Environmental Health & Safety | Use of Controlled Substances in Research and Scholarly Activities Program (2024)

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1.0 Purpose

This procedure addresses compliance with federal regulationsregarding registration, acquisition, use,storage, and disposal of U.S. Drug Enforcement Agency (DEA)listed Controlled Substances being used inWest Virginia University research, teaching, and serviceactivities. This program manual was developedpursuant to WVU Policy on Use of Controlled Substances inResearch and Scholarly Activity.

2.0 References

WVU Controlled Substance Website:

DEA Forms and Applications:Diversion Control Division | DEA Forms & Applications (usdoj.gov)

West Virginia Board of Pharmacy Forms and Applications:In-State Controlled Substance Permit - WV Board of Pharmacy (wvbop.com)

3.0 Responsibilities

3.1 Environmental Health & Safety

3.1.1 EHS will aid all University Member DEA Registrants inmaintaining compliance with applicable laws,policies and procedures. To support the lawful possessionand use of Controlled Substances byUniversity Members, EHS will maintain this program manualand supporting practice aids/for templates,as well as conduct training sessions, consultations, andaudits in conjunction with the EHS ChemicalHygiene and Controlled Substance programs.

3.1.2 The EHS Controlled Substances Manager will performRegistrant monitoring functions to maintaina complete and accurate roster of Controlled SubstancesUniversity Member registrants. Monitoringactivities include:

3.1.2.1 Maintaining copies of University Member registrationcertificates, renewals, andauthorized personnel forms.

3.1.2.2 Access to the IACUC protocol database, which enablesthe ability to observe animal careand use activities which have been approved to utilizeControlled Substances.

3.1.2.3 Workflow approval responsibilities in the WVUMountaineer Marketplace e-procurementsystem for system-tagged Controlled Substances.

3.1.2.4 Laboratory safety audits and inspections, close-outprocedures, and surveys andcoordination with college and department level chemicalhygiene officers.

3.1.2.5 Liaison contacts and periodic registrant informationinquiries with DEA and WVBOPcontacts.

3.1.2 EHS staff will escort DEA inspectors during theirinspections of labs and act as a liaison betweenthe inspectors and the DEA Registrant or authorized users.

3.1.3 EHS Controlled Substance Manager will approve allpurchases via PCPS procurementprocesses, overseedisposal and destructions of controlled substancesoncampus,coordinate with Registrants atend of license and lab close-outs.

3.2 Registrant

3.2.1 Apply for and maintain WVBOP and DEA registrations,including compliance to submitting anychanges and registration renewals.

3.2.2 Be present for inspections by WVBOP and DEA.

3.2.3 Manage the Controlled Substances in their possessionin accordance with the requirements offederal and state regulations.

3.2.4 Select, screen, and train Authorized Users. Create anddocument laboratory-specific training asneeded to train Authorized Users. Supervise the use ofControlled Substances by all Authorized Users.

3.2.5 Ensure that only the Registrant submits orders(acquisition) for Controlled Substances usingappropriate forms. Registrants must exercise signatureauthority for purchases of Schedule I and II drugs(see Ordering section of this procedure).

3.2.6 Must submit copies of in-date WVBOP and DEARegistration to OLAR office if acquiring ControlledSubstances from OLAR.

3.2.7 Ensure that Controlled Substances are secured andstored in accordance with federal and stateregulations. Maintain strict control inventory (see Storage& Security section of this procedure).

3.2.8 Maintain all required deduction cards, usage logs anddocumentation (see 5.11 Documentationsection of this procedure).

3.2.9 Conduct and document initial and biennial (every twoyears) inventory as per DEA regulations (seeDocumentation section of this procedure).

3.2.10 Report theft, loss, or significant inventorydiscrepancies of any Controlled Substances to the DEA,WVBOP, and EHS. (see 5.10 Controlled Substance Loss sectionof this procedure).

3.2.11 Report DEA and WVBOP inspection audit findings ofnon-compliance to WVU EHS within two (2)business days of notice received by the Registrant.

3.3 Authorized User

Authorized Users must be identified, screened, and certifiedby each Registrant who allows theindividual to engage in approved activities under theRegistrant’s registration. Examples of AuthorizedUsers: post-doctoral fellows, university staff, classifiedstaff, and graduate students. Typically, theAuthorized User reports directly to the Registrant or isfunded by the Registrant.

3.3.1 Complete the Personnel Screening Form for AuthorizedUsers prior to commencing use ofControlled Substances for the Registrant.

3.3.2 Complete laboratory-specific training on proceduresfor using Controlled Substances prior toworking with them.

3.3.3 Once certified by the Registrant, sign the AuthorizedUsers Signature Log specific to the Scheduleof authorized use.

3.3.4 Comply with university, federal, and stateregulations, policies, and procedures pertaining toproper registration, acquisition, storage, use, and disposalof Controlled Substances under the directsupervision of the DEA Registrant.

3.3.5 Complete all required documentation on deduction cardsand usage logs (see Documentationsection of this manual).

3.3.6 Store Controlled Substances appropriately in thelocation listed on the Registration and based onthe Registrant’s requirements for securing them by the endof each workday or when not in use.

3.3.7 Immediately report any theft, loss, or significantinventory discrepancies to the DEA Registrant,and, if necessary, EHS, the university police department,DEA, and other relevant authorities as requiredby federal law, state law, and University procedures (see5.10 Controlled Substance Loss section of thismanual).

3.3.8 Immediately report to the Registrant any felonyviolations or convictions.

4.0 Definitions and Terminology

For purposes of this procedure, the following terms aredefined as:

Administration: the act of dosing, injecting, or applying acontrolled substance.

Authorized User: a university member authorized totemporarily possess and use Controlled Substancesfor research under oversight by the DEA Registrant whoprocures it. An authorized user should be adirect report of the Registrant or be funded by theRegistrant. An authorization form must be kept onfile containing the signature of each Authorized User andthe signature of the Registrant documentingwhen the Authorized User was given authorization by theRegistrant. The form must be kept on file bythe Registrant for a period of two years after terminationof Controlled Substance use by the AuthorizedUser.

Bulk Form: a controlled substance as received from themanufacturer or supplier to be used in, orcapable of use in, the manufacture of the same or othernon-controlled substances in finished form(diluted or working form). Depending on the concentration ofthe Bulk Form, this form may be aconcentrated stock which is compounded by dilution orcombination with other drugs into a FinishedForm for administration to an animal or for in vitro use.

Cactus Sink: a secure waste solution for unused portions orpartial doses of Controlled Substances.

Controlled Substance (CS): any substance listed in theControlled Substances Act, Code of FederalRegulations (21 CFR, part 1300 to end) and West VirginiaCode 60A (Uniform Controlled Substances Act).Controlled Substances (CS) are drugs or other chemicals thathave the potential to be addictive or habitforming. Controlled Substances are divided into fiveschedules based on their potential to be habitforming (I = greatest, V = least habit forming) andusefulness in medical treatment. The DEA and WVBOPjointly regulate these substances. For a list of ControlledSubstances refer to “List of: Scheduling Actions,Controlled Substances, Regulated Chemicals (Aug 2021)”(Orange Book - List of Controlled Substances and Regulated Chemicals (usdoj.gov))published by the DEA.

Schedule I

Substances that have no currently accepted medical use inthe United States, a lack of acceptedsafety for use under medical supervision, and a highpotential for abuse.

