No, any unused controlled substances must be transferred to a Reverse Distributer, a registrant authorized to receive them. You can contact the nearest DEA Field Office for a list of authorized Reverse Distributors and determine the appropriate method to transfer the substance. Transfer requires specific paperwork, such as Form 222. See the following link to find authorized Reverse Distributors in your area.
The Reverse Distributor website.

No! Unless a researcher is also licensed as a pharmacist, he/she cannot sell, distribute, or dispense controlled substances.

Some suppliers are licensed to take back unused portions of the substances, however, some are not. You will have to ask your supplier if they can accept the substance. This transfer requires specific paperwork, such as Form 222.

Only to a Reverse Distributor, a registrant authorized to receive them. You can contact the nearest DEA Field Office for a list of authorized Reverse Distributors and determine the appropriate method to transfer the substance. Transfer requires specific paperwork, such as Form 222. See the following link to find authorized Reverse Distributors in your area.
The Reverse Distributor website

Logs should document each use of the controlled substance. The information required includes:

• The date of removal/use
• The person administering the substance
• The volume removed from the bottle
• The use (e.g., animal/s to whom it is administered; secondary aliquot)

For administration to animals:

• Record the species and an animal identification that is as specific as possible.
• An individual ID for each individual animal that has an individual ID
• A cage or group ID and total number of animals, if no individual ID exists
• At minimum, the total number of animals if no cage or group ID exists

When creating a secondary dilution/cocktail:

• Record the identification number for the secondary dilution/cocktail bottle

Templates for log books and inventory sheets:

Form 1: Controlled Substances Authorized User Signature Log

Form 2: Controlled Substances Access Log

Form 3: Controlled Substances Security Checklist

Form 4: Controlled Substances Order Receipt Log for Controlled Substances Schedules I and II

Form 5: Controlled Substances Order Receipt Log for Controlled Substances Schedules III-V

Form 6: Controlled Substances Inventory

Form 7: Controlled Substances Current Use and Disposition Log

Form 8: Controlled Substances Discrepancy Report

If a volume is removed from a primary bottle to create a dilution/cocktail in a secondary bottle, this use must be recorded in both bottles’ logs.

Document in the log for the primary bottle:

• the volume removed to make the secondary dilution/cocktail
• the identification number for the secondary dilution/cocktail bottle

Document in the log for the secondary dilution/cocktail bottle:

• the identification number for the originating primary bottle from which the substance was removed
• the volume from the primary bottle used to make the secondary dilution/cocktail

Templates for log books and inventory sheets:

Form 1: Controlled Substances Authorized User Signature Log

Form 2: Controlled Substances Access Log

Form 3: Controlled Substances Security Checklist

Form 4: Controlled Substances Order Receipt Log for Controlled Substances Schedules I and II

Form 5: Controlled Substances Order Receipt Log for Controlled Substances Schedules III-V

Form 6: Controlled Substances Inventory

Form 7: Controlled Substances Current Use and Disposition Log

Form 8: Controlled Substances Discrepancy Report

Records must include tracking of each individual bottle/vial of controlled substance. The best practice is to assign a unique identification to each bottle. One method to identify the primary bottle:

• The first 2 letters of the drug name (e.g., KE for ketamine)
• The date of receipt (e.g., dd/mm/yy)
• The number assigned to this specific bottle if more than 1 bottle of the drug is received on the same day

Example: If you receive 2 bottles of ketamine on January 7, 2015:

Bottle 1: KE010715-1; Bottle 2: KE010715-2

Secondary bottles (dilutions/cocktails from a primary bottle) must also have a unique identification.

• Identify the secondary dilution/cocktail bottle based on the primary bottle identification, for example, by adding a letter after the bottle number.

Example: A secondary dilution bottle from the above bottle 1 could be: KE011515-1A

A separate log, in which all volumes removed are documented, must be maintained for each primary and secondary controlled substance bottle.
Templates for log books and inventory sheets:

Form 1: Controlled Substances Authorized User Signature Log

Form 2: Controlled Substances Access Log

Form 3: Controlled Substances Security Checklist

Form 4: Controlled Substances Order Receipt Log for Controlled Substances Schedules I and II

Form 5: Controlled Substances Order Receipt Log for Controlled Substances Schedules III-V

Form 6: Controlled Substances Inventory

Form 7: Controlled Substances Current Use and Disposition Log

Form 8: Controlled Substances Discrepancy Report

Registrants must inventory all controlled substances on hand at least every 2 years.  An inventory record must contain:

• The date the inventory is completed
• Whether the inventory is completed at the beginning or end of the business day
• The names of each controlled substance
• The form of the substance (e.g., 10 mg tablet, 100mg/ml)
• The number of containers of each form and the number of dosage units in each container (e.g., 28 pills, 7.5 mls)

Templates for log books and inventory sheets:

Form 1: Controlled Substances Authorized User Signature Log

Form 2: Controlled Substances Access Log

Form 3: Controlled Substances Security Checklist

Form 4: Controlled Substances Order Receipt Log for Controlled Substances Schedules I and II

Form 5: Controlled Substances Order Receipt Log for Controlled Substances Schedules III-V

Form 6: Controlled Substances Inventory

Form 7: Controlled Substances Current Use and Disposition Log

Form 8: Controlled Substances Discrepancy Report

Controlled substances that are expired or will not be used may disposed of by one of these 3 methods:

• Returning the substance to the supplier:

Some suppliers are licensed to take back unused portions of the substances, however, some are not. You will have to ask your supplier if they can accept the substance. This transfer requires specific paperwork, such as Form 222.

