Frequently Asked Questions

The FAQ documents provide an in-depth review of State and Federal Requirements regarding using Dangerous Drugs for research.

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 to for Use of Dangerous Drugs in Non-Human Research

Under Georgia law, “Dangerous Drugs” are drugs that are 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.

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.

This is true. 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 a very broad 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 was approved by the FDA 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.

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

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 

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.

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.