Controlled substances
VCU expects that all individuals involved in the use of controlled substances for research will comply with all state and federal regulations regarding the procurement, recordkeeping, inventory, storage, use and disposal of those substances.
Principal investigators using controlled substances in research must obtain a Virginia Board of Pharmacy Controlled Substances Registration and a DEA Registration prior to ordering or using controlled substances.
VCU policy
Use of controlled substances in research
Regulations
- DEA Diversion Control Division
- Code of Federal Regulations, 21 CFR 1300-END
- New DEA registration applications (on the DEA site, click New Applications on the left)
- DEA registration renewal applications
- Current list of controlled substances in alphabetical order
- Virginia Board of Pharmacy regulations
- Virginia Board of Pharmacy registration application
Training
All individuals involved in the use of controlled substances must complete training prior to handling any controlled substance.
Individuals will need a VCU eID and password to access the Use of Controlled Substances in Research course in Canvas.
There are two options for self-enrolling in the course:
1. You can follow the prompts after clicking on this course link.
2. Alternatively, you can log in to Canvas - then, search for and enroll in the course.
- Click on Courses in the left-side navigation menu
- Click on All Courses at the bottom of the menu
- Click the Browse More Courses button
- Enter "controlled substances" into the search field and click the Search button
- When the course appears, click on the Join this Course button
After completing the training course, save or print the page that shows the course was completed successfully.
Authorized users must provide registrants with the page showing their passing score, so that it can be kept with the authorized user’s personnel screening forms.
Closing out registrations
Registrants wishing to terminate their active registration(s) must inform the DEA and the Virginia Board of Pharmacy of their intent to terminate. Contact controlsub@vcu.edu for the form that must be submitted to the DEA and the Virginia Board of Pharmacy when closing out a registration.
Disposal of controlled substances
A DEA registrant must dispose of out-of-date, damaged, or otherwise unusable or unneeded controlled substances by transferring them to a reverse distributor. The OVPRI has contracted with a DEA-authorized reverse distributor who can assist registrants with the proper disposal of controlled substances. Currently, there is no cost to VCU registrants for this service. Although OVPRI covers the cost of reverse distribution, OVPRI does not cover the cost of shipping the substances to the reverse distributor. OVPRI expects the registrant to cover that cost.
Procedures:
- Email controlsub@vcu.edu and provide the following information:
- Current state and DEA registration numbers and expiration dates
- List of controlled substances and amounts in need of disposal
- If requesting assistance with invoice payment, indicate this in your email
- If invoice payment by OVPRI has been requested, wait for the approval email from controlsub@vcu.edu before contacting the reverse distributor/vendor.
- Follow reverse distributor's instructions carefully and do not send any controlled substances until you are authorized to do so by the vendor (typically, you will need prior approval from the vendor).
- Upon receipt of the controlled substances, the reverse distributor will send you a report listing the substances they have accepted into their inventory and their DEA registration number. You should keep a copy of this report for your records.
- Upon receipt of the vendor’s invoice forward this invoice to controlsub@vcu.edu.
Information about Return Logistics International Service Center (RLI), a VCU contract vendor.
Website: www.returnlogistics.com
Address: 22 Artley Road
Savannah, GA 31408
Voice: (912) 748-5100
Fax: (912) 748-5102
Advance ship notice
Customers are required to fax, email or mail a completed ASN package to the return center. The ASN is provided by RLI after the customer contacts RLI with a request to ship. After RLI receives the completed package, RLI will issue the customer a return order number.
Note: Never ship any controlled substances to Return Logistics International (RLI) until you have been given a return order number. Make sure this number is on the shipping label.
If approved by controlsub@vcu.edu you may use the following billing information:
Company name: Virginia Commonwealth University
Contact name: Cathleen Finnerty
Contact title: Business manager
Contact phone: 804-828-3536, email: cafinner@vcu.edu
Address: 800 East Leigh Street, Suite 300, Box 980568
City: Richmond, State: VA, Zip: 23298-0568
Resources
- Use of controlled substances in research manual
- Procedure for Obtaining Buprenorphine ER
- Schedule VI information sheet
- Forms
To request a copy of a sample completed application or form, please email controlsub@vcu.edu.