· web viewboth the state of louisiana and the federal government regulate controlled...

USE OF CONTROLLED SUBSTANCES IN ANIMAL RESEARCH AND BENCH RESEARCH

TULANE UNIVERSITY

RESPONSIBLE UNIVERSITY OFFICIAL: Vice President for Research

RESPONSIBLE OFFICE: Office of Research

COORDINATING DEPARTMENTS: Research Compliance Office, Office of Environmental Health and Safety (OEHS), Tulane University Police Department (TUPD), Department of Comparative Medicine (DCM), Institutional Animal Care and use Committee (IACUC)

ISSUED DATE: December 7, 2016 EFFECTIVE DATE: December 7, 2016 LAST REVIEWED DATE: December 12, 2016 NEXT REVIEW DATE: December 1, 2017

WHO NEEDS TO KNOW THIS POLICY:

1. Tulane University (“Tulane”) faculty and staff who perform animal research with Controlled Substances and/or who perform bench research with Controlled Substances;

2. Faculty seeking to obtain or renew a Controlled Substances license; and3. Department chairs and other university officials who have responsibility for Tulane

faculty and staff who seek to obtain or already have a Controlled Substances license.

RESEARCH NOT SUBJECT TO THIS POLICY: Human subject research where Controlled Substances are utilized. Tulane Human Research Protection Program Standard Operating Procedures regulate such use of Controlled Substances in human subject research.

WEBSITE ADDRESS FOR THIS POLICY: https://tulane.edu/asvpr/research-compliance.cfm ______________________________________________________________________________

I. Introduction and Applicable Regulations

A. Introduction and Overview:

1. Both the State of Louisiana and the Federal Government regulate Controlled Substances used in research. The regulating entity for the State of Louisiana is the Louisiana Board of Pharmacy (“LABP”). The regulating entity for the Federal Government is the Drug Enforcement Agency (“DEA”).

2. The LABP and DEA require researchers seeking to utilize Controlled Substances to obtain both LABP and DEA registrations and to abide by LABP and DEA regulations regarding licensing, storage, distribution, use, and disposal of Controlled Substances. Such researchers are referred to in this policy as “Registrants”.

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The official version of this information will only be maintained in an on-line web format. Any and all printed copies of this material are dated as of the print date. Please make certain to review the material on-line prior to placing

reliance on a dated printed version.

http://www.labp.com/

https://tulane.edu/asvpr/research-compliance.cfm

https://tulane.edu/asvpr/irb/sops.cfm

https://tulane.edu/asvpr/irb/sops.cfm

3. Registration is an individual obligation; therefore, it is the responsibility of Tulane University (“Tulane”) researchers (“Registrants”) utilizing Controlled Substances in research to familiarize themselves with the regulations referenced herein. Failure to adhere to applicable laws and regulations may result in an immediate loss of the ability to conduct research using Controlled Substances at Tulane, loss of LABP and DEA license, termination of employment, and/or prosecution by law enforcement.

4. Registration has to be maintained at all times while Controlled Substances are being used in research or in the Registrant’s possession.

5. Registrants must utilize the Controlled Substances they order exclusively for their own research. Controlled Substances cannot be shared or transferred to others not supervised directly by the Registrant.

6. Registrants must supervise their employees, students and other agents who assist them in their Controlled Substances research. Supervising personnel includes: explaining what and how Controlled Substances will be used in the research, ensuring personnel are trained in Controlled Substances security and record-keeping procedures, and actively monitoring personnel’s use of Controlled Substances in research to ensure that this Policy and applicable laws and regulations are being followed.

7. Registrants must order Controlled Substances through Tulane Materials Management.

8. Registrants must keep Controlled Substances in a secure locked cabinet or safe and control access to the Controlled Substances.

9. Registrants must keep accurate records on the receipt and use of Controlled Substances. Registrants also must keep an initial and biennial inventory of their Controlled Substances. Records for Schedule I and II Controlled Substances must be kept separately.

10. Researchers must only dispose of Controlled Substances through the Tulane Office of Environmental Health and Safety (“OEHS”).

11. Registrants must immediately report any theft or significant loss of Controlled Substances to the Tulane University Policy Department (“TUPD”), Office of General Counsel, and the Research Compliance Office.

12. The Tulane National Primate Research Center (“TNPRC”) has additional policies and procedures to ensure proper handling, dispensing, and administering, and recording of all research activities at the TNPRC involving Controlled Substances. See Appendix I: TNPRC SOP 2.41.5 Controlled Substances; Appendix J: TNPRC Division of Veterinary Medicine, Controlled Drug Box Access Instructions, and Appendix K: TNPRC Morphine and Administration Protocol.

B. Applicable Laws and Regulations:

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1. State: The LABP lists all state laws and regulations applicable to CS at http://www.labp.com/index.cfm?md=pagebuilder&tmp=home&pid=308&pnid=0&nid=58, and has codified all such laws and regulations into the LABP Law Book.

2. Federal (DEA): Federal Controlled Substances Act (Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970), Title 21 Code of Federal Regulations (CFR) Parts 1300-1321.

