Pharmacy Law Practice Exam Questions
With Correct Answers
Which bFDCA bamendment bexempted bcertain bdrugs bfrom bthe b"adequate bdirections
bfor buse" blabeling brequirement bif bthey bbear b"Rx bonly" bon btheir blabels?
a. bDurham bHumphrey
b. bKefauver-Harris
c. bPrescription bDrug bMarketing
d. bWaxman-Hatch b- bcorrect banswers✔✔a. bDurham bHumphrey
The bFDCA bdefines ba b"new bdrug" bas ba bpreviously bapproved bdrug bentity bwith ba
bnew:
a. broute bof badministration.
b. bindication bfor buse.
c. bcombination bof bingredients.
d. ba band bb
e. ba, bb band bc. b- bcorrect banswers✔✔e. broute bof badministration, bindication bfor buse,
bcombination bof bingredients.
Which bof bthe bfollowing bcircumstances bwould bbe bconsidered b"adulteration" bunder
bthe bFDCA?
a. bA bdrug bis bprepared band bpackaged bunder bunsanitary bconditions.
b. bThe bdrug's bmanufacturing bprocedures bdo bnot bconform bto bGMP bstandards.
c. bThe bdrug bis bsubject bto bthe bPoison bPrevention bPackaging bAct band bis bnot
bpackaged baccordingly.
d. ba band bb
e. ba, bb band bc b- bcorrect banswers✔✔d. bA bdrug bis bprepared band bpackaged bunder
bunsanitary bconditions, bThe bdrug's bmanufacturing bprocedures bdo bnot bconform bto
bGMP bstandards.
Which bof bthe bfollowing bcircumstances bwould bbe bconsidered b"misbranding" bunder
bthe bFDCA?
a. bA bdrug's blabel bor blabeling bis bfalse bor bmisleading.
b. bA bprescription bfor ba blegend bdrug bis brefilled bwithout bthe bprescriber's
bauthorization.
,c. bA bdrug bis bsubject bto bthe bPoison bPrevention bPackaging bAct bis bnot bpackaged
baccordingly.
d. ba band bb
e. ba, bb band bc b- bcorrect banswers✔✔e. bA bdrug's blabel bor blabeling bis bfalse bor
bmisleading, bA bprescription bfor ba blegend bdrug bis brefilled bwithout bthe bprescriber's
bauthorization, bA bdrug bis bsubject bto bthe bPoison bPrevention bPackaging bAct bis bnot
bpackaged baccordingly.
The bpurpose bof bDESI bwas bto bprove befficacy bof bprescription band bOTC bdrugs bthat
bwere bmarketed:
a. bbetween b1938 band b1962.
b. bbefore b1938.
c. bafter b1962.
d. bnone bof bthe babove. b- bcorrect banswers✔✔a. bbetween b1938 band b1962.
6. bThe blabel bon bthe bcontainer bof ban bOTC bdrug bintended bfor bsale bdirectly bto ba
bpatient bmust binclude:
a. badequate bdirections bfor bsafe band beffective buse.
b. bcautions band bwarnings bneeded bfor bthe bprotection bof bthe buser.
c. bnet bcontents bof bthe bpackage
d. bname band baddress bof bthe bmanufacturer, bpacker, bor bdistributor
e. ball bof bthe babove
f. bonly ba, bb band bc b- bcorrect banswers✔✔e. badequate bdirections bfor bsafe band
beffective buse; bcautions band bwarnings bneeded bfor bthe bprotection bof bthe buser; bnet
bcontents bof bthe bpackage; bname band baddress bof bthe bmanufacturer, bpacker, bor
bdistributor
Which bof bthe bbelow bis(are) bofficially brecognized bby bthe bFDCA?
a. bUSP/DI
b. bUSP/NF
c. bHomeopathic bPharmacopeia
d. ba band bb
e. bb band bc b- bcorrect banswers✔✔e. bUSP/NF, bHomeopathic bPharmacopeia
According bto bthe bPrescription bDrug bmarketing bAct bof b1987, bno bperson bmay bsell,
bpurchase, bor btrade:
a. bprescription bdrug bsamples.
b. bOTC bdrug bsamples.
c. bstarter bpackages bof bprescription bdrugs.
d. ba band bb
e. ba, bb, band bc b- bcorrect banswers✔✔a. bprescription bdrug bsamples.
When ba bpharmacy brepackages ba bdrug bproduct bin bunit-dose bpackages, ba brecord
bshould bbe bmaintained bwhich bincludes bamong bother bthings bthe:
a. bpharmacy's bidentification bnumber bif bdifferent bfrom bthe bmanufacturer's blot
bnumber.
, b. bproduct's bmanufacturer bor bsupplier.
c. bexpiration bdate bof bthe boriginal bcontainer.
d. ba band bb
e. ba, bb, band bc b- bcorrect banswers✔✔e. bpharmacy's bidentification bnumber bif
bdifferent bfrom bthe bmanufacturer's blot bnumber, bproduct's bmanufacturer bor bsupplier,
bexpiration bdate bof bthe boriginal bcontainer.