Examples: heroin, lysergic acid diethylamide (LSD),marijuana (cannabis), methaqualone, 3,4-methylenedioxymethamphetamine (“Ecstasy”)

Schedule II

Drugs or other substances that have a high potential forabuse, abuse may lead to severepsychological or physical dependence. Currently have anaccepted medical use intreatment inthe United States or have a currently accepted medical usewith severe restrictions.

Examples of schedule II narcotics: hydromorphone (Dilaudid®), methadone(Dolophine®),meperidine (Demerol ®), oxycodone (OxyContin ®, Percocet ®),fentanyl (Sublimaze ®, Duragesic®), morphine, opium, codeine, hydrocodone.

Examples of schedule IIN stimulants: amphetamine (Dexedrine®, Adderall®),methamphetamine (Desoxyn ®), methylphenidate (Ritalin®).

Examples of other schedule II substances: amobarbital,glutethimide, pentobarbital

Schedule III

Drugs or other substances that have a potential for abuseless than Schedule I or II, abuse maylead to moderate or low physical or high psychologicaldependence. Currently have an acceptedmedical use in treatment in the United States.

Examples of schedule III narcotics: products containing notmore than 90 milligrams of codeineper dosage unit (Tylenol with Codeine ®), buprenorphine(Suboxone ®)

Examples of schedule IIIN non-narcotics: benzphetamine(Didrex ®), phendimetrazine, ketamine,and anabolic steroids such as Depo®-Testosterone

Schedule IV

Drugs or other substances that have a low potential forabuse relative to substances listed inSchedule III, abuse may lead to limited physical orpsychological dependence. Currently have anaccepted medical use in treatment in the United States.

Examples: alprazolam (Xanax®), carisoprodol (Soma®),clonazepam (Klonopin®), clorazepate(Tranxene®), diazepam (Valium®), lorazepam (Ativan®),midazolam (Versed®), temazepam(Restoril ®), and triazolam (Halcion ®), phenobarbital.

Schedule V

Substances that have a low potential for abuse relative tosubstances listed in Schedule IV.Consist primarily of preparations containing limitedquantities of certain narcotics.

Examples: cough preparations containing not more than 200milligrams of codeine per 100milliliters or per 100 grams (Robitussin AC®, Phenergan withCodeine®), and ezogabine.

Controlled Substance Research Protocol: a document submittedto WVU EHS, the DEA and WVBOPwhich describes the need for and use of ControlledSubstances in the Registrant’s research. For scheduleII through V substances, use the form provided- “Universityof West Virginia Controlled SubstancesResearch Protocol” on the WVU EHS website. To register toconduct research with Schedule I controlledsubstances, the Registrant must compete and submit theprotocol described in 21 CFR 1301.18.

Compounding: the mixing or diluting of pharmaceutical agentsinto a Finished Form for administrationfor which no similar Bulk Form is available. Compounding ofpharmaceutical agents for use inexperiments is allowed.

DEA Registrant: Often, but not always, the principalinvestigator, the DEA Registrant is a universityemployee designated to hold DEA registration who isresponsible for ordering, storing, using, anddisposing of Controlled Substances within his or herinventory.

Deduction Card: document provided to DEA Registrants, by WVUEHS, to record use of Bulk FormControlled Substances.

Disposal/Destruction: Expired, unusable, or unwantedControlled Substances must be disposed of usinga DEA and WVBOP approved method.

Diversion: a transfer of a Controlled Substance from alawful to an unlawful channel of distribution oruse. This includes administration of a Controlled Substanceby an individual that is not listed as anAuthorized User associated with the Registrant.

Drug Enforcement Administration (DEA): the agency within theUnited States Department of Justice thatenforces the federal Controlled Substances laws andregulations.

Environmental Health and Safety (EHS): the university unitresponsible for working with academic,research, and administrative units to promote compliance andresponsible behavior as required byhealth, safety, and environmental standards, codes,regulations, and University programs.Expired and/or Unusable Substances: Controlled Substances ormixtures containing ControlledSubstances for which the expiration date has passed fortablets, injections, liquid, powders, orpreparations compounded. This also includes ControlledSubstances that can no longer be used forresearch due to contamination, animal care and userequirements, remaining quantity, etc.

Finished Form: A Controlled Substance altered (e.g.,diluted, compounded) from Bulk Form which will beadministered for research. For example, Bulk Form diluted1:10 becomes a Finished Form. Finished Formsubstances may be retained and secured by Authorized Usersuntil depleted or unusable. All vials ofFinished Form substances must be properly labeled and have ausage log.

Institutional Animal Care and Use Committee (IACUC): theuniversity committee charged with oversightof the use of vertebrate animals in research andinstruction.

Location: a room or designated area where inventory ofControlled Substances is securely stored. Alocation is managed by a single DEA Registrant and has asingle building and room address with which itis associated. All Controlled Substances must be returned atthe end of their use each day to the storagearea on the registration.

Office of Animal Welfare (OAW): facilitates the review ofresearch protocols and grants involving livevertebrate animals.

Office of Laboratory Animal Resources (OLAR): WVU HealthSciences Center unit charged with providingguidance, support, and training for animal care and use inthe laboratory setting.

Principal Investigator (PI): the individual with finalresponsibility for the conduct of research or otheractivity described in a research proposal.

Power of Attorney: the Registrant is the only individual whomay order, dispense, or dispose ofControlled Substances listed in their registration. TheRegistrant must generate a Limited Power ofAttorney (POA) document in order to allow an Authorized Userto perform specific functions specificallyinvolving Schedule I or Schedule II substances. Theperson(s) having a Limited Power of Attorney (POA)may perform the following functions on behalf or in theabsence of the Registrant: sign the DEA Form222 to receive Schedule I and II substances, transferSchedule I or II substances for destruction, orperform biennial inventory. The Registrant must show theLimited Power of Attorney documents to theDEA upon request. A copy of the POA documents must beprovided to WVU EHS and OLAR (if obtainingSchedule II substances from OLAR). See 21 CFR part 1305.05(https://www.deadiversion.usdoj.gov/21cfr/cfr/1305/1305_05.htm)for generating a POA document. APOA document is not needed for Schedule III-VI substances.

Registration: formal grant of specific authority forControlled Substance activities by the DEA and/or

WVBOP sometimes referred to as a Registration Certificate.The Registration is specific to a single

physical location. If multiple Controlled Substance storagelocations are needed, then multiple

Registration Certificates are required. The Registrant isresponsible for maintaining their Controlled

Substance Registration in a current and active state.

Research: Systematic investigation, including researchdevelopment, testing and evaluation, designed todevelop or contribute to generalizable knowledge.

Teaching Institution Registration: attending veterinarianshold this registration for the administration ofControlled Substances to research animals while providingveterinary care. A DEA registration to ateaching institution (for Schedules II-V only) is overseenby an Institutional Veterinary Practitioner.

Transfer: an informal term used to describe the process toaffect change in the possession of aControlled Substance from the inventory of one DEARegistrant to another DEA Registrant.

University Member: all WVU full- and part-time faculty,classified or University staff, administrative staff,paid student assistants, students, volunteers, fellows andtrainees, visiting faculty and researchers, andthose employees and visitors covered by sponsored programagreements or other contractualarrangements are considered University Members for purposesof complying with ControlledSubstances regulations.

Usage Log: document available on the WVU EHS website, torecord use of Finished Form ControlledSubstances.

Usage Records: maintaining accurate, continuous, and currentrecords reflecting the acquisition,administration, disposal, and biennial inventory ofControlled Substances is necessary to properlydocument the use of the Controlled Substances within aclosed system of distribution. ControlledSubstance usage records are completed by each Registrant andAuthorized User.