C. What is a Controlled Substance?

1. A controlled Substance is a drug or other substance, or immediate precursor, included in Schedules I, II, III, IV, or V, as defined by: a. State law: LA-R.S. 40:964b. Federal/DEA List of Controlled Substances:

http://www.deadiversion.usdoj.gov/schedules/index.html#list

2. An updated and complete list of the Schedules for all Controlled Substances is published annually in Title 21 Code of Federal Regulations (“CFR”) §§ 1308.11 through 1308.15. See http://www.deadiversion.usdoj.gov/schedules/orangebook/orangebook.pdf.

II. Policy and Procedures for Controlled Substances used in Animal and Bench Research at Tulane

In accordance with Title 21, CFR, Parts 1300-1308 and state (LABP) Laws and Regulations, all Tulane employees who conduct research activities that involve Controlled Substances must comply with applicable federal and state laws and regulations regarding their use and possess and maintain all necessary LABP licenses and DEA registrations.

A. Who at Tulane may apply to the LABP and DEA for a Controlled Substances License?

1. Only Tulane University faculty who conduct research or teaching activities that involve Controlled Substances on Tulane property are eligible to apply for LABP or DEA registrations (“Registrant” or “Registrants”).1

2. Approval by the Vice President of Research (see Procedures in Section III) is required.

B. Registration Process – Tulane, LABP, and DEA Requirements:

1. Complete Training. Registrants must first complete the training module entitled, “Use of Controlled Substances in Research”, available on Tulane’s “Training Wave”.

1 Human subject research where Controlled Substances are utilized where this Policy is applicable, as noted in the introductory section, “Research Not Subject to This Policy”.

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http://www.deadiversion.usdoj.gov/schedules/orangebook/orangebook.pdf

https://www.deadiversion.usdoj.gov/schedules/index.html#list

https://www.legis.la.gov/Legis/Law.aspx?d=98877

https://www.deadiversion.usdoj.gov/21cfr/cfr/index.html



http://www.pharmacy.la.gov/assets/docs/Laws/LB_2015_FINAL_Rev0708.pdf

http://www.labp.com/index.cfm?md=pagebuilder&tmp=home&pid=308&pnid=0&nid=58

http://www.labp.com/index.cfm?md=pagebuilder&tmp=home&pid=308&pnid=0&nid=58

The Training Wave portal is located in Gibson Online (https://gibson.tulane.edu/), under either the "Staff" or "Faculty" tab and located in the "Tulane Resources" section of the "Staff Services" navigation pane. Registrants must retain completion of the training certificate, as it will be needed as part of the process of obtaining the LABP license and DEA registration.

2. Apply for a Controlled Dangerous Substances (“CDS”) license from the LABP. a) Applications for new licenses and renewal of licenses are located on the LABP

website at CDS Forms & Applications. i. Veterinarians should complete the LABP Application for New CDS

License for Practitioner.ii. Researchers should complete the LABP Application for New CDS

License for Selected Persons & Organizations . iii. The “Practice Address” on the form should list all locations where the

Registrant will store and use/utilize Controlled Substances under the Registrant’s license. Changes to the address where the Registrant stores Controlled Substances must be reported to the LABP within 10 days of the change using the LABP Request for Change of Address for Louisiana CDS License.

b) A “Letter of Verification”, provided by Tulane’s Vice President for Research, must be included with an application to the LABP for a new CDS license.

i. As part of the process for obtaining a Letter of Verification, the applicant’s department chair must appoint a monitor to conduct an annual records review of the required record keeping of the Registrant. Monitors must complete an on-line training module which outlines their roles and responsibilities and how to perform them. The department chair must provide the name and contact information for the monitor in the request for Letter of Verification.

ii. See Appendix D: Process, Requirements, and Request Form for obtaining a Letter of Verification.2

c) The LABP may require an applicant to complete a background check. If so, fingerprinting for the background check can be completed by TUPD.

d) The LABP, at its discretion, may inspect the location(s) where the Registrant lists that Controlled Substances will be stored and/or utilized.

e) If the LABP and/or DEA requests a copy of the applicant’s IACUC protocol as a condition of issuing the license and/or registration, the applicant should not provide the actual protocol. Instead, contact the Tulane IACUC Director to provide a letter for the LABP and/or DEA instead of providing the IACUC protocol.

3. Apply for DEA Registration under the Controlled Substances Act. The DEA will not accept an application until the Registrant has received a license from the LABP. a) New applications to the DEA: DEA Form 225 “Manufacturer, Distributor,

Researcher , Analytical Laboratory, Importer, Exporter” ;

2 Qualtrics to be used to take information from the letter of verification request form to populate the database of Registrants and assigned monitors.