Which bof bthe bfollowing bsituations bmay brequire ba bpharmacy bto bregister bwith bthe
bFDA, bbe bsubject bto bFDA binspections, band bcomply bwith bCGMP?
a. bCommunity bpharmacist bcompounds blarge bbulk bquantities bof binhaler bsolution band
bships bthe bproduct bto
numerous bout-of-state bpharmacies bfor bdispensing.
b. bHospital bpharmacy brepackages band brelabels ba bdrug bproduct bin bunit-dose
bpackaging bfor broutine buse bfor binpatients.
c. bCommunity bpharmacist bcompounds bdrugs bin banticipation bof bprescription bdrug
borders bbased bon broutine bprescribing bpatterns.
d. ba band bb
e. ba, bb, band bc b- bcorrect banswers✔✔a. bCommunity bpharmacist bcompounds blarge
bbulk bquantities bof binhaler bsolution band bships bthe bproduct bto bnumerous bout-of-state
bpharmacies bfor bdispensing.
According bto bthe bPoison bPrevention bPackaging bAct bof b1970, ba bpharmacist bmay
breuse:
a. ba bglass bcontainer bon ba bprescription brefill, bprovided ba bnew bchild-resistant
bclosure bis bused.
b. bplastic bnon-child-resistant bcontainers band blids bon bprescriptions bfor bwhich bthe
bpatient bhas brequested bwaiver.
c. bplastic bchild-resistant bcontainers band blids bon bprescription brefills.
d. ba band bb
e. ba, bb band bc b- bcorrect banswers✔✔d. ba bglass bcontainer bon ba bprescription brefill,
bprovided ba bnew bchild-resistant bclosure bis bused, bplastic bnon-child-resistant
bcontainers band blids bon bprescriptions bfor bwhich bthe bpatient bhas brequested bwaiver.
It bis bnot bnecessary bto bdispense ban boral bprescription bdrug bfor bhuman buse bin ba
bchild-resistant bcontainer bif bthe:
I. bpatient brequests bstandard bpackaging.
II. bprescriber brequests bstandard bpackaging bon bthe bprescription bfor ba bspecific
bpatient.
III. bprescriber brequests ba bblanket bwaiver bfor bchild-resistant bpackaging bfor ball bof
bthe bprescriptions bof bone
patient.
IV. bpharmacist, bin bhis/her bprofessional bjudgment, bdeems bit bis bnot bnecessary.
a. bI
b. bI band bII
c. bII band bIII
d. bII, bIII band bIV b- bcorrect banswers✔✔b. b
With Correct Answers
Which bFDCA bamendment bexempted bcertain bdrugs bfrom bthe b"adequate bdirections
bfor buse" blabeling brequirement bif bthey bbear b"Rx bonly" bon btheir blabels?
a. bDurham bHumphrey
b. bKefauver-Harris
c. bPrescription bDrug bMarketing
d. bWaxman-Hatch b- bcorrect banswers✔✔a. bDurham bHumphrey
The bFDCA bdefines ba b"new bdrug" bas ba bpreviously bapproved bdrug bentity bwith ba
bnew:
a. broute bof badministration.
b. bindication bfor buse.
c. bcombination bof bingredients.
d. ba band bb
e. ba, bb band bc. b- bcorrect banswers✔✔e. broute bof badministration, bindication bfor buse,
bcombination bof bingredients.
Which bof bthe bfollowing bcircumstances bwould bbe bconsidered b"adulteration" bunder
bthe bFDCA?
a. bA bdrug bis bprepared band bpackaged bunder bunsanitary bconditions.
b. bThe bdrug's bmanufacturing bprocedures bdo bnot bconform bto bGMP bstandards.
c. bThe bdrug bis bsubject bto bthe bPoison bPrevention bPackaging bAct band bis bnot
bpackaged baccordingly.
d. ba band bb
e. ba, bb band bc b- bcorrect banswers✔✔d. bA bdrug bis bprepared band bpackaged bunder
bunsanitary bconditions, bThe bdrug's bmanufacturing bprocedures bdo bnot bconform bto
bGMP bstandards.
Which bof bthe bfollowing bcircumstances bwould bbe bconsidered b"misbranding" bunder
bthe bFDCA?
a. bA bdrug's blabel bor blabeling bis bfalse bor bmisleading.
b. bA bprescription bfor ba blegend bdrug bis brefilled bwithout bthe bprescriber's
bauthorization.
,c. bA bdrug bis bsubject bto bthe bPoison bPrevention bPackaging bAct bis bnot bpackaged
baccordingly.
d. ba band bb
e. ba, bb band bc b- bcorrect banswers✔✔e. bA bdrug's blabel bor blabeling bis bfalse bor
bmisleading, bA bprescription bfor ba blegend bdrug bis brefilled bwithout bthe bprescriber's
bauthorization, bA bdrug bis bsubject bto bthe bPoison bPrevention bPackaging bAct bis bnot
bpackaged baccordingly.
