Solution and AnswerHGuide: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions
hg hg hg hg hg hg hg h g hg hg hg hg
, 10e, hg
2026, 9798214116068; Chapter 1: Consumer Safety and Drug Regulations hg hg h g hg hg h g hg hg
SolutionandAnswerGuide g
h g
h g
h
COLBERT, JAMES & KATRANCHA, ESSENTIALS OF PHARMACOLOGY FOR HEALTH PROFESSIONS, 10
HG HG HG HG HG HG HG HG HG HG
E, HG 2026, 9798214116068; CHAPTER 1: CONSUMER SAFETY AND DRUG REGULATIONS
HG HG HG HG HG HG HG HG
TABLE OF CONTENTS HG HG
Chapter Review Quiz Answers ................................................................................................ 1
hg hg hg
CHAPTER REVIEW QUIZ ANSWERS HG HG HG
The first major U.S. drug law was passed in the year
hg hg hg hg hg hg hg hg hg hg hg and was called the
g
h hg hg hg
.
Answer: 1906; Pure Food and Drug Act hg hg hg hg hg hg
Feedback: The Pure Food and Drug Act was passed in the U.S. in 1906. It was the firstHg
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg
ov ernment attempt to establish consumer protection in the manufacture of drugs and foo
h g hg hg hg hg hg hg hg hg hg hg hg hg
ds.
USP stands for
h g h g hg
Answer: United States Pharmacopeia hg hg hg
Feedback: The United States Pharmacopeia (USP) is a reference that specifies the offici
hg hg hg hg hg hg hg hg hg hg hg hg
h g al U.S. standards for making individual drugs.
hg hg hg hg hg hg
NF stands for
h g h g hg
Answer: National Formulary hg hg
Feedback: The National Formulary (NF) is a reference that specifies the official U.S. stand
hg hg hg hg hg hg hg hg hg hg hg hg hg hg
ards for making individual drugs. It has been combined with the United States Pharmacope
hg hg hg hg hg hg hg hg hg hg hg hg hg
h ia (USP) into one reference book, the USP/NF
g hg hg hg hg hg hg hg
Which drug law established the USP and NF (which are now one)? Answe
hg hg hg hg hg hg hg hg hg hg hg hg
h g r: The Pure Food and Drug Act
hg hg hg hg hg hg
Feedback: The 1906 Pure Food and Drug Act established two references of officially appro
hg hg hg hg hg hg hg hg hg hg hg hg h g
ved drugs: the USP and NP, which were subsequently combined into one single refere
hg hg hg hg hg hg hg hg hg hg hg hg hg
nce source. hg
The agency that requires you to keep a record of each controlled substance transa
hg hg hg hg hg hg hg hg hg hg hg hg hg
ctio n is the hg hg hg hg
Answer: Drug Enforcement Administration (DEA)
hg hg hg hg
©H2026HCengageHLearning,HInc.HAllHRightsHReserved.HMayHnotHbeHscanned,HcopiedHorHduplicated,HorHpostedHtoHaHpublicly 1
accessibleHwebsite,HinHwholeHorHinHpart.
, Solution and AnswerHGuide: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions
hg hg hg hg hg hg hg h g hg hg hg hg
, 10e, hg
2026, 9798214116068; Chapter 1: Consumer Safety and Drug Regulations hg hg h g hg hg h g hg hg
Feedback: The Drug Enforcement Administration enforces security and accountability related
hg hg hg hg hg hg hg hg hg h
gto controlled substances. Anyone who dispenses, receives, sells, or destroys controlled subs
hg hg hg hg hg hg hg hg hg hg hg hg
tances must keep on hand special DEA forms, indicating the exact current inventory and a tw
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg
h o-year inventory of every controlled substance transaction.
g hg hg hg hg hg hg
Schedule C- hg
has the lowest potential for abuse. Answer: Schedul
hg hg hg hg hg hg hg hg h
g e C-V has the lowest potential for abuse
hg hg hg hg hg hg hg
Feedback: The 1970 Controlled Substances Act classified abused and addicting drugs into fi
hg hg hg hg hg hg hg hg hg hg hg hg h
gve levels, or schedules, according to their medical value, harmfulness, and potential for
hg hg hg hg hg hg hg hg hg hg hg hg hg
abus e or addiction: C-I, C-II, C-III, C-IV, and C-V, with class C-
hg hg hg hg hg hg hg hg hg hg hg hg
I being the highest potential for abuse, and C-V with the lowest potential for abuse.
