TheCommonwealthofMassachusettsExecutiveOfficeofHealthandHumanServicesDepartmentofPublicHealth
BureauofHealthProfessionsLicensure
239CausewayStreet,Suite500,Boston,MA02114
CHARLESD.BAKER
Governor
KARYNE.POLITO
LieutenantGovernor
Tel:617-973-0800
TTY:617-973-0988
MARYLOUSUDDERS
Secretary
MONICABHAREL,MD,MPH
Commissioner
STERILECOMPOUNDINGREPORTINGFORM
January1-June30(year)
July1–December31(year)
AllMassachusettspharmaciesthatarelicensedbytheMassachusettsBoardofRegistrationinPharmacy(“Board”)andengageincompoundingofsterileproductsarerequiredtocompleteandsubmitproduct,volume,distribution,andcompliancedataeverysixmonthspursuantto247CMR6.15(5).ThisreportingprocessisdesignedtoensurethatallpharmacieslicensedbytheBoardthatperformsterilecompoundingareincompliancewithallstateandfederallawsandregulations,includinginparticulartheUnitedStatesPharmacopeia(USP)GeneralChapter797PharmaceuticalCompounding–SterilePreparations.ThecompletedformmustbesubmittedtotheBoardonorbeforeAugust15forthefirsthalfoftheyearorFebruary15forthesecondhalf.
Massachusettspharmaciesthatdonotengageinsterilecompounding,asdefinedinUSPGeneralChapter797,areNOTrequiredtosubmitthisformtotheBoard.Hospitalpharmaciesengagedinsterilecompoundingarenotrequiredtosubmitthisformatthistime.
TheFAILUREofanyMassachusettspharmacythatperformssterilecompoundingtoprovidetherequestedinformationtotheBoardbythedeadlinemaybegroundsfordisciplineunder247CMR10.03(q).
AnyMassachusettspharmacythatperformssterilecompoundingthatdoesNOTprovidetherequestedinformationtotheBoardbytherequireddateisNOTauthorizedtoengageinsterilecompoundingandmustIMMEDIATELYCEASEpreparinganddispensingallsterileproducts.
PleaseelectronicallysubmittheSterileCompoundingReportingFormandTableofCSPPrescriptionsfoundat:
PleaseNote:TableofCSPPrescriptionsmustbesubmittedusingBoardprovidedtemplateinExcelformatonly(i.e.notpdfversions).
AllquestionsregardingtheSterileCompoundingReportingFormand/ortheTableofCSPPrescriptionsshouldbedirectedtoWilliamFrisch,MichelleChan,.
Thankyou.
NameofMassachusettsPharmacy
StreetAddress
City/Town
ZipCode
Tel.No.
FaxNo.
PharmacyE-mail MADrugStorePermitNumbers:
DrugStore(DSNo.)orNuclearPharmacy(NUNo.)
Exp.Date
ControlledSubstance(CSNo.)
Exp.Date
ListanyotherregistrationsbelowrelatedtotheMassachusettsPharmacy(e.g.,manufacturer,wholesaledistributor):
DEARegistrationNo. _ DCPRegistrationNo. _ FDARegistrationNo. _ (manufacturer/distributoronly)Other:
AnswerallofthefollowingquestionsforthespecifiedreportingperiodONLY
A.STERILECOMPOUNDINGACTIVITY:
1.IndicatethetotalnumberofprescriptionsdispensedbymonthandbyUSPGeneralChapter797risk-levelcategory(low,medium,high)forthereportingperiodlistedbelow:
LowRiskCompounding:singlevolumetransfersofnotmorethan3steriledosageformsandnotmorethan2entriesintoasterilecontainer(e.g.,hydratingsolutions,irrigations,antibioticsandoncologymedications).
MediumRiskCompounding:thecompoundingprocessincludescomplexasepticmanipulationsotherthansinglevolumetransfer(e.g.,TPN,cardioplegiasolutions,multiplesterileingredientadmixtures).
HighRiskCompounding:non-sterileingredients,includingmanufacturedproductsnotintendedforsterileroutesofadministration,areincorporatedoranon-steriledeviceisemployedbeforeterminalsterilization.
