DEA Controlled Substances Training

Requirements for obtaining, securing, using, and disposal.

Training Outline

There are four areas that this training will focus on:

1. Understanding DEA controlled substances

2. Obtaining licensure

3. Securing, documenting, and using your substance in the lab

4. Disposal of the controlled substance

Introduction

DEA controlled substances are commonly used on campus as a part of research experiments or studies.

These substances are highly regulated due to their effects on the human central nervous system and their potential for abuse.

Definition of Controlled Substances

Controlled substances are any drugs or chemical substances whose possession and use are regulated under the United States Controlled Substances Act, or the North Carolina Controlled Substances Act.

Controlled substances have stimulant, depressant, or hallucinogenic effects on the higher functions of the central nervous system, and tend to promote abuse or physiological/psychological dependence.

Government Oversight

The federal law is administered by the U.S. Department of Justice, Drug Enforcement Administration (DEA).

Locally, the North Carolina Department of Health and Human Services (DHHS), Drug Control Unit administers the state law.

Schedules

Substances regulated under the U.S. Controlled Substances Act (CSA) are categorized in one of five schedules.

• Schedule I substances have the most restrictions

• Schedule V substances have the least restrictions.

Schedules I-VSchedule I: Drug or other substance with a high potential for abuse, no

currently accepted medical use in treatment in the United States, and a lack of accepted safety protocols for use under medical supervision.

Examples: Diamorphine (heroin), marijuana

Schedule II: High potential for abuse; a currently accepted use in treatment in the United States, or currently accepted medical use with severe restrictions; abuse may lead to severe psychological or physical dependence.

Examples: Cocaine, morphine, pentobarbital

Schedule III: Potential for abuse less than Schedule I or II substances; currently accepted medical use in treatment in the United States; abuse may lead to moderate or low physical dependence or high psychological dependence.

Examples: Ketamine, buprenorphine, testosterone

Schedule IV: Low potential for abuse relative to Schedule III; currently accepted medical use in treatment in the United States; abuse may lead to limited physical or psychological dependence relative to Schedule III.

Examples: Diazepam, barbital

Schedule V: Low potential for abuse relative to Schedule IV; currently accepted medical use in treatment in the United States; abuse may lead to limited physical or psychological dependence relative to Schedule IV.

Examples: Pregabalin, lacosamide

Who Can Obtain These Substances?

Only registered personnel with the appropriate state and federal licenses can order controlled substances. Some departments here at UNC have one or more persons who maintain controlled substance licenses, and order these substances for authorized researchers within their department; other departments require each investigator seeking to use controlled substances to obtain their own licenses.

Contact your department administrator to determine licensing and ordering requirements within the department.

Register With DHHS-DCU (first) and then DEA

If you are required to obtain licensure:

You must first register at the state level with the NC-DHHS, Drug Control Unit.

Obtaining the state license number is required prior to requesting a federal DEA license.

At this time, the NC-DHHS, Drug Control Unit does not have a Webpage or online information available.

Contact the NC-DHHS, Drug Control Unit by phone at 919-733-1765 in order to begin the registration process.

The DEA Office of Diversion Control website will assist with all of the federal requirements for licensure.

Fees

North Carolina DHHS:

The registration fee is currently $125 for researchers and $100 for analytical laboratories.

DEA:

Because UNC is a state institution, UNC personnel are exempt from the Federal registration fee.

Licensure

Once registration at the State and Federal level is complete, and you have passed a background check and received your licenses for controlled substances, you can proceed to ordering.

Note that the NC-DHHS, Drug Control Unit and the DEA often send out inspectors to verify that adequate security is in place before they issue the licenses.

Security

In order to be considered for a license, you must demonstrate that you have the ability to manage the controlled substances in accordance with all regulatory requirements including security, inventory, and recordkeeping.

Security

Regardless of Schedule, all controlled substances must be kept under lock and key, in a substantially constructed cabinet or safe, and accessible only to authorized personnel.

Schedule I and II substances have the highest security requirements, and must be stored in an approved safe, steel cabinet, or vault. There are specific facility security requirements for researchers and analytical laboratory personnel.

Security

Left: Sturdy lockable steel cabinet for storage of controlled substances.Middle: Safe that is anchored to the wall and approved for Schedule I-II controlled substances.Right: Wood laminate casework island with drawers that could be pried open, and laminate wall cabinets with glass doors; not appropriate areas for secure storage of controlled substances.

Additional Users

Schedule I substances may not be issued to anyone other than the license holder, or used by anyone other than the license holder. If additional personnel need to use Schedule I substances, they must individually register with NC-DHHS, Drug Control Unit and DEA.

For substances in Schedules II-V, the registrant may authorize additional personnel to use the substances for approved activities. The registrant is required to screen these employees prior to authorization.

Use the questionnaire in Chapter 9 of UNC’s Lab Safety Manual Appendix 9-B to record these answers. Registrants must maintain the answers to these screening questions for authorized personnel in a secure place, away from the purview of unauthorized personnel.

Security

Inventory and recordkeeping is a very important requirement of using controlled substances.

