Policy

Current Approved Policy

Investigators whose research falls within the scope of the Controlled Substances and Dangerous Drugs Policy are expected to know and adhere to the requirements of applicable federal and state laws/regulations. Failure to follow the applicable laws/regulations or the Controlled Substances and Dangerous Drugs Policy can result in loss of privilege to use these drugs in research at Emory, civil action or license revocation by licensing agencies, and/or criminal prosecution by law enforcement agencies.

The applicable laws/regulations set forth requirements within the following broad categories: (a) registering with state and federal agencies; (b) establishing certain physical security measures; (c) establishing personnel screening measures; (d) procuring; (e) disposing; and (f) record keeping.

Pending Policy 7.25 Revisions

Policy 7.25, “The Use of Controlled Substances and Dangerous Drugs in Research,” has undergone significant revisions that are currently pending approval.

Summary of Key Changes:

The 2025 Policy 7.25 significantly expands scope and oversight, now covering List I & II Chemicals, Dangerous Drugs, and the manufacturing of Controlled Substances, with added provisions for basic science and Schedule I Research. A formal “Policy Exception” process has been introduced, requiring justification, safeguards, and review by RCDC/IDS and institutional leadership. Enforcement authority has been strengthened, giving RCDC explicit compliance powers and outlining detailed corrective actions. 

New pre-registration requirements mandate centralized RCDC approval, identification of all authorized personnel with access to and ordering capabilities of Controlled Drugs, and completion of background checks and drug screenings. The regulatory licensing framework has been enhanced with a comprehensive licensing table, building-specific DEA/GBP licenses disclosure requirements, and specific initial and annual compliance audits for Schedule I researchers. Additional requirements for disclosures for moving registered locations and separation from Emory were included.   

Security, storage, and reporting procedures have been expanded, including restricted undergraduate access, DEA approval for storage modifications, mandatory RCDC notifications, annual self-inspections, and QA/QI RCDC led internal inspections. Procurement and recordkeeping processes are strengthened, with centralized eProcurement, clarified DEA Form 222 requirements, structured procedures for returns, recalls, imports, exports, and transfers, and expanded labeling, temperature, and inventory requirements. 

Finally, the glossary has been updated with new key definitions, and the policy consolidates previous Dangerous Drugs requirements from Policy 7.29, creating a more comprehensive, streamlined framework for compliance and oversight.