hg hg hg hg hg hg hg hg hg hg hg hg hg hg
How long must you keep an inventory record of each controlled substance transaction at your
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg
office? hg
Answer: Two years hg hg
Feedback: The Drug Enforcement Administration (DEA) enforces security and accounta bil
hg hg hg hg hg hg hg hg hg hg
ity related to controlled substances, including a two-
hg hg hg hg hg hg hg
year inventory of every controlled substance transaction (see also feedback to questio
hg hg hg hg hg hg hg hg hg hg hg
n 5).hg
Three responsibilities of the FDA include:
hg hg hg hg hg
Answer: Three responsibilities of the FDA include any of the following:
hg hg hg hg hg hg hg hg hg hg
Overseeing testing of all proposed new drugs before they are released into the U.S. m
hg hg hg hg hg hg hg hg hg hg hg hg hg hg
arket
Inspecting plants where foods, drugs, medical devices, or cosmetics are made Revie
hg hg hg hg hg hg hg hg hg hg hg
wing new drug applications and petitions for food additives
hg hg hg hg hg hg hg hg
Investigating and removing unsafe drugs from the marke hg hg hg hg hg hg hg
t Ensuring proper labeling of foods, cosmetics, and drug
hg hg hg hg hg hg hg hg
s
Feedback: The increase in the number of drugs produced for marketing brought dangers to
hg hg hg hg hg hg hg hg hg hg hg hg hg hg
the public. The federal FDAHwas established to ensure that some basic standards would be
hg hg hg hg hg hg hg hg hg hg hg hg hg hg
followed. Its responsibilities include the five listed in the answer above.
hg hg hg hg hg hg hg hg hg hg
What types of drugs are listed in the C-V schedule?
hg hg hg hg hg hg hg hg hg
Answer: Drugs that have the lowest abuse potential among the five classes or sche
hg hg hg hg hg hg hg hg hg hg hg hg hg
dule s of controlled substance; these consist primarily of cough suppressants containing
hg hg hg hg hg hg hg hg hg hg hg hg
codei ne and antidiarrheal preparations such as diphenoxylate
hg hg hg hg hg hg hg
Feedback: Schedule C- hg hg
V consists primarily of preparations for cough suppressants containing codeine and prepar
hg hg hg hg hg hg hg hg hg hg hg h
ations for diarrhea (e.g., diphenoxylate). Examples include promethazine with codeine, Ch
g hg hg hg hg hg hg hg hg hg hg hg
eratussin AC, and Lomotil. hg hg hg
,
, Solution and AnswerHGuide: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions
hg hg hg hg hg hg hg h g hg hg hg hg
, 10e, hg
2026, 9798214116068; Chapter 1: Consumer Safety and Drug Regulations hg hg h g hg hg h g hg hg
What method is recommended for securing the controlled substances at your office?
hg hg hg hg hg hg hg hg hg hg hg
.
Answer: The drugs should be kept inside a locked safety box, which is then placed with
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg
in in a cupboard that is also locked.
h g hg hg hg hg hg hg
Feedback: The Drug Enforcement Administration enforces security and accountability related
hg hg hg hg hg hg hg hg hg hg
t o controlled substances; this includes keeping all controlled substances inside
h g hg hg hg hg hg hg hg hg hg
locked safety box, which is then placed within a cupboard that is also locked.
hg hg hg hg hg hg hg hg hg hg hg hg hg
If a patientHcalls to request a refill of a PercocetH(C-
hg hg hg hg hg hg hg hg hg
II) prescription, how would you reply?
hg hg hg hg hg hg
Answer: A refill for a C- hg hg hg hg hg
II substance cannot be called into a pharmacy as a new prescription is required by law
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg
.
