Solutiond andd AnswerHGuide:d Colbert,d Jamesd &d Katrancha,d Essentialsd ofd Pharmacologyd ford Healthd Professions,d 10e
,
2026,d 9798214116068;d Chapterd 1:d Consumerd Safetyd andd Drugd Regulations
SolutionandAnswerGuide d d d
COLBERT, JAMES & KATRANCHA, ESSENTIALS OF PHARMACOLOGY FOR HEALTH PROFESSIONS, 10
D D D D D D D D D D
E,D2026,D 9798214116068;D CHAPTERD 1:D CONSUMERD SAFETYD ANDD DRUGD REGULATIONS
TABLE OF CONTENTS D D
ChapterdReviewdQuizdAnswers ................................................................................................. 1
CHAPTER REVIEW QUIZ ANSWERS
D D D
Thed firstd majord U.S.d drugd lawd wasd passedd ind thed yeard andd wasd calledd the
d
.
Answer:d 1906;d Pured Foodd andd Drugd Act
Feedback:dThedPuredFooddanddDrugdActdwasdpasseddindthedU.S.dind1906.dItdwasdthedfirstHgov
d ernmentdattemptdtodestablishdconsumerdprotectiondindthedmanufacturedofddrugsdanddfoods.
USPd standsd ford
Answer:d Unitedd Statesd Pharmacopeia
Feedback:dThedUniteddStatesdPharmacopeiad(USP)disdadreferencedthatdspecifiesdthedofficid
aldU.S.dstandardsdfordmakingdindividualddrugs.
NFd standsd ford
Answer:d Nationald Formulary
Feedback:dThedNationaldFormularyd(NF)disdadreferencedthatdspecifiesdthedofficialdU.S.dstandda
rdsdfordmakingdindividualddrugs.dItdhasdbeendcombineddwithdthedUniteddStatesdPharmacoped ia
d(USP)dintodonedreferencedbook,dthedUSP/NF
WhichddrugdlawdestablisheddthedUSPdanddNFd(whichdarednowdone)?dAnswed
r:dThedPuredFooddanddDrugdAct
Feedback:dThed1906dPuredFooddanddDrugdActdestablisheddtwodreferencesdofdofficiallyd approve
dd drugs:d thed USPd andd NP,d whichd wered subsequentlyd combinedd intod oned singled refere
nced source.
Thedagencyd thatd requiresd youdtod keepd ad recordd ofd eachd controlledd substanced transactiod
ndisdthed
Answer:d DrugdEnforcementd Administrationd(DEA)
©H2026HCengageHLearning,HInc.HAllHRightsHReserved.HMayHnotHbeHscanned,HcopiedHorHduplicated,HorHpostedHtoHaHpublicly 1
accessibleHwebsite,HinHwholeHorHinHpart.
, Solutiond andd AnswerHGuide:d Colbert,d Jamesd &d Katrancha,d Essentialsd ofd Pharmacologyd ford Healthd Professions,d 10e
,
2026,d 9798214116068;d Chapterd 1:d Consumerd Safetyd andd Drugd Regulations
Feedback:dThedDrugdEnforcementdAdministrationdenforcesdsecuritydanddaccountabilitydrelatedd t
odcontrolleddsubstances.dAnyonedwhoddispenses,dreceives,dsells,dorddestroysdcontrolleddsubsdtan
cesdmustdkeepdondhanddspecialdDEAdforms,dindicatingdthedexactdcurrentdinventorydanddadtwd o-
yeardinventorydofdeverydcontrolleddsubstancedtransaction.
ScheduledC-
dhasdthedlowestdpotentialdfordabuse.dAnswer:dScheduld
edC-Vdhasdthedlowestdpotentialdfordabuse
Feedback:dThed1970dControlleddSubstancesdActdclassifieddabuseddanddaddictingddrugsdintodfidv
ed levels,d ord schedules,d accordingd tod theird medicald value,d harmfulness,d andd potentiald ford abusd
edordaddiction:dC-I,dC-II,dC-III,dC-IV,danddC-V,dwithdclassdC-
Id beingd thed highestd potentiald ford abuse,d andd C-Vd withd thed lowestd potentiald ford abuse.
