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Solution and AnswerHGuide: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions, 10e,

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Solutioni andi AnswerHGuide:i Colbert,i Jamesi &i Katrancha,i Essentialsi ofi Pharmacologyi fori Healthi Professions,i 10e,
2026,i 9798214116068;i Chapteri 1:i Consumeri Safetyi andi Drugi Regulations




SolutionandAnswerGuide i i i


COLBERT,IJAMESI &I KATRANCHA,I ESSENTIALSI OFI PHARMACOLOGYI FORI HEALTHI PROFESSIONS,I 10
E,I 2026,I 9798214116068;I CHAPTERI 1:I CONSUMERI SAFETYI ANDI DRUGI REGULATIONS


TABLE OF CONTENTS
I I




ChapteriReviewiQuiziAnswers .................................................................................................. 1




CHAPTER REVIEW QUIZ ANSWERS
I I I




Thei firsti majori U.S.i drugi lawi wasi passedi ini thei yeari andi wasi calledi the
i

.

Answer:i 1906;i Purei Foodi andi Drugi Act

Feedback:iTheiPureiFoodiandiDrugiActiwasipassediinitheiU.S.iini1906.iItiwasitheifirstHgovi ernm
entiattemptitoiestablishiconsumeriprotectioniinitheimanufactureiofidrugsiandifoods.


USPi standsi fori

Answer:i Unitedi Statesi Pharmacopeia

Feedback:iTheiUnitediStatesiPharmacopeiai(USP)iisiaireferenceithatispecifiesitheiofficii aliU.
S.istandardsiforimakingiindividualidrugs.
NFi standsi fori

Answer:i Nationali Formulary

Feedback:iTheiNationaliFormularyi(NF)iisiaireferenceithatispecifiesitheiofficialiU.S.istandiardsif
orimakingiindividualidrugs.iItihasibeenicombinediwithitheiUnitediStatesiPharmacopei iai(USP)iin
toioneireferenceibook,itheiUSP/NF
WhichidrugilawiestablisheditheiUSPiandiNFi(whichiareinowione)?iAnswei r:iTh

eiPureiFoodiandiDrugiAct

Feedback:iThei1906iPureiFoodiandiDrugiActiestablisheditwoireferencesiofiofficiallyi approvedi dr
ugs:i thei USPi andi NP,i whichi werei subsequentlyi combinedi intoi onei singlei refere
ncei source.
Theiagencyi thati requiresi youitoi keepi ai recordi ofi eachi controlledi substancei transactioiniisit
hei
Answer:i Drugi Enforcementi Administrationi(DEA)




©H2026HCengageHLearning,HInc.HAllHRightsHReserved.HMayHnotHbeHscanned,HcopiedHorHduplicated,HorHpostedHtoHaHpublicly 1
accessibleHwebsite,HinHwholeHorHinHpart.

, Solutioni andi AnswerHGuide:i Colbert,i Jamesi &i Katrancha,i Essentialsi ofi Pharmacologyi fori Healthi Professions,i 10e,
2026,i 9798214116068;i Chapteri 1:i Consumeri Safetyi andi Drugi Regulations


Feedback:iTheiDrugiEnforcementiAdministrationienforcesisecurityiandiaccountabilityirelatedi toic
ontrolledisubstances.iAnyoneiwhoidispenses,ireceives,isells,ioridestroysicontrolledisubsitancesim
ustikeepionihandispecialiDEAiforms,iindicatingitheiexacticurrentiinventoryiandiaitwi o-
yeariinventoryiofieveryicontrolledisubstanceitransaction.
ScheduleiC-

hasitheilowestipotentialiforiabuse.iAnswer:iSchedulieiC
i


-Vihasitheilowestipotentialiforiabuse

Feedback:iThei1970iControllediSubstancesiActiclassifiediabusediandiaddictingidrugsiintoifiivei lev
els,i ori schedules,i accordingi toi theiri medicali value,i harmfulness,i andi potentiali fori abusieioriaddict
ion:iC-I,iC-II,iC-III,iC-IV,iandiC-V,iwithiclassiC-
Ii beingi thei highesti potentiali fori abuse,i andi C-Vi withi thei lowesti potentiali fori abuse.
Howilongimustiyouikeepianiinventoryirecordiofieachicontrolledisubstanceitransactioniatiyourioffice?
i