WV Board of Pharmacy (WVBOP): the agency authorized to carryout the WV Uniform ControlledSubstances Act (WV Code, Chapter 60A).

5.0 Procedure

5.1 Registration

5.1.1 The researcher responsible for projects involvingControlled Substances (ordering, storing, usagedisposal) must register with WVBOP and DEA. This researcheris referred to as the “DEA Registrant”.

5.1.2 Registrants are typically principal investigators andare linked to an individual laboratory.Registration is linked to a specific physical address (asingle physical location) where ControlledSubstances are stored. The Registrant must have oversight ofthe Controlled Substance use to serve asthe DEA and WVBOP Registrant.

5.1.3 A summary table of DEA registration requirements andlimitations is available at 21 CFR 1301.13(e)(1). University Members conducting research withControlled Substances will typically qualify toobtain a Research/Researcher DEA registration, which alsoallows certain coincident activities such asinstructional activities and chemical analysis. DEAPractitioner registrations for physicians, dentists,veterinarians, and other health care professionals permitcertain coincident research and instructionalactivities, but it is the understanding of EHS thatPractitioner registrations cannot be used for animal orhuman research protocols. WVU and DEA require a separate DEAResearch registration for non-clinicalresearch for Practitioners. University Members, who arelicensed veterinarians, may obtain a DEAPractitioner registration pursuant to their lawful licensedpractice of veterinary medicine. Other DEAregistration business activities, such as Chemical Analysis,may require additional consultation with theEHS Controlled Substances Manager.

5.1.4 Each individual Registrant (principal investigator) isresponsible for obtaining appropriateregistrations and adhering to applicable state and federalregulatory requirements when working withControlled Substances. Registrants will be responsible forthe oversight of all Controlled Substances ontheir applications.

5.1.4.1 PIs must complete the West Virginia UniversityControlled Substances Research Protocoland submit it to WVU’s EHS department via the ControlledSubstance Manager. Protocols will beused to establish initial communication to inform EHS ofintent to pursue a Controlled Substanceregistration by the PI and to begin other documentation.Furthermore, it will be used by EHS toconsult, provide recommendations and guidance, and updateDEA registrants, as needed.

5.1.4.2 PIs must complete and submit the West Virginia Boardof Pharmacy (WVBOP)Application for Permit or Renewal to Handle ControlledSubstances. The DEA application will notbe approved without a WVBOP license. The DEA registration ispredicated on state authority.

5.1.4.2.1 University Employees ware consideredstate/government employees and assuch qualify for fee waiver for DEA license fees (WestVirginia Code of State Rules §15-2-4.2.2, 15 CSR 2). WVU Research Corporation Employees do notmeet the state rulerequirements for WVBOP fee exemption.

5.1.4.2.2 The WVBOP application contains an entry field fora DEA registration number.For initial applications, an applicant will not have a validDEA registration since a stateBOP registration must first be obtained. Applicants aretypically permitted to note thison the initial application. For applicants who werepreviously registered elsewhere, priorDEA registration numbers should not be entered, as they arenot valid for a new WVUlocation.

5.1.4.2.3 The WVBOP application contains an entry field fora “Consultant Pharmacist”.It is the understanding of EHS that supplying an informationfor this field is notnecessary for the application. Consult with EHS for theappropriate information to enter.

5.1.4.3 After receiving the WVBOP permit, PIs must completeand submit DEA-225 (newapplication for registration). For Schedules II-V, DEA Form225 can be completed online. ForSchedule I substances, DEA Form 225 and the protocol in 21CFR 1301.18 must be submitted(cannot apply online for initial Schedule I application).

5.1.4.3.1 University Employees are consideredstate/government employees and as suchqualify for fee waiver for DEA license fees (21 CFR1301.21). WVU Research CorporationEmployees do not meet the federal regulation requirement forDEA fee exemption.Inorder for University employees to obtain a DEA fee waiver,they will need informationfrom an institutional “certifying official”. Consult withEHS to obtain this certification.

5.1.4.4 Prior to issuance of a registration, an inspectorwill schedule an inspection with theapplicant (Registrant) to ensure that appropriate safeguardsare in place to secure ControlledSubstances. Notify WVU EHS of the DEA inspection time andschedule a preview of the storagesite prior to DEA arrival.

5.1.4.5 Upon receiving their DEA registration certificate,PIs are required to send a copy to WVUEHS.

5.1.4.6 Registrants must not allow their registration tolapse until all Controlled Substances areused or transferred.

5.1.4.7 DEA and WVBOP registrations are valid for one yearand must be renewed annually.Complete DEA Form 225A for renewal. Notify WVU EHS ofrenewal status. Renewals for bothWVBOP and DEA Registrations are completed online:

WVBOP:Renewal: Controlled Substance Permit - WV Board of Pharmacy (wvbop.com)

DEA:Diversion Control Division | DEA Forms & Applications (usdoj.gov) (see“Renewal Applications”)

5.1.4.7.1 Renewal applications will require similar input orinformation consistent withinitial applications explained in 5.1.4.2 and 5.1.4.3.

5.1.4.8 Agencies (WVBOP & DEA) must be notified of anychanges to drug code, schedule, name,address (address change requires approved state license forthe new address first) or anyinformation required on the application or Registration.Changes can be submitted to the DEAat:Diversion Control Division | DEA Forms & Applications (usdoj.gov)(see “Makechanges to DEA Registration”).

5.1.4.9 In addition to the initial inspection conductedduring the application process, followingregistration approval, the DEA and/or WVBOP may conductunannounced routine inspections.Notify WVU EHS immediately if DEA officials arrive for aninspection. In preparing for aninspection, the DEA will refer to their database for thelist of substances approved for theRegistrant, so ensuring that the DEA is notified of changesis extremely important. Substances ina Registrant’s inventory that do not match the DEA’sdatabase is cause for a finding of violationof the law.

During inspection the DEA may inspect for:

-Expired Controlled Substances

-Documentation is available, complete, and correct

-Vial inventory numbers have a corresponding DeductionCard/Usage Log

-The remaining quantity per Deduction Card/Usage Log and theactual physical quantity isapproximately the same

-Verification that all drug invoices present have a largered “C” on them, date of receipt, andsignature of the person receiving the shipment (see section5.4.3).

-Verification that DEA Form 222 order forms for Schedule Ior II are present for each compound(unused DEA 222 Forms should be stored in a securedlocation).

-Verification that DEA Form 222 order forms have the numberof packages received and thedate received columns completed at the time of receipt (Anincomplete DEA-222 form can incura $10,000 fine from the DEA) (refer to section 5.3.3).

-Verification of appropriate security and storage based onSchedule and license type

5.1.4.10 Under no circ*mstances are Controlled Substances tobe abandoned by a DEA/WVBOPRegistrant. Registrants are expected to properly dispose ofControlled Substancesinventorywhen Controlled Substances are no longer required or priorto departure from their Universityposition. See “Controlled Substance Disposal” section 5.9 inthis procedure.Any person who isregistered with the DEA who violates record-keeping requirementsor abandons ControlledSubstances is subject to the civil penalties outlined in the United States Code (USC): 21 USC Sec.842. Note that abandoning substances is equivalent to diversion of a Controlled Substance to anunauthorized person.

5.1.4.11 Registrants seeking to modify or terminate theirresearch laboratory use license and/orregistration must notify WVU EHS prior to any changes. Ifappropriate, registrants must followthe WVU EHS close-outs procedures timeline. See “ControlledSubstance Disposal” section 5.9 inthis procedure.

