a2needsa2toa
2bea2bya2aa2physician a2anda2aa2pharmacista2thata2havea2aa2DEAa2numbera2indicatinga
2theira2propera2registration a2witha2thea2agency.
16. Druga2standardsa2 ensurea2consistency a2ina2alla2thea2areasa2EXCEPT
a. strength
b. purity
c. quality
d. size
Answer:a2 d
Feedback:a2Druga2standardsa2assurea2consumers a2thata2thea2drugsa2theya2takea2area2ofa2
uniforma2strength,a2purity,a2anda2quality.
17. Thea2Federala2Food,a2Drug,a2anda2Cosmetica2Acta2ofa21938a2establisheda2whicha2agency?
a. NDC
b. DEA
c. FDA
d. USP
Answer:a2 c
Feedback:a2Thea2Federala2Food,a2Drug,a2anda2Cosmetica2Acta2ofa21938a2establisheda2t
hea2Fooda2anda2Druga2Administrationa2(FDA)a2undera2thea2Department a2ofa2Healtha2a
nda2Humana2Services a2toa2enforcea2thea2provisions a2ofa2thea2Act.
©a22026a2Cengagea2Learning,a2Inc.a2Alla2Rightsa2Reserved.a2Maya2nota2bea2scanned,a2copieda2ora2duplicate
d,a2ora2posteda2toa2aa2publicly
4
accessiblea2website,a2ina2wholea2ora2ina2part.