Howdlongdmustdyoudkeepdandinventorydrecorddofdeachdcontrolleddsubstancedtransactiondatdyourdof
fice?d
Answer:d Twod years
Feedback:dThedDrugdEnforcementdAdministrationd(DEA)denforcesdsecuritydanddaccountadbilit
ydrelateddtodcontrolleddsubstances,dincludingdadtwo-
yeardinventorydofdeverydcontrolleddsubstancedtransactiond(seedalsodfeedbackdtodquestiond
5).
Threed responsibilitiesd ofd thed FDAd include:
Answer:d Threed responsibilitiesd ofd thed FDAd included anyd ofd thed following:
OverseeingdtestingdofdalldproposeddnewddrugsdbeforedtheydaredreleaseddintodthedU.S.dmar
ket
Inspectingdplantsdwheredfoods,ddrugs,dmedicalddevices,dordcosmeticsdaredmadedReview
ingdnewddrugdapplicationsdanddpetitionsdfordfooddadditives
Investigatingdanddremovingdunsafeddrugsdfromdthedmarketd
Ensuringdproperdlabelingdofdfoods,dcosmetics,dandddrugs
Feedback:dThedincreasedindthednumberdofddrugsdproduceddfordmarketingdbroughtddangersdtodt
hedpublic.dThedfederaldFDAHwasdestablisheddtodensuredthatdsomedbasicdstandardsdwoulddbedfoll
owed.dItsdresponsibilitiesdincludedthedfivedlisteddindthedanswerdabove.
Whatd typesd ofd drugsd ared listedd ind thed C-Vd schedule?
Answer:d Drugsd thatd haved thed lowestd abused potentiald amongd thed fived classesd ord schedule
dsdofdcontrolleddsubstance;dthesedconsistdprimarilydofdcoughdsuppressantsdcontainingdcodeid
nedanddantidiarrhealdpreparationsdsuchdasddiphenoxylate
Feedback:d ScheduledC-
Vdconsistsdprimarilydofdpreparationsdfordcoughdsuppressantsdcontainingdcodeinedanddpreparda
tionsdforddiarrhead(e.g.,ddiphenoxylate).dExamplesdincludedpromethazinedwithdcodeine,dChder
atussindAC,danddLomotil.
,
, Solutiond andd AnswerHGuide:d Colbert,d Jamesd &d Katrancha,d Essentialsd ofd Pharmacologyd ford Healthd Professions,d 10e
,
2026,d 9798214116068;d Chapterd 1:d Consumerd Safetyd andd Drugd Regulations
Whatd methodd isd recommendedd ford securingd thed controlledd substancesd atd yourd office?
.
Answer:dTheddrugsdshouldd bedkeptd insided adlockeddsafetydbox,d whichd isdthendplaceddwithind
indadcupboarddthatdisdalsodlocked.
Feedback:dThedDrugdEnforcementdAdministrationdenforcesdsecuritydanddaccountabilitydrelateddt
d odcontrolleddsubstances;dthisdincludesdkeepingdalldcontrolleddsubstancesdinside
lockedd safetyd box,d whichd isd thend placedd withind ad cupboardd thatd isd alsod locked.
Ifd ad patientHcallsd tod requestd ad refilld ofd ad PercocetH(C-
II)d prescription,d howd wouldd youd reply?d
Answer:d Ad refilld ford ad C-
IId substanced cannotd bed calledd intod ad pharmacyd asd ad newd prescriptiond isd requiredd byd law
.
Feedback:dThed1970dControlleddSubstancesdActdsetHregulationsdgoverningdwhichdschedulesdmd
aydhavedprescriptionsdphoneddindtodthedpharmacy.dAdrefilldfordadC-
IId substanced cannotd bed calledd intod ad pharmacy;d ad newd writtend prescriptiond isd required.
Ad patientHhasd ad rared diseased thatd requiresd medicationd ford onlyd ad smalld populationd ofd patient
s.dWhichdactdhasdalloweddtheirddrugdtodbedproduceddevendthoughditdisdnotdprofitabledtodthedpd harmaceu
ticaldindustry?
