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OSU C o n t r o ll e d S u b s t an c e s T r a i n i n g M o du l e for Researchers

Guidelines for the purchase, storage, use, and disposal of controlled substances used in research and teaching activities at Oregon State University (OSU).

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OSU C o n t r o ll e d S u b s t an c e s T r a i n i n g M o du l e for Researchers

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  1. June 2019 OSU ControlledSubstancesTraining Module for Researchers

  2. Applicability • Guidelines forthepurchase,storage, use, and disposalofcontrolledsubstancesusedin researchandteachingactivitiesatOregon State University (OSU). OREGON STATE UNIVERSITY

  3. Definitions • AuthorizedAgent:aco-investigator,graduatestudent, post docormember of laboratorystaffauthorizedby the registranttoaccessthesecurestoragecabinet,dispense, administer, andtrackcontrolled substances. • ControlledSubstance:Adrugor chemicalwhosemanufacture, possession, oruse isregulatedbyagovernment, such as illicit drugs orprescriptionmedications thatare designatedacontrolleddrug. Thecurrentofficial scheduleof controlledsubstances(I, II, III, IV andV)can befoundat online at https://www.deadiversion.usdoj.gov/schedules/index.html OREGON STATE UNIVERSITY

  4. Definitions (cont.) • ClinicalSetting:Asetting whereacontrolled substance isused in a medical or veterinary application. • Non-ClinicalSettings:Asetting whereacontrolled substance isusedinresearchortesting,whichisnota clinical usageofthecontrolledsubstance. • Registrant:Anindividualwhoisregisteredwith theDEAand whose name is on theDEAlicense. OREGON STATE UNIVERSITY

  5. LicensingandRegistration Requirements • Principal Investigators (PI’s)whouse,orplantouse,controlledsubstancesintheirresearchmustregisterwiththeFederalDrugEnforcementAgency (DEA)and obtainaDEA Controlled Substance Research license. • Thelicense/registrationmust be obtained priortopurchasingandusingcontrolled substances. OREGON STATE UNIVERSITY

  6. ObtainingDEA Registration • For research, use DEA Form 225. You may fill out an online form if the controlled substance is schedule II-V; if schedule I you must print and mail the form along with 3 copies of the required additional information. • There is no cost associated with the registration. • Registration assistance is available at 1-800-882-9539oratDEA.Registration.Help@usdoj.gov • Approval takes 3-6 months and includes a visit from the local DEA office. OREGON STATE UNIVERSITY

  7. Additional Requirements • PI’s must obtain a letter of exemption from the Oregon Board of Pharmacy. • Once a PI obtains a DEA controlled substance registration as a researcher, the PI must submit a letter to the Oregon Board of Pharmacy. • The letter needs to explain who the PI is, the research the PI is performing, and how controlled substances are used and secured. Also, a copy of your DEA registration must be attached. OREGON STATE UNIVERSITY

  8. Responsibilities oftheRegistrant • PI’s whousecontrolled substancesintheir researchmustobtain andkeepa currentDEAlicense/registration. Renewal is every year. • A practitioner registration cannot be used for both patient/animal care and research. A separate research registration must be obtained. • Registrants may notallowthe license/registrationtolapse until allcontrolled substancesarespent,disposed of, or transferredtoanotherregisteredperson. OREGON STATE UNIVERSITY

  9. Responsibilities oftheRegistrant (cont.) • Allfaculty,staff andstudentsareresponsibleforfull compliancewithstate, andfederallawand DEAregulations governingthe purchase,storage,use, anddisposal of controlledsubstances. • Registrantshaveultimateresponsibilityforensuring proper acquisition,use,maintenance,security, accountability, and disposal oftheircontrolledsubstances. OREGON STATE UNIVERSITY

  10. Designating AuthorizedAgents • Registrants areresponsibleforallsecurityprovisionspertainingtothecontrolled substances inaccordancewiththerequirementsoftheregulations. • Registrants may designate authorized agents who may engage in approved activities under the direction of the Registrant. • Authorized Agents must complete The Authorized Users Screening Form and be added the Authorized Users log and signed by the PI. OREGON STATE UNIVERSITY

  11. Purchasing • Registrantswhopurchase andreceive Schedule III-V controlledsubstances mustretain purchaseorders and packing receipts fortwoyears fromthe date of receipt and have themavailableforinspection. • Registrantswhopurchase andreceive Schedule I and II controlledsubstances mustretain DEA222forms, purchase ordersandpackingreceiptsfortwoyears fromthe date ofreceiptand have themavailable forinspection. OREGON STATE UNIVERSITY

