controlled substance training environmental health & safety deona willes, deputy director, ehs...

Controlled Substance Training

Environmental Health & SafetyDeona Willes, Deputy Director, EHS

Dan Shapiro, Director, Office of ComplianceVivek Dharne, Safety Specialist II, EHS

Environmental Health & Safety


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.


Controlled Substances Schedules

Schedule Medical Use/ Value

Potential for abuse Examples

I None High Heroin, LSD, Marijuana

II Medium High

Cocaine, Pentobarbital (Nembutal), Ritalin, Methamphetamine, Oxycodone, Fentanyl, Hydromorphone

III Medium MediumKetamine, Buprenorphine, Phendimetrazine, Aanabolic, Euthanasia (Euthasol)

IV High Medium Diazepam, Lorazepam, Midazolam

V High Minimum Codeine®, Ezogabine


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


Research Advisory Panel of California (RAPC) (Schedule I and II)

• DEA Website: http://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.

http://oag.ca.gov/research


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


Step 1. PI Obtains a DEA License

• Obtain Individual DEA Registration• DEA: http://www.deadiversion.usdoj.gov/drugreg

/

• Memo w/ Instructions – 9/17

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

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

How to Complete DEA Form 225Section 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.


How to Complete DEA Form 225 (con’t).

Section 2 – Business ActivityFor 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).


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.


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.


How to Complete DEA Form 225 (Con’t.)

Section 5 – LiabilityAnswer each question in this section truthfully. As indicated, provide an explanation for any “yes” answers.

Controlled Substance Program


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.



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.



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.



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.



Step 2: PI obtains

authorization from EHS to

use Controlled Substance


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


Step 3: Order

controlled substances

via eMarket

Step 3: Options to buy Controlled Substances via eMarket



Option 1: Forms

Select “Controlled Substance Request Form” (Research Only)


Controlled Substances Request Form


Option 2: Non-Catalog form


sPI information and lab location

Attachments: MWI - Due

Diligence FormDEA registration


Option 3: Catalog Punchout


DEA License # required



Schedule II - Additional Requirement

Form 222 www.deadiversion.usdoj.gov/faq/dea222.htm

• Directly submitted to vendor

• Must submit a copy to EHS with purchase request

• Supplier Identification required

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



Ordering Form 222


Step 4: EH&S

Reviews and Approves

Order

• 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


Step 4: EHS Reviews and Approves CS order


Step 5: Lab Receives CS Order


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.


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


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


Physical Security/Storage

• EHS must approve storage locations

• Maintain controlled substances in original containers

• Any diluted CS mixtures must be labeled and locked up


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


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

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


Step 6: Waste

Disposal


• 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


Transferring a Controlled Substance

• CS transfer allowed between two CSA’s

• EHS approval required prior to transfer

• “Transfer of CS” form - Contact EHS


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


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


Contact Information

• Environmental Health & Safety: (323) 442-2200

• email: [email protected]

• DPS: (213) 740 4321 or (323) 442-1000

• DEA: http://www.justice.gov/dea/index.htm

• Office of Compliance: (213) 740-8258

mailto:[email protected]

http://www.justice.gov/dea/index.htm

controlled substance training environmental health & safety deona willes, deputy director, ehs...

Documents

css slide

research use of schedule

usc schedule

ezogabine slide

ehsdps slide

dea form

safety specialist

dea license