TotalNumberofPrescriptions/OrdersRiskLevel
Month / #Low / #Medium / #High / Total
2.DoesthepharmacyholdalicenseinanyotherstatethanMassachusetts?
YesNo
Ifyes,identifyallotherstate(s)inwhichthepharmacyholdsalicenseandindicatethestatusofeachnon-residentlicenseas:active,expired,onprobation,restrictedorrevoked.
Alabama / Active / Expired / Probation / Restricted / RevokedAlaska / Active / Expired / Probation / Restricted / Revoked
Arizona / Active / Expired / Probation / Restricted / Revoked
Arkansas / Active / Expired / Probation / Restricted / Revoked
California / Active / Expired / Probation / Restricted / Revoked
Colorado / Active / Expired / Probation / Restricted / Revoked
Connecticut / Active / Expired / Probation / Restricted / Revoked
Delaware / Active / Expired / Probation / Restricted / Revoked
D.C. / Active / Expired / Probation / Restricted / Revoked
Florida / Active / Expired / Probation / Restricted / Revoked
Georgia / Active / Expired / Probation / Restricted / Revoked
Hawaii / Active / Expired / Probation / Restricted / Revoked
Idaho / Active / Expired / Probation / Restricted / Revoked
Illinois / Active / Expired / Probation / Restricted / Revoked
Indiana / Active / Expired / Probation / Restricted / Revoked
Iowa / Active / Expired / Probation / Restricted / Revoked
Kansas / Active / Expired / Probation / Restricted / Revoked
Kentucky / Active / Expired / Probation / Restricted / Revoked
Louisiana / Active / Expired / Probation / Restricted / Revoked
Maine / Active / Expired / Probation / Restricted / Revoked
Maryland / Active / Expired / Probation / Restricted / Revoked
Michigan / Active / Expired / Probation / Restricted / Revoked
Minnesota / Active / Expired / Probation / Restricted / Revoked
Mississippi / Active / Expired / Probation / Restricted / Revoked
Missouri / Active / Expired / Probation / Restricted / Revoked
Montana / Active / Expired / Probation / Restricted / Revoked
Nebraska / Active / Expired / Probation / Restricted / Revoked
Nevada / Active / Expired / Probation / Restricted / Revoked
NewHampshire / Active / Expired / Probation / Restricted / Revoked
NewJersey / Active / Expired / Probation / Restricted / Revoked
NewMexico / Active / Expired / Probation / Restricted / Revoked
NewYork / Active / Expired / Probation / Restricted / Revoked
NorthCarolina / Active / Expired / Probation / Restricted / Revoked
NorthDakota / Active / Expired / Probation / Restricted / Revoked
Ohio / Active / Expired / Probation / Restricted / Revoked
Oklahoma / Active / Expired / Probation / Restricted / Revoked
Oregon / Active / Expired / Probation / Restricted / Revoked
Pennsylvania / Active / Expired / Probation / Restricted / Revoked
RhodeIsland / Active / Expired / Probation / Restricted / Revoked
SouthCarolina / Active / Expired / Probation / Restricted / Revoked
SouthDakota / Active / Expired / Probation / Restricted / Revoked
Tennessee / Active / Expired / Probation / Restricted / Revoked
Texas / Active / Expired / Probation / Restricted / Revoked
Utah / Active / Expired / Probation / Restricted / Revoked
Vermont / Active / Expired / Probation / Restricted / Revoked
Virginia / Active / Expired / Probation / Restricted / Revoked
Washington / Active / Expired / Probation / Restricted / Revoked
WestVirginia / Active / Expired / Probation / Restricted / Revoked
Wisconsin / Active / Expired / Probation / Restricted / Revoked
Wyoming / Active / Expired / Probation / Restricted / Revoked
Other: / Active / Expired / Probation / Restricted / Revoked
Other: / Active / Expired / Probation / Restricted / Revoked
3.DoesthepharmacydispenseCompoundedSterilePreparations(CSPs)toanystatesand/orjurisdictionsoutsideofMassachusetts?
