Controlled substances 08/08/11

ControlledSubstances

University of CaliforniaLearning OnLine

Environmental Health& Safety (EH&S)Wendy ScottKaren JanigaJanette De La Rosa Ducut, Ed.D.

CSPAControlled Substances

Program Administrators

2

1. Identify and define controlled substances2. Obtain authorizations (i.e., CSUA)3. Store and secure4. Order and receive5. Maintain usage logs and report biennial inventory6. Follow policies for transfers, imports, and exports7. Properly dispose8. Prevent diversion and report losses9. Prevent illicit activities

and be familiar with repercussions

Objectives

3

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Controlled SubstancesChemicals whose manufacture, possession, and use are regulated by government

4

Definition

Controlled SubstancesPrevent unauthorized use of analgesics, anesthetics, or euthanasia.

Analgesics Euthanasia

Anesthesia

Alcohol Tobacco Caffeine Chocolate 5

Definition

Schedules

I II III IV VCategorize intoSchedules I-V based on

Medical valuePotential for abusePotential for psychic, physical, or physiologic dependenceHarmful pharmacologic effectsContribution to public health risks

6

Identification

High LowCIII

Identify common examples of Schedules I-V

Schedule I

Schedule II

Schedule III

Schedule IV

Schedule V

heroin marijuana

methamphetamine cocaine

vicodinandrogen(steroids)

diazepam rohypnol

pregabalin

7

Identification

pentobarbital

ketamine buprenorphine

Isoflurane

8

Definition

Ketamine

Ibuprofen

Choose one: Which is a Controlled Substance?

Ethanol

HINT:View DEAwebsite

Which is a Controlled Substance?

9

Definition

Choose one:

Ketamine (an anesthetic used in research animals) is DEA regulated

Isoflurane (an anesthetic), Ibuprofen (a pain reliever), and Ethanol are not DEA-regulated. Look for the letter “C” on the bottle.

CIIIIsoflurane Ketamine

Ibuprofen Ethanol

Diazepam(“valium”)

Rohypnol(“roofies”)

10

Identification

RobitussinA-C

Tylenolwith Codeine

Choose one: Which has a higher potential for habit

forming dependency?

HINT:View DEAwebsite

C-IV

C-IV C-V

C-III

HINT:View DEAwebsite

Identification

Choose one:

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Which has a higher potential for abuse?

Tylenol with Codeine has a higher potential for abuse because it contains a habit forming opiate.

Identify potential for abuse based on the schedule (I=high V=low)

Rohypnol(“roofies”)

RobitussinA-C

C-IV C-V

Diazepam(“valium”)

Tylenolwith Codeine

C-IVC-III

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Identification

Narcotic? N = No Y = Yes

Schedule

13

Identification

Schedules

I II III IV V

Lists

I II

Listed ChemicalsPrevent illicit manufacture of

controlled substances (i.e., methamphetamine)

Methamphetamine

14

Identification

Pseudoephedrine

List IDirect precursors or catalysts

critical to manufacturingcontrolled substances

List IISolvents and common chemicals

that could be usedfor large scale manufacture of

controlled substances15

Identification

Iodine

Advil ®

16

Identification

Xylazine

Cocaine

Choose one: Which can be used to manufacture controlled

substances?

HINT:View DEAwebsite

HINT:View DEAwebsite

Advil ®

Identification

Cocaine

Choose one: Which can be used to manufacture controlled

substances?

Methamphetamine

Xylazine

Iodine

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Iodine is key in synthesizing a controlled substance, and regulated in concentrations of 2.2% or more.

Implement controls for List I chemicals. Advil (non listed), Xylazine (non listed), and Cocaine (Schedule II) are not List I chemicals.

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Identification

Schedules

I II III IV V

Lists

I II

Precursor ChemicalsControl chemicals that may beused in the production of illegaldrugs (i.e., ecstasy).

Precursors

ExamplesSafrole | Piperonal | Isosafrole

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Identification

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Identification

Identification

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1. Identification2. CSUA3. Storage site controls and security4. Orders, delivery, and receipt5. Usage logs and

biennial inventory6. Transfers, Imports, and Exports7. Disposal8. Diversion and Loss Reporting9. Illicit activities and repercussions

Topics

DEA RegistrationUse controlled substances only as authorizedby EH&S

Controlled Substance Use Authorization (CSUA)Acquire, use, store, and dispose as authorized by EH&S.