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http://www.deadiversion.usdoj.gov/drugreg/index.html


https://tulane.edu/asvpr/iacuc/contact.cfm

http://www.pharmacy.la.gov/assets/docs/Forms/120_CDSAddressChange_20120701F.pdf

http://www.pharmacy.la.gov/assets/docs/Forms/120_CDSAddressChange_20120701F.pdf

http://www.pharmacy.la.gov/assets/docs/Forms/110_AppNewCDSLicMisc_20120701F.pdf

http://www.pharmacy.la.gov/assets/docs/Forms/110_AppNewCDSLicMisc_20120701F.pdf

http://www.pharmacy.la.gov/assets/docs/Forms/101_AppNewCDSLicPractitioners_2013-0815-F.pdf

http://www.pharmacy.la.gov/assets/docs/Forms/101_AppNewCDSLicPractitioners_2013-0815-F.pdf

http://www.pharmacy.la.gov/index.cfm?md=pagebuilder&tmp=home&pid=200

http://tulane.edu/oehs/upload/Training-Wave-Location.pdf

http://tulane.edu/oehs/upload/Training-Wave-Location.pdf

https://gibson.tulane.edu/

https://gibson.tulane.edu/

b) Renewal applications to the DEA: DEA Form 225a “Manufacturer, Distributor, Researcher , Analytical Laboratory, Importer, Exporter” ;

c) New application forms and renewal application forms are available at http://www.deadiversion.usdoj.gov/drugreg/index.html.

d) The DEA, at its discretion, may inspect a location where Controlled Substances are to be stored prior to issuing a registration. Registrants who indicate to the DEA that Schedule I Controlled Substances will be utilized should expect a DEA inspection prior to DEA approval of the registration, and unannounced inspections at lease annually once such registration is approved.

e) If the LABP and/or DEA requests a copy of the applicant’s IACUC protocol as a condition of issuing the license and/or registration, the applicant should not provide the actual protocol. Instead, contact the Tulane IACUC Director to provide a letter for the LABP and/or DEA instead of providing the IACUC protocol.

4. Once received, the LABP CDS License and the DEA Certificate of Registration (DEA Form 223) must be maintained at the registered location in a readily retrievable manner and kept available for official inspection (see http://www.deadiversion.usdoj.gov/pubs/manuals/pract/section2.htm).

5. Once DEA and LABP licenses have been obtained, register the licenses with Tulane OEHS by contacting the OEHS Help Desk at [email protected] or 504-988-2871.3 Only license holders who have registered licenses with OEHS are able to utilize the on-site destruction of expired or unwanted Controlled Substances services provided by OEHS.

C. Annual Registration Renewal:

Both the LABP and the DEA require an annual renewal.

D. Storage of Controlled Substances:

1. Registrants must provide effective controls and procedures to guard against theft or diversion of controlled substances. The LABP and DEA evaluate physical security measures based on the type and amount of Controlled Substances on hand; the Registrant’s location in a high or low crime area; the number of persons who have access to the Controlled Substance storage area; the presence and use of an alarm system; and any prior history of drug diversion. See Louisiana Administrative Code, Title 46, Chapter 27, § 2713, Security Requirements.

2. Containers: Controlled Substances should be stored in their original, labeled containers, and they should be stored separately from general chemicals.

3. Schedule I Substances: Schedule I Controlled Substances must be kept in a securely locked, substantially constructed cabinet. See 21 CFR 1301.75 (a). A strong metal

3 Qualtrics to be used to populate the database of Registrants and assigned monitors. 5



https://www.deadiversion.usdoj.gov/21cfr/cfr/1301/1301_75.htm

http://www.pharmacy.la.gov/assets/docs/Laws/Web_LAC46_Chap27_2016-0720.pdf

http://www.pharmacy.la.gov/assets/docs/Laws/Web_LAC46_Chap27_2016-0720.pdf

mailto:[email protected]

http://www.deadiversion.usdoj.gov/pubs/manuals/pract/section2.htm

https://tulane.edu/asvpr/iacuc/contact.cfm



cabinet, safe, refrigerator, or freezer securely fastened to the floor or wall in a manner that prevents it from being readily removed is generally acceptable.

4. Controlled substances listed in Schedules II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet safe, refrigerator, or freezer. See 21 CFR 1301.75 (b).

5. Rooms in which Controlled Substances are stored must be locked when the Registrant or an Authorized User are not present in the room. The Registrant must control access to the room and keep a list of all persons to whom the Registrant has issued a key, key card, or key code for room access. Appendix G: Access Log may be used for this purpose. The Registrant must immediately disable access for persons who no longer require access to perform job duties; persons who no longer work for Registrant and/or Tulane; and persons whose access to Controlled Substances must be terminated because of security concerns.

6. For additional guidance, see the DEA’s Controlled Substances Security Manual – Security Requirements for Practitioners (including researchers).

E. Purchasing, Invoice, and Acquisition Records (21 CFR – Part 1304.04):

1. All purchasing of Controlled Substances must be done through Tulane Materials Management using the Tulane Requisition Form.4

a) See Tulane Materials Management Purchasing Policy and Procedures Manuel, Section 10.3, “Controlled Substances”.

2. Registrants must maintain complete, current, and accurate purchasing records for Controlled Substances that are accessible from all locations where Controlled Substances are stored and/or utilized/administered.

