DEA Licenses and Controlled Substances
This is a restricted or nonstandard commodity
Proper registration with the state of Pennsylvania and the Drug Enforcement Agency is required when purchasing government controlled substances.
Under the Pennsylvania Controlled Substance, Drug, Device, and Cosmetic Act, researchers are authorized to receive prescription drugs and are exempt from registration or licensure as long as the research is within the scope of their professional approved research protocol. However, a licensed distributor must perform due diligence and obtain verification documentation to ensure that parties they ship product to are authorized to receive it.
The University has consulted with a large distributor of prescription drugs and devices, Henry Schein Animal Health (formerly Butler Schein Animal Health), and has developed a “Certification of Exemption Memorandum,” which can be downloaded from: https://rcco.pitt.edu/sites/default/files/CertificationOfExemption.doc.
Researchers should complete this form, and the investigator’s Department Chair or Dean must sign the form to verify that they have a need to order prescription drugs. The signed form must then be submitted to the distributor, with a copy sent to Purchasing Services (3328 Cathedral of Learning, Pittsburgh, PA 15260).
University Guidelines regarding Controlled Substances
- The University’s Research Conduct and Compliance Office provides a guide called Controlled Substances Guidelines
- Purchasing Services provides a guide called Ordering DEA Controlled Substances Guidelines
- A flowchart of the Purchasing Method for DEA Controlled Substances and Prescription Drugs / Devices is also available
Obtaining a DEA License
All principal investigators who desire to purchase, possess, and use controlled substances (Schedule I-V) for laboratory research must register, and maintain active registration, with the Federal Drug Enforcement Administration (DEA).
- To apply for a federal registration, call the DEA office at (888) 393-8231 (Philadelphia) or (800) 882-9539 (Washington), or online.
- Principal investigators who hold a DEA registration for the clinical use of controlled substances should incorporate, into this same registration, the controlled substances that will be used for laboratory research being conducted under their direction.