5.1.4.12 The OAW, as part of the animal care and usepost-approval monitoring program andmembers of the Animal Care and Use Committee (IACUC), aspart of the semi-annual inspectionof animal use areas will review Controlled Substances,storage, and usage records forcompliance with USDA regulations and NIH guidelines. Theseinstitutional inspections do notconstitute a review of a Registrant’s compliance with DEAand/or WVBOP regulations. The OAWand IACUC inspections are mandated under the University’sPublic Health Service assurance toNIH and required by the USDA for research using regulatedspecies.

5.1.5 Important Points for Application Forms

A. Addresses for state and federal registrations must be thesame.

B. Address must be a single physical geographic location(building name and room number) for securestorage of the Controlled Substances.

C. Postal Address vs Physical Address: if the specificlocation does not have a US Postal delivery (thestorage location is a lab bench in the back room), then listthe nearest postal delivery address, and onthe next line list the geographic location by building/roomnumber. Addresses must have the geographiclocation of the Controlled Substance storage cabinet.

D. Shipping Address: The “Ship To” address is the address onthe federal DEA registration. It is a violationto ship to any address other than the federal DEA addresslisted on the Registration certificate. Thisaddress must be the storage location (not a PO Box).

E. The Schedules of substances listed on one registration(federal DEA) must be the same as theSchedules listed in the other registration (WVBOP).

5.2 Registrant Screening and Selection Process forAuthorized Users

5.2.1 Having Authorized Users associated with the WVBOP andDEA Registration is not required;however, it is necessary if anyone other than the Registrantwill have access to the ControlledSubstances storage or administration under the Registration.Every University Member identified by theRegistrant as being an Authorized User must compete thescreening process/forms.

5.2.2 The Registrant is solely responsible for thecompliance of their Authorized Users associated withtheir Registration in accordance with DEA and/or WVBOPRegulations.

5.2.3 Personnel Screening Form (21 CFR 1301.90) - This form(on WVU EHS website) must be completedprior to the Registrant authorizing the individual to workwith Controlled Substances. If the answer toany of the three (3) questions below is “yes”, then theperson should not be allowed to possess oradminister Controlled Substances.

5.2.3.1 Question 1: Within the past five years, have youbeen convicted of a felony, or within thepast two years, of any misdemeanor, or are you presentlycharged with committing a criminaloffense? (Do not include any traffic violations, juvenileoffenses or military convictions, exceptby general court-martial).

5.2.3.2 Question 2: In the past three years, have youknowingly used narcotics, amphetamines,or barbiturates other than those prescribed to you by aphysician?

5.2.3.3 Question 3: Have you ever been denied a DEAregistration, had a DEA registrationrevoked or surrendered a DEA registration for cause?

5.2.4 A copy of the personnel form must be sent to the WVBOPand DEA during the initial applicationprocess. Both new hires and students must complete the formprior to becoming an Authorized User.Keep the questionnaires in a separate secured file at theregistered location for two years after thetermination of the individual being an Authorized User.These documents are considered sensitive andshould be locked securely as with other sensitive employmentinformation held by the Registrant.

5.2.5 The DEA Registrant and Authorized Users must conductan annual review of the Screening Formfor the duration of a given Authorized User’s involvement inControlled Substances work.

5.2.7 Authorized Users Signature Log– This form must beinitially completed by each Authorized Userafter the Registrant screens and then certifies the personis an Authorized User associated with theirRegistration. The Signature Log is kept with theRegistrant’s Controlled Substance notebook. Scan a copyof the signature log to WVU EHS when there is an update (newor terminated authorized user).

5.2.8 The “termination date” on the Personnel Screening Formand Authorized Users Signature Log iscompleted by the DEA Registrant once the Authorized User isno longer authorized to come in contactwith the Registrant’s Controlled Substances. Once thetermination date is documented and theRegistrant and Authorized User (previously) have signed theforms, scan a copy of the Signature Log toWVU EHS. Once an Authorized User status has been terminated,the location of the key to open theControlled Substance storage cabinet and/or any codes neededto access the Controlled Substancesneed to be changed.

5.3 Acquisition: Purchasing Controlled Substances

5.3.1 Registrants may only acquire Controlled Substanceswithin the schedule listed on their approvedWVBOP and DEA Registrations. Controlled Substances can beobtained through the purchasing methodsand vendor sources in this section or through a permissibleRegistrant-to-Registrant transfer describedin Section 5.8.

5.3.2 Controlled Substances may be ordered/purchased throughstandard WVU PCPS procurementprocesses via Mountaineer Marketplace catalog andnon-catalog ordering, such as through WholesaleDistributor and Pharmacy vendors.

5.3.2.1 The WVU/WVURC PCard Manual prohibits purchases ofControlled Substances.Ordering/purchasing exceptions require the approval of PCPSand EHS Controlled SubstanceManager.

5.3.3 WVU OLAR is a Wholesale Distributor and stocks somecommonly used veterinary ControlledSubstances in Schedules II-V. Examples of Schedule IIsubstances that OLAR dispenses includepentobarbital and Fatal-Plus. OLAR will only sell ControlledSubstances to Registrants that have providedOLAR with scanned copies of their valid DEA Registration andWVBOP Registration Certificate. Purchasesare made within the OLAR purchasing system. Additionally,the purchasing database only allowspurchasers to select substances within the schedules ontheir Registration.

5.3.3.1 Before OLAR can dispense any Schedule II ControlledSubstance to a Registrant, acompleted DEA Form 222 must be received.

5.3.4 The National Institute on Drug Abuse (NIDA) has a DrugSupply Program (DSP) to provideControlled Substances, other chemical substances, marijuana,and nicotine research cigarettes forresearch purposes to investigators working in the area ordrug abuse, drug addiction, prevention, andtreatment at academic institutions.

5.3.4.1 To obtain substances from NIDA, researchinvestigators are required to submit theirrequests along with necessary documents to the NIDA DrugSupply Program for consideration. Guidelines can be found atOrdering Guidelines for Research Chemicals and Controlled Substances

5.3.4.2 If ordering Schedule I or II Controlled Substancesfrom NIDA, DEA Form-222 is required.

5.3.5. Registrants can also obtain Controlled Substancesthrough the DEA’s Controlled SubstanceOrdering System (CSOS) (https://www.deaecom.gov/).Registering with DEA CSOS enables electronicordering without the need to prepare a paper Form 222 inorder to purchase Schedule I and IIsubstances.

5.3.6 Purchasing Documentation - Schedule I and IIControlled Substances

5.3.6.1 DEA and WVBOP Registrants can obtain Schedule I andII Controlled Substances using acompleted and signed DEA Form 222. The Registrant must makea copy of the completed,original DEA Form 222 for their records and then submit theoriginal to the supplier. Thesupplier retains the original DEA Form 222 in their files.

5.3.6.2 Registrants can request official order forms (Form222) (Schedule I & II Registrants Only)from deadiversion.usdoj.gov/online_forms_apps.html.

5.3.6.3 DEA Form 222 is unique to each Registrant. DO NOTshare DEA Form 222 with otherRegistrants.

5.3.6.4 NO corrections are to be made on DEA Form 222. If amistake is made, the form must bevoided and a new form used. To void the form, draw a lineacross it and write “Void”, sign anddate underneath the line. Retain voided forms for two years.

5.3.6.5 DEA Form 222 must be completely filled out. However,the National Drug Code (NDC)number is not required. If it is available from themanufacturer, it can be inserted in theappropriate box.