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CSUA

Controlled Substance Use Authorization (CSUA)Obtain before purchasing or usingIdentify authorized personnel, storage location (security measures), and proposed useUpdate regularly

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CSUA

Authorized Personnel must:Satisfy personnel screening requirements (forms)

Complete trainingAdhere to proceduresand program elements

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CSUA

Berkeley Los Angeles

San Diego

Irvine

Riverside

San Francisco

Davis

Merced Santa Barbara

Santa Cruz

Review campus-specific CSUA requirements

26

CSUA

SorryInformation is not available for that campus

NEXT

Berkeley Los Angeles

San DiegoRiverside

San Francisco

Santa Barbara

Santa Cruz

27

CSUA

Davis Irvine

Merced

UCB

Application1. Submit a Project

Registration FormAccess online at EH&S website

2. Complete background check at UCPDfor each Authorized Personnel

Request for Live Scan ServiceDisclosure FormValid Identification

3. Schedule inspectioncontact (510) 642-3073

4. Complete trainingGo to http://www.ehs.berkeley.edu/healthsafety.html

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CSUA

UCB

Modifications

Submit a Project Update Registration FormAccess online at EH&S website

Go to http://www.ehs.berkeley.edu/healthsafety.html 29

CSUA

NEXT

Berkeley Los Angeles

San DiegoRiverside

San Francisco

Santa Barbara

Santa Cruz

Review campus-specific CSUA requirements

30

CSUA

Davis Irvine

Merced

31

UCD

Application1. Complete training2. Receive authorization

through EH&S3. Obtain departmental

approval to use DaFIS Approval Authorization or Cancellation form

Go to http://accounting.ucdavis.edu/forms/ApprovalAuth.doc

CSUA

NEXT

Berkeley Los Angeles

San DiegoRiverside

San Francisco

Santa Barbara

Santa Cruz

Review campus-specific CSUA requirements

32

CSUA

Davis Irvine

Merced

UCI

Application1. Submit a CSUA Form

Access online at EH&S website

2. Complete a Screening Data Sheet for each Authorized Personnel

3. Complete training

Go to http://www.ehs.uci.edu/programs/occhlth/control.html 33

CSUA

NEXT

Berkeley Los Angeles

San DiegoRiverside

San Francisco

Santa Barbara

Santa Cruz

Review campus-specific CSUA requirements

34

CSUA

Davis Irvine

Merced

UCM

Application1. Submit a CSUA

Application formAccess online at EH&S website

2. Complete a Personnel Data Sheetfor each Authorized Personnel

3. Complete training

Go to http://ehs.ucmerced.edu 35

CSUA

NEXT

Berkeley Los Angeles

San DiegoRiverside

San Francisco

Santa Barbara

Santa Cruz

Review campus-specific CSUA requirements

36

CSUA

Davis Irvine

Merced

UCR

Application1. Submit a CSUA

applicationAccess online at EH&S website

2. Complete Personnel Screening Data Formfor each Authorized Personnel

3. Complete training

Go to http://ehs.ucr.edu/controlledsubstances 37

CSUA

NEXT

Berkeley Los Angeles

San DiegoRiverside

San Francisco

Santa Barbara

Santa Cruz

Review campus-specific CSUA requirements

38

CSUA

Davis Irvine

Merced

UCSD

Application1. Manage in the portal

My Research Safetythrough the onlineCSUA Application

2. Schedule a site visit3. Complete training

Go to http://ehs.ucsd.edu/myresearchsafety

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CSUA

UCSD

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CSUA

UCSD CSUA components

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PROPERTIESAllow user to leave interaction: AnytimeShow ‘Next Slide’ Button: Show alwaysCompletion Button Label: Next