Registrants must maintain complete and accurate inventory records for all controlled substances. These records must be in or near the primary work area, separate from all other records and documents, and available for inspection during regular work hours.

Record Keeping

Records must include at least the following information:

Receipt of Controlled Substances: A separate and current record indicating the date received, name and address of supplier, the type, strength, and concentration of substance, and the amount received. The person receiving the substance must sign each record.

Use of Controlled Substance: A separate and current record for the storage and use of each controlled substance. Each use is a subtraction from the starting quantity, and the running amount must equal the total amount remaining. These logs are often called "substance balance log sheets."

Inventory of Controlled Substance: In addition to the balance log records, initial and biennial inventory records are required for Schedule I and II substances.

Labeling of Controlled Substances: All containers of controlled substances must be individually identified with specific, detailed information, i.e. name , schedule, lot number, quantity of the controlled substance(s) per container, etc.

Recording Waste Disposal: Any controlled substances that are no longer needed by the registrant or become expired must be properly destroyed and disposed. Please contact the EHS Hazardous Materials Manager (919-962-5509) for assistance. Each disposal must be witnessed by EHS regardless of quantity.

Security

• Maintain all of these records for a period of at least three years from the date of the last entry. In the event of an audit by DEA or NC-DHHS, Drug Control Unit, you will need to produce these records.

Loss, Theft, or Misuse

In the event that controlled substances are lost, stolen, or used in an unauthorized manner, the registrant must immediately contact the UNC Police at 919-962-8100 (or 911), and the DEA Office of Diversion Control in Greensboro, phone number 336-547-4219.

These events are likely to trigger audits. Please follow the facility and personnel security measures outlined earlier to reduce the chances of loss, theft, or misuse of controlled substances.

Disposal

The registrant must account for all controlled substances upon their disposal. Using DEA form 41, document the destruction of all controlled substances and keep the documentation for three years. This form should be sent to both the NC-DHHS, Drug Control Unit and UNC EHS.

All excess, expired, contaminated, spilled, or no longer needed controlled substances are destroyed and disposed of by the methods described on the following slides.

Waste/Contaminated Product Disposal

In cases where small amounts (~<0.5 ml by volume, i.e. unused part of injection, broken patch) of controlled substances are leftover from an experiment or procedure, the registrant may properly dispose of the unused materials according to methods described in Chapter 9 of the UNC Laboratory Safety Manual.

– This destruction must also be documented on Form 41.

Important: Do not place any substances down the sink’s drain!

Drug Buster®, kitty litter, and disposal containers can be provided by EHS upon request.

Expired/Unwanted Product Disposal

In cases where product is unwanted or expired, registrants must contact NC-DHHS AND UNC EHS representatives to schedule a controlled substance destruction. When large quantities are identified (e.g. retirement), registrants may also need to contact a DEA certified reverse distributor to arrange for reverse disposal. Because this list changes due to registration requirements, please contact:

– NC-DHHS, Drug Control Unit at 919-733-1765 or

– DEA Diversion Control at 336-547-4219 or

– EHS Hazardous Materials Manager (919-962-5509) for approved vendors

Unknown Registrant Product Disposal

If you find any controlled substances on campus with no registrant please perform the following steps:

– Secure the substance by locking it in your controlled substances cabinet, lockable safe or desk drawer. Contact the Department Chair and the EHS Hazardous Materials Manager (919-962-5509) to make them aware of the found substance.

– Contact the local DEA agent to arrange for a witness to the destruction of the found controlled substance(s). Please document this communication and contact the EHS Hazardous Materials Manager (919-962-5509) for help and any additional instruction.

Importing and Exporting DEA Controlled Substances

If you plan to import controlled substances into the United States, or export them out of the United States, you must complete additional forms. See the Import/Export pages of the DEA Office of Diversion Control website for additional information.

Laboratory Safety Plan

DEA Controlled Substances must be identified and listed within the UNC EHS laboratory safety plan.

https://itsapps.unc.edu/LabSafetyPlan/

This information must be filled out in the Schedule B -Hazardous Chemicals and Equipment section of the lab safety plan.

The DEA Controlled Substance section is linked with the Schedule B of the laboratory safety plan.

Laboratory Safety Plan- Schedule B

IACUC Specific Information

For users who have animal research protocols, IACUC requires documentation of controlled substance use from the bottle to the animal. In many cases, especially when a cocktail of two or more drugs is created, researchers have a main sheet with a bottle balance for each controlled substance, and a second sheet for administration once the drugs are combined.

Drug Log Template:https://research.unc.edu/files/2012/11/Drug-Log-Template.pdf

Additional helpful IACUC compliance documents:

IACUC DEA Controlled Substances Informational Material: http://research.unc.edu/files/2013/03/CCM3_039065.pdf

IACUC policies and procedures are found at the following site:http://research.unc.edu/offices/iacuc/policies-procedures/

Information and Contacts

• UNC EHS: 919-962-5507• UNC EHS Hazardous Waste Manager:

919-962-5509• UNC Laboratory Safety Manual: DEA

Controlled Substances: Chapter 9• NC-DHHS, Drug Control Unit: 919-733-1765• Online versions of the Federal registration

forms: DEA Office of Diversion Control website.