After-approval Information
Below, we detail the information you need to know after receiving approval to purchase Controlled Substances and Dangerous drugs. This section will detail the following:
How to order drugs
The documentation you need to maintain
Drug Disposal
Renewing your registration
Inspections
Ordering Drugs
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.
- Controlled Substances, Schedule I and II, 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.
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.
Maintaining Documentation
Controlled Substances
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
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.
Dangerous Drugs
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.
A researcher must retain separate records for Dangerous Drugs for two (2) years after the final disposition of the drugs. Records must be kept for:
- ordering & receipt records
- logs of current use & disposition
Templates for these forms can be found on our Forms Page.
Drug Disposal
If your drug is expired or you do not longer need it, you need to dispose of it according to GA and DEA requirements:
Controlled Substances
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), make sure to fill
out FORM 13a to document the receipt, use, and disposition. When the CS is expired or no longer needed, complete drug information FORM 13b. Research Staff should Request Waste Collection from EHSO (Complete all sections. In the Comments box, 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 13b in the presence of the EHSO staff member. Finally, ln FORM 13a, under the Reason for Use column, note “Self-destruction-Rx Destroyer: expired” or "Self-destruction -Rx Destroyer: no longer needed." Keep these forms in your records.
Dangerous Drugs
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.
Renewals
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.