Controlled Substances

General Information

The primary contact for the controlled substance program is OVPRI. Environmental Health & Safety-Safety Risk Management (EHS-SRM) is available to assist laboratories in managing the use of controlled substances in research. To be able to purchase, use, or keep controlled substances the PI is required to apply for and receive both the Drug Enforcement Agency (DEA) license AND the Virginia Board of Pharmacy (VBP) Controlled Substance Registration.

“Controlled Substance” is defined as a drug or other substance, or immediate precursor included in schedule I, II, III, IV or V of the Controlled Substance Act (21 CFR, part 1300 to end) or Title 54.1, Section 3400 of the Code of Virginia. NOTE: The DEA does not regulate Schedule VI drugs. Registrants must obtain a Virginia Board of Pharmacy for schedule VI substances (e.g. isoflurane).

Controlled Substances may only be used for authorized, legitimate medical or scientific research purposes to the extent permitted by the registrant’s license and registration and in conformity with state and federal statutes and regulations.

Controlled Substance Program Compliance

EHS-SRM Responsibilities

EHS-SRM staff will be responsible to assist Principal Investigators to maintain compliance with the program through consultation.  EHS-SRM will be conducting controlled substance compliance inspections during each laboratory’s annual laboratory safety assessment and a report on the findings will be sent to the Principal Investigator. 

BioRAFTand Controlled Substances

EHS-SRM will be using BioRAFT to manage all compliance inspections of each laboratory’s controlled substance program.  BioRAFT is also used to maintain records of all laboratories that use controlled substances.