What is the process when working with Drug Enforcement Administration (DEA) materials?

For advice and guidance on the registration process and use of controlled substances/dangerous drugs at Emory and the Biosafety Protocol Submission and Approval (BIORAFT) process, please contact the Biosafety Officer within the Environmental Health and Safety Office (EHSO).

 

Kalpana Rengarajan
Associate Director of EHSO
 Research Safety
 404-727-8863
 krengar@emory.edu 

 

Esmeralda Meyer
Assistant Director of EHSO
 Research Safety
 404-727-8083
 evargas@emory.edu 

If your research requires the use of controlled substances and/or dangerous drugs, approvals from the Georgia Board of Pharmacy (GBP) and Drug Enforcement Agency (DEA) are required.

 

Different legal and policy requirements apply to investigators who are performing bench research or animal research using Controlled Substances and to health care and veterinary practitioners using controlled substances to provide care to patients/clients. 

 

The Office of Compliance provides an FAQ on State and Federal Requirements, tutorials and offers a number of forms to assist investigators in the Emory research community conducting bench research or animal research using Controlled Substances or Dangerous Drugs.

A researcher must register with both the federal Drug Enforcement Agency (DEA) and the State of Georgia Board of Pharmacy (GBP). A practitioner that has a DEA registration for controlled substances must also have a researcher's permit issued by the GBP in order to use the controlled drugs in a research capacity. The Georgia Drugs and Narcotics Agency (GDNA) will then conduct a site inspection before registration is issued. Roger Knight (rknight@emory.edu) can assist with the process of placing orders through the Procurement Department once all appropriate registrations have been obtained. 

 The application for a Georgia researcher's permit can be found on the website of the Georgia Bureau of Pharmacy. 

 

DEA registration information and application forms can be found on DEA's website at: https://www.deadiversion.usdoj.gov/drugreg/. Researchers should use DEA Form 225 for their initial application and Form 225a for renewals. 

 The Registrant is responsible for contacting the GDNA to arrange for an inspection only after the GBP has notified the Registrant that his/her application has been processed. Contact information for the GDNA can be found at the agency's website. 

Additional guidance on this process is available in the FAQs for State of Georgia and Federal Law Requirements to Obtain Prescription Drugs and/or Controlled Substances for Use in Animal or Bench Research information guide.

The Office of Compliance provides tutorials and offers a number of forms to assist investigators in the Emory research community conducting bench research or animal research using Controlled Substances or Dangerous Drugs.  IACUC mandates this training for all registrants and their employees and agents.

After the application is approved by the GBP, the researcher must install a locker or cabinet where the controlled substances can be securely stored. Expect site visits by GBP/DEA personnel to evaluate the secured locker and storage area. Additionally, the researcher will be required to undergo a DEA background check and provide additional information, as requested. 

You, as the researcher (registrant), are ultimately responsible for the safe handling, use, control, security, disposal, and recordkeeping of the controlled substances procured under your registration. This includes the prohibition of distributing drugs to anyone who does not have a GBP/DEA registration, including colleagues on or off campus.  The DEA must pre-approve any transfer/distribution of a controlled substance to a registered individual.

Yes, both the DEA, GBP and the Georgia Drugs and Narcotics Agency (GDNA) have the authority to oversee and inspect facilities before and after the registration is approved.  The Division of Animal Resources (DAR) monitor will also review the use of controlled substances during DAR audits. Controlled substances should be listed in each laboratory’s chemical inventory; include the expiration dates to help manage and properly dispose of drugs prior to their expiration. 

 

After the completion of research study involving controlled substances, the researcher/registrant can arrange for a DEA reverse distributor to accept and dispose of the substances or, the researcher/registrant can bring the substances to a University –sponsored on-campus destruction event that is supervised by appropriate state law enforcement agents.

 

All records relating to the ordering, procurement, inventory and use of Controlled Substances in research must be maintained for at least for three years: the current year in which the document is generated, plus an additional two years.

 

 

The following are Emory University policies that govern research use of Controlled substances and Dangerous Drugs.