Frequently Asked Questions

A Researcher’s Guide to the Controlled Substance Program

Frequently Asked Questions (FAQs)

 

What are “Controlled Substances”?

What are schedule numbers and DEA codes?

What does the new UCSC Controlled Substance Program include?

What is the Controlled Substance Use Authorization (CSUA) form?

What is the personnel Authorization form?

How do I order Controlled Substances?

Where / how do I receive controlled substances?

How do I store controlled substances?

How do I store Controlled Substances during field work?

How do I store Listed/Precursor chemicals?

How long do I keep copies of my controlled substance use logs?

What DEA registrations does UCSC maintain for research?

Can I transfer controlled substances to another UCSC Authorized Principal Investigator?

Can I transfer controlled substances to another individual at another University or

institution?

What do I do with empty controlled substance containers?

How do I dispose of expired or unused Controlled Substances?

What is the campus-wide biennial inventory?

How do I report a loss or theft?

What are the consequences of engaging in illicit activities?

Who do I contact with questions?What are “Controlled Substances”?

 What are “Controlled Substances”?

Narcotic and non-narcotic drugs under the jurisdiction of the federal Controlled Substances Act

and the California Uniform Controlled Substances Act, including, but not limited to, those

substances listed in 21 CFR §1308.11-1308.15 are known as “scheduled” controlled substances

or “scheduled”drugs.(http://www.deadiversion.usdoj.gov/21cfr/cfr/2108cfrt.htm ).

Note that many prescription drugs, such as xylazine or atropine, are not controlled substances.

What are schedule numbers and DEA codes?

The federal government assigns each controlled substance a schedule number (I through V)

according to its medicinal value, harmfulness, and potential for abuse or addiction. The DEA

code is a 4-digit number assigned to each controlled substance. Find schedule numbers and DEA

codes at the DEA Web site

A higher schedule number indicates the substance has more medicinal value and less potential

for abuse or addiction. The letter "N" can also accompany the schedule number, signifying the

substance is non-narcotic. If the DEA Web site has "N" in the NARC column, the item is nonnarcotic

and is denoted by the Roman numeral and an “N” (e.g., III N). If the DEA Web site has

a "Y" in the NARC column, the item is narcotic and is denoted so by the absence of the "N"

(e.g., III).

The most common controlled substances used in research at UCSC, their schedule numbers, and

their DEA codes are:

Substance Schedule DEA Code

Buprenorphine III 9064

Diazepam IV N 2765

Ketamine III N 7285

Pentobarbital (e.g., Nembutal) II N 2270

Pentobarbital & non-controlled active ingredients (e.g., B-Euthanasia) III N 2271

What is the Controlled Substance Use Authorization (CSUA) form?

The Controlled Substance Use Authorization (CSUA) form documents the controlled substances

used by the PI, the reason for this use, the storage location, and the project personnel who may

contact the controlled substances (personnel may be added later). A CSUA form must be

submitted to the Program Administrator (EH&S) and updated as appropriate each year. EH&S

will issue a CUSA upon demonstration of a valid use (approved animal use protocol by the

IACUC) and approval of higher management (Department Chair).

When should I submit the Controlled Substance Use Authorization (CSUA) form?

You may submit the form concurrent with application to IACUC. Notify EH&S when the

protocol is approved. You may submit personnel authorization forms while IACUC approval is

pending. You should resubmit when adding any additional substances.

Submit a CSUA form update as appropriate if any facts or circumstances materially change (new

PI, additional locations, and so forth).

What is the personnel Authorization form?

The Authorization form informs the Program Administrator (EH&S) that a Responsible

Individual (Principal Investigator) has identified other researchers for inclusion as authorized

controlled substance users. The Authorization form also documents the individual’s

acknowledgement of responsibility to notify the Controlled Substance Program Administrator

(EH&S) of any controlled substance loss or diversion. Since diverting controlled substances from

research purposes is one way controlled substances are acquired for illicit use, the Authorization

form helps to identify people with a criminal history of controlled substance diversion or prior

registration violations.

How do I order Controlled Substances?

The Principal Investigator must determine the need for and sign all requisitions for Controlled

Substances, regardless of dollar value. Purchase requests must be submitted through the CruzBuy

system, using the DEA Controlled Substance form or the Hazardous Materials form, checking the

“Controlled substance” box. The CruzBuy system requires EH&S notification on all controlled

substance orders. No orders may be placed by departmental personnel directly with vendors and/or

using a personal or UCSC credit card.

How do I obtain Controlled Substances through other channels for my research?