NEXT

Berkeley Los Angeles

San DiegoRiverside

San Francisco

Santa Barbara

Santa Cruz

Review campus-specific CSUA requirements

42

CSUA

Davis Irvine

Merced

UCSC

Application1. Submit a CSUA Form

Access online at EH&S website

2. Complete the personnel C.S. Authorization Formfor each Authorized Personnel

Go to http://ehs.ucsc.edu/lab_research_safety 43

CSUA

NEXT

Berkeley Los Angeles

San DiegoRiverside

San Francisco

Santa Barbara

Santa Cruz

Review campus-specific CSUA requirements

44

CSUA

Davis Irvine

Merced

UCSFApplication1. Manage in the portal

Research Information Online (RIO) through the online CSA Application

2. Complete an Information on Authorized User formfor each Authorized Personnel

3. Fill out a Controlled Substance Release Signature Cardfor each Authorized Recipient

4. Complete Controlled Substances Inventory form

Go to http://or.ucsf.edu/ehs 45

CSUA

NEXT

Berkeley Los Angeles

San DiegoRiverside

San Francisco

Santa Barbara

Santa Cruz

Review campus-specific CSUA requirements

46

CSUA

Davis Irvine

Merced

State of CaliforniaOffice of the Attorney General

Obtain State authorization forresearch involving:

Schedule I (Animal) Schedule I or II (Human) Drug Abuse (Substances Abuse Treatment)

Go to http://ag.ca.gov

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CSUA

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1. Identification2. CSUA3. Storage site controls and security4. Orders, delivery, and receipt5. Usage logs and

biennial inventory6. Transfers, Imports, and Exports7. Disposal8. Diversion and Loss Reporting9. Illicit activities and repercussions

Topics

Controls and Security

Provide effective controls to guard against theft, prevent illegal drug use, and protect public from harm.

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Storage Site Controls and Security

DO NOTShare facilitiesTransfer to another container

Valium

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Storage Site Controls and Security

DO NOTShare facilitiesTransfer to another containerKeep other chemicals in the same unitStore in a corridor

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Storage Site Controls and Security

Locked roomor closet

Storage Site Controls and Security

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Choose one:

What is the best placeto store controlled

substances?

Locked cabinet

Bottom drawer ofmetal filing cabinet

Locked box

Locked roomor closet

Security

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Choose one:

What is the best placeto store controlled

substances?

Locked cabinet

Bottom drawer ofmetal filing cabinet

Locked box

Locked cabinets, inaccessible from above or below, are the best place to store controlled substances.

Do not store in rooms (that can be broken into), or portable safes or security boxes that can be easily moved. Do not place in bottom drawers of metal filing cabinets that can be accessed from above.

Storage Site Controls and Security

Schedule III – V

Storage UnitStore according to ScheduleLock at all timesKeep only controlled substancesand log booksAnchor to floor

Schedule I – II 55

Storage Site Controls and Security

Schedule III – VSchedule I – II 56

Storage UnitStore according to ScheduleLock at all timesKeep only controlled substancesand log booksAnchor to floor

Storage Site Controls and Security

EquipmentPadlocks: Ensure screws or bolts are inaccessibleDrawers: Assign top drawer to use as storage, if possible.

Not acceptableAcceptable 57

Storage Site Controls and Security

Access ControlRestrict access to authorized personnelKeep keys in physical custody

CSUAAuthorized Personnel

• Janette Ducut

• Russell Vernon

• Karen Janiga

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Storage Site Controls and Security

UseControlledSubstances

securely

Use only within your area

Keep controlled substances on campus

Return to storage when not in use 59

Storage Site Controls and Security

Storage Site Controls and Security

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Choose one:

Where candiluted mixtures be

placed?

Waste containerin fume hood

Top drawer of metalfiling cabinet

Steel portablelocked box

Trash container

5% Barbital

5% Barbital

Waste containerin fume hood

Top drawer of metalfiling cabinet

Steel portablelocked box

Trash container

Security

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Choose one:

What is the best placeto store controlled

substances?

Place all controlled substances, including diluted mixtures, in approved locked storage units when not in use.

Trash containers, waste containers in fume hoods, and steel locked boxes are easily accessed…and should not be used to store controlled substances.

Storage Site Controls and Security

What do you think?What is the proper disposal for needles

with controlled substances residue?

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Storage Site Controls and Security

Dilute withwater and pour

down drain

Recap needleand placed in

locked storage

Place inrigid container

Place inbroken glass

box

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Storage Site Controls and Security

Dilute withwater and pour

down drain

Recap needleand placed in

locked storage

Place inrigid container

Place inbroken glass

box

Dispose of needles used to inject controlled substancesinto rigid containers.Pouring substances down the drain will harm the environment. Recapping needles increases your chance of accidents. Needles can puncture through broken glass boxes.