Answer:d Thed Orphand Drugd Actd ofd 1983
Feedback:dThed1983dOrphandDrugdActdprovidesdpharmaceuticaldcompaniesdfinancialdincendti
vesd tod developd medicationsd ford diseasesd thatd affectd onlyd ad smalld numberd ofd people,d sod thd
atdorphanddrugsdthatdwoulddotherwisedbedofdlowdprofitabilitydwoulddbedavailabledtodpatientsdwit
hdrareddiseases.
AdpatientHcallsdintodthedofficedaskingdfordadnewdprescriptiondfordadnarcoticdmedicationdthatHtheydhda
vedbeendtakingd fordsixdmonths.dYoudbringd upd theirdchartdandd noticedthatdwhereasd theydhaved beden
drequestingdnewd prescriptionsd everyd 23ddays,d thedmedicationd shouldd lastd 30ddays. d Additionalld y,dt
hedpatientdalsodmentionsdthatdtheydfeeldthatdtheydaredindneeddofdadhigherddose,danddtheydbecdomed
agitateddanddirritabledwhendyoudtelldthemdthatdtheydwilldneeddandappointment.dWhatddodyoudthinkdof
dthis?dWhatdshouldd youddo?
Answer:dThedmedicationdtakingdbehaviordsuggestsdadpotentialdpatterndofddrugdabuse.dNeverthde
less,dthedmostdappropriatedactiondshoulddbedtodnotifydthedpatient’sdphysiciandsodthatdtheydcandass
essdthedrealdneeddfordandincreasedindtheddosedand/ordfrequencydofdadministration.
Feedback:dThedprescriptiondfilldrecorddindicateddthatdthedpatientdisdgettingdthednarcoticdmoredfredq
uentlydthandwhatdisdalloweddbydtheirdphysiciandfordtheirdmedicaldcondition.dGivendthedhighdpotedntia
ldofdnarcoticdabuse,dsuchdrequestsdneeddtodbedaddresseddbydthedphysician.
Eachddrugdisdgivendad
numberdtodidentifydthedmanufacturer,dtheddrug,danddthedpda
ckagedsize.
FDA
dUS
PdD
EAd
NDC
Answer:d d
©H2026HCengageHLearning,HInc.HAllHRightsHReserved.HMayHnotHbeHscanned,HcopiedHorHduplicated,HorHpostedHtoHaHpublicly 3
accessibleHwebsite,HinHwholeHorHinHpart.
,
2026,d 9798214116068;d Chapterd 1:d Consumerd Safetyd andd Drugd Regulations
SolutionandAnswerGuide d d d
COLBERT, JAMES & KATRANCHA, ESSENTIALS OF PHARMACOLOGY FOR HEALTH PROFESSIONS, 10
D D D D D D D D D D
E,D2026,D 9798214116068;D CHAPTERD 1:D CONSUMERD SAFETYD ANDD DRUGD REGULATIONS
TABLE OF CONTENTS D D
ChapterdReviewdQuizdAnswers ................................................................................................. 1
CHAPTER REVIEW QUIZ ANSWERS
D D D
Thed firstd majord U.S.d drugd lawd wasd passedd ind thed yeard andd wasd calledd the
d
.
Answer:d 1906;d Pured Foodd andd Drugd Act
Feedback:dThedPuredFooddanddDrugdActdwasdpasseddindthedU.S.dind1906.dItdwasdthedfirstHgov
d ernmentdattemptdtodestablishdconsumerdprotectiondindthedmanufacturedofddrugsdanddfoods.
USPd standsd ford
Answer:d Unitedd Statesd Pharmacopeia
Feedback:dThedUniteddStatesdPharmacopeiad(USP)disdadreferencedthatdspecifiesdthedofficid
aldU.S.dstandardsdfordmakingdindividualddrugs.
NFd standsd ford
Answer:d Nationald Formulary
Feedback:dThedNationaldFormularyd(NF)disdadreferencedthatdspecifiesdthedofficialdU.S.dstandda
rdsdfordmakingdindividualddrugs.dItdhasdbeendcombineddwithdthedUniteddStatesdPharmacoped ia
d(USP)dintodonedreferencedbook,dthedUSP/NF
WhichddrugdlawdestablisheddthedUSPdanddNFd(whichdarednowdone)?dAnswed
r:dThedPuredFooddanddDrugdAct
Feedback:dThed1906dPuredFooddanddDrugdActdestablisheddtwodreferencesdofdofficiallyd approve
dd drugs:d thed USPd andd NP,d whichd wered subsequentlyd combinedd intod oned singled refere
nced source.