The Principal Investigator must contact EH&S when CS will be received from another institution

or outside of CruzBuy (no cost) options.

Where / how do I receive controlled substances?

Authorized personnel may pick up controlled substances at the Student Health Services Pharmacy.

You must have a Controlled Substance Authorization form on file with EH&S, with either the

“Research Use and Pharmacy Pick-Up” or the “Pharmacy Pick-Up Only” box checked. Photo ID

will be required by the Pharmacy.

How do I store controlled substances?

Controlled substance storage and use locations must be approved by EH&S. Controlled substances

must be stored securely in a manner adequate for safeguarding, and should be separated from other

drugs, chemicals or items. This practice will help to prevent loss by limiting access to only those

who are assigned to work with controlled substances. Access should be be limited to as few

researchers as possible. When in use, controlled substances should never be left unattended.

How do I store Controlled Substances during field work?

Controlled substances must be stored in a locked box either under direct control of an Authorized

person or in a locked building or vehicle when not in use during field work.

How do I store Listed/Precursor chemicals?

Listed/Precursor chemicals must be stored according to hazard class, following the UCSC

hazardous material storage requirements. No specific security is required.

How long do I keep copies of my controlled substance use logs?

At least 2 years from the final disposition of the controlled substance. The logs must be readily

available for periodic review by EH&S and/or the DEA.

UCSC maintains a research registration for each the main campus and Long Marine Labs.

An additional registration is maintained for export.

Can I transfer controlled substances to another UCSC Authorized Principal Investigator?

Intra-campus transfer of a controlled substance will be approved by EH&S if the following

criteria are met:

The controlled substance must have been acquired under the UCSC DEA registration.

The  PI receiving the substance(s) must have authorization for this controlled substance.

The transfer is approved by EH&S.

Both parties maintain documentation of any approved transfer.

EH&S receives a copy of the transfer log.

Can I transfer controlled substances between UCSC registrations?

In some circumstances controlled substance transfers are permitted by DEA. Contact

EH&S for specific details.

Can I transfer controlled substances to another individual at another University or

institution?

Not generally. Under very limited circumstances can controlled substances procured under

UCSC’s DEA registration be transferred to a non-UCSC individual. Contact EH&S for specific

details.

What do I do with empty controlled substance containers?

Authorized personnel may dispose of empty controlled substance containers by defacing the label

and discarding in the trash.

How do I dispose of expired or unused Controlled Substances?

These are disposed through the Cowell Student Health Pharmacy utilizing a transfer form.

Contact EH&S at ehs@ucsc.edu or 459-2553 for assistance.

What is the campus-wide biennial inventory?

Every 2 years, each Authorized UCSC PI and/or research personnel must inventory their

controlled substances during a one-day institutional inventory at either the opening or close of

business (21 CFR §1304.11(b)). The Controlled Substance Program Administrator (EH&S) will

select the exact date and time for the biennial inventory.

How do I report a loss or theft?

Authorized personnel are expected to report missing controlled substances to their supervisor, the

Controlled Substance Program Administrator (EH&S), and the UCSC Police Department as soon

as the loss is discovered. The Program Administrator will investigate inventory discrepancies or

loss of Controlled Substances. UCSC Police will investigate the diversion or theft of Controlled

Substances; file a report by contacting the police at (831) 459-2231.

If any imminent safety threat exists, contact UCSC Police or 911.

Diversion, Loss, or Theft Reporting

Any incident of suspected theft or significant loss of controlled substances, must immediately be

reported to:

Marijuana Research

Please see our page on Marijuana Research

1. Environmental Health & Safety (EH&S)

831- 459 -2553

2. UCSC Police Department (UCSC PD)

831- 459-2231.

In response, EH&S will report to the Drug Enforcement Administration (DEA) within 24 hours (21

CFR §1301.91) using DEA Form 106. UCSC Police will create a police report to document the theft

or loss. Reports will be kept confidential to the extent permitted by law and other University policies.

What are the consequences of engaging in illicit activities?

It is the position of the DEA that employees who possess, sell, use or divert controlled substances

will subject themselves not only to State or Federal prosecution for any illicit activity, but shall

also immediately become subject of independent action regarding their continued employment.

UCSC will assess the violation and determine whether to suspend, transfer, terminate or take other

action against the employee.

Who do I contact with questions?

Direct any questions regarding this program to ehs@ucsc.edu or EH&S at 9-2553.

UCSC Controlled Substance Program Staff

Lisa Wisser (lwisser@ucsc.edu) CS Administrator   831-459-5772

Terra Haddad (thaddad@ucsc.edu) 831-459-5114