PTCB Exam 2026 Questions and Answers

PTCB Exam 2026 Questions and
Answers
PureAFoodAandADrugAActAofA1906A-
AAnswerAallAmanufacturersAareArequiredAtoAproperlyAlabelAaAdrugAwithAtruthfulAinformation


HarrisonANarcoticsAActAofA1914A-
AAnswerAincreasedAregulationAofAopioidsAandAcocaineAandArequiredAaAprescriptionApriorAtoA
dispensing


SulfanilamideATragedyAofA1937A-AAnswerA100ApeopleAdiedAafterAuseAofAsulfanilamide
ledAtoApassageAofAFood,ADrug,AandACosmeticAActAofA1938


Food,ADrug,AandACosmeticsAActAofA1938A-AAnswerA-
GaveAtheAFDAAmoreAauthorityAandAresponsibility
-IncreasedAtheAaccountabilityAofAdrugAcompaniesAregardingAtheAsafetyAofAdrugs
-AddedAtheAlabel,A"warning,AmayAbeAhabitAforming"
-ThisAactAalsoAcreatedAtheAUSAPharmacopeiaAandAtheANationalAFormulary


Durham-HumphreyAAmendmentAofA1951A-
AAnswerAProhibitsAdispensingAofAlegendAdrugsAwithoutAaAprescription.AAlsoAcreatedAtheAdis
tinctionAbetweenARxAandAOTCAmedications.


ThalidomideATragedyAofA1962A-
AAnswerA10,000AchildrenAdiedAfromAaAThalidomideAsideAeffect,AwasAmarketedAasAaAsedativ
eAandAhypnoticAusedAforAinsomnia,AanxietyAandAgastritis.ALedAtoAstricterAdrugAresearch,Ade
velopment,AandAregulations.AOnlyA50%AofAtheAchildrenAsurvived.


Kefauver-HarrisAAmendmentAofA1962A-
AAnswerA•AAlsoAknownAasAtheA"DrugAEfficacyAAmendment".
•ARequiredAdrugAmanufacturersAtoAprovideAproofAofAtheAeffectivenessAandAsafetyAofAtheirAd
rugsAbeforeAapprovalA.
•ARequiredAdrugAadvertisingAtoAbeAmoreAcloselyAregulatedAandAdiscloseAaccurateAinformatio
nAaboutAsideAeffects


ComprehensiveADrugAAbuseAPreventionAandAControlAActAofA1970A-
AAnswerAAKAAtheA"ControlledASubstanceAAct"

, OccupationalASafetyAandAHealthAAdministrationA(OSHA)A-AAnswerA


DrugAListingAActAofA1972A-AAnswerAEstablishAtheANDCA(NationalADrugACode)AnumberA
5A-A4A-A2A
FirstA5:AtheAmanufacturer
2ndA4:AtheAdrugAproduct
FinalA2:ApackageAsizeAandApackaging


MedicalADeviceAAmendmentAofA1976A-AAnswerARequiresApre-
marketAapprovalAforAsafetyAandAeffectivenessAofAlife-sustainingAandAlife-
supportingAmedicalAdevices.


ResourceAConservationAandARecoveryAActAofA1976A-
AAnswerAGivesAtheAEPAAcompleteAauthorityAinAtheAdisposalAofAhazardousAsubstances.


OrphanADrugAActAofA1983A-
AAnswerAPassedAforAdrugsAthatAtreatAdiseasesAthatAaffectAveryAfewApeopleAtoAhelpAwithAta
xAreliefAandAotherAincentivesAforAmanufacturesAtoAdevelpAandAmarketAsuchAdrugs.


DrugAPriceACompetitionAandAPatentATermARestorationAActAofA1984A-
AAnswerAEncouragesAtheAmanufacturingAprocessAofAgenericAdrugsAbyAcompaniesAandAformed
AtheAmodernAsystemAofAgenericAdrugAregulation.ATheAactAoutlinesAtheAprocessAforAdrugAco
mpaniesAtoAfileAanAabbreviatedAnewAdrugA(ANDA)AtoAreceiveAapprovalAofAaAgenericAdrugAb
yAtheAFDA.


PrescriptionADrugAMarketingAActAofA1987A-
AAnswerASolidifiedAlegalAsupplyAchannelAofArxAdrugsAfromAmanufacturerAtoAauthorizedAdistr
ibutors,ApreventAtheAsellingAofAcounterfeitAdrugs.


OmnibusABudgetAReconciliationAActA(OBRA)AofA1990A-
AAnswerArequiresApharmacistsAtoAofferAcounselingAtoAMedicaidApatientsAregardingAmedicatio
nsAwhichAincludesADUR


FDAASafeAMedicalADevicesAActAofA1990A(SMDA)A-
AAnswerAImplementedAmedicalAdeviceAreportingAofAseriousAincidentsAthatAoccurAfromAtheAus
eAofAmedicalAdevices.