Feedback: The 1970 Controlled Substances Act setHregulations governing which schedules
hg hg hg hg hg hg hg hg hg hg
m ay have prescriptions phoned in to the pharmacy. A refill for a C-
hg hg hg hg hg hg hg hg hg hg hg hg hg
II substance cannot be called into a pharmacy; a new written prescription is required.
hg hg hg hg hg hg hg hg hg hg hg hg hg
A patientHhas a rare disease that requires medication for only a small population of patient
hg hg hg hg hg hg hg hg hg hg hg hg hg hg
s. Which act has allowed their drug to be produced even though it is not profitable to the p harma
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg h g
ceutical industry? hg
Answer: The Orphan Drug Act of 1983 hg hg hg hg hg hg
Feedback: The 1983 Orphan Drug Act provides pharmaceutical companies financial incen
hg hg hg hg hg hg hg hg hg hg h
tives to develop medications for diseases that affect only a small number of people,
g hg hg hg hg hg hg hg hg hg hg hg hg hg hg
so th at orphan drugs that would otherwise be of low profitability would be available to pati
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg
ents with rare diseases.
hg hg hg
A patientHcalls into the office asking for a new prescription for a narcotic medication thatHthey h
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg
ave been taking for six months. You bring up their chart and notice that whereas they have b
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg
e en requesting new prescriptions every 23 days, the medication should last 30 days. Additi
hg hg hg hg hg hg hg hg hg hg hg hg hg hg
onall y, the patient also mentions that they feel that they are in need of a higher dose, and they
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg
bec ome agitated and irritable when you tell them that they will need an appointment. What do
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg h
you think of this? What should you do?
g hg hg hg hg hg hg hg
Answer: The medication taking behavior suggests a potential pattern of drug abuse. Neverth
hg hg hg hg hg hg hg hg hg hg hg hg h
eless, the most appropriate action should be to notify the patient’s physician so that they can
g hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg h
assess the real need for an increase in the dose and/or frequency of administration.
g hg hg hg hg hg hg hg hg hg hg hg hg hg
Feedback: The prescription fill record indicated that the patient is getting the narcotic more fre
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg
quently than what is allowed by their physician for their medical condition. Given the high pote
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg
ntial of narcotic abuse, such requests need to be addressed by the physician.
hg hg hg hg hg hg hg hg hg hg hg hg
Each drug is given a hg hg hg hg hg
number to identify the manufacturer, the drug, and the p
hg hg hg hg hg hg hg hg hg hg
ackage size. hg
FDA h
USP g
DE hg
AN hg
DC
Answer: d hg
©H2026HCengageHLearning,HInc.HAllHRightsHReserved.HMayHnotHbeHscanned,HcopiedHorHduplicated,HorHpostedHtoHaHpublicly 3
accessibleHwebsite,HinHwholeHorHinHpart.
hg hg hg hg hg hg hg h g hg hg hg hg
, 10e, hg
2026, 9798214116068; Chapter 1: Consumer Safety and Drug Regulations hg hg h g hg hg h g hg hg
SolutionandAnswerGuide g
h g
h g
h
COLBERT, JAMES & KATRANCHA, ESSENTIALS OF PHARMACOLOGY FOR HEALTH PROFESSIONS, 10
HG HG HG HG HG HG HG HG HG HG
E, HG 2026, 9798214116068; CHAPTER 1: CONSUMER SAFETY AND DRUG REGULATIONS
HG HG HG HG HG HG HG HG
TABLE OF CONTENTS HG HG
Chapter Review Quiz Answers ................................................................................................ 1
hg hg hg
CHAPTER REVIEW QUIZ ANSWERS HG HG HG
The first major U.S. drug law was passed in the year
hg hg hg hg hg hg hg hg hg hg hg and was called the
g
h hg hg hg
.
Answer: 1906; Pure Food and Drug Act hg hg hg hg hg hg
Feedback: The Pure Food and Drug Act was passed in the U.S. in 1906. It was the firstHg
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg
ov ernment attempt to establish consumer protection in the manufacture of drugs and foo
h g hg hg hg hg hg hg hg hg hg hg hg hg
ds.
USP stands for
h g h g hg
Answer: United States Pharmacopeia hg hg hg
Feedback: The United States Pharmacopeia (USP) is a reference that specifies the offici
hg hg hg hg hg hg hg hg hg hg hg hg
h g al U.S. standards for making individual drugs.