3. Ordering (DEA Form 222), invoice, acquisition, inventory, and use logs and records of Schedules I and II Controlled Substances must be maintained separately from all other records of the Registrant and must be adequately secured. See 21 CFR 1304.04, Maintenance of records and inventories. Such log and records are to be stored in a locked cabinet at all times except during the time of immediate use.

a) A DEA Form 222 is required when ordering a Schedule I or II Controlled Substance in addition to an invoice. A purchaser must submit Copy 1 and Copy 2 of the DEA Form 222 to the supplier and retain Copy 3 (blue copy) in the purchaser's files. Copy 3 (blue) of the DEA Form 222 must be completed by the Registrant.

b) It is important that the DEA Form 222 be complete and free from errors; therefore, Registrants should be precise in completing the DEA Form 222. For

4 Qualtrics to be used to capture information for purposes of maintaining an inventory of Controlled Substances at Tulane, as OEHS signs off on the requisition form.

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http://matmgmt.tulane.edu/policies_and_procedures_manual.html#10

http://matmgmt.tulane.edu/policies_and_procedures_manual.html#10

http://www.tulane.edu/~admin/tams/pdf/Requisition.pdf

http://www.deadiversion.usdoj.gov/21cfr/cfr/1304/1304_04.htm

https://www.deadiversion.usdoj.gov/pubs/manuals/sec/sec_req.htm

https://www.deadiversion.usdoj.gov/pubs/manuals/sec/sec_req.htm



detailed guidance, see 21 CFR 1305.13, Procedure for filling DEA Forms 222, and DEA Form 222 Questions & Answers.

4. Invoice and acquisition records of Controlled Substances listed in Schedules III, IV, and V shall be maintained either separately from all other records of the Registrant or in such form that the information required is readily retrievable from the ordinary business records of the Registrant. See 21 CFR 1304.04, Maintenance of records and inventories.

5. All Controlled Substances supplier invoices, shipping documents, and/or packing slips must be retained and marked with the exact date the Controlled Substance was received.

6. All invoice and acquisition records must be maintained for at least 2 years from the date of such records and be readily retrievable for inspection by authorized employees of the DEA. See 21 CFR 1304.21, General requirements for continuing records. For Controlled Substances paid for by a sponsor, the Registrant must abide by the record keeping requirements of the sponsor if the sponsor’s record retention time period is longer than 2 years.

F. Transfer or Distribution of Controlled Substances is Prohibited:

1. Tulane requires that the Registrant utilize any Controlled Substance ordered under their registration solely for their research as described in the Registrant’s initial application, amendment(s), and renewal applications submitted to DEA and LABP.

2. Tulane does not permit the Registrant or an Authorized User to transfer or provide Controlled Substances to any other persons for use in those persons’ research or for any other use.

3. Registrants are to dispose of unwanted, expired, or excess Controlled Substances as per the Disposal of Controlled Substances section of this policy.

G. Inventory Requirements:

1. Registrants must maintain inventory records for all Controlled Substances on hand as required by 21 CFR – Part 1304.11. If a Registrants delegates any inventory duties to an Authorized User, the Registrant is still responsible for the adequacy, accuracy, and completeness of the inventory.

2. An Initial inventory must be taken upon first acquisition of Controlled Substances.

3. A subsequent inventory must be taken at least every second year (biennial inventory) following the initial inventory and whenever the Registrant has on hand a substance that was previously not controlled but is now controlled due to a change in regulations.

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https://www.deadiversion.usdoj.gov/faq/dea222.htm


4. All inventories must be:a) documented separately; b) labeled/identified as an “inventory”; c) signed and dated by the Registrant; and d) labeled as to whether the inventory was taken on the opening or closing of

business (i.e., at the start of the workday or at the end of the workday) on the date the inventory was taken.

5. For each Controlled Substance, the inventory shall include:

a) The name of the substance;b) Each finished form of the substance (e.g., 10-milligram tablet or 10-milligram

concentration per fluid ounce or milliliter);c) The number of units or volume of each finished form in each commercial

container (e.g., 100-tablet bottle or 3-milliliter vial); andd) The number of commercial containers of each such finished form (e.g. four 100-

tablet bottles or six 3-milliliter vials).

6. Records of inventories must be maintained and made available to the DEA upon request for at least 2 years from the date of the inventory, as required by 21 CFR – Part 1304.04, “Maintenance of records and inventories”. For Controlled Substances paid for by a sponsor, the Registrant holder must abide by the record keeping requirements of the sponsor if the sponsor’s record retention time period is longer than 2 years.

7. See Appendix C: Controlled Substances Inventory Form.

H. Utilization/Dispensing Records:

1. Utilization records for use of Controlled Substances (Controlled Substances Utilization Logs) are required by 21 CFR – Part 1304.22, “Continuing Records”.

2. Utilization/Drug Logs must be maintained in a separate, bound ledger, to include a separate ledger for each product.

3. Each utilization log includes the exact product name and a record of each withdrawal with the date, amount, nature of use, and dispenser’s signature.