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1. Identification2. CSUA3. Storage site controls and security4. Orders, delivery, and receipt5. Usage logs and

biennial inventory6. Transfers, Imports, and Exports7. Disposal8. Diversion and Loss Reporting9. Illicit activities and repercussions

Topics

OrderingRestrict activities to authorized personnelSubmit requests to Purchasing department

CSUAAuthorized Personnel

• Janette Ducut

• Russell Vernon

• Karen Janiga

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Orders, Delivery, and Receipt

Berkeley Los Angeles

San Diego

Irvine

Riverside

San Francisco

Davis

Santa Barbara

Santa Cruz

Review campus-specific ordering requirements

67

Orders, Delivery, and Receipt

Merced

OrdersSorry

Information is not available for that campus

NEXT

68

Orders, Delivery, and Receipt

Berkeley Los Angeles

San DiegoRiverside

San Francisco

Davis

Santa Barbara

Santa Cruz

Irvine

Merced

UCI

69

Orders, Delivery, and Receipt

Purchasing/AccountingLink

Submit a request using the PAL or PalWeb systems

Student Health Center Pharmacy

Manufacturer You

DeliveryReceive email from Student Health Center PharmacyPickup Monday through Friday (8:00 am – 12:00 pm)Ensure Authorized Personnel brings UC identification

70

Orders, Delivery, and Receipt

ReceiptPlace in locked storage

unit immediately

71

Orders, Delivery, and Receipt

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NEXT

Berkeley Los Angeles

San DiegoRiverside

San Francisco

Davis

Review campus-specific ordering requirements

Santa Barbara

Santa Cruz

Orders, Delivery, and Receipt

Irvine

Merced

UCM

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Orders, Delivery, and Receipt

Purchase RequisitionSubmit a Purchase

Request using CatBuy.

http://purchasing.ucmerced.edu

PurchasingManufacturer You

DeliveryReceive notification from PurchasingEnsure Principal Investigator (PI) signs / verifies delivery

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Orders, Delivery, and Receipt

UCM

ReceiptPlace in locked storage

unit immediately

75

Orders, Delivery, and Receipt

UCM

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NEXT

Berkeley Los Angeles

San DiegoRiverside

San Francisco

Davis

Review campus-specific ordering requirements

Santa Barbara

Santa Cruz

Orders, Delivery, and Receipt

Irvine

Merced

Order using eBuy which you can access from your department’s SAA using EACS

77

UCROrders, Delivery, and Receipt

Go to R’Space online at http://rspace.ucr.edu

Click on “Log in”

Enter your UCR NetIDand password

Click on “Log in”

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Orders, Delivery, and Receipt

Click on “Create Order”

Enter the following:User contactUser phoneOrder descriptionDescriptionUOM

Janette Ducut

Research

1 90 mg 9804 100.00 8.25 108.25 08/01/2007 Requested

(951) 827-5528

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Orders, Delivery, and Receipt

EH&SManufacturer You

DeliveryReceive email from EH&SEnsure Authorized Personnel is available

80

Orders, Delivery, and Receipt

ReceiptPlace in locked storage

unit immediately

81

Orders, Delivery, and Receipt

82

NEXT

Berkeley Los Angeles

San DiegoRiverside

San Francisco

Davis

Review campus-specific ordering requirements

Santa Barbara

Santa Cruz

Orders, Delivery, and Receipt

Irvine

Merced

UCSD

ApplicationManage through CSUA OnlineAccess in the “My Research Safety” portal

Go to http://ehs.ucsd.edu/myresearchsafety 83

Orders, Delivery, and Receipt

84

Orders, Delivery, and Receipt

85

Orders, Delivery, and Receipt

86

Orders, Delivery, and Receipt

Submit a signed Supplemental Information Report

EH&SManufacturer You

DeliveryReceive email from EH&SPickup by appointment ONLYEnsure Authorized Personnel brings UC identification

87

Orders, Delivery, and Receipt

ReceiptPlace in locked storage

unit immediately 88

89

NEXT

Berkeley Los Angeles

San DiegoRiverside

San Francisco

Davis

Review campus-specific ordering requirements

Santa Barbara

Santa Cruz

Orders, Delivery, and Receipt

Irvine

Merced

Order using CruzBuywhich you can access from http://purchasing.ucsc.edu

90

UCSCOrders, Delivery, and Receipt

91

Click on “Forms” tabor link under Shop

Orders, Delivery, and Receipt

Locate the DEA Controlled Substances Form

Click on“View Form”