Thedagencyd thatd requiresd youdtod keepd ad recordd ofd eachd controlledd substanced transactiod
ndisdthed
Answer:d DrugdEnforcementd Administrationd(DEA)
©H2026HCengageHLearning,HInc.HAllHRightsHReserved.HMayHnotHbeHscanned,HcopiedHorHduplicated,HorHpostedHtoHaHpublicly 1
accessibleHwebsite,HinHwholeHorHinHpart.
, Solutiond andd AnswerHGuide:d Colbert,d Jamesd &d Katrancha,d Essentialsd ofd Pharmacologyd ford Healthd Professions,d 10e
,
2026,d 9798214116068;d Chapterd 1:d Consumerd Safetyd andd Drugd Regulations
Feedback:dThedDrugdEnforcementdAdministrationdenforcesdsecuritydanddaccountabilitydrelatedd t
odcontrolleddsubstances.dAnyonedwhoddispenses,dreceives,dsells,dorddestroysdcontrolleddsubsdtan
cesdmustdkeepdondhanddspecialdDEAdforms,dindicatingdthedexactdcurrentdinventorydanddadtwd o-
yeardinventorydofdeverydcontrolleddsubstancedtransaction.
ScheduledC-
dhasdthedlowestdpotentialdfordabuse.dAnswer:dScheduld
edC-Vdhasdthedlowestdpotentialdfordabuse
Feedback:dThed1970dControlleddSubstancesdActdclassifieddabuseddanddaddictingddrugsdintodfidv
ed levels,d ord schedules,d accordingd tod theird medicald value,d harmfulness,d andd potentiald ford abusd
edordaddiction:dC-I,dC-II,dC-III,dC-IV,danddC-V,dwithdclassdC-
Id beingd thed highestd potentiald ford abuse,d andd C-Vd withd thed lowestd potentiald ford abuse.
Howdlongdmustdyoudkeepdandinventorydrecorddofdeachdcontrolleddsubstancedtransactiondatdyourdof
fice?d
Answer:d Twod years
Feedback:dThedDrugdEnforcementdAdministrationd(DEA)denforcesdsecuritydanddaccountadbilit
ydrelateddtodcontrolleddsubstances,dincludingdadtwo-
yeardinventorydofdeverydcontrolleddsubstancedtransactiond(seedalsodfeedbackdtodquestiond
5).
Threed responsibilitiesd ofd thed FDAd include:
Answer:d Threed responsibilitiesd ofd thed FDAd included anyd ofd thed following:
OverseeingdtestingdofdalldproposeddnewddrugsdbeforedtheydaredreleaseddintodthedU.S.dmar
ket
Inspectingdplantsdwheredfoods,ddrugs,dmedicalddevices,dordcosmeticsdaredmadedReview
ingdnewddrugdapplicationsdanddpetitionsdfordfooddadditives
Investigatingdanddremovingdunsafeddrugsdfromdthedmarketd
Ensuringdproperdlabelingdofdfoods,dcosmetics,dandddrugs
Feedback:dThedincreasedindthednumberdofddrugsdproduceddfordmarketingdbroughtddangersdtodt
hedpublic.dThedfederaldFDAHwasdestablisheddtodensuredthatdsomedbasicdstandardsdwoulddbedfoll
owed.dItsdresponsibilitiesdincludedthedfivedlisteddindthedanswerdabove.
Whatd typesd ofd drugsd ared listedd ind thed C-Vd schedule?
Answer:d Drugsd thatd haved thed lowestd abused potentiald amongd thed fived classesd ord schedule
dsdofdcontrolleddsubstance;dthesedconsistdprimarilydofdcoughdsuppressantsdcontainingdcodeid
nedanddantidiarrhealdpreparationsdsuchdasddiphenoxylate
Feedback:d ScheduledC-
Vdconsistsdprimarilydofdpreparationsdfordcoughdsuppressantsdcontainingdcodeinedanddpreparda
tionsdforddiarrhead(e.g.,ddiphenoxylate).dExamplesdincludedpromethazinedwithdcodeine,dChder
atussindAC,danddLomotil.