4. Utilization/Dispensing Records must be maintained and made available to the DEA upon request for at least 2 years from the most recent date contained on the Controlled Substances Utilization Log, as required by 21 CFR – Part 1304.04, “Maintenance of records and inventories.” For Controlled Substances paid for by a sponsor, the Registrant holder must abide by the record keeping requirements of the sponsor if the sponsor’s record retention time period is longer than 2 years.

5. See Appendix B: Controlled Substances Utilization Log.

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I. Authorized Users:

1. The Registrant cannot hire or utilize any employee, agent, or student whose work requires them to have access to Controlled Substances if that person has been convicted of a felony relating to Controlled Substances, or has had a DEA registration denied, revoked or surrendered for cause.

2. The Registrant must require all employees, students, or other agents who will be working with Controlled Substances to complete and sign the “Tulane University Controlled Substances Authorized User Attestation” prior to beginning any work with Controlled Substances. See Appendix E: Tulane University Controlled Substances Authorized User Attestation. The Registrant must also complete and sign the Tulane University Controlled Substances Authorized User Attestation prior to any work with Controlled Substances. In addition, employees will be expected to undergo any criminal background or any other checks routinely required of employees by Tulane’s Workforce Management Organization. Submit all completed Authorized User Attestation to WFMO for review. The proposed Authorized User cannot begin work with Controlled Substances until the Authorized User Attestation has been acknowledged by WFMO.

3. Authorized Users must follow all the rules and regulations applicable to Registrants and as outlined in this policy. Registrants are responsible for supervising all Authorized Users who have access to CS acquired under their CS License.

4. Tulane does not permit the Registrant or an Authorized User to transfer or provide Controlled Substances to any other persons for use in those persons’ research or for any other use.

5. The Registrant must keep as part of their Controlled Substances records all completed Authorized User Attestations. Authorized User Attestations for individuals no longer conducting research utilizing Controlled Substances under the Registrant are to be maintained but may be maintained separately from active Authorized Users for a period of 2 years from the date the individual ceased to conduct research or other activities involving Controlled Substances under the Registrant. For Controlled Substances paid for by a sponsor, the Registrant holder must abide by the record keeping requirements of the sponsor if the sponsor’s record retention time period is longer than 2 years.

6. Authorized Users who work with Controlled Substances in research and who are convicted of a felony relating to Controlled Substances or have a DEA registration or LABP license denied, revoked, or surrendered for cause while working for the Registrant, must immediately report such events to the Registrant, and the Registrant immediately must terminate their access to Controlled Substances at Tulane. Registrants are encouraged to keep a log of persons working for them that the

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Registrant has authorized to work with Controlled Substances. The “Controlled Substances Authorized User Signature Log” may be used for this purpose. See Appendix H: Controlled Substances Authorized User Signature Log.

J. Theft or Loss of Controlled Substances:

1. In the event of a theft or significant loss of a Controlled Substance, Registrants and Authorized Users must immediately report the theft of loss to the TUPD and comply with all follow-up actions as directed by the TUPD. Contact the TUPD dispatch line for the applicable campus:

a) Downtown Campus: 504.988.5555b) TNPRC: 985.871.6411c) Uptown Campus: 504.865.5911

Although an Authorized User may make such reporting to TUPD, the Registrant is responsible for ensuring such reporting is done.

2. 21 CFR – Part 1301.76, “Other security controls” , requires Registrants to report to the DEA all thefts of any Controlled Substance (whether the theft is subsequently recovered or not) and any “significant loss” of any Controlled Substance using DEA Form 106 within one business day of discovery of such loss of theft. DEA encourages online submission of a completed DEA Form 106. The Registrant is the responsible party for completing such reporting to the DEA.

3. Pursuant to 21 CFR – Part 1301.76, when determining whether a loss is “significant”, a Registrant should consider, among others, the following factors:

a) The actual quantity of Controlled Substances lost in relation to the type of business;

b) The specific Controlled Substances lost;c) Whether the loss of the Controlled Substances can be associated with access to

those Controlled Substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the Controlled Substances;

d) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses;

e) If known, whether the specific Controlled Substances are likely candidates for diversion; and

f) If known, local trends and other indicators of the diversion potential of the missing Controlled Substance.

4. Registrants are to consult with General Counsel, Research Compliance, and TUPD in determining whether a loss of Controlled Substances is “significant”.

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http://www.deadiversion.usdoj.gov/21cfr_reports/theft/index.html

https://www.deadiversion.usdoj.gov/webforms/dtlLogin.jsp




K. What to do in the event of a DEA or LABP inspection:5

1. Registrants must contact TUPD when such inspections occur, before allowing any inspection or actions by the inspector.

2. Offer the inspector(s) a conference room or other location in which to wait. Advise the inspector(s) that Tulane University policy requires Registrants to contact TUPD when such inspections occur.