5.3.6.5.1 Only one item may be entered on each numberedline. An item consists of oneor more commercial or bulk containers of the same finishedor bulk form and quantityof the same substance.

5.3.6.5.2 The number of lines completed must be noted at thebottom of the form.

5.3.6.5.3 DEA Forms 222 for carfentanil, etorphinehydrochloride, and diprenorphine,must contain only these substances.

5.3.6.5.4 The name and address of the supplier from who theControlled Substances arebeing ordered must be entered on the form. Only one suppliermay be listed on anyform.

5.3.6.5.5 A purchaser may cancel part or all of an order ona DEA Form 222 by notifyingthe supplier in writing of the cancellation. The suppliermust indicate the cancellation onthe original DEA Form 222 sent by the purchaser by drawing aline through the canceleditems and printing “canceled” in the space provided for thenumber of items shipped.

5.3.6.6 When the ordered substances are received, thepurchaser must record on their copy ofDEA Form 222 the number of commercial or bulk containersfurnished for each item and thedates on which the containers are received.

5.3.6.7 A limited Power of Attorney document must be used ifthe Registrant plans to giveanother individual signatory authority to sign DEA Form 222and obtain Schedule I and IIControlled Substances on their behalf (21 CFR 1305.05). Ifthe Registrant personally orders andobtains the Schedule I and II Controlled Substances, then aPower of Attorney document is notneeded. For instructions on creating a Power of Attorney, seehttps://www.deadiversion.usdoj.gov/21cfr/cfr/1305/1305_05.htm.

The power of attorney must be available for inspectiontogether with other order records.

5.3.6.9 DEA Form 222 must be maintained separately, in asecure location, from all otherrecords. The Registrant is responsible for securing theforms and retaining executed (copy,supplier will have original) unexecuted, voided, unaccepted,and defective forms.

5.3.6.9.1 Forms should be retained for two years and beavailable for inspection.

5.3.6.9.2 Executed DEA Forms 222 (copy, supplier will haveoriginal) and any attachedstatements or other related documents must be secured at theregistered locationprinted on the DEA Form 222.

5.3.6.9.3 Unexecuted DEA Forms 222 may be kept (securely)and may be executed at alocation other than the registered location printed on theform, provided that allunexecuted forms are delivered promptly to the registeredlocation upon an inspectionof the location by an officer authorized to makeinspections, or to enforce, any Federal,State, or local law regarding Controlled Substances (21 CFR1305.12e)

5.3.6.9.4 The Registrant should make a list of the uniqueform numbers and record thedate when each is used. If any used or unused DEA Forms 222are lost or stolen, it mustbe reported to the Special Agent in charge of the DEA in theDivisional Office responsible forthe area in which the registrant is located, stating theserial number of each form stolen or lost.

5.3.6.9.5 If the registration of any purchaser terminates(because the purchaser dies,ceases legal existence, discontinues business, surrendersthe registration), is suspendedor revoked, or the name or address on the registrationchanges for all Schedule I & IIControlled Substances for which the purchaser is registered,the purchaser must returnall unused DEA Forms 222 (21 CFR 1301.52).

5.3.6 Purchasing Documentation Schedule III - V ControlledSubstances – Orders and purchases by aRegistrant can be documented through standard procurementprocesses. A copy of the Registrant’sCertificate should be attached to the requisition. –

5.4 Receiving Controlled Substances

5.4.1 Controlled Substances must be shipped directly to theDEA Registrant at the address indicated onthe DEA Registration. The Controlled Substance(s) must beopened, and the contents verified by theRegistrant. Any discrepancies must be rectified with thesupplier and/or vendor. If discrepancies cannot berectified, the DEA Registrant must contact the DEA andWVBOP to report the discrepancy within five (5) business days.

5.4.2 The DEA Registrant must sign (full name) and date thepurchase receipt (packing slip) and keep it withh the Deduction Card (provided by WVU EHS). Document ared “C” on the purchase receipt to signify thatControlled Substances are listed. Ensure the quantityand name/lot # of Controlled Substance receivedeceived is on the purchase receipt.

5.4.3 Once received, Controlled Substances must beimmediately secured in the location indicatedon theRegistration and in accordance with federal and stateregulations (see Storage and Security sectionof this procedure).

5.5 Storage and Security

5.5.1 Registrants must keep Controlled Substances in asubstantially constructed, not easily moved, andsecurely locked steel cabinet (or safe) that meets DEA(https://www.deadiversion.usdoj.gov/21cfr/cfr/1301/1301_72.htm)/WVBOP requirements. ControlledSubstances must not be visible through a glass panel.

5.5.1.1 Schedule I-II: Securely locked, substantiallyconstructed safe or steel cabinet that isanchored to a wall or the floor.

5.5.1.2 ScheduleIII-V: Securely locked, substantially constructed safe or steel cabinet.net

5.5.1.3 Schedule I-V substances can be stored together aslong as security measures meetSchedule I-II requirements.

5.5.1.4 Ensure two levels of security (e.g., locks) are inplace and always used.

5.5.1.5 Portable storage boxes or storage in high-activityareas (e.g., corridors) are not allowed.

5.5.1.6 Controlled Substances requiring refrigeration mustbe locked in a container securelyfastened within a refrigeration unit unless therefrigeration unit can be locked from the outside.

5.5.2 The Registrant must restrict access to locked roomsand locked storage cabinets (safes) containingControlled Substances. The Controlled Substance storageareas shall be accessible only to an absoluteminimum number of specifically authorized individuals. TheRegistrant must determine how theirAuthorized Users will access substances.

5.5.2.1 Keys to Controlled Substance storage must be securedsuch as establishing a key controlsystem (e.g., a log to track who has a key). Keys should belimited to a minimum number ofAuthorized Users.

5.5.2.2 If using combination locks, the combination shouldbe giving to a minimum number ofAuthorized Users and the combination should be changed asAuthorized Users (withknowledgeof the combination) terminate use of Controlled Substances.

5.5.3 Records and documentation on Controlled Substancesmust also be secured.

5.4.4 All Controlled Substances must be kept locked in theirstorage location except for the actual timerequired to remove and actively work with them. They mustthen be replaced back into the approvedsecure storage location listed in the Registration. It isabsolutely required that Controlled Substances,when not in use, are located in the secure location at theaddress on the Registration. Do NOT leaveControlled Substances unattended.

5.4.5 Standard narcotic cabinets can be purchased throughvarious vendors. Remember that DEAregulations(https://www.deadiversion.usdoj.gov/21cfr/cfr/1301/1301_72.htm) require thatthe cabinet(safe) be secured so that it cannot be easily removed.

5.4.6 The steel cabinet or safe, if necessary, depending onthe quantities and type of ControlledSubstances stores, needs equipped with an alarm systemwhich, upon attempted unauthorized entry,transmits a signal directly to a central protection companyor a local or State police agency which has alegal duty to respond, or a 24-hour control station operatedby the registrant.

5.6 Administering (Dispensing) Controlled Substances

5.6.1 The DEA/WVBOP Registrant and their Authorized Usersare the only individuals permitted accessto the Controlled Substances in the inventory.

5.6.2 Administering or dispensing Controlled Substancesoccurs when an Authorized User obtains the requireded quantity of Controlled Substance from theControlled Substances storage for administration duringan experiment. The Authorized User must completedocumentation of Controlled Substances use bymaking a written record of the substance administered,quantity used, and any wastage. Every ml,mg, tablet, etc. of a Controlled Substances must beaccounted for in the records.

