Frequently Asked Questions


The FAQ documents provide an in-depth review of State and Federal Requirements regarding the use of Controlled Substances for research.

For additional guidance, see these documents:

If you have a question or would like to discuss one of the FAQs, please contact us at oric@emory.edu

FAQs: State of Georgia and Federal Law Requirements for Use of Controlled Substances in Research

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.

Yes. There is a general list of controlled substances on the Drug Enforcement Administration (DEA) website at http://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf.

In addition, individual states can include additional substances as Controlled Substances over and above substances on the DEA list. Here is a link to the Georgia Code list of all substances considered to be Controlled Substances in Georgia: http://www.lexisnexis.com/hottopics/gacode/.

On the home page click “I agree.” In the table of contents, type the following code sections individually into the search box to get information on what drugs are included in specific schedules:

  • For Schedule I Controlled Substances type “16-13-25”
  • For Schedule II Controlled Substances type “16-13-26”
  • For Schedule III Controlled Substances type 16-13-27”
  • For Schedule IV Controlled Substances types “16-13-28” •
  • For Schedule V Controlled Substances type “16-13-29”
  • For non-narcotic drugs excluded from schedules of Controlled Substance type “16-1329.1”

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.

If you do not have a Georgia practitioner license (medical, veterinary, or another practitioner license), you will be required to obtain a Georgia Researcher Permit and DEA Researcher Registration. If you do have a Georgia practitioner license (medical, veterinary, or another practitioner license), you may have other requirements depending on the research you are conducting and the controlled substance schedule.

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.

Registration requirements depend on if you are a practitioner, the Schedule of the drug to be used in the research, and the type of research. See the following charts for a summary of permit/registration requirements:

  • I HAVE a Georgia practitioner license (medical, veterinary, or another practitioner license). What else do I need from state or federal agencies to order Controlled Substances for use in my research?
    • You will need a Georgia Researcher permit from the Georgia Board of Pharmacy (GBP)
    • A Schedule I drug will require a Drug Enforcement Administration (DEA) Researcher Registration. This Registration is not needed for schedules II to V
  • I DO NOT HAVE a Georgia practitioner license (e.g., medical, veterinary, or another practitioner license). What else do I need from state or federal agencies to order Controlled Substances for use in my research?
    • You will need both a Georgia Research Permit from the GBP and a Research Registration from the DEA

Note: DEA allows practitioners to dispense or conduct research with controlled substances in schedule II, III, IV, or V for human research if the applicant is authorized to dispense or conduct research concerning controlled substances under the laws of the State in which he/she practices. Georgia, however, requires a separate researcher permit to use controlled substances in research. 

The registration process can be summarized as follows:

  1. You must apply for the Georgia permit first. This can be done by completing the GBP’s “Pharmacy Facility Application.” See specific directions below. (Note: If you change to a different Controlled Substance schedule during the course of your research, you will need to file a new Georgia registration application. [See Pharmacy Facility Application, pg. 3, “Purpose of Applications” section, “Change in Schedule”].
  2. The Georgia Drugs and Narcotics Agency (GDNA) will need to inspect your facility before the permit is granted. They will check to ensure you have appropriate security, procedures, and documentation.
  3. Once you have the Georgia permit, you can apply for the DEA registration. This can be done by completing the DEA Form 225 and submitting other needed documentation online.
  4. The DEA may rely on the GDNA inspection or come to inspect at its discretion.
  5. DEA Registration is site-specific. If you conduct your research at more than one location, you will need a separate registration for each separate address. DEA Registration for Schedule I Controlled Substances is also protocol specific, so if you change your research protocol, you will need to 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].

Go to the webpage for the Georgia Board of Pharmacy (GBP) at http://gbp.georgia.gov/. Click on “Applications and Forms.” Click on the form entitled “Pharmacy Facility Application.” Complete pages 3, 6, 7, 15, 16, and 17. Submission will require a brief resume and current photo (2x2 passport-style), as well as proof of U.S. citizenship or qualified alien status (i.e., lawful permanent resident, granted asylum, or admitted as a refugee). The initial application needs to be sent by U.S. Postal Service with a check. Thereafter renewals can be done online with a credit card.

The GDNA will come to inspect your site before the GBP will issue the Georgia Researcher Permit. To pass the inspection, you will need to ensure that you have appropriate processes and documentation in place for security, record-keeping, procurement, and disposal.

To find out what you need, go to our training page and carefully read the slide presentation. Next, go to our Forms page where you will find the forms you need to put in place to keep track of Controlled Substances.

Use these forms and keep them up to date. Finally, familiarize yourself with our policy.

To apply, go to this link: https://apps.deadiversion.usdoj.gov/webforms2/spring/main?execution=e1s1 

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.

The renewal periods for the GBP and the DEA permits do not synchronize. DEA usually will send 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 years. 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 Practitioners 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. Late renewal applications will not be accepted by the DEA.

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.

Registrants must order Controlled Substances for research through Emory’s Procurement Department https://www.finance.emory.edu/home/Procure%20and%20Pay/how_to_buy_in_the_marketplace/index_procure_pay_labresearchgoods.html.  You must provide a copy of the Georgia Board of Pharmacy (GBP) Researcher permit or practitioner license and DEA registrations when you order the controlled substances. A Registrant must order Schedule I and II Controlled Substances himself/herself, or alternatively, delegate a responsible person to perform orders by signing a Power of Attorney form. Schedule I and II Controlled Substances must be ordered using hardcopy DEA Form 222 or the DEA’s electronic Controlled Substances Ordering System (CSOS) process. To establish a CSOS account, the Registrant must contact McKesson, an Emory vendor of Controlled Substances, and complete the necessary registration form with DEA.  

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 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.

No. 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 permits and registration, it is illegal to possess or use Controlled Substances for research purposes.

Promptly on discovery, notify the Emory Police Department; EHSO, and ORIC.  EHSO and ORIC can assist researchers in completing reports to DEA and GDNA and researchers are advised to contact either of these units before submitting reports to DEA/GDNA. Find more information here.

Reports to Emory units should be made using the Controlled Substances Discrepancy Report Form – FORM 5.

Contact information for Emory units to which reports should be made is listed on Form 5.

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)