3. Immediately contact the TUPD dispatch line for the applicable campus:


4. TUPD will contact the Tulane Office of General Counsel (504.865.5783) to advise of the inspection.

5. See Appendix A, Sample DEA Checklist of Required Records for Researchers.

L. Disposal of Controlled Substances:

1. Disposal of Controlled Substances, including small amounts of Controlled Substances and expired Controlled Substances, must be done in coordination with the Tulane Office of Environmental Health and Safety (“OEHS”) and the TUPD. Information on scheduling disposal of Controlled Substances is available on the OEHS website at http://tulane.edu/oehs/disposal-of-controlled-substances.cfm. Contact information for the OEHS Hazardous Waste Supervisor is as follows:

OEHS Hazardous Waste SupervisorOffice phone: 504-988-5486Direct line: 504-988-2871Mobile phone: 504-460-4051Email: [email protected] OEHS Website: http://tulane.edu/oehs/

2. Empty bottles or containers that previously contained Controlled Substances do not have to be disposed of through this process.

M. Monitoring:

1. An annual monitoring must be conducted by the monitor appointed by the applicable department chair for each Registrant using the form entitled, “Controlled Substances Monitoring Form”, available as Appendix F, Controlled Substances Monitoring

5 This section of the policy does not apply to inspections that LABP and/or DEA may conduct prior issuance of a license. However, Registrants are encouraged to contact the Research Compliance Office to discuss such inspections as part of Tulane’s efforts to provide resources to future applicants.

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http://tulane.edu/oehs/


http://tulane.edu/oehs/disposal-of-controlled-substances.cfm

Form. The completed monitoring form must be submitted to Loula Burton, Senior Program Coordinator, Office of the Vice President for Research, [email protected] upon completion of records review but no later than the end of the academic year, June 30th.6 The annual monitoring must be completed for all Registrants active in each academic year.

2. The Research Compliance Office will follow-up on compliance issues noted by the monitor that could not be resolved during the monitoring visit. The Research Compliance Office will coordinate resolution of activities that are noncompliant with this policy.

3. The departmental chair shall appoint one monitor for all Controlled Substances license holders within that department (i.e., one monitor per department).

4. Within 30 days of being appointed as a monitor, all assigned monitors are to complete the training entitled, “Use of Controlled Substances in Research”, available on Tulane’s “Training Wave”.

5. The monitor may choose to conduct the monitoring in conjunction with TUPD if so requested by a monitor (i.e., TUPD shall accompany the monitor upon request when performing the annual monitoring). Additionally, TUPD shall be available to assist monitors as needed. To arrange TUPD to accompany a monitoring, or to request TUPD assistance during a monitoring, contact TUPD as follows:


6. As part of the IACUC’s ongoing Post Approval Monitoring (“PAM”) program, where possible, information obtained during PAM activities will be provided to assist in keeping the central list of Registrants and inventory of Controlled Substances current and accurate.

N. Departing Registrants:

1. Registrants leaving Tulane are required to notify LABP and DEA of the change. Tulane will not notify the LABP and DEA on behalf of the Registrant.

2. Disposal of a Registrant’s current inventory of Controlled Substances on hand must be completed prior to the Registrant’s departure from Tulane. Registrants are to conduct disposal in accordance with the section “Disposal of Controlled Substances” above. Transfer of Controlled Substances is such situations is prohibited.

O. Deviations from this Policy: Any requests for deviations from this policy should be submitted in writing to Tulane’s Vice President for Research.

6 Qualtrics will be used to capture the data for purposes of a central list of all Registrants and assigned monitors. 12




1. Version published on December 7, 2016 (Original Publication)

III. Appendices to this document:

A. Appendix A: Sample DEA Checklist of Required Records for Researchers

B. Appendix B: Sample Controlled Substances Log

C. Appendix C: Sample Controlled Substances Inventory Form

D. Appendix D: Process, Requirements, and Request Form for Obtaining a Letter of Verification

E. Appendix E: Tulane University Controlled Substances Authorized User Attestation

F. Appendix F: Controlled Substances Monitoring Form

G. Appendix G: Access Log

H. Appendix H: Controlled Substances Authorized User Signature Log

I. Appendix I: TNPRC SOP 2.41.5 Controlled Substances (available upon request from the TNPRC Department of Veterinary Medicine and the RCO)

J. Appendix J: TNPRC Division of Veterinary Medicine, Controlled Drug Box Access Instructions (available upon request from the TNPRC Department of Veterinary Medicine and the RCO)

K. Appendix K: TNPRC Morphine and Administration Protocol (available upon request from the TNPRC Department of Veterinary Medicine and the RCO)

7.

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Appendix A: SAMPLE DEA CHECKLIST OF REQUIRED RECORDS FOR RESEARCHERS*

I. INVENTORIES – Of ALL Controlled Substances on hand:

A. Initial Inventory – must be taken upon first engaging in business as a DEA Registered Researcher.B. Subsequent Inventory – must be taken every second year following initial inventory, AND

whenever substances become CONTROLLED.C. All Inventories – must be complete, accurate, documented separately, identified as an Inventory,

signed by the Registrant, dated and indicated opening or close of business.

II. RECEIPTS – Of ALL Controlled Substances from ALL sources:

A. Schedules I and II Substances – Pursuant to DEA Form 222, all transactions must be pursuant to official order forms. Receipts MUST be logged-in on the purchaser’s copy of each form.