hg hg hg hg hg hg
NF stands for
h g h g hg
Answer: National Formulary hg hg
Feedback: The National Formulary (NF) is a reference that specifies the official U.S. stand
hg hg hg hg hg hg hg hg hg hg hg hg hg hg
ards for making individual drugs. It has been combined with the United States Pharmacope
hg hg hg hg hg hg hg hg hg hg hg hg hg
h ia (USP) into one reference book, the USP/NF
g hg hg hg hg hg hg hg
Which drug law established the USP and NF (which are now one)? Answe
hg hg hg hg hg hg hg hg hg hg hg hg
h g r: The Pure Food and Drug Act
hg hg hg hg hg hg
Feedback: The 1906 Pure Food and Drug Act established two references of officially appro
hg hg hg hg hg hg hg hg hg hg hg hg h g
ved drugs: the USP and NP, which were subsequently combined into one single refere
hg hg hg hg hg hg hg hg hg hg hg hg hg
nce source. hg
The agency that requires you to keep a record of each controlled substance transa
hg hg hg hg hg hg hg hg hg hg hg hg hg
ctio n is the hg hg hg hg
Answer: Drug Enforcement Administration (DEA)
hg hg hg hg
©H2026HCengageHLearning,HInc.HAllHRightsHReserved.HMayHnotHbeHscanned,HcopiedHorHduplicated,HorHpostedHtoHaHpublicly 1
accessibleHwebsite,HinHwholeHorHinHpart.
, Solution and AnswerHGuide: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions
hg hg hg hg hg hg hg h g hg hg hg hg
, 10e, hg
2026, 9798214116068; Chapter 1: Consumer Safety and Drug Regulations hg hg h g hg hg h g hg hg
Feedback: The Drug Enforcement Administration enforces security and accountability related
hg hg hg hg hg hg hg hg hg h
gto controlled substances. Anyone who dispenses, receives, sells, or destroys controlled subs
hg hg hg hg hg hg hg hg hg hg hg hg
tances must keep on hand special DEA forms, indicating the exact current inventory and a tw
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg
h o-year inventory of every controlled substance transaction.
g hg hg hg hg hg hg
Schedule C- hg
has the lowest potential for abuse. Answer: Schedul
hg hg hg hg hg hg hg hg h
g e C-V has the lowest potential for abuse
hg hg hg hg hg hg hg
Feedback: The 1970 Controlled Substances Act classified abused and addicting drugs into fi
hg hg hg hg hg hg hg hg hg hg hg hg h
gve levels, or schedules, according to their medical value, harmfulness, and potential for
hg hg hg hg hg hg hg hg hg hg hg hg hg
abus e or addiction: C-I, C-II, C-III, C-IV, and C-V, with class C-
hg hg hg hg hg hg hg hg hg hg hg hg
I being the highest potential for abuse, and C-V with the lowest potential for abuse.
hg hg hg hg hg hg hg hg hg hg hg hg hg hg
How long must you keep an inventory record of each controlled substance transaction at your
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg
office? hg
Answer: Two years hg hg
Feedback: The Drug Enforcement Administration (DEA) enforces security and accounta bil
hg hg hg hg hg hg hg hg hg hg
ity related to controlled substances, including a two-
hg hg hg hg hg hg hg
year inventory of every controlled substance transaction (see also feedback to questio
hg hg hg hg hg hg hg hg hg hg hg
n 5).hg
Three responsibilities of the FDA include:
hg hg hg hg hg
Answer: Three responsibilities of the FDA include any of the following:
hg hg hg hg hg hg hg hg hg hg
Overseeing testing of all proposed new drugs before they are released into the U.S. m
hg hg hg hg hg hg hg hg hg hg hg hg hg hg
arket
Inspecting plants where foods, drugs, medical devices, or cosmetics are made Revie
hg hg hg hg hg hg hg hg hg hg hg
wing new drug applications and petitions for food additives
hg hg hg hg hg hg hg hg
Investigating and removing unsafe drugs from the marke hg hg hg hg hg hg hg
t Ensuring proper labeling of foods, cosmetics, and drug
hg hg hg hg hg hg hg hg
s
Feedback: The increase in the number of drugs produced for marketing brought dangers to
hg hg hg hg hg hg hg hg hg hg hg hg hg hg
the public. The federal FDAHwas established to ensure that some basic standards would be
hg hg hg hg hg hg hg hg hg hg hg hg hg hg
followed. Its responsibilities include the five listed in the answer above.
hg hg hg hg hg hg hg hg hg hg
What types of drugs are listed in the C-V schedule?
