1. Controlled Substance Training Environmental Health & Safety Deona Willes, Deputy Director, EHS Dan Shapiro, Director, Office of Compliance Vivek Dharne, Safety Specialist II, EHS Environmental Health & Safety

2. What are Controlled Substances? Controlled Substances (CS) are chemicals identified by the U. S. Drug Enforcement Agency (DEA) as having a high potential for illicit abuse and are therefore strictly regulated.

3. Environmental Health & Safety Controlled Substances Schedules Schedule Medical Use/ Value Potential for abuse Examples I NoneHigh Heroin, LSD, Marijuana II MediumHigh Cocaine, Pentobarbital (Nembutal), Ritalin, Methamphetamine, Oxycodone, Fentanyl, Hydromorphone III Medium Ketamine, Buprenorphine, Phendimetrazine, Aanabolic, Euthanasia (Euthasol) IV HighMedium Diazepam, Lorazepam, Midazolam V HighMinimum Codeine®, Ezogabine

4. Environmental Health & Safety CS’s Commonly Used at USC Schedule II - Pentobarbital (Nembutal) Schedule III - Ketamine (Ketaset) - Buprenorphine (Buprenex) - Euthasol Schedule IV -Phenobarbital (Luminal) * Halothane, Isoflurane, & Xylazine are not CS’s

5. Environmental Health & Safety Research Advisory Panel of California (RAPC) (Schedule I and II) DEA Website: http://oag.ca.gov/researchhttp://oag.ca.gov/research Authorized Investigator must separately obtain RAPC approval for any research involving Schedule I drugs, human subjects research with Schedule II drugs, or any research for the treatment of drug abuse Authorized Researcher must provide EHS with a copy of all application materials and a copy of the RAPC’s approval Contact EHS for assistance if you intend to conduct research with Schedule I.

6. Environmental Health & Safety Authorized Investigator Responsibilities: Comply with Federal, State and USC requirements Obtain CSA for Schedule II-V CSs Ensure all users adhere to CS requirements Keep CSs in a secured area Complete CS training Maintain all required documents Coordinate waste management with EHS Report loss immediately to EHS/DPS

7. Environmental Health & Safety

9. Step 1. PI Obtains a DEA License Obtain Individual DEA Registration DEA: http://www.deadiversion.usdoj.gov/drugreg/ http://www.deadiversion.usdoj.gov/drugreg/ Memo w/ Instructions – 9/17

10. How to Complete DEA Form 225 Section 1 – Applicant Identification 1.Insert your name as the applicant. 2.Under “Place of Business”, use the address of the primary lab in which you will be using CS’s. 3.Provide your Social Security Number, not a tax identification number. Environmental Health & Safety

11. How to Complete DEA Form 225 (con’t). Section 2 – Business Activity For business activity, select “Researcher w/Sched II-V.” IMPORTANT NOTE: Applications for research use of Schedule I Controlled Substances (e.g., heroin, LSD, peyote, methaqualone) require a separate DEA registration, as well as authorization from the Research Advisory Panel of California (RAPC). Environmental Health & Safety

12. How to Complete DEA Form 225 (con’t). Section 3 – Drug Schedules Select all options corresponding to Schedules III-V. If you use sodium pentobarbital, also select “Schedule II N (Non-Narcotic)” and check the box to request official order forms to purchase schedule II controlled substances. Do not provide any information in the “Manufacturers Only” section. Environmental Health & Safety

13. How to Complete DEA Form 225 (con’t.) Section 4 – State Licenses There is no state controlled substance registration program in California. If you are applying via U.S. mail, insert “N/A” to the right of “State License Number” and proceed to Section 5. If you are applying on-line: – Type “Not applicable” for the State License Number. – Select “California” as the State of Issuance. – Select an expiration date after the date you are submitting your registration. Environmental Health & Safety

14. How to Complete DEA Form 225 (Con’t.) Section 5 – Liability Answer each question in this section truthfully. As indicated, provide an explanation for any “yes” answers. Controlled Substance Program Environmental Health & Safety

15. How to Complete DEA Form 225 (Con’t.) Section 6 – Exemption From Application Fee Leave this section blank. As a private university, USC and its researchers are not exempt from the application fee. Environmental Health & Safety

16. How to Complete DEA Form 225 (con’t.) Section 7 – Method of Payment Insert your method of payment. If the DEA registration is needed to perform the scope of work and is permissible under the terms of a grant or external funding mechanism, then grant or other external funds may be used for payment. If the registration does not satisfy this requirement, the expense may be charged to a departmental unrestricted account. Environmental Health & Safety

17. How to Complete DEA Form 225 (con’t.) Section 8 – Applicant’s Signature If you are applying via U.S. mail, sign and date the form. If you are applying on-line, type your name in the “e-Signature” box where indicated. Environmental Health & Safety

18. How to Complete DEA Form 225 (con’t.) Section C – Schedule and Drug Codes If you are applying via U.S. mail, check all drug codes you handle. If you are applying on-line, this section is not required. Environmental Health & Safety

