Researchers intending to use controlled substances in laboratory or animal work must register with both the Georgia Board of Pharmacy (GBP) and the federal Drug Enforcement Agency (DEA).
Researchers should first register with GBP as a “Research Pharmacy” facility. Following successful application to the GBP, the Researcher must additionally obtain a researcher registration from the DEA (DEA form 225) in order to obtain/possess controlled substances for animal or basic research.
The DEA researcher registration requires annual renewal. The GBP registration expires the end of June of each even-numbered year. Both state and federal registrations must be kept current as long as you possess controlled substances.
Certain circumstances would require a researcher to maintain more than one registration with GBP and DEA. Examples include:
- A protocol using a Class-I controlled substance requires separate GBP and DEA registrations for the C-I controlled substance; examples of C-I may include hallucinogenic substances, opiates, or cannabimimetic agents.
- Researcher registration is specific to the geographical location where controlled substances will be used. For example, a researcher using controlled substances at both Whitehead and Yerkes must have separate registrations for each location.
Secure management of all controlled substances is required. The DEA, the Georgia Drugs and Narcotics Agency (GDNA), and other authorized law agencies, or University representatives, may conduct an audit at any reasonable time, inspecting the Registrant’s program and records including security, inventory and tracking documentation. Audits have occurred at Emory over the past year, so be prepared!
Researchers should ensure that they are ready for a DEA inspection by taking the following actions:
- Maintain contemporaneous documentation, demonstrating an orderly & secure system.
- Meticulous and legible completion of all relevant recordkeeping forms, provided on the University website. http://www.orc.emory.edu/controlled-substances/forms.html
- Timely disposal of expired/unwanted inventory through an authorized reverse distributor.
Please read the Emory University policy, http://policies.emory.edu/7.25 (rev. Nov.7, 2013) and review the online tutorial http://www.orc.emory.edu/controlled-substances/training.html.
Email the Office of Research Compliance ORC@emory.edu or call 7-2398 to schedule a brief training session for your department, or to set up a practice inspection.
Christine Cramer, Research Compliance Specialist
Office of Research Compliance