5.6.3 Use of a Bulk form Controlled Substance is documentedon the Deduction Card (provided by WVUEHS when substance is received).

5.6.4 If a Finished Form of the Controlled Substance will beused multiple times (e.g. vial of diluted Controlled Substance provides several doses) record thequantity of the Bulk Form used to make theFinishedForm of the Controlled Substance on a Usage Log(wvu-controlled-substances-usage-log.pdf).

5.6.5 At the end of each research use, Authorized Users mustreturn all Controlled Substances to thesecure approved storage area at the physical location on theRegistration Certificate.

5.7 Transport of Controlled Substances between UniversityBuildings

5.7.1 Small quantities of Finished Form substances foradministration may be transported between differentbuilding addresses for use (e.g.: from lab tovivarium, vet clinic to field animal). Controlled Substances must always be stored in accordance with DEA andWVBOP regulations.

5.7.2 Bulk Form substances cannot be transported betweenuniversity buildings unless being distributed(via Form 222, packing slip, transfer) to a Registrant.

5.7.3 A DEA Registrant cannot give his or her ControlledSubstance to another researcher to have itcompounded, diluted, tested, disposed, etc., unless therecipient researcher is a Registrant authorizedto receive the Controlled Substance, and the substance hascompleted a permissible Transfer (seeSection 5.8).

5.8 Disposal and Destruction of Controlled Substances

5.8.1 Controlled Substances that are no longer supported byan active approved protocol, or areexpired, damaged, contaminated, residual (waste) orotherwise unusable or unneeded must beappropriately disposed of. Coordination with WVU EHSControlled Substances Manager is required forany disposal actions to be performed by University MemberRegistrants. The most common disposalmethods available to University Member Registrants aredestruction and reverse distribution.

5.8.1.1 Destruction of Controlled Substances is performedand documented by the Registrantand must be destroyed by a mechanism rendering themunusable, irretrievable, andunrecoverable by an approved DEA and WVBOP method. The EHSControlled SubstancesManager can provide witnessing and other assistance forRegistrant-performed destructionsupon request.

5.8.1.2 Reverse distribution is the process by which aRegistrant has its Controlled Substancesinventory collected by a company/vendor possessing a Reversedistributing DEA Registration.The reverse distribution is documented in a manner similarto a Registrant-to- Registranttransfer, with the Reverse distributing Registrant thenresponsible for performing anddocumenting destruction. Use of a reverse distributor vendorcan be cost-prohibitive for anindividual Registrant. Coordinating Controlled Substancesdisposal needs with EHS enablesadvanced planning for hosting periodic Reverse distributionevents which can service multipleUniversity Member Registrants if/as warranted.

5.8.2 Bulk (Stock) Vials

Registrants are responsible for disposing of sealed orpartially used Bulk (stock) Controlled Substancesby Reverse Distribution or Controlled Substance Destruction.DEA Form 41 must accompany any on sitedestructions.

Disposal can be accomplished by transferring the sealed orpartially used Bulk (stock) Form ControlledSubstance (in original container) directly to a ReverseDistributor or via Registrant-performeddestruction.

5.8.2.1 Complete WVU Controlled Substance RegistrantTransfer for Disposal Form available onthe EHS website at:Controlled Substance Disposal

5.8.2.2 E-mail completed forms to the Controlled SubstanceManager (Subject line: ControlledSubstance Disposal Form) to coordinate disposal with EHSHazardous Materials team andReverse Distributor, as needed.

5.8.2.3 The Deduction Card must document ReverseDistribution and retain Reverse Distributiondocumentation.

5.8.2.4 Bulk/Stock vials containing less than 10% of theoriginal volume may be renderedunusable and discarded into a Cactus Sink. This wastage mustbe documented on the DeductionCard as well as on the documentation located at the CactusSink and be witnessed by anotherAuthorized User.

5.8.2.5 Completed DEA for 41 for registrant record ofControlled Substance Destructionsavailable on the EHS website at:Controlled Substance Disposal

5.8.3 Finish (Compounded) Form Vials

Finished Form or compounded drugs (anesthetic mixtures orControlled Substance dilutions) that areexpired or no longer usable must be destroyed by acomparable method rendering the substanceunusable, unrecoverable, and irretrievable.

5.8.4 Labeling Expired Drugs Awaiting Reverse Distributionor Destruction

Expired or unusable substances must be labeled, separated,and stored securely according to DEArequirements for the highest-level Schedule associated withthe Controlled Substances that requiredisposal. Each vial must be labeled as “expired” or “waste”and placed into a separate box or baglabeled as “DO NOT USE-EXPIRED” clearly on the outside ofthe box. The closed, labeled box must bekept within the same cabinet where inventory is stored.Expired compounds must remain on theinventory until reverse distributed.

5.8.5 Controlled Substance waste cannot be combined into onebottle for consolidation. Each individualcontainer of Controlled Substance must be maintained andtracked separately until disposal. At the timeof disposal, an entry shall be made on each container’sDeduction Card/Usage Log documentingdisposal.

5.8.6 Empty drug vials/containers may be disposed in thestandard lab waste stream, after defacing thelabel as EMPTY.

5.8.7 Controlled Substances injected into animals, consumedin a reaction, or converted into a non-recoverablehazardous waste mixture may be disposed of through routine waste disposal procedures(contact WVU-EHS with any questions).

5.8.8 Orphaned Controlled Substances - Continued possessionof Controlled Substances following theexpiration of a DEA or Board of Pharmacy Registration isunlawful. Registrant University Members musteliminate all Controlled Substances inventory in theirpossession via approved disposal or by apermissible Registrant-to-Registrant transfer prior toRegistration expiration. In the event thatControlled Substances are found on University premises forwhich a valid Registrant cannot be located(e.g. Registrant no longer with the University):

5.8.8.1 Ensure the Controlled Substance is secured.

5.8.8.2 Contact WVU EHS (Controlled Substances Manager304-293-6925, Main 304-293-3792 orHSC 304-293-7953) and submit a Hazardous Waste DisposalRequest Form(Hazardous Waste Disposal).Email form to EHS_Chemicals@mail.wvu.edu (Subject line:Orphaned Substance)

5.8.8.3 WVU EHS will notify UPD and arrange transfer of theControlled Substance to UPD, whowill secure the substance while awaiting DEA approval fordestruction.

5.8.8.4 DEA Form 41 will be completed to documentdestruction of the orphaned ControlledSubstance(s). The form must be kept as a record ofdestruction for at least two years inaccordance with 21 U.S.C. 827.

5.9 Controlled Substance Loss

5.9.1 If any Controlled Substance has been stolen,misplaced, or lost from the lab’s control, theRegistrant will immediately notify WVU EHS (304-293-0952),university police (304-293-3036), and theDEA.

DEA-Charleston

2 Union Square Ste 300

Charleston, West Virginia 25302

(304)-347-5209

Fax: (304)-347-5212

5.9.2 This includes required reporting for unauthorizeduses, unauthorized destruction, and a significantexplained loss (e.g., dropped and broken bottle) of anyControlled Substance. Any discrepancies orlosses of the material must be noted on the DeductionCard/Usage Log.

5.9.3 The DEA requires Registrants to notify the FieldDivision Office of the Administration in their area,in writing, of theft or significant loss of any ControlledSubstance, disposal receptacles, or listedchemicals within one business day of discovery of such lossor theft (fax a report to the above DEAnumber).

