Animal Care & Use

Using Controlled Substances in Research at the University of Georgia

Guidelines and FAQs

Researchers can obtain and use controlled substances in their research. However, researchers are required to obtain specific permits/licenses to do so.

Researchers can obtain and use controlled substances in their research. However, researchers are required to obtain specific permits/licenses to do so.

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.”

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.

Some Colleges or Departments may hold a license under which researchers, as authorized agents on the license, may use controlled substances (schedule II-V only). Note that anyone using the substances must be listed on the license as an authorized user. This does not allow one license holder to sell, distribute, or dispense controlled substances to a researcher who is not listed as an authorized user on the license (with the exception of a researcher who is also licensed as a pharmacist, and possesses a pharmacist distribution license).

Contact your department head to see if your department has such a license.

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:

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.

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 are available at these links:

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 are available at these links:

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 are available at these links:

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 are available at these links:

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.

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

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

  1. Returning the substance to the supplier
  2. Transferring the substances to a “Reverse Distributor”, a registrant authorized to receive and destroy such materials
  3. Destroying the substance on site

 

  1. 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.

  1. 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. A link is also supplied below. Transfer requires specific paperwork, such as Form 222.

The Reverse Distributor website.

  1. 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”.

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. A link is also supplied below.

Transfer requires specific paperwork, such as Form 222.

To find a reverse distributor , go to the DEA Diversion website.

Only 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”.

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

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

Schedule III (CIII) Substances

The controlled substances in this schedule have an abuse potential and dependence liability less than those in CI and CII, and have an accepted medical use in the U.S. They include preparations containing limited quantities of certain narcotic drugs, and other nonnarcotic drugs.

Examples: Buprenorphine, ketamine, telazol (tiletamine & zolazepam)

Schedule IV (CIV) Substances

The controlled substances in this schedule have an abuse potential and dependence liability less than those listed in CIII and have an accepted medical use in the U.S.

Examples: Butorphanol, diazepam, midazolam

Schedule V (CV) Substances

The controlled substances in this schedule have an abuse potential and dependence liability less than those listed in CIV and have an accepted medical use in the U.S. They are often available without prescription, and include preparations containing limited quantities of certain narcotic drugs generally for antitussive and antidiarrheal purposes.

Other Resources

Templates for log books and inventory sheets are available at these links:

Other informational resources

USA DOJ Office of Diversion Control

Georgia DEA Field Office

Contact a Registration Program Specialist at the Atlanta Division Office:

75 spring Street SW

Suite 800

Atlanta, GA 30303

888-219-8689/866-533-6983

References

US Department of Justice, DEA office of Diversion Control

DEA Practitioner’s Manual 2006

Georgia State Board of Pharmacy

Title 26. Food, Drugs, and Cosmetics. Chapter 4. Pharmacists and Pharmacies. Article 3. Practice of Pharmacy

Georgia Drugs and Narcotics Agency

Georgia Veterinary Medical Association

Office of Research Compliance, The Ohio State University

Acknowledgements

Office of Animal Welfare Assurance, Duke University, for the Excel log and inventory form templates