ControlledSubstancesinResearch Oversight Program

Laboratory Preparation Checklist

Building: ______Room: ______

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ControlledSubstanceLicensingandRegistration
MIR338.3132and 21C.F.R.1301 / Yes / No / Comments/Action
DoesafacultymemberpossessacurrentStateofMichigan(SOM)controlledsubstanceresearchlicenseorSOMpractitionercontrolledsubstancelicense?
IstheSOMlicensepresentonsiteorreadilyretrievable?
Doesthe address on SOMlicensecorrespondwiththelaboratoryaddressandroomnumberwhere the controlledsubstancesarestored?
DoesafacultymemberpossessacurrentDEA225researcherregistrationorDEA224practitionerregistration?
IstheDEACertificateofRegistrationForm223presentonsiteorreadilyretrievable?
Doesthe address on the DEAregistrationcorrespondwiththelaboratoryaddressandroomnumberwhere the controlledsubstancesarestored?
Are research activitieswithinthescopeofSOMlicenseandDEA registration? (E.g., substance schedule, manufacturing, analytical research, etc.)
HasSOM licenseandDEA registration informationbeen entered intotheUniversityofMichiganControlled Substance in Research online (CSIR) database?
Inventory Records (Initial, Annual, Biennial, Closing)
MIR338.3151- 338.3152and21C.F.R.1304 / Yes / No / Comments/Action
Was an initial inventory performed (new DEA registrations or address change)?
Are the initial, SOM annual, and DEA biennial inventory records for the last two years on site?
Are the inventory records readily retrievable?
Was an SOM annual inventory performed and mailed to theSOM Bureauof HealthProfessions during4/1 -6/30 of the previous or current year?
Was a DEA biennial inventory performed and retained on site?
Are schedule I - II inventory records kept separate from schedule III - V inventory records?
Were exact inventory quantities and amounts reported for schedule I - II controlled substances?
Was a closing inventory performed (moving, transferring, retiring)?
UsageRecords (General Inventory, Multi-dose, Diluted Solution)
MIR338.3151- 338.3152and21C.F.R.1304 / Yes / No / Comments/Action
Are the usage records (logs, general inventory) forthe lasttwoyears retainedonsite?
Are the usage records readily retrievable?
Are the usage records for schedule I - II substances kept separate from the usage records for schedule III –V substances?
Were the general inventory and usage records recently reconciled for accuracy?
Are waste amounts signed by both the DEA registrant (or authorized agent) and a witness?
Are individual containers or packages labeled with a unique identifier to assist in usage record tracking?
Domulti-dose vialshave theirown usagelog?
Do diluted solutions of controlled substances have their own usage log?
Does the general inventory document transfers of expired or unneeded controlled substances toa reverse distributor for disposal or destruction?
InvoiceandPurchaseRecords
MIR338.3153and21C.F.R.1305 / Yes / No / Comments
Are supplier invoices for controlled substances readily retrievable?
Aresupplierinvoices forschedule I- II controlled substances kept separately from supplierinvoicesforschedule III - V controlled substances?
Do all invoices contain the following: Name, address, DEA registration numbers of supplier and purchaser,order date, drug names, strengths, container forms, and quantities received?
Areallinvoicessignedanddated uponreceiptor delivery?

Form Last Updated: 02/03/15Date Checklist Completed: ______1 of4

ControlledSubstancesinResearch Oversight Program

Laboratory Preparation Checklist

Building: ______Room: ______

DEAForm222 (ScheduleIandIIOrderForms)
MIR338.3153and21C.F.R.1305 / Yes / No / Comments
Are unusedand executedDEAForm 222sstored ina locked and secure location?
Areunusedor executedDEA Form222sreadily retrievable?
Are there anymissing DEAForm 222s?If so, havemissing formsbeenreported totheDetroit DEAoffice?
Do unusedDEAForm222s withmistakesorthose returned from supplier have "VOID" marked across the form?
Are allexecuted DEAForm222s signedbytheDEA registrant?
Do allscheduleIorIIshipmentshaveacorresponding DEA Form222?
Are allcopy 3(Purchaser) sectionsof executedDEA Form222s complete and accurate?
Disposal
21C.F.R.1317 / Yes / No / Comments
AreexpiredorunneededcontrolledsubstanceskeptinasubstantiallyconstructedcabinetuntilpickupbyanOSEHHazardousMaterialscontractedreversedistributor?
ArealldisposalformsandDEAForm222sassociatedwithareversedistributortransferkeptonsite?
Were non-recoverablewasteamountsproperly disposed of?
Are non-recoverable waste amounts documented in the inventory or usage record with two signatures (DEA registrant or authorized agent and one witness)?
LossorTheft
MI R 338.3414 and 21C.F.R.1301.76 / Yes / No / Comments
Haveallactualorsuspectedcasesoftheftorsignificantlossbeen reported totheU-M DepartmentofPublicSafety,MI Bureau ofHealth Professions, andDEA?
Was aDEA Form 106submittedforactualorsuspectedcasesoftheftorsignificantloss?
Havelosses incurred duringshipmentbeen reported tothe supplier?
Are non-recoverable lossesdocumentedininventoryorusage record withtwo signatures (authorizedagentandwitness)?
Security
MIR338.3141-338.3145and21C.F.R.1301.71–1301.93 / Yes / No / Comments
Havepoliciesor standard operating procedures beendevelopedbythelaboratorywith respect tostorage,administering,and record keepingof controlled substances?
Arethe controlled substances stored ina securely locked,substantiallyconstructedcabinetorsafethatis anchored toawallorthefloor?
Is the storage cabinet located at the address (building and room) as identified on the DEA registration?
Doesthe controlled substancestoragelocationhaveminimaltrafficflow?
Isthelabor room withthestoragecabinetlockedwhenthe registrants or authorized agents are not present?
Are controlled substances requiring refrigeration securely stored orlockedina refrigerator?

Form Last Updated: 02/03/15Date Checklist Completed: ______1 of4

ControlledSubstancesinResearch Oversight Program

Laboratory Preparation Checklist

Building: ______Room: ______

Isaccessto controlled substanceskepttoaminimalnumberofauthorizedagents?
Are keystothe controlled substancestoragecabinetlockedup or secured whennotinuse?
Dothelocksonthestorage room andcabinethavethecapabilitytobe reset or rekeyed ifanauthorizedagent resigns, isterminated,oralossortheftissuspected?
Isanauthorizedpersonnellogkeptonsite?
Is the authorized personnel log updated frequently?
Have background checksbeen performed on authorized agents and authorized personnel?
Ifaformal background checkwasnot performed, have all authorized agents read and signed an "AuthorizedAgent Screening Statement? Are screening statementskeptonfile.
Are all screening statements complete and kept on site?
Arecontrolledsubstancesdelivereddirectlytoareceivingindividualinthelaboratory?

Form Last Updated: 02/03/15Date Checklist Completed: ______1 of4