5.9.4 For theft or loss in transit, the Registrant must alsocomplete and submit to the Field DivisionOffice in their area, DEA Form 106 “Report of Theft or Lossof Controlled Substances” regarding the lossor theft (21 CFR 1301.76 (b) and 21 USC 830 (b)(1)(c)).

5.9.5 For loss of Controlled Substances due to accidentallyspilling or container breakage, the Registrantmust complete and submit DEA Form 41. Witnesses must signDEA-Form 41 for the loss of material.

5.9.6 DEA Form 106 can be found atDiversion Control Division | DEA Forms & Applications (usdoj.gov)under the “Reporting Forms” section.

5.9.7 If a container of a Bulk Form Controlled Substance isstolen, broken or spilled, the loss must bedocumented on the Deduction Card and a witness(es) must alsosign and date the deduction (preferablya member of WVU EHS and another Authorized User). If safeand feasible to do so, attempt to quantifythe spilled material.

5.9.8 If a container of a Finished Form Controlled Substanceis stolen, broken or spilled, the loss must bedocumented on the Usage Log and a witness(es) must sign anddate the deduction (preferably amember of WVU EHS and another Authorized User). If safe andfeasible to do so, attempt to quantifythe spilled material.

5.10 Documentation

5.11.1 DEA Registrants must maintain complete and accurateinventory records for all ControlledSubstances that demonstrate a closed system of distribution.Controlled Substances must be accountedfor with documents that support acquisition (ordering),receiving, administration (use), inventory, anddisposal. An accurate, continuous, and current record isrequired and necessary to validate proper useof Controlled Substances. Organization and retention ofdocumentation are discussed in theRecordkeeping section of this procedure.

5.10.2 Receipt of Controlled Substance

5.10.2.1 When a Controlled Substance is received from amanufacturer or vendor, theaccompanying paperwork (order form, shipping documents, andinvoices) must be retained aspart of the Controlled Substance official record.

5.10.2.2 You must maintain a record of the receipt of eachControlled Substance, indicating datereceived, date opened, name and address of supplier, thestrength or concentration, andamount of the Controlled Substance received (will bedocumented on Deduction Card).

5.10.2.3 After receiving a Controlled Substance, contact WVUEHS who will provide a DeductionCard and WVU inventory number. Every vial/container musthave its WVU inventory numberclearly and indelibly marked onto it. The Deduction Cardwill also state the WVU inventorynumber. Do NOT use a Controlled Substance until it has aDeduction Card and WVU inventorynumber.

5.10.3 When a delivery of Controlled Substance is receivedfrom a vendor (bulk (stock) form), it must beissued a WVU inventory number. The following numberingconvention will be used for consistency:

5.10.3.1 Lot number on container/package - MMDDYY of receipt- First & Last Initials of DEARegistrant. Example: a vial of Ketamine (lot # 123456) forDEA Registrant John Smith thatarrivedat WVU on June 8, 2020 would be listed as 123456-060820-JS

5.10.3.2 If multiple vials with the same lot # arrive on thesame day, use lower case letters todistinguish specific vials. For example, if three vials ofKetamine (Lot# 123456) for DEARegistrant John Smith arrived on June 8, 2020, the vialswould be assigned WVU inventorynumbers of 123456-060820a-JS, 123456-060820b-JS,123456-060820c-JS. (It may be helpful foreach vial to be given its own Deduction Card).

5.10.4 All containers of Controlled Substances must beproperly labeled. If the research laboratory re-packages, compounds,or dilutes Controlled Substances (Finished Form), then appropriately label therepackaged, compounded or diluted substance and store it inthe approved secure location listed on theRegistration.

Note, compounded (Finished Form) Controlled Substances(mixed co*cktails or diluted ControlledSubstances) cannot be transferred between DEA Registrants.

5.10.5 Finished forms (mixtures, dilutions) must be labeledwith their own unique inventory numberthat links the Finished Form vial back to the Bulk (stock)vial used to create the Finished Form.

5.11.5.1 Use the Bulk Form lot number, the date the FinishedForm was made, and theabbreviation “FF” (for Finished Form). For example, if theBulk Form vial had lot number“123456” and the Finished Form was made on 09/06/21, thenthe diluted vial would benumbered “FF-123456-09/06/21”. If there are multiple vialsof Bulk Form, include the lower-caseletter from the Bulk Form WVU identification number in the Finished Form inventorynumber.

For example:

5.10.5.2 If multiple Finished Form vials are made on thesame day (from the same Bulk Formlot), include a suffix after the date:

5.10.5.3 Diluted or compounded Controlled Substances thatwill be stored at least overnight inthe safe/secured location must be properly labeled with thefollowing information:

• Name of Controlled Substance
• Unique inventory number
• Final concentration
• Volume per container
• Expiration date (if applicable)

5.10.5.4 Each Finished Form vial must be issued acorresponding usage log to document use anddisposal.

Exception: if a Controlled Substance dilution or mixturewill be used for a single application,documentation on the Deduction Card is sufficient, aseparate Usage Log is not required.

5.10.6 The Deduction Card (Bulk Form) and Usage Log(Finished Form) will state the starting quantity ofthe substance. Each use is a subtraction from the startingquantity, and the running (decreasing) amountshould equal the total amount remaining on-hand. Each recordof use must be documented and signedby the DEA Registrant or Authorized User working with theControlled Substance. The DeductionCard/Usage Log should also include details of any ControlledSubstance lost, destroyed, or stolen.

5.10.7 The following details should be documented on theDeduction Card/Usage Log every time aControlled Substance is used in research:

• Date
• Building/Room
• Specific Research Experiment
• Strength/Quantity/Form of Controlled Substance
• Controlled Substance Administration (Animal Species/CellCulture/Equipment + ID)

5.11 Good Documentation Practices

5.11.1 Good Documentation Practices should be adhered towhen documenting information forControlled Substances. All documented information should be:

5.11.2 Attributable to a specific individual.

5.11.2.1 Sign and date documentation in a way that it isclear who has documented the data.

5.11.2.2 Full name should be printed/signed. Initials canonly be used when they correspond toa full name on the same document. For example, if anindividual will sign multiple columns ofatable, sign the full name in the first column with initialsin parenthesis, subsequent columns willrequire initials only.

5.11.2.3 Never sign for another individual on any document.Only sign for work performedyourself.

5.11.2.4 If any information/signature/date is to berepeated, the same should be rewritten. Ditto (--“---) marking or “as above” should NOT be used.

5.11.3 Legible: all recorded information (includingsignatures) should be identifiable.

5.11.4 Contemporaneous: record entries at the time ofactivity occurrence

5.11.5 Original: the first record made by the appropriateperson

5.11.6 Accurate: consistent and real representation of facts

5.11.7 Enduring: long-lasting and durable

5.12.7.1 Use an indelible pen. DO NOT use pencil, erasableor water-soluble ink.

5.12.7.2 Do not discard or destroy any Controlled Substancedocumentation unless theretention period expiry has been reached.

5.11.8 Correction of entry errors

5.11.8.1 Incorrect entries in Controlled Substance documentsshould NOT be overwritten orblacked out to make it unreadable (DO NOT USE white out orcorrection tape)

5.11.8.2 Always use a single strike through thedocumentation to mark the incorrect entry insuch a manner that the incorrect entry remains readable.

5.11.8.3 If possible, document the correct entry near thestrikeout entry and sign and date thedocumentation change. Alternatively, using correspondingsuperscript numbers (enclosesuperscripts in a circle), document the correct entry at thebottom of the document andsignand date the documentation change.