,
, Solutiond andd AnswerHGuide:d Colbert,d Jamesd &d Katrancha,d Essentialsd ofd Pharmacologyd ford Healthd Professions,d 10e
,
2026,d 9798214116068;d Chapterd 1:d Consumerd Safetyd andd Drugd Regulations
Whatd methodd isd recommendedd ford securingd thed controlledd substancesd atd yourd office?
.
Answer:dTheddrugsdshouldd bedkeptd insided adlockeddsafetydbox,d whichd isdthendplaceddwithind
indadcupboarddthatdisdalsodlocked.
Feedback:dThedDrugdEnforcementdAdministrationdenforcesdsecuritydanddaccountabilitydrelateddt
d odcontrolleddsubstances;dthisdincludesdkeepingdalldcontrolleddsubstancesdinside
lockedd safetyd box,d whichd isd thend placedd withind ad cupboardd thatd isd alsod locked.
Ifd ad patientHcallsd tod requestd ad refilld ofd ad PercocetH(C-
II)d prescription,d howd wouldd youd reply?d
Answer:d Ad refilld ford ad C-
IId substanced cannotd bed calledd intod ad pharmacyd asd ad newd prescriptiond isd requiredd byd law
.
Feedback:dThed1970dControlleddSubstancesdActdsetHregulationsdgoverningdwhichdschedulesdmd
aydhavedprescriptionsdphoneddindtodthedpharmacy.dAdrefilldfordadC-
IId substanced cannotd bed calledd intod ad pharmacy;d ad newd writtend prescriptiond isd required.
Ad patientHhasd ad rared diseased thatd requiresd medicationd ford onlyd ad smalld populationd ofd patient
s.dWhichdactdhasdalloweddtheirddrugdtodbedproduceddevendthoughditdisdnotdprofitabledtodthedpd harmaceu
ticaldindustry?
Answer:d Thed Orphand Drugd Actd ofd 1983
Feedback:dThed1983dOrphandDrugdActdprovidesdpharmaceuticaldcompaniesdfinancialdincendti
vesd tod developd medicationsd ford diseasesd thatd affectd onlyd ad smalld numberd ofd people,d sod thd
atdorphanddrugsdthatdwoulddotherwisedbedofdlowdprofitabilitydwoulddbedavailabledtodpatientsdwit
hdrareddiseases.
AdpatientHcallsdintodthedofficedaskingdfordadnewdprescriptiondfordadnarcoticdmedicationdthatHtheydhda
vedbeendtakingd fordsixdmonths.dYoudbringd upd theirdchartdandd noticedthatdwhereasd theydhaved beden
drequestingdnewd prescriptionsd everyd 23ddays,d thedmedicationd shouldd lastd 30ddays. d Additionalld y,dt
hedpatientdalsodmentionsdthatdtheydfeeldthatdtheydaredindneeddofdadhigherddose,danddtheydbecdomed
agitateddanddirritabledwhendyoudtelldthemdthatdtheydwilldneeddandappointment.dWhatddodyoudthinkdof
dthis?dWhatdshouldd youddo?
Answer:dThedmedicationdtakingdbehaviordsuggestsdadpotentialdpatterndofddrugdabuse.dNeverthde
less,dthedmostdappropriatedactiondshoulddbedtodnotifydthedpatient’sdphysiciandsodthatdtheydcandass
essdthedrealdneeddfordandincreasedindtheddosedand/ordfrequencydofdadministration.
Feedback:dThedprescriptiondfilldrecorddindicateddthatdthedpatientdisdgettingdthednarcoticdmoredfredq
uentlydthandwhatdisdalloweddbydtheirdphysiciandfordtheirdmedicaldcondition.dGivendthedhighdpotedntia
ldofdnarcoticdabuse,dsuchdrequestsdneeddtodbedaddresseddbydthedphysician.
Eachddrugdisdgivendad
numberdtodidentifydthedmanufacturer,dtheddrug,danddthedpda
ckagedsize.
FDA
dUS
PdD
EAd
NDC
Answer:d d
©H2026HCengageHLearning,HInc.HAllHRightsHReserved.HMayHnotHbeHscanned,HcopiedHorHduplicated,HorHpostedHtoHaHpublicly 3
accessibleHwebsite,HinHwholeHorHinHpart.