B. Retain Invoices – Retain every Controlled Substance invoice from the supplier, marking it with the exact date items were received.

III. UTILIZATION/DISPENSING RECORDS - For Controlled Substances:

A. Maintain a separate, bound dispensing/utilization ledger.B. Recorded information must include:

1. Exact product name (do not combine similar products and preferably one drug per page); and2. Record each withdrawal and include the following information: date, amount, nature of use,

and dispenser’s signature.

IV. CONTROLLED SUBSTANCES RETURNED TO SUPPLIERS (OR GIVEN TO OTHER RESEARCHERS/PRACTITIONERS):

A. Official order forms (Schedule II) and/or other documentation must be executed and retained by both parties.

V. CONTROLLED SUBSTANCES TO BE DESTROYED :

A. Controlled substances may ONLY be destroyed by a Reverse Distributor. Note: the Tulane OEHS process for Disposal of Controlled Substances meets the regulatory requirements for disposal via a “Reverse Distributor.”

VI. THEFTS OR LOSSES OF CONTROLLED SUBSTANCES :

A. Local police must be notified immediately.B. DEA must be notified.C. Theft report (DEA Form 106) must be completed.

More information at https://www.deadiversion.usdoj.gov/

DEA New Orleans Divisional Office Diversion Investigator Rita Esquivel-Blatt3838 N. Causeway Blvd., Suite 1800 [email protected] New Orleans, LA 70002 504/840-1066504/840-1100

*The DEA may revise such forms at any time without notice to Tulane.

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https://www.deadiversion.usdoj.gov/



http://www.deadiversion.usdoj.gov/faq/dea222.htm

Appendix B: Controlled Substances Utilization Log – Tulane UniversityInvestigator: Department:

Room number and building name where drugs are stored:

Drug: Bottle #: Initial Amount: Concentration:

Lot Number: Date Issued: Expiration Date:

DateSpecies (if applicable)

Animal ID (if applicable)

Amt. Used

Balance Purpose Initials

Please note: Completed original forms must be kept on file.

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Appendix C: Controlled Substances Inventory Form - Tulane University - to be completed when Controlled Substances first obtained for research and at least every two years thereafter and whenever a substance becomes controlled or changes schedule

Date:

Time: Opening or Close of Business?

DEA Registrant (Print Name):DEA Registrant Address (as it appears on DEA Form 223):

DEA Registration #:

Inventory Performed by: Print Name Signature

Inventory Witness: Print Name Signature

Controlled Substance

DEA Schedule

*

Controlled Substance

Form

(e.g. tablets, powder,

injectable liquid)

# of Containers

Container Volume

(e.g. # of tablets, or ml

of liquid)

Concentration

(e.g. mg/ml or mg/tablet)

* Schedule I and II drugs must be separated from all other drugs or placed on a separate form.

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Appendix D: Process, Requirements, and Request Form for Obtaining Letter of Verification from the Tulane Vice President for Research as part of an application for or renewal of a Louisiana Board of Pharmacy (“LABP”) Controlled Dangerous Substance (“CDS”) license and Drug Enforcement Agency (“DEA”) Controlled Substances (“CS”) registration

Applicant completes Tulane Controlled Substances Letter of Verification Request Form (available on the Tulane RCO website) including the following:

1. Certification by the applicant’s department chair or supervisor that the applicant is a legitimate researcher with a full-time faculty appointment with the Tulane School of , Department of .

2. Certification that the applicant’s research requires the use of CS and the purpose for the use of the CS in the applicant’s research.

3. Certification that the applicant is a “legitimate researcher” in that the applicant understands the legal and regulatory obligations of a license holder, including all record-keeping and security requirements.

4. The applicant’s training completion certificate for Tulane training entitled, “Use of Controlled Substances in Research”.

5. All proposed locations as to where the CS will be stored and utilized.

6. Certification that the applicant will cooperate with Tulane’s CS monitoring process, including the TUPD and Research Compliance Office inspections/audits regarding CS.

7. Signature by the applicant’s department chair or supervisor indicating that the applicant is a full-time faculty member whose research requires the use of CS.

8. Appointment by the applicant’s department chair or supervisor of a monitor to conduct an annual records review of the required record keeping of the Registrant, including name and contact information for the monitor.

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http://www2.tulane.edu/asvpr/research-compliance.cfm

Appendix E: Tulane University Controlled Substances Authorized User Attestation (based on 21 CFR 1301.90)

Tulane University (“Tulane”) requires that all employees who have access to Controlled Substances used in animal research or bench research as a part of their work duties complete the following questionnaire in order to ensure compliance with federal regulations governing controlled substances found at 21 CFR Section 1301.90. The U.S. Drug Enforcement Agency requires the collection of this information in order to “fairly assess the likelihood of an employee committing a drug security breach.” The information collected on this form will only be used by Tulane to assess an employee’s security risk with respect to working with controlled substances.