  12. InventoryRecords • Registrants areresponsibleformaintainingappropriaterecords andinventoriesofallDEAcontrolledsubstanceactivityforaminimumof twoyears fromtheinitialreceipt. • Recordsmust provideacompleteaudit trail, frompurchase,receipt or acquisitionto dispensingordisposal. • Recordsmust bereadilyavailableforreviewbycompliancepersonnelorother authorized regulatory agencies. OREGON STATE UNIVERSITY

  13. InventoryRecords (cont.) • Registrants mustmaintainareal-timerecord of the acquisition, administration, and disposalforeachDEAcontrolledsubstanceincludedonhis orherinventory. • Theregistrantmust documenttheuse of each DEAcontrolledsubstance. OREGON STATE UNIVERSITY

  14. InventoryRecords (cont.) • Records pertainingtocontrolledsubstances in ScheduleIandIImust bemaintainedseparatelyfromallotherrecordsoftheregistrant. • RecordsforScheduleIII,IV, andVcontrolled substancesmaybemaintainedeitherseparatelyfromallotherrecordsoftheregistrant or insuch formthat theinformationrequiredisreadilyretrievablefromtheordinary businessrecords. OREGON STATE UNIVERSITY

  15. Storage ofControlled Substances • Storage ofcontrolled substances mustcomplywith federalrequirements. • Registrants areresponsibleforestablishingand maintainingeffective controlsand proceduresto preventunauthorizedaccess,theft,ordiversion of controlledsubstances. • Thecontrolledsubstances storageareas shallbe accessible onlytoanabsoluteminimum number of specificallyauthorizedagents.When it isnecessaryfor non-authorizedpersons toenter thestorageareas,the registrantshallensureadequate observationbyan authorizedperson. OREGON STATE UNIVERSITY

  16. Storage ofControlledSubstances (cont.) • Registrantsare directly responsible for: • Establishing adequate security to prevent unauthorizedaccesstocontrolledsubstances. • Establishing adequate security to prevent the diversionofcontrolledsubstances. • Storing controlledsubstancesinasecure location andina securely locked, substantially constructed cabinet,or security cabinet (i.e.,not easily broken into ormoved). OREGON STATE UNIVERSITY

  17. DisposalofControlled Substances • Theregistrantisresponsiblefor thereturn ordisposal of controlledsubstancesinaccordancewithfederal requirements. • OSU EnvironmentalHealth and Safetywill provide assistance andguidance in thisarea. OREGON STATE UNIVERSITY

  18. DestructionandDisposalRecords • Registrantsmust document the disposalof controlled substancesandacopy of DEAForm41mustbemaintainedwiththeregistrant’srecordsto provide accountability forthe disposalofthesecontrolled substances. • Whenaregistrant leavesthe University orrescinds theirlicense,arrangements fordisposaland/ortransferofall theircontrolled substances must bemadepriortodepartureand licensetermination. OREGON STATE UNIVERSITY

  19. ReportingSignificantLoss • Theregistrant mustnotify thelocal DEAfield office (Portland) inwriting withinonebusinessdayafter the discovery oftheft or significantlossofany DEAcontrolled substances. Awritten reporttotheDEA,usingDEAForm106,mustbesubmitted within 15daysafter the discovery. • OSU Public Safetyand Environmental Health & Safety mustbe notified along with theDEA. • Theftor significantlosses mustbereportedwhether ornot thecontrolled substances aresubsequentlyrecovered and/or theresponsible parties are identified and actiontaken against them. OREGON STATE UNIVERSITY

  20. Failureto Comply • Compliancewithallfederalregulations isthesoleresponsibilityoftheRegistrantastheDEAlicenseholderandmayresultinpersonal,civil, and/orcriminalliability. • Failuretocomplymay alsoresult inUniversitydisciplinaryactionand/or suspensionorterminationofresearch. OREGON STATE UNIVERSITY

  21. Additional Information • Environmental Health & Safety website – Controlled Substances • DEA website Consultation provided by the Hazardous Waste Safety Officer All forms mentioned in this presentation are found on EH&S website Controlled Substances or DEA website OREGON STATE UNIVERSITY

  22. Certification • To receive credit for completing this training, close this file and go to the link directly below the training link and click “Acknowledgement of Controlled Substance Guideline Training.” A copy of your training acknowledgement must be kept as part of your DEA license file. OREGON STATE UNIVERSITY

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