Controlled Substance Guidelines
Policy and Procedures for the Ording and Use of Prescription Drugs and Devices and Controlled Substances for Non-Clinical Laboratory Research
- Authorized Agent(s) of the Principal Investigator means a maximum of 1-2 designated (i.e., by the principal investigator) members of the principal investigator’s research or administrative staff who have completed a DEA Screening Certification and have been authorized, by the University’s Office of Human Resources, to have knowledge of the principal investigator’s DEA registration number; to order, receive or dispense prescription drugs, prescription devices and controlled substances1 ; to access secured controlled substances storage cabinets/safes; and to maintain respective accountability records on behalf of the principal investigator (e.g., in the absence of the principal investigator).
- Authorized Laboratory Personnel means members of the principal investigator’s research staff who have completed a DEA Screening Certification and have been authorized, by the University’s Office of Human Resources, to receive, administer, or otherwise use controlled substances in the conduct of the principal investigator’s laboratory research. Authorized Laboratory Personnel may include Authorized Agents of the Principal Investigator.
- Practitioner License means a license issued by the Pennsylvania Department of Health to practice medicine, veterinary medicine, dentistry, nursing, or pharmacy.
- Certification of Exemption memorandum means a formal (i.e. written) notification indicating the principal investigator’s affiliation with the University of Pittsburgh and authorization to possess prescription (i.e., legend) drugs and devices. This memorandum replaces the Registration Exemption previously issued by the Pennsylvania Department of Health.
• A Certification of Exemption memorandum is required only for principal investigators who do not possess a Practitioner License or an exemption letter from the Pennsylvania Department of Health.
• The Certification of Exemption memorandum must be signed by the principal investigator’s dean or department chair.