Frequently Asked Questions

Controlled Substances are drugs for which there is a potential for abuse/addiction. Controlled Substances are divided into Schedules I -V depending on their medicinal value and potential for abuse.

• Schedule I Controlled Substances are considered to have no medicinal value and a high potential for abuse.
• Schedule II Controlled Substances have medicinal value but high potential for abuse.
• Schedule III – V Controlled Substances have medicinal value and lesser potential for abuse.

The laws for using Controlled Substances in research are not exactly the same in all states, but they are very similar. This similarity stems from the fact that substantial and comprehensive federal regulations governing the use of Controlled Substances influence state laws.

The amount of time it takes to get a permit varies depending on individual circumstances and agency caseload. A wait of at least two to three months is not unusual.

Use of Schedule 1 Controlled Substances in a clinical trial with human subjects requires obtaining a researcher permit from the GBP and registration with the DEA in addition to IRB approval. Investigators are advised to create an SOP for managing the Schedule 1 drug. Click here for an SOP Template. If an Emory investigator holds the Investigational New Drug application (IND), the investigator must first obtain this from the FDA. Click here for IND information, including IND submission forms and templates.

Investigators should consult with the Office of Research Integrity and Compliance (ORIC) to look at potential issues with state law and FDA research regulations. The Emory IRB will direct investigators to submit a completed Investigator Checklist for Use of Schedule 1 Controlled Substances to ORIC at oric@emory.edu for review of any research study using a Schedule 1 Controlled Substance. ORIC will perform a compliance review to ensure that processes are in place to meet state and federal requirements.

Generally, the GDNA and DEA will look for the following documentation:

• Log of persons with access to the room where Controlled Substances are stored;
• Log of persons authorized to use Controlled Substances;
• Log of all orders and receipts of Controlled Substances;
• Initial and biennial inventory log; 
• Running use and disposition log for each container of Controlled Substances

Generally, the GDNA and DEA will look for the following security safeguards:

• Locks on rooms where Controlled Substances are stored 
• Controlled Substances must be stored in securely locked cabinets or safes that cannot be easily moved and constructed so that forced entry is easily detected. Schedule I Controlled Substances must be kept in narcotics safe or similar container.
• There should be controlled access to the room in which the Controlled Substances are stored; a list must be maintained of persons with keys/codes to enter the room. Access to storage cabinets must be limited to only those authorized to work with Controlled Substances.
• Persons with access to Controlled Substances must be trained on applicable laws & procedures. They cannot have been convicted of a felony related to controlled substances or have had a DEA registration revoked. 
• Schedule I and Schedule II must be kept separately from Schedule III to V Controlled Substances.

Emory conducts background checks and drug screens in new hires as part of their health assessment or separately if they work in a laboratory. Registrants are required to ensure that Form 3 is filled by anyone in the lab in contact with the drug.

Emory University Policy generally prohibits registrants from transferring controlled substances to another registrant. See Emory Policy 7.25, Research Use of Controlled Substances, Section C.ii, Personnel Security Requirements, Section (2).

If you do not have the appropriate researcher’s permit and registration, possessing or using Controlled Substances for research is illegal.

You must engage an appropriately licensed reverse distributor to dispose of extra or expired Controlled Substances. Researchers must ensure that all Controlled Substances are properly disposed of when the substances expire, the Registrant’s DEA registration is not renewed, or when the Registrant no longer conducts research at Emory University using Controlled Substances or leaves Emory University. This may require establishing an account with an approved Reverse Distributor vendor, e.g., The Rx Exchange (http://therxe.com).

For Controlled Substances obtained by prescription (like Buprenorphine SR), make sure to fill
out FORM 13a to document the receipt, use, and disposition. When the CS is expired or no longer needed, complete drug information FORM 13b. Research Staff should Request Waste Collection from EHSO (Complete all sections. In the Comments box note "C/S Rx Destroyer Request"). EHSO will schedule a pick-up with the Researcher and come onsite to witness the disposal of the CS using RxDestroyer. Two witnesses will be required to verify that the physical quantity being destroyed matches the data on Form 13b in the presence of the EHSO staff member. Finally, ln FORM 13a, under the Reason for Use column, note “Self-destruction-Rx Destroyer: expired” or "Self-destruction -Rx Destroyer: no longer needed." Keep these forms in your records.