YesNo
Ifyes,identifyallstate(s)andjurisdictionsoutsideofMassachusettswhichthepharmacydispensesto.
AlabamaAlaskaArizonaArkansasCaliforniaColoradoConnecticutDelawareD.C.
FloridaGeorgiaHawaiiIdaho
IllinoisIndianaIowaKansasKentuckyLouisianaMaineMarylandMichiganMinnesotaMississippiMissouriMontana
NebraskaNevada
NewHampshireNewJerseyNewMexicoNewYorkNorthCarolinaNorthDakotaOhio
OklahomaOregonPennsylvaniaRhodeIsland
SouthCarolinaSouthDakotaTennesseeTexas
UtahVermontVirginiaWashingtonWestVirginiaWisconsinWyoming
Other: Other:
4.Isthepharmacycurrentlyregistered,licensed,orpermittedasawholesaledistributorinanystate?
YesNo
Ifyes,identifyallotherstate(s)whichthepharmacyiscurrentlyregistered,licensed,orpermittedasawholesaledistributor.
AlabamaAlaskaArizonaArkansasCaliforniaColoradoConnecticutDelawareD.C.
FloridaGeorgiaHawaiiIdaho
IllinoisIndianaIowaKansasKentuckyLouisianaMaineMarylandMichiganMinnesotaMississippiMissouriMontana
NebraskaNevada
NewHampshireNewJerseyNewMexicoNewYorkNorthCarolinaNorthDakotaOhio
OklahomaOregonPennsylvaniaRhodeIsland
SouthCarolinaSouthDakotaTennesseeTexas
UtahVermontVirginiaWashingtonWestVirginiaWisconsinWyoming
Other: Other:
5.Identifyallwholesaledistributors,includingbothcontractedentitiesandmanufacturers,thatthepharmacyreceivesproductsfrom,includingchemicals,medications,syringes,vials,andotherrelatedequipmentandmaterialsrequiredtoproduceCSPs:
AmerisourceBergenAmericanReagentAnda
ApothecareProductsAPP
ASD
AttentusBaxterBbraunBellcoBioSoln
CAPS-BirminghamCAPS-ChicagoCAPS-LehighValleyCardinal
CSLBehringCubistFagron
FFFEnterprisesGallipot
HaemoneticsHDSmith
HealthcareLogisticsHealthcareTechnologiesHospira
IndependenceMedicalIntegratedMedicalIMS
JOM
KinrayLetcoLetzo
LibertyIndustriesLifelineMcKesson
MedicalSpecialtiesMedisca
MedlineMSDODC
PCCA
SagentSandorPharm
SmithsMedical
SunPharmaceuticalsVygon
WestWardWolfMedica
Other: Other: Other: Other: Other: Other: Other: Other: Other: Other:
6.Identifyallmanufacturersthatprovidethepharmacywithnon-sterileActivePharmaceuticalIngredients(API):
AndaBellcoFagronFreedomGallipotLetco
MallinckrodtGroup
McKessonMediscaODCPCCA
Other: Other: Other:
Other: Other: Other: Other: Other: Other: Other:
B.STAFFING/TRAINING/COMPETENCYEVALUATIONS:
1.
a)Identifybyname,titleandlicensenumberofallpharmacypersonnelengagedinpreparingCSPs.(Attachadditionalpagesifnecessary.)
Name / Title / License#Name / Title / License#
Name / Title / License#
Name / Title / License#
Name / Title / License#
Name / Title / License#
Name / Title / License#
Name / Title / License#
Name / Title / License#
Name / Title / License#
Name / Title / License#
Name / Title / License#
Name / Title / License#
Name / Title / License#
Name / Title / License#
Name / Title / License#
Name / Title / License#
Name / Title / License#
Name / Title / License#
Name / Title / License#
Name / Title / License#
Name / Title / License#
Name / Title / License#
Name / Title / License#
Name / Title / License#
b)Statethecurrentnumberofpharmacistsinvolvedinanywayinthepreparationand/ordispensingofCSPs.
