Expiration-Dating-of-Unit-Dose-Repackaged-Solid-Or

ExpirationDatingofUnit-DoseRepackagedSolidOralDosageFormDrugProductsGuidanceforIndustryDRAFTGUIDANCEThisguidancedocumentisbeingdistributedforcommentpurposesonly.Commentsandsuggestionsregardingthisdraftdocumentshouldbesubmittedwithin60daysofpublicationintheFederalRegisterofthenoticeannouncingtheavailabilityofthedraftguidance.Submitelectroniccommentsto(HFA-305),FoodandDrugAdministration,5630FishersLane,rm.1061,Rockville,MD20852.AllcommentsshouldbeidentifiedwiththedocketnumberlistedinthenoticeofavailabilitythatpublishesintheFederalRegister.Forquestionsregardingthisdraftdocument,contact(CDER)BillHarveyat240-402-4180.U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)August2017PharmaceuticalQuality/ManufacturingStandards(CGMP)Revision1ExpirationDatingofUnit-DoseRepackagedSolidOralDosageFormDrugProductsGuidanceforIndustryAdditionalcopiesareavailablefrom:OfficeofCommunications,DivisionofDrugInformationCenterforDrugEvaluationandResearchFoodandDrugAdministration10001NewHampshireAve.,HillandaleBldg.,4thFloorSilverSpring,MD20993-0002Phone:[phone]or301-796-3400;Fax:[phone]Email:[e-mail](CDER)August2017PharmaceuticalQuality/ManufacturingStandards(CGMP)Revision1ContainsNonbindingRecommendationsDraft—NotforImplementationTABLEOFCONTENTSI.INTRODUCTION.............................................................................................................1II.BACKGROUND...............................................................................................................2III.POLICY.............................................................................................................................2ContainsNonbindingRecommendationsDraft—NotforImplementation1ExpirationDatingofUnit-DoseRepackagedSolidOralDosage1FormDrugProducts2GuidanceforIndustry1345Thisdraftguidance,whenfinalized,willrepresentthecurrentthinkingoftheFoodandDrug6Administration(FDAorAgency)onthistopic.Itdoesnotestablishanyrightsforanypersonandisnot7bindingonFDAorthepublic.Youcanuseanalternativeapproachifitsatisfiestherequirementsofthe8applicablestatutesandregulations.Todiscussanalternativeapproach,contacttheFDAstaffresponsible9forthisguidanceaslistedonthetitlepage.10111213I.INTRODUCTION1415Thelastfewdecadeshaveseenanincreasingdemandinvarioushealthcaresettingsforsolid16oraldosageformdrugproductsrepackagedintounit-dosecontainers,whichholdaquantityof17drugforadministrationasasingledose.Theincreaseinunit-doserepackaginghasledto18questionsregardingstabilitystudiesandappropriateexpirationdatesfortheserepackaged19products.ThisguidancedescribestheconditionsunderwhichFDAdoesnotintendtotakeaction20regardingrequiredstabilitystudiesfortheserepackagedproductsandtheexpirationdateto21assignunderthoseconditions.22223Thisguidanceaddressesrepackagingofprescriptionandover-the-countersolidoraldosageform24drugsintounit-dosecontainersbycommercialpharmaceuticalrepackagingfirmsthatare25requiredtoregisterwithFDAundersection510oftheFederalFood,Drug,andCosmeticAct26(FD&CAct)andtocomplywithcurrentgoodmanufacturingpractice(CGMP)regulationsin2127CFRparts210and211.32829Theguidancedoesnotaddressrepackaginginvolvingthefollowing:3031•Otherdosageforms(e.g.,sterile,liquid,topical).32331ThisguidancehasbeenpreparedbytheOfficeofPharmaceuticalQualityintheCenterforDrugEvaluationandResearchattheFoodandDrugAdministration.2ThisdraftguidancereplacesthedraftguidanceforindustryExpirationDatingofUnit-DoseRepackagedDrugs:CompliancePolicyGuide(2005).Inaddition,thisdraftguidance,oncefinal,willsupersedeCompliancePolicyGuide480.200ExpirationDatingofUnit-DoseRepackagedDrugs(1995).3Asdescribedin21CFR207.3(a)(8),manufacturingorprocessingincludesrepackagingorotherwisechangingthecontainer,wrapper,orlabelingofanydrugpackagetofurtherthedistributionofthedrugfromtheoriginalplaceofmanufacturetothepersonwhomakesfinaldeliveryorsaletotheultimateconsumer.ContainsNonbindingRecommendationsDraft—NotforImplementation234•ProductsrepackagedbyState-licensedpharmacies,Federalfacilities,andoutsourcing35facilitiesasdefinedundersection503BoftheFD&CAct.43637Ingeneral,FDA’sguidancedocumentsdonotestablishlegallyenforceableresponsibilities.38Instead,guidancesdescribetheAgency’scurrentthinkingonatopicandshouldbeviewedonly39asrecommendations,unlessspecificregulatoryorstatutoryrequirementsarecited.Theuseof40thewordshouldinAgencyguidancesmeansthatsomethingissuggestedorrecommended,but41notrequired.4243II.BACKGROUND4445FDA’sCGMPregulationsforfinishedpharmaceuticalsrequirethateachdrugproductbearan46expirationdatedeterminedbyappropriatestabilitytestingandthatthedatemustberelatedto47anystorageconditionsstatedonthelabeling,asdeterminedbystabilitystudies(§§211.137(a)48and(b)).5Theexpirationdateforadrugp