• Transferring the substances to a “Reverse Distributor”, a registrant authorized to receive and destroy such materials:

Substances may only be transferred to a Reverse Distributor, a registrant authorized to receive them. You can contact the nearest DEA Field Office for a list of authorized Reverse Distributors and determine the appropriate method to transfer the substance. Transfer requires specific paperwork, such as Form 222. See the following link to find authorized Reverse Distributors in your area.
The Reverse Distributor website

• Destroying the substance on site

Substances can only be destroyed on site with pre-approval from the DEA. Permission to destroy a controlled substance must be obtained from the local DEA Field Office in order to destroy the substance on site.

Specific methods must be used, that render the substance “non-retrievable”. Note that methods such as flushing, rinsing down the drain, mixing with materials such as coffee grounds or cat litter are not acceptable. Commercially available active-charcoal chemical digestion can be used to appropriately render the substance “non-retrievable”.

For an alphabetical listing of controlled substances, go to the DEA Diversion website.

Researchers who wish to use controlled substances in their research must register with both the State Board of Pharmacy and the federal DEA.

*Note: Researchers with other professional licenses (veterinarian, pharmacist, medical doctor) may have different license options/requirements.

At Georgia State University, researchers are currently required to obtain their own DEA license. Note that anyone using the substances must be listed on the license as an authorized user.

STEP 1.  State of Georgia

First, a researcher must obtain a Georgia Board of Pharmacy Researcher Permit. The application is available at the Board of Pharmacy website. The form for researcher applications is the “Pharmacy Facility Application.” On the form, under “License Type” choose “Researcher Pharmacy” and complete the appropriate sections of the form. According to the form, you should allow a minimum of 25 business days for processing of the application.

STEP 2. Federal

Once the Georgia Board of Pharmacy issues a permit, a researcher must obtain a federal DEA license. Form 225 is the appropriate federal application form for research use of controlled substances. According to the DEA Diversion Office, the average processing time for a new DEA registration is 4-6 weeks.

The Office of Diversion Control website includes links for online registration and renewal forms, as well as a pdf of Form 225. Note researchers registering for Schedule I approval cannot submit their initial application online.

Information and assistance for federal application can be found at:

• The Office of Diversion Control website
• From a DEA field office (see Informational Resources below for contact information)
• By contacting the Registration Call Center at 1-800-882-9539.

If any controlled substances are lost or stolen, the registrant must notify the nearest DEA Field Office and complete DEA Form 106.

The use of controlled substances is regulated by federal and state laws and regulations. The US Department of Justice Drug Enforcement Agency (DEA) is the lead federal law enforcement agency responsible for enforcing these laws and regulations. In Georgia, the State Board of Pharmacy provides the oversight.

Both federal and state guidelines govern the responsible use of controlled substances in research, and the use of controlled substances by researchers requires registration and licensing at the federal and state levels.

On the federal level, researchers are considered “practitioners,” which includes “physicians, dentists, veterinarians, researchers, hospitals, pharmacies, or other persons registered to do research, to dispense, or to use in teaching or chemical analysis a controlled substance in the course of professional practice.” In Georgia, the State Board of Pharmacy defines a “drug researcher” as “…a person, firm, corporation, agency, department, or other entity which handles, possesses, or utilizes controlled substances or dangerous drugs, as defined in Chapter 13 of Title 16, for purposes of conducting research, drug analysis, animal training, or drug education, as such purposes may be further defined by the board, and is not otherwise registered as a pharmacist, pharmacy, drug wholesaler, distributor, supplier, or medical practitioner.”

Controlled substances are categorized into one of five schedules based on the substance’s medical use, potential for abuse, and safety or dependence liability.

Schedule I (CI) Substance
The controlled substances in this schedule are those that have no accepted medical use in the United States (U.S.), are not accepted as safe for use under medical supervision, and have a high abuse potential.

Examples: heroin, marijuana, LSD, peyote

Schedule II (CII) Substances
The controlled substances in this schedule have a high abuse potential with severe psychological or physical dependence liability, but have accepted medical use in the U.S. CII controlled substances consist of certain narcotic, stimulant, and depressant drugs.

Examples: fentanyl, pentobarbital

Controlled substances are categorized into one of five schedules based on the substance’s medical use, potential for abuse, and safety or dependence liability.

Schedule I (CI) Substance
The controlled substances in this schedule are those that have no accepted medical use in the United States (U.S.), are not accepted as safe for use under medical supervision, and have a high abuse potential.

Examples: heroin, marijuana, LSD, peyote

Schedule II (CII) Substances
The controlled substances in this schedule have a high abuse potential with severe psychological or physical dependence liability, but have accepted medical use in the U.S. CII controlled substances consist of certain narcotic, stimulant, and depressant drugs.

Examples: fentanyl, pentobarbital

The regulations specify the minimum security standards for controlled substances. Controlled substances must be stored in a securely locked cabinet of “substantial construction” (i.e., metal). The cabinet should not be easily broken into or removed. For example, a metal drug “lock box” bolted to the wall or other fixed surface.

The US DOJ DEA Office of Diversion Control “Controlled Substances Security Manual: Security Requirements for Practitioners” has more information.

Registrants must maintain specific records. See your registration documents for more details.

Record keeping, in general, requires:

• Records must show the flow of controlled substances, from acquisition, to administration, to disposal. Time points to include are: acquisition, dispensing/administration, distribution, loss/stolen, disposal, and inventory.
• There must be 2 physically separate files—one file for schedule I and II substance records and one file for schedule III – V substance records. These files can be stored in the same location.
• Copies of order forms (DEA Form 222) must be stored in a securely locked cabinet.
• Records must be maintained for at least 2 years.
• Records must be readily retrievable.