5.11.8.4 If the error is not easily identifiable (e.g.,misspelled word), document the reason forcorrecting the entry.

5.11.9 Blank/unused space in Controlled Substance documentsshould be NA’ed (make a single linestriking through portions of unused tables), signed, anddated.

5.12 Controlled Substances Inventory Requirements (21 CFR1304.11)

5.12.1 The Registrant is responsible for maintaining aControlled Substances inventory for Schedule I–Vsubstances. The inventory must be maintained at theregistered location and made available for two (2)years after the substance(s) has been used or disposed.

5.12.2 Each inventory shall contain a complete and accuraterecord of all controlled substances on handon the date the inventory is taken, and shall be maintainedin written, typewritten, or printed form atthe registered location.

5.12.3 A separate inventory shall be made for eachregistered location and each independent activityregistered. The inventory may be taken either at opening ofbusiness or at close of business on theinventory date and it shall be indicated on the inventoryform.

5.12.4 Initial Inventory: Once a DEA Registration is issued,the Registrant must take an initial inventory,which is an actual physical count of all ControlledSubstances in their possession. The Registrant willmake a record showing what is on hand, typically zero,during the initial inventory.

5.12.5 Biennial inventory: After the initial inventory istaken, the registrant shall take a new inventory ofall stocks of Controlled Substances on hand at least everytwo years. The biennial inventory may betaken on any date which is within two years of the previousbiennial inventory date.

5.12.6 Inventory date for newly Controlled Substances:inventory must be updated on the effective dateof a rule (from the DEA) when a substance is added to theSchedule (list of Controlled Substances). Everyregistrant required to keep records who possesses thatsubstance shall take an inventory of all stocks ofthe substance on hand. Thereafter, such substance shall beincluded in each inventory made by theRegistrant.

5.12.7 Inventory log sheets are available on the websiteassociated with this procedure. The inventorymust be maintained in the documentation notebook.

5.12.7.1 The inventory must document the Registrants name,DEA registration number, storagelocation, Controlled Substance(s) name, DEA Schedule, WVUinventory number, quantity(volume/weight/count), Container Quantity,Strength/Concentration, and Form (liquid, powder,tablets) for all Controlled Substances.

5.12.7.2 For any Controlled Substance that is damaged,defective, impure, or expired andawaiting disposal, this must be noted on the inventory alongwith the reason for the substancebeing maintained by the Registrant in such a state andwhether such substance is capable of usein the manufacture of any Controlled Substance in FinishedForm.

5.12.7.3 Any discrepancies identified between actualphysical quantity and remaining quantityaccording to the Deduction Card/Usage Log should be reportedto WVU EHS within one businessday.

5.13 Recordkeeping Requirements

5.13.1 A Controlled Substances notebook must be maintained(file, folder, binder) containing thedocumentation of Controlled Substance transactionsdemonstrating a closed system of distribution.

5.13.2 An accurate, continuous, and current recordreflecting the acquisition, administration (use),disposal, and biennial inventory of Controlled Substances inSchedules I – V is necessary to validateproper documentation of use of Controlled Substances.

5.13.3 Records must be maintained for two years after thedepletion or destruction of the ControlledSubstance.

5.13.4 Authorized User Forms

5.14.4.1 As described in section 5.2 of this manual, theRegistrant must maintain clearancerecords for every Authorized User associated with theRegistration. These forms containsensitive information and should not be stored in theControlled Substance notebook. Instead,the Personnel Screening Form should be locked securely aswith other sensitive employmentinformation maintained by the Registrant.

5.14.4.2 The Authorized User Signature Log must bemaintained with the Controlled Substancenotebook associated with the appropriate Schedule.

5.14.4.3 Forms must be retained for two (2) years after theAuthorized User is no longerassociated with the Registration.

5.13.5 Suggested Controlled Substances Notebook SectionsBased on Required Documentation. Pagedividers and plastic sheet protector pockets are very usefulwhen organizing the different sections andindividual vials.

1. Background Information

- Copy of current in-date DEA Registration and WVBOPRegistration Certificate

- Controlled Substance Research Protocol

- Copy of amendments to Registration(s)

2. Authorized Users

- Authorized User Signature Log specific to Schedules inRegistration(s)

-Documentation of any training given to the Authorized Userby the Registrant.

- Copy of Power of Attorney (for Schedule I and II only)

3. Inventory

- Initial inventory

- Biennial inventories

4. Acquisition/Purchasing

- Purchasing log/Tracking form used to track ControlledSubstance acquisition,numbering/tracking system, and disposal. Suggested columnsinclude:

Date of purchase

Date of arrival

Name, manufacturer, lot number, concentration, WVU inventorynumber

Expiration date

Individual Authorized User assigned to bottle/vial (ifneeded)

Date of when vial/bottle was disposed/emptied

-For how to store DEA Forms 222, see section 5.3.3.9

5. Controlled Substance Usage and Disposal Log form

- Stock (Bulk form) vial log - Every vial must have a WVUinventory number and associatedDeduction card. If multiple vials of the same ControlledSubstance, with the same lot numberarrive on the same day, they can be associated with a singleDeduction Card (seeDocumentation section in this manual).

- Maintain packing slips (signed and dated) with DeductionCards – photocopy packingslip when multiple substances are purchased at once. EachControlled Substance willneed to be easily associated with its packing slip andmaking copies simplifies thisprocess.

- Copy of completed DEA Form 222 – Required for Schedule Iand II purchases. Keep blankoriginals locked.

- Compounded/Dilution (Finished form) vial log – eachcompounded vial created must have ausage log. The compounded vial must have a unique trackingnumber that references/links it tothe original Stock/Bulk vial number (see Documentationsection in this manual).

-Documentation of Controlled Substance use must be donecontemporaneously on theDeduction Card/Usage Log.

-The last entry in the usage portion of the forms shouldrefer to the record of disposal (e.g, vialempty (remaining balance should be ~0), expired-reversedistributed, waste-reversedistributed). Make a single line through any remaining(blank) columns of the usage portion,NA,, sign, and date.

6. Reverse Distribution

- Copy of WVU Controlled Substance Registrant Transfer forDisposal Form

- Maintain copies of Reverse Distribution confirmation.

6.0 Termination of License

If the DEA Registrant desires to terminate their work withControlled Substances (e.g. the lab is closingor the DEA Registrant is retiring), the DEA Registrant mustnotify WVU EHS Controlled SubstancesManager immediately for assistance in properly concludingControlled Substance work. The Registrantmust dispose of or transfer all Controlled Substances priorto closing the lab or before allowing the DEAregistration to expire. The DEA should be notified to cancelthe registration and will inform theRegistrant of any additional requirements.West Virginia University.

7.0 Associated Forms

Authorized User Screening Form (WVU EHS Website)

Authorized User Signature Log (WVU EHS Website)

DEA From 222 for transfer of Schedule I & II drugs

DEA Form 41 for documenting loss of material fromspills/broken bottles

DEA Form 106 for documenting drug theft/loss during transit

Deduction Card (Issued by WVU EHS)

New Registrant Application

West Virginia University Controlled Substances ResearchProtocol

WVBOP Application for Permit or Renewal to Handle ControlledSubstances

DEA-Form 225 New Application for Registration

Schedule III-V Transfer Form (WVU EHS Website)

Transfer for Disposal Form (WVU EHS Website)

Usage Log (WVU EHS Website)

DEA Forms can be found at:Diversion Control Division | DEA Forms & Applications (usdoj.gov)