Statethecurrentnumberofpharmacytechniciansinvolvedinanywayinthepreparationand/ordispensingofCSPs.
2.Doallpharmacistsandpharmacytechniciansinvolvedinthepreparationand/ordispensingofCSPshavedocumentedtrainingconsistentwithUSP797?
YesNo
3.Doallpharmacistsandpharmacytechniciansinvolvedinthepreparationand/ordispensingofCSPsundergoatleastoneregularlyscheduledcompetencyvalidationevery12months?
YesNo
Ifyes,specifythefrequencyofcompetencyvalidations:
EverymonthEvery2months
Every3months
Every4months
Every5months
Every6months
Every7months
Every8months
Every9months
Every10months
Every11months
Every12months
C.QUALITYASSURANCE
Pleasecompletethefollowingtable:
TypeofEquipment/Resources / Howmanyofeachdoesthepharmacyhave? / HavetheybeenISOcertifiedwithinthepast6months?Laminarairflowhoods / YesNoN/A
Biologicalsafetycabinets(BSCs) / YesNoN/A
CompoundingAsepticIsolators(CAIs,gloveboxes) / YesNoN/A
CompoundingAsepticContainmentIsolators(CACIs) / YesNoN/A
Cleanrooms,positivepressure / YesNoN/A
AnteRooms,positivepressure / YesNoN/A
Cleanrooms,negativepressure / YesNoN/A
1.
a)Identifyallsterilizationprocessesusedbypharmacy:
FilterDryHeatOther:
SteamAutoclave
b)DoesthepharmacyfollowUSP797>standardsforsterilizationofCSPs?
YesNoN/A
c)Ifused,doesthepharmacyproperlysterilizenon-sterilevials,non-sterilestoppers,oranyothernon-sterilecomponentsinthepreparationofCSPs?
YesNoN/A
d)Haspharmacyverifiedthatallmethodsachievesterilitywhilemaintainingappropriatestrength,purity,quality,andpackagingintegrity?
YesNoN/A
2.Doesthepharmacystore,use,andmaintainallsuppliesandequipmentusedtoprepareCSPsinaccordancewithmanufacturers’specifications?
YesNo
3.WhenwasthemostrecentUSP<797>GapAnalysiscompleted?mm/dd/yyyy)
4.DoesthePharmacyhaveadatadrivenQualityAssurance/PerformanceImprovementProgram?
YesNo
5.DoesthepharmacyalwaysuseUSP797Beyond-Use-Dating?
YesNo
IfthepharmacydoesnotalwaysuseUSP797>Beyond-Use-Dating,answerthefollowingquestions:
a)Forwhatrisklevel(s)doesthepharmacyextendtheUSP797>Beyond-Use-Date?
LowMediumHigh
b)Whatisthepharmacy’slongestBeyond-Use-Date(indays)?andwhatisthisCSP’srisklevel?
LowMediumHigh
c)DoesthepharmacyusescientificliteratureinordertoestablishBeyond-Use-Dating?
YesNo
d)DoesthepharmacyindependentlyvalidateitsBeyond-Use-Dating?
YesNo
D.COMPLIANCE/SANCTIONS
1.DoesthepharmacyonlyprepareanddispenseCSPsafterreceiptofavalidprescriptionforasinglepatient?
YesNo
2.CheckallrisklevelsofCSPsthepharmacypreparedduringthereportingperiod.
LowMediumHigh
3.DoesthepharmacymaintainawrittenpolicyandproceduremanualforpreparinganddispensingCompoundedSterilePreparationsinconformancewithUSP797?
YesNo
4.DidthepharmacyengageinbatchcompoundingofCSPsduringthisreportingperiod?
YesNo
Ifyes:
a)Howmanyunitswereinthelargestbatch?(Units=1cassette,1bag,1syringe,etc.)
b)Doesthepharmacyperformsterilitytestingonallbatches?
YesNo
Ifno,pleaseexplainwhynot.
c)Doesthepharmacyperformendotoxintestingonallbatches?
YesNo
Ifno,pleaseexplainwhynot.
5.Hasthepharmacybeendisciplined,asdefinedin247CMR6.15,duringthereportingperiod?