hg hg hg hg hg hg hg hg hg
Answer: Drugs that have the lowest abuse potential among the five classes or sche
hg hg hg hg hg hg hg hg hg hg hg hg hg
dule s of controlled substance; these consist primarily of cough suppressants containing
hg hg hg hg hg hg hg hg hg hg hg hg
codei ne and antidiarrheal preparations such as diphenoxylate
hg hg hg hg hg hg hg
Feedback: Schedule C- hg hg
V consists primarily of preparations for cough suppressants containing codeine and prepar
hg hg hg hg hg hg hg hg hg hg hg h
ations for diarrhea (e.g., diphenoxylate). Examples include promethazine with codeine, Ch
g hg hg hg hg hg hg hg hg hg hg hg
eratussin AC, and Lomotil. hg hg hg
,
, Solution and AnswerHGuide: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions
hg hg hg hg hg hg hg h g hg hg hg hg
, 10e, hg
2026, 9798214116068; Chapter 1: Consumer Safety and Drug Regulations hg hg h g hg hg h g hg hg
What method is recommended for securing the controlled substances at your office?
hg hg hg hg hg hg hg hg hg hg hg
.
Answer: The drugs should be kept inside a locked safety box, which is then placed with
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg
in in a cupboard that is also locked.
h g hg hg hg hg hg hg
Feedback: The Drug Enforcement Administration enforces security and accountability related
hg hg hg hg hg hg hg hg hg hg
t o controlled substances; this includes keeping all controlled substances inside
h g hg hg hg hg hg hg hg hg hg
locked safety box, which is then placed within a cupboard that is also locked.
hg hg hg hg hg hg hg hg hg hg hg hg hg
If a patientHcalls to request a refill of a PercocetH(C-
hg hg hg hg hg hg hg hg hg
II) prescription, how would you reply?
hg hg hg hg hg hg
Answer: A refill for a C- hg hg hg hg hg
II substance cannot be called into a pharmacy as a new prescription is required by law
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg
.
Feedback: The 1970 Controlled Substances Act setHregulations governing which schedules
hg hg hg hg hg hg hg hg hg hg
m ay have prescriptions phoned in to the pharmacy. A refill for a C-
hg hg hg hg hg hg hg hg hg hg hg hg hg
II substance cannot be called into a pharmacy; a new written prescription is required.
hg hg hg hg hg hg hg hg hg hg hg hg hg
A patientHhas a rare disease that requires medication for only a small population of patient
hg hg hg hg hg hg hg hg hg hg hg hg hg hg
s. Which act has allowed their drug to be produced even though it is not profitable to the p harma
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg h g
ceutical industry? hg
Answer: The Orphan Drug Act of 1983 hg hg hg hg hg hg
Feedback: The 1983 Orphan Drug Act provides pharmaceutical companies financial incen
hg hg hg hg hg hg hg hg hg hg h
tives to develop medications for diseases that affect only a small number of people,
g hg hg hg hg hg hg hg hg hg hg hg hg hg hg
so th at orphan drugs that would otherwise be of low profitability would be available to pati
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg
ents with rare diseases.
hg hg hg
A patientHcalls into the office asking for a new prescription for a narcotic medication thatHthey h
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg
ave been taking for six months. You bring up their chart and notice that whereas they have b
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg
e en requesting new prescriptions every 23 days, the medication should last 30 days. Additi
hg hg hg hg hg hg hg hg hg hg hg hg hg hg
onall y, the patient also mentions that they feel that they are in need of a higher dose, and they
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg
bec ome agitated and irritable when you tell them that they will need an appointment. What do
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg h
you think of this? What should you do?
g hg hg hg hg hg hg hg
Answer: The medication taking behavior suggests a potential pattern of drug abuse. Neverth
hg hg hg hg hg hg hg hg hg hg hg hg h
eless, the most appropriate action should be to notify the patient’s physician so that they can
g hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg h
assess the real need for an increase in the dose and/or frequency of administration.
g hg hg hg hg hg hg hg hg hg hg hg hg hg
Feedback: The prescription fill record indicated that the patient is getting the narcotic more fre
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg
quently than what is allowed by their physician for their medical condition. Given the high pote
hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg hg
ntial of narcotic abuse, such requests need to be addressed by the physician.
hg hg hg hg hg hg hg hg hg hg hg hg
Each drug is given a hg hg hg hg hg
number to identify the manufacturer, the drug, and the p
hg hg hg hg hg hg hg hg hg hg
ackage size. hg
FDA h
USP g
DE hg
AN hg
DC
Answer: d hg
©H2026HCengageHLearning,HInc.HAllHRightsHReserved.HMayHnotHbeHscanned,HcopiedHorHduplicated,HorHpostedHtoHaHpublicly 3
accessibleHwebsite,HinHwholeHorHinHpart.