19. Step 2: PI obtains authorization from EHS to use Controlled Substance

20. Environmental Health & Safety Step 2. PI obtains authorization from EHS to use Controlled Substances Submit the following: Form A – “CSA Application” Form A-I – “Authorized Users and Locations” EH&S staff currently meeting with labs

21. Environmental Health & Safety Step 3: Order controlled substances via eMarket

22. Step 3: Options to buy Controlled Substances via eMarket Environmental Health & Safety

23. Option 1: Forms

24. Select “Controlled Substance Request Form” (Research Only) Environmental Health & Safety

25. Controlled Substances Request Form Environmental Health & Safety

27. Option 2: Non-Catalog form Environmental Health & Safety sPI information and lab location

28. Attachments: MWI - Due Diligence Form DEA registration Environmental Health & Safety

29. Option 3: Catalog Punchout Environmental Health & Safety

32. DEA License # required Environmental Health & Safety

33. Schedule II - Additional Requirement  Form 222 www.deadiversion.usdoj.go v/faq/dea222.htm www.deadiversion.usdoj.go v/faq/dea222.htm Directly submitted to vendor Must submit a copy to EHS with purchase request Supplier Identification required

34. Ordering Form 222

35. Environmental Health & Safety

36. Step 4: EH&S Reviews and Approves Order

37. All requisitions via eMarket will be routed for approval to EHS (Sch III to V). Form 222 (Sch II) – Submit a copy to EHS EHS will approve only if – PI has valid DEA registration – PI has valid CSA authorization with EHS – Controlled substances matches with the protocol – Requisition has PI/end user and location listed Environmental Health & Safety Step 4: EHS Reviews and Approves CS order

38. Environmental Health & Safety Step 5: Lab Receives CS Order

39. Environmental Health & Safety Step 5. Delivery of CS Order to Lab Controlled Substance will be directly delivered to the lab by vendor Usage log form should be generated by the lab to keep track of usage and disposal. Log form is available on the EHS website. PI is responsible for all the controlled substance present in this lab and for usage records.

40. Environmental Health & Safety Physical Security/Storage Implement access control to deter theft/diversion All security measures and devices must be approved by EHS Only Authorized Investigators and Authorized Users may have access

41. Environmental Health & Safety Physical Security / Storage Schedule III-V: Maintain in locked, substantially- constructed cabinet w/o wheels Schedule I-II: Keep in locked safe, vault or steel cabinet attached to building structure, within lockable room Must separate Schedule I-II drugs and their records from Schedule III - V drugs/records

42. Environmental Health & Safety Physical Security/Storage EHS must approve storage locations Maintain controlled substances in original containers Any diluted CS mixtures must be labeled and locked up

43. Environmental Health & Safety Inventory Maintain accurate records of all CSs on hand Usage log/ Disposal form Conduct and maintain Annual inventory – Form E EH&S will review Annual inventory during inspection Strict enforcement

44. Environmental Health & Safety Usage Log Each CS container has its own ID # and Usage Log Each time a CS is removed from original container … record it immediately! Physical amount in container should match the Usage Log AT ALL TIMES

45. Schedule II Register – DEA registration – EHS: Obtain CSA Ordering: – Form 222 – EHS needs a copy Storage: Locked safe, vault or steel cabinet Schedule III – V Register – DEA registration – EHS: Obtain CSA Ordering: – eMarket – EHS approval Storage: Locked substantially constructed cabinet w/o wheels

46. Environmental Health & Safety Step 6: Waste Disposal

47. Environmental Health & Safety PI can dispose empty vial in trash after defacing the label Usage log should be kept in lab for inspection for 3 years after disposal of vial For expired drugs EHS will coordinate disposal of CS’s and containers Completed Usage Log must accompany expired or unused CS Usage Log signed by Authorized Investigator or User Contact EHS for questions regarding CS waste Step 6: Waste Disposal

48. Environmental Health & Safety Transferring a Controlled Substance CS transfer allowed between two CSA’s EHS approval required prior to transfer “Transfer of CS” form - Contact EHS

49. Environmental Health & Safety Theft or Loss Notify EHS at 323-442-2200 Phone Call DPS at −UPC: 213-740-4321 −HSC: 323-442-1200 EHS will conduct an investigation EHS will assist with submission of all necessary documents to DEA

50. Environmental Health & Safety Monitoring Annual EHS Inspection Possible random and unannounced inspections by EHS. DEA may audit at any time, unannounced EHS will review: −Adequacy of security −Usage logs / Disposal records −Authorized Users

51. Environmental Health & Safety Contact Information Environmental Health & Safety: (323) 442-2200 email: labsafety@usc.edulabsafety@usc.edu DPS: (213) 740 4321 or (323) 442-1000 DEA: http://www.justice.gov/dea/index.htmhttp://www.justice.gov/dea/index.htm Office of Compliance: (213) 740-8258