The bpurpose bof bDESI bwas bto bprove befficacy bof bprescription band bOTC bdrugs bthat
bwere bmarketed:
a. bbetween b1938 band b1962.
b. bbefore b1938.
c. bafter b1962.
d. bnone bof bthe babove. b- bcorrect banswers✔✔a. bbetween b1938 band b1962.
6. bThe blabel bon bthe bcontainer bof ban bOTC bdrug bintended bfor bsale bdirectly bto ba
bpatient bmust binclude:
a. badequate bdirections bfor bsafe band beffective buse.
b. bcautions band bwarnings bneeded bfor bthe bprotection bof bthe buser.
c. bnet bcontents bof bthe bpackage
d. bname band baddress bof bthe bmanufacturer, bpacker, bor bdistributor
e. ball bof bthe babove
f. bonly ba, bb band bc b- bcorrect banswers✔✔e. badequate bdirections bfor bsafe band
beffective buse; bcautions band bwarnings bneeded bfor bthe bprotection bof bthe buser; bnet
bcontents bof bthe bpackage; bname band baddress bof bthe bmanufacturer, bpacker, bor
bdistributor
Which bof bthe bbelow bis(are) bofficially brecognized bby bthe bFDCA?
a. bUSP/DI
b. bUSP/NF
c. bHomeopathic bPharmacopeia
d. ba band bb
e. bb band bc b- bcorrect banswers✔✔e. bUSP/NF, bHomeopathic bPharmacopeia
According bto bthe bPrescription bDrug bmarketing bAct bof b1987, bno bperson bmay bsell,
bpurchase, bor btrade:
a. bprescription bdrug bsamples.
b. bOTC bdrug bsamples.
c. bstarter bpackages bof bprescription bdrugs.
d. ba band bb
e. ba, bb, band bc b- bcorrect banswers✔✔a. bprescription bdrug bsamples.
When ba bpharmacy brepackages ba bdrug bproduct bin bunit-dose bpackages, ba brecord
bshould bbe bmaintained bwhich bincludes bamong bother bthings bthe:
a. bpharmacy's bidentification bnumber bif bdifferent bfrom bthe bmanufacturer's blot
bnumber.
, b. bproduct's bmanufacturer bor bsupplier.
c. bexpiration bdate bof bthe boriginal bcontainer.
d. ba band bb
e. ba, bb, band bc b- bcorrect banswers✔✔e. bpharmacy's bidentification bnumber bif
bdifferent bfrom bthe bmanufacturer's blot bnumber, bproduct's bmanufacturer bor bsupplier,
bexpiration bdate bof bthe boriginal bcontainer.
Which bof bthe bfollowing bsituations bmay brequire ba bpharmacy bto bregister bwith bthe
bFDA, bbe bsubject bto bFDA binspections, band bcomply bwith bCGMP?
a. bCommunity bpharmacist bcompounds blarge bbulk bquantities bof binhaler bsolution band
bships bthe bproduct bto
numerous bout-of-state bpharmacies bfor bdispensing.
b. bHospital bpharmacy brepackages band brelabels ba bdrug bproduct bin bunit-dose
bpackaging bfor broutine buse bfor binpatients.
c. bCommunity bpharmacist bcompounds bdrugs bin banticipation bof bprescription bdrug
borders bbased bon broutine bprescribing bpatterns.
d. ba band bb
e. ba, bb, band bc b- bcorrect banswers✔✔a. bCommunity bpharmacist bcompounds blarge
bbulk bquantities bof binhaler bsolution band bships bthe bproduct bto bnumerous bout-of-state
bpharmacies bfor bdispensing.
According bto bthe bPoison bPrevention bPackaging bAct bof b1970, ba bpharmacist bmay
breuse:
a. ba bglass bcontainer bon ba bprescription brefill, bprovided ba bnew bchild-resistant
bclosure bis bused.
b. bplastic bnon-child-resistant bcontainers band blids bon bprescriptions bfor bwhich bthe
bpatient bhas brequested bwaiver.
c. bplastic bchild-resistant bcontainers band blids bon bprescription brefills.
d. ba band bb
e. ba, bb band bc b- bcorrect banswers✔✔d. ba bglass bcontainer bon ba bprescription brefill,
bprovided ba bnew bchild-resistant bclosure bis bused, bplastic bnon-child-resistant
bcontainers band blids bon bprescriptions bfor bwhich bthe bpatient bhas brequested bwaiver.
It bis bnot bnecessary bto bdispense ban boral bprescription bdrug bfor bhuman buse bin ba
bchild-resistant bcontainer bif bthe:
I. bpatient brequests bstandard bpackaging.
II. bprescriber brequests bstandard bpackaging bon bthe bprescription bfor ba bspecific
bpatient.
III. bprescriber brequests ba bblanket bwaiver bfor bchild-resistant bpackaging bfor ball bof
bthe bprescriptions bof bone
patient.
IV. bpharmacist, bin bhis/her bprofessional bjudgment, bdeems bit bis bnot bnecessary.
a. bI
b. bI band bII
c. bII band bIII
d. bII, bIII band bIV b- bcorrect banswers✔✔b. b
