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.

Some prescription drugs are Controlled Substances. If you use Controlled Substances in research, then you must follow the rules for Controlled Substances to obtain them. The rules for Dangerous Drugs only apply to prescription drugs that are not also Controlled Substances.

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.

GBP

State laws vary regarding requirements to purchase prescription drugs that are not Controlled Substances for use in research. For example, Florida and Tennessee have laws very similar to those in Georgia, but North Carolina does not. Find a go-by document for the GBP application here.

The time it takes to get a permit varies depending on individual circumstances and agency caseload. A wait of at least five weeks is typical. The Georgia Drugs and Narcotics Agency (GDNA) must inspect your facility before granting the permit. They will check to ensure you have appropriate security, procedures, and documentation.

DEA

To apply, go to this link: https://www.deadiversion.usdoj.gov/drugreg/registration.html 

You can apply online by clicking “Complete DEA Form 225 Online.” Before completing Form 225, read the instructions on the page. Under the "Select Your Business Category," select "Researcher" under "Form 225". Under "Select One Business Activity," choose if you request a Schedule I or Schedule II registration, and click "Continue."

The DEA may rely on an inspection of your site by the Georgia Drugs and Narcotics Agency, or it may perform an additional inspection of your site.

Find this Pre-Registration Inspection Checklist to prepare for the inspection process.

DEA Registration is site-specific. You are required to keep the drug stored at the same address that shows in your registration. In addition, DEA does not allow the drug to be used at a different address, so you must make arrangements to have the drug stored safely in the same building where the drug will be used. You will need a separate registration for each address if you conduct your research at multiple locations. DEA Registration for Schedule I Controlled Substances is also protocol specific, so if you change your research protocol, you must file a supplemental protocol with DEA. Permission is also required to increase the amount of Schedule I Controlled Substances used under the protocol. [See 21 CFR Section 1301.18].

The 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.

For Schedule I studies: 

Investigators must consult the Office of Research Integrity and Compliance (ORIC) to examine potential issues with state law and FDA research regulations. ORIC will perform a compliance review to ensure that processes are in place to meet state and federal requirements. Complete the Investigator Checklist for Use of Schedule 1 Controlled Substances and submit it to ORIC at oric@emory.edu. 

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. 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. 

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

Templates for these forms can be found on the Office of Research Integrity and Compliance website.

Registrant must keep all records relating to Controlled Substance ordering, procurement, use, and inventory for three (3) years from the final disposition of the drug. Records for Schedule I and II Controlled Substances must be kept separately from records for Schedule III to V Controlled Substances. Completed inspection forms/materials provided to the Researcher by the GDNA and/or the DEA for application approval must be perpetually retained with the respective active registration.

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 a 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.

Registrants must order Controlled Substances and Dangerous Drugs for research through Emory’s Procurement Department. 

DOCUMENTS TO PROVIDE TO PROCUREMENT

• Copy of the Georgia Board of Pharmacy (GBP) Researcher permit or practitioner license (for Controlled Substances and Dangerous Drugs) and DEA registrations (for Controlled Substances).
• A Registrant must order Schedule I and II Controlled Substances themselves or, alternatively, delegate a responsible person to perform orders by signing a Power of Attorney form.
• Orders for Schedules (Class) I or II Controlled Substances must be made using hardcopy DEA Form 222 or the Controlled Substances Ordering System (CSOS) process.
• To establish a CSOS account, the Registrant must contact the Emory-approved vendor for Controlled Substances and complete the necessary registration form with the DEA.

Purchase exception: If you cannot buy the drug through procurement due to the vendor's restriction or other reasons, please complete this form and send it to oric@emory.edu. After reviewing and approving the information, we will route it for your signature and procurement review using DocuSign. Please contact us to discuss the information required to prevent delays.

Do not share your drugs! The researcher’s permits and practitioner licenses do not allow distribution to other researchers, even if the other researcher has the appropriate researcher’s permit or practitioner license. Furthermore, permits are geographically limited to the particular facility (i.e., room) registered.

The renewal periods for the GBP and the DEA permits do not synchronize. DEA usually sends a reminder about 45 days before expiration; the GBP will never send a reminder.

• GBP: The GBP Researcher permit will always expire on June 30 of the even-numbered year. The Georgia researcher’s permit application can be found on the GBP website at http://gbp.georgia.gov/ using: (a) Online Services; (b) Renew Online.
• DEA: The DEA registration must be renewed annually, with the renewal date a year from the original issue month. Researchers must submit renewal Form 225a and Practitioner renewal Form 224a. DEA will send only one renewal notification to the registrant. Additionally, renewal applications must be received no later than the current license expiration date. A new application must be submitted if you allow your license to expire. The DEA will not accept late renewal applications.

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), fill
out FORM 13 (last page on this form) to document the receipt, use, and disposition. When the CS expires or is no longer needed, update the record. 

Research Staff should Request Waste Collection from EHSO (Complete all sections. In the "method of destruction, 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 13 (box 3) in the presence of the EHSO staff member. Finally, under Box 4, under the Reason for Use column, note “Self-destruction-Rx Destroyer: expired” or "Self-destruction-Rx Destroyer: no longer needed" and update the balance. Keep these forms in your records.

Please fill out the Controlled Substances Discrepancy Report: Form 5 (DOCX) for the theft or loss of any amount of a controlled substance to the following:

• Emory Environmental Health & Safety Office (EHSO) 
  • Scott Thomaston, Director Environmental Programs: (404) 727-1349: Fax – (404) 727-9778 Email – sthom07@emory.edu
  • Maureen Thompson – Health & Safety Officer, Emory Primate Center: (404) 727-8012; Fax (404) 727-7197 Email – mthomp2@emory.edu
• Emory Office of Research Integrity and Compliance (ORIC)
  • Maria Davila, ORIC Director, at 404-712-8676 or maria.davila@emory.edu.

Thefts or losses of any amount of a controlled substance must be reported to the Emory Police, Drug Enforcement Agency (DEA), Georgia Pharmacy Board (GPB), and Georgia Drugs and Narcotics Agency (GDNA). 

Researchers are advised to contact either EHSO or ORIC for assistance in completing reports to DEA, GBP, and GDNA before submission.

• Emory Police Department (EPD)- Submit completed Form 5 to Deputy Chief Burt Buchtinec to Fax (404) 727-3614 or via email at BBUCHTI@emory.edu. You may call him for questions at (404) 727-6115
• DEA- Complete and submit DEA Form 106 online at https://www.deadiversion.usdoj.gov/21cfr_reports/theft/ within one business day of discovery.
• GDNA- FAX copy of DEA Form 106 to (404) 651-8210. For questions, contact them at (404) 656-5100. Report it within 48 hours of discovery.
• GBP-Within 48 hours of discovery, fax a copy of the completed Dangerous Drugs Discrepancy Form to (470) 386-6137.