Controlled Substance Guidelines
Guidelines for the Ordering and Use of Prescription Drugs and Devices and Controlled Substances for Non-Clinical Laboratory Research
State and Federal Registration Requirements
- All principal investigators with a need 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)1. This registration must be surrendered when the use of controlled substances in the investigator’s laboratory is terminated.
- Principal investigators who hold a DEA registration for the clinical use of controlled substances can incorporate, into this same registration, the controlled substances that will be used for laboratory research being conducted under their direction if two provisions are satisfied:
- DEA regulations require a separate registration for each location where controlled substances are received, secured, and utilized. Accordingly, clinicians who receive or store controlled substances in their clinical practice cannot use the same registration to order controlled substances for their laboratory.
- The address listed on the clinician’s DEA registration must correspond to the laboratory location where controlled drugs are delivered, secured, and utilized.
- The transfer of controlled substances between principal investigators is discouraged, and can only be performed if both investigators have a currently-active DEA license that covers the particular drug being transferred. Such transfers require proper recordkeeping, including the completion of DEA 222 forms for Schedule 2 controlled substances. Prior to transferring a drug to another investigator, the local DEA office should be contacted at 412-777-1870 to ensure that all required documentation is obtained.