After-approval Information

It is important to have access to a copy of your GBP and DEA license information for ordering and documentation purposes.

DEA will mail your license document to the address on file (that was added in the license). For GBP, use this guidance to create an account and print the license.

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.
• Orders for Schedules (Class) I or II Controlled Substances must be made using hardcopy DEA Form 222 or the Controlled Substances Ordering System (CSOS) process.
• To establish a CSOS account, the Registrant must contact the Emory-approved vendor for Controlled Substances and complete the necessary registration form with the 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.

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.

EHS-461, Weighing Hazardous Powders: The Environmental Health and Safety Office's (EHSO) guidance on weighing hazardous powders.

This document applies to all personnel that weigh hazardous powders at Emory University and Emory Healthcare. 

An inventory is a complete and accurate record determined by an actual physical count of all CI-V Controlled Substances on hand when the inventory is conducted. CI-II inventories should be separate from CIII-V inventories.

You should conduct an Initial Inventory once you receive your license. The initial inventory should always be zero because it should be conducted before you order any drug. You must conduct the inventory at the beginning or end of the business day and note it on the inventory form. (BoB or CoB). Form 6, found at Forms should be used to conduct this inventory.  

The Registrant must perform a physical inventory of all Controlled Substances on hand within two years (Biennial Inventory) following the date of the initial inventory. The Biennial Inventory should count all drugs, including expired drugs and working bottles. You must conduct the inventory at the beginning or close of business (workday- before you start using the drug for your research or after work is complete for the day) and note it on the inventory form as BoB or CoB.

All Controlled Substances and Dangerous Drugs must be disposed of in a way that is compliant with local, state and federal regulations:

Registrants must ensure that all CS and DD are properly disposed of when:

• the CS/DD expires
• a CS/DD is spilled and the spill is collected
• the Registrant no longer conducts research
• the Registrant retires their license

the Registrant leaves Emory University 

CONTROLLED SUBSTANCES (CS)

Pursuant to 21 CFR 1317.05(a), all DEA Researchers must engage in one of the two following options for the destruction of controlled substances obtained by their DEA license:

Onsite Destruction - DEA Researchers may engage in the destruction of a CS onsite in a way that renders the CS non-retrievable and is environmentally safe. The destruction must be documented on DEA Form 41.  To remain complaint with all local, state, and federal regulations, Emory has launched the Onsite CS Destruction Program through EHSO. To participate in this method of destruction the Registrant must:

Enroll in the program using the following link: PI Enrollment Form for Onsite CS Destruction Program

Take the training course entitled Onsite Destruction of Controlled Substances . All users who will participate in the program must take the training as well.    

Use this link to review a one-page summary of the process. 

Reverse Distribution – DEA Researcher may engage an appropriately licensed reverse distributor to dispose Controlled Substances. This may require establishing an account with an approved Reverse Distributor vendor, e.g., The Rx Exchange (http://therxe.com).

Controlled Substances obtained by prescription (like Buprenorphine SR), fill
out FORM 13 (last page on this form) to document the receipt, use, and disposition. When the CS expires or is no longer needed, update the record. 

Research Staff should Request Waste Collection from EHSO (Complete all sections. In the "method of destruction, 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 13 (box 3) in the presence of the EHSO staff member. Finally, under Box 4, under the Reason for Use column, note “Onsite-destruction-Rx Destroyer: expired” or "Onsite-destruction-Rx Destroyer: no longer needed" and update the balance. Keep these forms in your records.

DANGEROUS DRUGS (DD)

Complete FORM I for Dangerous Drug Destruction Log.

Dangerous Drugs may be disposed of through the Emory University Environmental Health and Safety Office (EHSO). Visit ehso.emory.edu, then scroll down to Request Waste Collection link under the "I’d like to…" section.

Follow the instructions in the guidance provided and use the waste template “General Pharmaceutical” and list the drug names in the Additional Hazardous Waste Label Information field. 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 or Onsite Destruction.

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.

If you receive a notification for a DEA inspection, contact us immediately at oric@emory.edu. We can assist you by attending the inspection and explaining the process and what to expect.