Answer:i Twoi years

Feedback:iTheiDrugiEnforcementiAdministrationi(DEA)ienforcesisecurityiandiaccountaibilityire
lateditoicontrolledisubstances,iincludingiaitwo-
yeariinventoryiofieveryicontrolledisubstanceitransactioni(seeialsoifeedbackitoiquestioni5).
Threei responsibilitiesi ofi thei FDAi include:


Answer:i Threei responsibilitiesi ofi thei FDAi includei anyi ofi thei following:

OverseeingitestingiofialliproposedinewidrugsibeforeitheyiareireleasediintoitheiU.S.imarket
Inspectingiplantsiwhereifoods,idrugs,imedicalidevices,ioricosmeticsiareimadeiReviewingi
newidrugiapplicationsiandipetitionsiforifoodiadditives
InvestigatingiandiremovingiunsafeidrugsifromitheimarketiE
nsuringiproperilabelingiofifoods,icosmetics,iandidrugs

Feedback:iTheiincreaseiinitheinumberiofidrugsiproducediforimarketingibroughtidangersitoitheipu
blic.iTheifederaliFDAHwasiestablisheditoiensureithatisomeibasicistandardsiwouldibeifollowed.iItsir
esponsibilitiesiincludeitheifiveilistediinitheiansweriabove.


Whati typesi ofi drugsi arei listedi ini thei C-Vi schedule?


Answer:i Drugsi thati havei thei lowesti abusei potentiali amongi thei fivei classesi ori scheduleisiofi
controlledisubstance;itheseiconsistiprimarilyioficoughisuppressantsicontainingicodeiineiandia
ntidiarrhealipreparationsisuchiasidiphenoxylate
Feedback:i ScheduleiC-
Viconsistsiprimarilyiofipreparationsiforicoughisuppressantsicontainingicodeineiandiprepariation
siforidiarrheai(e.g.,idiphenoxylate).iExamplesiincludeipromethazineiwithicodeine,iChieratussini
AC,iandiLomotil.

, Whati methodi isi recommendedi fori securingi thei controlledi substancesi ati youri office?
.

Answer:iTheidrugsishouldi beikepti insidei ailockedisafetyibox,i whichi isitheniplacediwithini iniaic
upboardithatiisialsoilocked.
Feedback:iTheiDrugiEnforcementiAdministrationienforcesisecurityiandiaccountabilityirelatediti oic
ontrolledisubstances;ithisiincludesikeepingiallicontrolledisubstancesiinside
lockedi safetyi box,i whichi isi theni placedi withini ai cupboardi thati isi alsoi locked.
Ifi ai patientHcallsi toi requesti ai refilli ofi ai PercocetH(C-
II)i prescription,i howi wouldi youi reply?i
Answer:i Ai refilli fori ai C-
IIi substancei cannoti bei calledi intoi ai pharmacyi asi ai newi prescriptioni isi requiredi byi law
.
Feedback:iThei1970iControllediSubstancesiActisetHregulationsigoverningiwhichischedulesimiayi
haveiprescriptionsiphonediinitoitheipharmacy.iAirefilliforiaiC-
IIi substancei cannoti bei calledi intoi ai pharmacy;i ai newi writteni prescriptioni isi required.
Ai patientHhasi ai rarei diseasei thati requiresi medicationi fori onlyi ai smalli populationi ofi patient
s.iWhichiactihasialloweditheiridrugitoibeiproducedievenithoughiitiisinotiprofitableitoitheipi harmaceuticaliin
dustry?
Answer:i Thei Orphani Drugi Acti ofi 1983

Feedback:iThei1983iOrphaniDrugiActiprovidesipharmaceuticalicompaniesifinancialiincenitives
i toi developi medicationsi fori diseasesi thati affecti onlyi ai smalli numberi ofi people,i soi thiatiorphani

drugsithatiwouldiotherwiseibeiofilowiprofitabilityiwouldibeiavailableitoipatientsiwithirareidiseases
.
AipatientHcallsiintoitheiofficeiaskingiforiainewiprescriptioniforiainarcoticimedicationithatHtheyihiaveibe
enitakingi forisiximonths.iYouibringi upi theirichartiandi noticeithatiwhereasi theyihavei beienirequestingi
newi prescriptionsi everyi 23idays,i theimedicationi shouldi lasti 30idays.i Additionalliy,itheipatientialsoim
entionsithatitheyifeelithatitheyiareiinineediofiaihigheridose,ianditheyibeciomeiagitatediandiirritableiwh
eniyouitellithemithatitheyiwillineedianiappointment.iWhatidoiyouithinkiofithis?iWhatishouldiyouido?
Answer:iTheimedicationitakingibehaviorisuggestsiaipotentialipatterniofidrugiabuse.iNeverthieless
,itheimostiappropriateiactionishouldibeitoinotifyitheipatient’siphysicianisoithatitheyicaniassessitheire
alineediforianiincreaseiinitheidoseiand/orifrequencyiofiadministration.