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Orders, Delivery, and Receipt

Complete the form

Check the box next toControlled Substance

Click on “Add”

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Student Health Services Pharmacy

Manufacturer You

DeliveryReceive email from EH&SEnsure Authorized Personnel is available

94

Orders, Delivery, and Receipt

ReceiptPlace in locked storage

unit immediately

95

Orders, Delivery, and Receipt

96

NEXT

Berkeley Los Angeles

San DiegoRiverside

San Francisco

Davis

Review campus-specific ordering requirements

Santa Barbara

Santa Cruz

Orders, Delivery, and Receipt

Irvine

Merced

98

1. Identification2. CSUA3. Storage site controls and security4. Orders, delivery, and receipt5. Usage logs and

biennial inventory6. Transfers, Imports, and Exports7. Disposal8. Diversion and Loss Reporting9. Illicit activities and repercussions

Topics

Usage Log

Document physical use, complete use and/or disposal.

Retain for 3 years

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Usage Logs & Biennial Inventory

Biennial Inventory

Declare every 2 years

Receive email and complete form

100

Usage Logs & Biennial Inventory

Maintain all documentationin a central filing system

101

Usage Logs & Biennial Inventory

CentralFiling System

102

Usage Logs & Biennial Inventory

Usage Logs and Biennial

104

1. Identification2. CSUA3. Storage site controls and security4. Orders, delivery, and receipt5. Usage logs and

biennial inventory6. Transfers, Imports, and Exports7. Disposal8. Diversion and Loss Reporting9. Illicit activities and repercussions

Topics

Berkeley Los Angeles

San Diego

Irvine

Riverside

San Francisco

Davis

Merced Santa Barbara

Santa Cruz

Review campus-specific requirements

105

Transfers, Imports, & Exports

Transfer Log

Update Usage Log

Complete Transfer Log

106

Transfers, Imports, & Exports

Go tohttp://ehs.ucsc.edu/lab_research_safety/controlled_substances.php

107

Transfers, Imports, & Exports

Berkeley Los Angeles

San Diego

Irvine

Riverside

San Francisco

Davis

Merced

Review campus-specific requirements

Santa Barbara

Santa Cruz NEXT

Shareor hand over to another person in a different laboratory

108

Transfers, Imports, & Exports

Transport (Ship)to another facility / campus that uses similar substances

Contact EH&Sor dispose

Choose one:

What do you do withextra controlled

substances?

109

Transfers, Imports, & Exports

Contact EH&Sor dispose

Do not Transfer or Export controlled substances

Sharing or handing over is considered transferring.

Transporting, shipping, relocating, or “passing on” is considered exporting.

Shareor hand over to another person in a different laboratory

Transport (Ship)to another facility / campus that uses similar substances

Choose one:

What do you do withextra controlled

substances?

110

Transfers, Imports, & Exports

EH&S, Purchasing, or Pharmacy

Police or UCPD

Choose one:

Who can I getcontrolled substances

from?Colleaguefrom another laboratory

111

Transfers, Imports, & Exports

EH&S, Purchasing, or Pharmacy

Police or UCPD

Choose one:

Colleaguefrom another laboratory

Do not Import controlled substances.

Obtaining controlled substances from anyone else (even if you have the same controlled substances in your own inventory) is considered importing.

Who can I getcontrolled substances

from?

113

1. Identification2. CSUA3. Storage site controls and security4. Orders, delivery, and receipt5. Usage logs and

biennial inventory6. Transfers, Imports, and Exports7. Disposal8. Diversion and Loss Reporting9. Illicit activities and repercussions

Topics

Berkeley Los Angeles

San Diego

Irvine

Riverside

San Francisco

Davis

Merced Santa Barbara

Santa Cruz

Review campus-specific disposal requirements

114

Disposal

NEXT

115

Berkeley Los Angeles

Riverside

San Francisco

Davis

Merced

SorryInformation is not available for that campus

Santa Barbara

Santa Cruz

Disposal

San Diego

Irvine

Usage Log

Document disposal on Usage Log

116

Disposal

Disposal

Dispose unused controlled substances as hazardous waste with EH&S

Deface label and discard empty containers into regular trash

Deface label of empty containers

117

Disposal

118

Obtain a label from the Online Tag Program (OTP) before beginning your work.