YesNo
Ifyes:
a) Didthepharmacyreportthedisciplinaryaction(s)totheMassachusettsBoardofRegistrationinPharmacy?
YesNo
Ifno,pleaseexplainwhynot.
Identifytheagencyoragenciesthatdisciplinedthepharmacy:
N/AMedicareMedicaidDEA
FDA
AlabamaBORPAlaskaBORPArizonaBORPArkansasBORP
CaliforniaBORPColoradoBORPConnecticutBORPDelawareBORP
D.C.BORP
FloridaBORPGeorgiaBORPHawaiiBORPIdahoBORPIllinoisBORPIndianaBORPIowaBORPKansasBORPKentuckyBORPLouisianaBORPMaineBORPMarylandBORPMichiganBORPMinnesotaBORPMississippiBORP
MissouriBORPMontanaBORPNebraskaBORPNevadaBORP
NewHampshireBORPNewJerseyBORPNewMexicoBORPNewYorkBORPNorthCarolinaBORPNorthDakotaBORPOhioBORP
OklahomaBORPOregonBORP
PennsylvaniaBORP
RhodeIslandBORP
SouthCarolinaBORPSouthDakotaBORPTennesseeBORPTexasBORP
UtahBORPVermontBORPVirginiaBORPWashingtonBORPWestVirginiaBORPWisconsinBORPWyomingBORPOther: Other:
6.Didthepharmacyexperienceanyadversechangeinstatusofaccreditation,asdefinedin247CMR6.15,includingbutnotlimitedtowithdrawal,discontinuance,termination,revocation,suspension,probation,orwarning,duringthereportingperiod?
YesNo
Ifyes:
a)DidthepharmacyreportthischangeinstatustotheMassachusettsBoardofRegistrationinPharmacy?
YesNo
b)Forwhichaccreditationorganization(s)?
PCAB
JointCommission
Other:
Other:_Other:_Other:_
Other:_
E.LEGISLATIVEREPORTINGREQUIREMENTS
1.FillouttheTableofCSPPrescriptionsforThisReportingPeriodinExcelthatisprovidedontheBoard’swebsiteunderMandatedReportingForms.
2.Whatisthenumberofin-stateindividualsterilecompoundedprescriptionsorordersforendusersyourpharmacyhasdispensedduringthisreportingperiod?
3.Whatisthenumberofout-of-stateindividualsterilecompoundedprescriptionsorordersforendusersyourpharmacyhasdispensedduringthisreportingperiod?
4.HavetheMORandallpharmacistsandtechniciansonstaffcompletedallrequiredCEcredits?
YesNo
5.ListthenameandtitleoftheMORandallprincipalmanagers(includeallcurrentmanagersinthepharmacy;notjuststerilecompounding).
Name Name Name Name Name Name Name Name Name Name
Title Title Title Title Title Title Title Title Title Title
6.Attachalistofthenameandtitleofeveryemployeeatthefacility(remembertoincludeallnon-licensedandnon-pharmacyindividuals).
7.IsthepharmacycompliantwithallrequestsforinformationbytheMassachusettsBoardofRegistrationinPharmacy?
YesNo
Comments:
Attestationregardingcompliancewithlawsandregulations:
I,(name),theManagerofRecordof(nameofpharmacy),attestunderthepainsandpenaltiesofperjurythat (nameofpharmacy)isincompliancewithalllawsandregulationspertinenttosterilecompounding,includingUSPGeneralChapter797-SterilePreparations. (nameofpharmacy)onlydispensesmedicationpursuanttoavalidprescriptionasdefinedinM.G.L.c.94C,§19forasinglepatient,regardlessofwhetherthemedicationispreparedforaMassachusettsorout-of-statepatient.
PrintNameofManagerofRecord:
MARPhLicenseNumber:
SignatureofManagerofRecord:
Date:
PleasedirectanyquestionsregardingthisformtoWilliamFrisch,MichelleChan,
DONOTsubmitthisformbymeansotherthanE-mail.Mailedpaperandfaxedcopieswillnotbeaccepted. Thankyou.