Feedback:iTheiprescriptionifillirecordiindicatedithatitheipatientiisigettingitheinarcoticimoreifreiquentl
yithaniwhatiisiallowedibyitheiriphysicianiforitheirimedicalicondition.iGivenitheihighipoteintialiofinarcoti
ciabuse,isuchirequestsineeditoibeiaddressedibyitheiphysician.
Eachidrugiisigiveniai
numberitoiidentifyitheimanufacturer,itheidrug,ianditheipiack
ageisize.
FDAi
USPi
DEAi
NDC

Answer:i d


©H2026HCengageHLearning,HInc.HAllHRightsHReserved.HMayHnotHbeHscanned,HcopiedHorHduplicated,HorHpostedHtoHaHpublicly 3
accessibleHwebsite,HinHwholeHorHinHpart.

, Solutioni andi AnswerHGuide:i Colbert,i Jamesi &i Katrancha,i Essentialsi ofi Pharmacologyi fori Healthi Professions,i 10e,
2026,i 9798214116068;i Chapteri 1:i Consumeri Safetyi andi Drugi Regulations


Feedback:iTheiNationaliDrugiCodei(NDC)iisiaidirectoryiofinumericalicodesithatiallowiidentiificatio
ni ofi ai drug,i asi welli asi thei packagei sizei andi thei manufacturer.i Thisi directoryi providesiailistiofiallid
rugsimanufacturediforicommercialidistribution.iTheiNDCiisicomprisediofithreeiparts:itheifirstHpartiisi
fiveinumbersiandiidentifiesitheimanufacturer,itheisecondipartiisifouriniumbersi andi identifiesi thei dr
ug,i andi thei thirdi parti isi twoi digitsi andi identifiesi thei packagei sizie.


Answeritheiquestionsiconcerningitheifollowingithreeidrugilabels:ia.iWihichi
drug(s)irequiresiaiprescription?
Answer:i Morphinei Sulfatei andi Procardiai (nifedipine)

Feedback:iBothiMorphineiandiProcardiai(nifedipine)irequireiaiprescriptioniandicannotibeipurichas
edioveritheicounter.
Whichidrug(s)icanibeiboughtiwithoutiaiprescription?iAnsiwe

r:iAcetaminophen

Feedback:iAcetaminophenicanibeiobtainedioveritheicounterifromianyipharmacyiwithoi utiai
prescription.
Whichidrug(s)irequire(s)iaiDEAinumber?iAins

wer:iMorphineiSulfate

Feedback:i Morphineiisiai controlledisubstancei thati requiresi noti onlyiaiprescriptioni buti alsoi thiatithe
iorderingiandidispensing,irespectively,ineedsitoibeibyiaiphysicianiandiaipharmacistithatihaveiaiDEAi

numberiindicatingitheiriproperiregistrationiwithitheiagency.


DrugistandardsiensureiconsistencyiiniallitheiareasiEXCEPTistre
ngth
purityi
quality
isize


Answer:i d

Feedback:iDrugistandardsiassureiconsumersithatitheidrugsitheyitakeiareiofiuniformistrengith,ip
urity,iandiquality.
Thei Federali Food,i Drug,i andi Cosmetici Acti ofi 1938i establishedi whichi agency?
NDC
iDEA

iFDAi

USP

Answer:i c

Feedback:i Thei Federali Food,i Drug,i andi Cosmetici Acti ofi 1938i establishedi thei Foodi andi DruigiAd
ministrationi(FDA)iunderitheiDepartmentiofiHealthiandiHumaniServicesitoienforceitheipriovisionsiofi
theiAct.




©H2026HCengageHLearning,HInc.HAllHRightsHReserved.HMayHnotHbeHscanned,HcopiedHorHduplicated,HorHpostedHtoHaHpublicly 4
accessibleHwebsite,HinHwholeHorHinHpart.

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