Disposal

Go to http://otp.ucop.edu

119

Login with your Username & Password and click on Login

120

Click on Createa New Tag

121

Enter information into the fields

122

Enter the words Controlled Substanceand the full chemical name (no abbreviations)

Ensure numbers add up to 100

Check the hazard class(es)

123

Click on

Save and Print Tag

124

Click on the

Click Here link

125

Verify accuracy of information

Note the tracking number assigned

Print the label

Affix to container

126

Click onMain

127

Click on theChecked items ready for disposalbutton to notify EH&S that your waste is ready to be picked up

128

Your waste should now be listed in the “Containers Ready for Disposal” section.

NOTE: Your waste will not be picked up until it is listed here.

129

130

Store in approved sharps container

Contaminated Sharps

Disposal

131

Store until the container reaches the fill line.

Contaminated Sharps

Do not exceed fill line

Disposal

132

NEXT

Berkeley Los Angeles

Riverside

San Francisco

Davis

Merced

Review campus-specific disposal requirements

Santa Barbara

Santa Cruz

Disposal

San Diego

Irvine

UCI

133

Disposal

Usage Log

Document disposal on Usage Log

Disposal

Dispose unused controlled substances

Submit a disposal request to EH&S

Submit a Disposal Request to EH&S

134

Disposal

UCI

Disposal

Complete the Disposal Request form and retain a copy for your records

135

Disposal

UCI

136

NEXT

Berkeley Los Angeles

Riverside

San Francisco

Davis

Merced

Review campus-specific disposal requirements

Santa Barbara

Santa Cruz

Disposal

San Diego

Irvine

UCSD

137

Disposal

Usage Log

Document disposal on Usage Log

UCSDMy ResearchSafetyLogin to CSUA

Application online

138

Disposal

UCSDEmptyContainers

Deface label and discard empty containers into regular trash

Deface label of empty containers

139

Disposal

140

NEXT

Berkeley Los Angeles

Riverside

San Francisco

Davis

Merced

Review campus-specific disposal requirements

Santa Barbara

Santa Cruz

Disposal

San Diego

Irvine

UCSC

Usage Log

Document disposal on Usage Log

141

Disposal

UCSCDisposal

Dispose unused controlled substances by contacting EH&S

Deface label and discard empty containers into regular trash Deface label of

empty containers

142

Disposal

143

NEXT

Berkeley Los Angeles

Riverside

San Francisco

Davis

Merced

Review campus-specific disposal requirements

Santa Barbara

Santa Cruz

Disposal

San Diego

Irvine

145

1. Identification2. CSUA3. Storage site controls and security4. Orders, delivery, and receipt5. Usage logs and

biennial inventory6. Transfers, Imports, and Exports7. Disposal8. Diversion and Loss Reporting9. Illicit activities and repercussions

Topics

Diversion

Prevent using a controlled substances obtained legitimately for illegitimate purposes.

Report suspicious activity (confidentially, if needed)

146

Diversion and Loss Reporting

Loss reportingContact EH&S or UCPD

147

Diversion and Loss Reporting

Audits andInspections

Provide access to records

Review adequacy of security measures

148

Diversion and Loss Reporting

150

1. Introduction2. CSUA3. Storage site controls and security4. Orders, delivery, and receipt5. Use logs and

biennial inventory6. Transfers, Imports, and Exports7. Disposal8. Diversion and Loss Reporting9. Illicit activities and repercussions

Topics

CriminalActivity

151

Illicit Activities and Repercussions

152

Report illicit activities

Illicit Activities and Repercussions

154

1. Identify and define controlled substances2. Obtain authorizations (i.e., CSUA)3. Store and secure4. Order and receive5. Maintain usage logs and report biennial inventory6. Follow policies for transfers, imports, and exports7. Properly dispose8. Prevent diversion and report losses9. Prevent illicit activities

and be familiar with repercussions

Summary

155

For more informationVisit your campus website for more information

Take Test

156

Test

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Irvine

Riverside

San Francisco

Davis

Merced Santa Barbara

Santa Cruz

To receive credit for this courseplease complete the test