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). In this notice, we will use the term “Dangerous Drugs” to refer to prescription drugs that are not Controlled Substances.

Yes. Here is the link to the list: http://www.lexisnexis.com/hottopics/gacode. Click on the link. On the home page, click “I agree.” On the page with a table of contents type “16-13-71” in the search box, and then click on “search.” You will be directed to Georgia Code Section 1613-71. Click on the link for the section and you will be taken to the page(s) that list “Dangerous Drugs.” The list is very long. At the end of the list, you will see drug/dosages of drugs that are excepted from being considered Dangerous Drugs.

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.

Practitioners: You do not need additional permits if you are licensed as a practitioner (e.g., MD, DO, DDS, DVM, etc.) in the State of Georgia. You may obtain Dangerous Drugs for research using your practitioner license.

Non-Practitioners: If you are a researcher who is not licensed as a practitioner (e.g., a researcher who has a Ph.D. degree but does not hold an MD degree), then you must obtain a Researcher Permit from the State of Georgia to be able to obtain Dangerous Drugs for research. You should provide Emory Purchasing a copy of the Georgia Board of Pharmacy (GBP) Researcher permit or practitioner license when you order the prescription drugs. 

Go to the webpage for the Georgia Board of Pharmacy 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 must be sent by U.S. Postal Service with a check. After that, renewals can be done online with a credit card.

The amount of time it takes to get a permit varies depending on individual circumstances and agency caseload. A wait of at least 5 weeks is not unusual. The Georgia Drugs and Narcotics Agency (GDNA) will need to inspect your facility before the permit is granted. They will check to make sure you have appropriate security, procedures, and documentation set up.

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 that comport 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. The area in which the cabinet (or safe) is kept must be limited to a finite number of 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 of persons authorized to use Dangerous Drugs;
  • Log of all orders and receipts of Dangerous Drugs;
  • Running use and disposition log for each container of Dangerous Drugs.
Look in 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 

No. Researcher’s permits and practitioner licenses do not allow for 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.

No. 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.

Dangerous Drugs may be disposed of through the Emory University Environmental Health and Safety Office (EHSO). Contact EHSO at http://www.ehso.emory.edu/ and go to “Waste Collection.” Complete the required information, and a representative from EHSO will remove and properly dispose of the drug. Please note that EHSO cannot handle drugs designated as Controlled Substances, which must be disposed of via a licensed reverse distributor.

Contac us at oric@emory.edu for guidance or to accompany you during inspections.