1. Question. Within the past five years, have you been convicted of a felony, or within the past two years, of any misdemeanor or are you presently formally charged with committing a criminal offense? (Do not include any traffic violations, juvenile offenses or military convictions, except by general court-martial.)

____Yes ____No

If the answer is yes, furnish details of conviction, offense, location, date and sentence.

2. Question. In the past three years, have you ever knowingly used any narcotics, amphetamines or barbiturates, other than those prescribed to you by a physician?

____Yes ____No

If the answer is yes, furnish details.

3. Question: Have you completed the training entitled, “Use of Controlled Substances in Research”, available on Tulane’s “Training Wave?

____Yes ____No

If the answer is yes, attached completed training certificate. If the answer is no, stop and do not submit this form until you have completed the training.

Statement of Employee:

I attest that my answers above are true and correct. I attest that if my of our answers above change, I will notify the Registrant immediately (within 24 hours). I understand my disclosures above will not necessarily disqualify me as an authorized user, but I understand that a dishonest statement will disqualify me. If I have knowledge of drug diversion from Tulane University (e.g., by a colleague, student, fellow employee, etc.), I agree that it is my obligation to report such information to the Tulane University Police Department. This information will be treated as confidential and Tulane University shall take all reasonable steps to protect the confidentiality of the information and my identity, as the employee furnishing the information. I understand that failure to report information of drug diversion will be considered in determining the feasibility of continuing to allow an employee to work in a drug security area.

Signature Date

Printed Name:

Name and Department of Registrant that Authorized User will be working under:

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Appendix FControlled Substances Monitoring Form

Use of Controlled Substances in Research by DEA Registrants – to be submitted to Loula Burton, Senior Program Coordinator, Office of the Vice President for Research,

[email protected] in the Tulane Office of Research upon completion of Monitoring

DEA Registrant Name, Department, Building, and Room No. where records review

occurred:

Reviewer Name and Department:

Date of Review: (mm/dd/yyyy)

Are the Registrant’s Louisiana Board of Pharmacy (LABP) license and DEA registration current?

Yes: No:

If no, describe plan for remediation:

If LABP license and/or DEA registration are not current, are Controlled Substances present?

No: Yes:

If yes, describe plan for remediation:

Supplier invoices and shipping records for each purchase are retained in a separate file and marked with the date of receipt of the material.

Yes: No:


If Schedule I and/or II substances are present, all transactions for purchase are recorded pursuant to official order forms (DEA Form 222). Receipts must be attached to the purchaser’s copy of each form.

Yes: No:


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Check Utilization Logs:

Utilization logs are maintained in a separate, bound ledger, to include a separate ledger for each product.

Each utilization log includes the exact product name and a record of each withdrawal with the date, amount, nature of use and dispenser’s signature.

Yes: No:


A record is maintained of Controlled Substances returned to suppliers and/or disposed of through the approved OEHS procedure. Disposal records are to be separately maintained from other records.

Yes: No:


Were Controlled Substances transferred to other researchers/Registrants or received from other researchers/Registrants?

Yes: No:

If yes, describe plan for remediation:

Check that inventory records are complete for all Controlled Substances on-hand:

Initial inventory was taken upon first acquisition of Controlled Substance

Subsequent inventory was taken at least every second year following the initial inventory and whenever a substance that was previously not controlled becomes controlled

All inventories are documented separately, identified as an inventory, signed and dated by the Registrant, and indicate whether the inventory was taken on the opening or closing of business on the date the inventory was taken

Yes: No:


If theft or loss has occurred, TUPD and DEA were notified and appropriate forms were completed and maintained.

Yes: No:


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Are Controlled Substances adequately secured? Two locks must be in place to adequately secure Controlled Substances. A laboratory door that is locked when authorized personnel are absent can serve as one of the two locks. Within the laboratory, Controlled Substances must be secured within a locked cabinet, safe, refrigerator, or freezer that cannot be moved or transported (must be affixed).

Yes: No:

If no, notify TUPD and the RCO. If possible, take a picture of the location at issue and upload with this completed form. The monitor should institute a plan for remediation immediately where possible.

Is the log of Authorized Users complete and up to date?

Yes: No:


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Appendix G: Access LogRegistrant’s Name: Registrant’s Department:Location (room number/name and building):Instructions: List below all persons to whom Registrant has issued a key, key code, or other access device to enter the room or area housing the Controlled Substances.

Recipient’s Name

Recipient’s Title

Date Access Device Issued

Recipient’s Initials

Registrant’s Initials

Date Access Device Returned

or Terminated

Registrant’s Initials

Recipient’s Initials

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Appendix H: Controlled Substances Authorized User Signature Log

List the names, titles, and signatures of all persons (employees, agents, and students) designated by the Registrant as persons Registrant has authorized to assist in conducting research using Controlled Substance at this location.

Note: For security, the number of individuals who have access to controlled substances should be limited to the minimum number necessary.

Registrant Name:

Registration Location:

Registrant’s Department:

Research Protocol No./Name:

Employee/Agent Name(Print or Type) Job Title Signature

Name and Schedule of Controlled Substances to be Used

Registrant's Initials Date

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