Frequently Asked Questions

Under Georgia law, “Dangerous Drugs” are drugs available only by prescription from a licensed healthcare professional or the purchase of which is restricted to licensed healthcare professionals. Dangerous Drugs do not include prescription drugs that are “Controlled Substances,” i.e., drugs that have the potential for addiction/abuse and are classified as “controlled substances” under state or federal law. Find a list here.

Dangerous Drugs also do not include over-the-counter drugs (including certain lower-dose forms of drugs that would be considered prescription drugs if they were in higher-dose forms)—the term “Dangerous Drugs” refers to prescription drugs that are not Controlled Substances.

The list of “Dangerous Drugs” covers substances that many would not consider “dangerous” in the colloquial sense, such as injectable sterile saline.

The definition of prescription or “Dangerous Drugs” in the Georgia Code stems from the federal Food Drug and Cosmetic Act. That Act has an extensive definition of prescription drugs, including (a) any drug that, because of toxicity or other potentially harmful effects, method or use, or measures necessary for use, is not safe except when used under the supervision of a practitioner who is licensed to administer the drug; and (b) any drug that the FDA approved on the condition that they would be dispensed only under prescription. Sometimes, a drug may be considered a prescription drug in one dose but not another (e.g., ibuprofen is a prescription drug except in a single dose of 200 mg. or less).

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.

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

Even if you have the appropriate researcher’s permit or practitioner license, you may only acquire Dangerous Drugs from an appropriately licensed supplier.

Emory Finance has procedures and vendors for procurement of Dangerous Drugs on their website: https://www.finance.emory.edu/home/Procure%20and%20Pay/how_to_buy_in_the_marketplace/index_procure_pay_labresearchgoods.html.  If you do not have the appropriate researcher’s permit or practitioner license, possessing or using Dangerous Drugs for research is illegal.

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.

Generally, the GDNA requires the same security safeguards for Dangerous Drugs as they and the DEA require for Controlled Substances:

• The Dangerous Drugs must be stored in appropriate conditions, at temperatures complying with their labeling requirements, and the storage area must be easy to clean and maintain.
• Dangerous Drugs must be stored in securely locked cabinets (or narcotics safes) where access is restricted to authorized personnel.
• Access to the cabinet (or safe) must be limited only to persons authorized to work with Dangerous Drugs. T
• The area where the cabinet (or safe) is kept must be limited to a few personnel.
• Persons with access to Dangerous Drugs must be trained on applicable laws & procedures.
  • They cannot have been convicted of a felony related to Dangerous Drugs/Controlled Substances or have had a Dangerous Drugs/Controlled Substances license/registration/permit revoked.

Generally, the GDNA will require the following documentation:

• Log persons authorized to use Dangerous Drugs;
• Log all orders and receipts of Dangerous Drugs;
• Running use and disposition log for each container of Dangerous Drugs.

Look on our Forms Page for the above-referenced documents.

A researcher must retain separate records for Dangerous Drugs for two (2) years after final disposition of the drugs. Records must be kept for:

• ordering & receipt records
• logs of current use & disposition 

Please, fill out the Dangerous Drugs Discrepancy Report: Form E (DOCX) for the theft or loss of any amount of dangerous drugs 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 dangerous drugs must be reported to the Emory Police, 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 GBP and GDNA before submission.

• Emory Police Department (EPD)- Submit completed Form E 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
• GDNA- FAX copy of Form E 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 Form E to (470) 386-6137

Prior to leaving Emory or retiring, you must properly dispose of your dangerous drugs through EHSO and then close your license with the Georgia Board of Pharmacy (GBP).  Do not transfer your drugs without consulting RCRA’s Office of Research Integrity and Compliance (ORIC) at oric@emory.edu and obtaining approval to transfer them to another Researcher, as Emory University Policy 7.25,does not generally permit the transfer of Dangerous Drugs.  

To close your GBP license, you must write a letter on Emory letterhead requesting that your license number (include license #PHRSxxxxxxxxxx) be retired and the effective date. You must state that all dangerous drugs and controlled substances (if applicable) were destroyed prior to retirement. The letter must be signed and emailed to Annie Ruth Parks (aparks@dch.ga.gov) and Marcilla Cospy (mcospy@gdna.ga.gov).  Please cc: ORIC@emory.edu