Essentials of
Pharmacology for
Health
Professions, 8th
Edition, Bruce
Colbert, Ruth
Woodrow
,CHAPTER 1: CONSUMER SAFETY AND DRUG REGULATIONS
p p p p p p
TRUE/FALSE
1. Theppharmaceuticalpmanufacturerphaspthepauthorityptopaddpadditionalpactivep
ingredientsptopappreviouslypapprovedppharmaceuticalpproduct.
ANS:p F
Accordingptopthep1938pFederalpFood,pDrug,pandpCosmeticpActpandpAmendmen
tspofp1951pandp1962,pallplabelspmustpbepaccuratepandpincludepaplistingpofpallpacti
vepandpinactivepingredients.
PTS:p 1
2. Drugpstrengthpmaypvarypwithpeachplotpnumberpofpapmedication.
ANS:p F
Thep1906pPurepFoodpandpDrugpActpestablishedpthatpallpdrugspmarketedpinpthepU
nitedpStatespmeetpminimalpstandardspofpstrength,ppurity,pandpquality.
PTS:p 1
3. ThepPurepFoodpandpDrugpActpofp1906pestablishedpdrugpstandardspandpofficialp
drugpreferences.
ANS:p T
ThispactpestablishedpthatpallpdrugspmarketedpinpthepUnitedpStatespmeetpminima
lpstandardspofpstrength,ppurity,pandpquality.p Itpalsopestablishedptwopofficialprefer
encespthatpestablishedpthepstandardspforpmakingpeachpdrug:p The
U.S.pPharmacopeiap(USP)pandpthepNationalpFormularyp(NF).
PTS:p 1
4. Thep1906pPurepFoodpandpDrugpActpestablishedpconsumerpprotectionsptoppr
eventpthepinclusionpofp“dangerouspingredients”pwithoutpthepknowledgepofpth
epconsumer.
ANS:p T
Morphinepisponepexamplepofpapdangerouspingredientpthatpmayphavepbeenpinclud
edpwithoutpthepknowledgepofpthepconsumer.
PTS:p 1
5. Medicationplabelspneedponlypincludeptheptradepnamepofpthepdrug.
ANS:p F
Labelspmustpincludepaplistingpofpallpactivepandpinactivepingredients,pwarningplab
elsponpcertainppreparations,pandpgenericpnamespforpthepmedication
, PTS:p 1
6. Thepprescriberpofpthepmedicationpisptheponlyphealthpcarepprofessionalpwhopisp
responsiblepforpbeingpawarepofpnewpmedications,plaws,pandprestrictions.
ANS:p F
Thephealthpcarepworkerpinvolvedpinpadministrationpofpapmedicationpalsopbearspt
hepresponsibilitypofpbeingpawarepofptheplawspandprestrictionsppertinentptopthatp
medication.
PTS:p 1
7. Apdouble-
lockedpsystempisptheprecommendedpmethodpforpmaintainingpsecuritypofpcontrol
ledpsubstances.
ANS:p T
Apdouble-
lockedpsystempmaypincludeptwopseparatepkeypentriesporpanpelectronicpuserpiden
tificationpandppasswordpaccesspsystem.
PTS:p 1
8. Healthpcarepworkersparepresponsiblepforpmaintainingprecordspofpallpcontrolledp
substancespreceived,pdispensed,pandpdestroyed.
ANS:p T PTS:p 1
9. Controlledpsubstanceprecordspareptopbepkeptpforp10pyears.
ANS:p F
Recordspforptheppreviousp2pyearspmustpbepavailablepatpallptimespforpinspection.p
PTS:p 1
MULTIPLEpCHOICE
1. Identifypthepdrugpstandardpinpthepfollowingplist.
a. Color c. Shape
b. Strength d. Taste
ANS:p B
Feedback
A Colorpispnotpapstandard.
B Correct!
C Shapepispnotpapstandard.
D Tastepispnotpapstandard.
, PTS:p 1
2. Thepriskpofpdeathpfrompthepusepofpstreetpdrugspversuspprescriptionp
medicationspispmostlypduepto:
a. aplackpofpcontrolpoverpquality,ppurity,p
andpstrengthpmakespstreetpdrugspdan
gerous.
b. thepriskpispthepsamepforpbothpsourcesp
ofpthepsamepsubstance.
c. streetpdrugsparepapprovedpforpuse.
d. thepneedpforpapprescriptionpmakespdru
gsphardptopobtain.
ANS:p A
Feedback
A Correct!
B Theplackpofpenforcementpofpdrugpstan
dardspinpillegalpstreetpdrugspposespaps
ignificantpdangerpforpthepconsumer.
C Thepexactpcompositionpofpapstreetpdru
gpispunknown,pandpitpmaypcontainpdan
gerouspcontaminantsporpundisclosedp
additionalpdrugs.
D Streetpdrugsparepillegal.
PTS:p 1
3. Drugpstandardspregulatepdrugpmanufacturepsopthatpmedicationspofpthepsamep
namepwillpbepofpthepsame:
a. strength,p purity,p andp quality.
b. shape,pcolor,pandptaste.
c. purity,pshape,pandpcolor.
d. quality,pcolor,pandpshape.
ANS:p A
Drugpstandardspstatepthatpallppreparationspofpthepsamepdrugpnamepmustpbepofp
uniformpstrength,ppurity,pandpquality.
PTS:p 1
4. Thep1906pPurepFoodpandpDrugpActpincludespwhichpofpthepfollowingpprovisions?
a. Regulationpofpdrugspsoldpinpthe