Controlled Substance Guidelines

Guidelines for the Ordering and Use of Prescription Drugs and Devices and Controlled Substances for Non-Clinical Laboratory Research. Policy and Procedures for the Ording and Use of Prescription Drugs and Devices and Controlled Substances for Non-Clinical Laboratory Research.  Download complete guide.

Definitions

  1. 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).
  2. 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.
  3. Practitioner License means a license issued by the Pennsylvania Department of Health to practice medicine, veterinary medicine, dentistry, nursing, or pharmacy.
  4. 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.

Ordering of Controlled Substances and Prescription Drugs and Devices Through External Vendors1

  1. Controlled substances: To permit internal auditing, orders of controlled substances for laboratory research may only be placed through Henry Schein Animal Health Supply (Henry Schein). Permission must be specifically granted by University Purchasing Services for the use of an alternate external vendor for the ordering of controlled substances (i.e., should the desired controlled substance not be available through Henry Schein).
    • Orders for controlled substances shall be submitted separate from orders for other prescription drugs or laboratory equipment and supplies.
    • For Schedule III-V controlled substances:
      • If the order total is $5000 or less, place the order through the University’s PantherExpress system directly to Henry Schein. FAX (800-483-8329) or e-mail (tlauer@HenryScheinVet.com), to Henry Schein, a copy of 1) the principal investigator’s Certification of Exemption memorandum2 or currently active Practitioner License and 2) the principal investigator’s currently active DEA registration. Specify the corresponding PantherExpress requisition number on these documents so as to permit their linkage with the controlled substances order.
      • If the order total is over $5000, submit an electronic requisition through the University’s PantherExpress system. FAX (412-624-9339) or deliver (3309 Cathedral of Learning), to University Purchasing Services, a copy of 1) the principal investigator’s Certification of Exemption memorandum2 or the principal investigator’s currently active Practitioner License; and 2) the principal investigator’s currently active DEA registration. Specify the corresponding PantherExpress requisition number on these documents so as to permit their linkage with the controlled substances order.
  • For Schedule II controlled substances:
    • Deliver (3309 Cathedral of Learning) to University Purchasing Services
      • 1) the original of the first two pages of a completed DEA Form 2223
      • 2) a copy of the principal investigator’s Certification of Exemption memorandum2 or the principal investigator’s currently active Practitioner License
      • 3) a copy of the principal investigator’s currently active DEA registration. University Purchasing Services will subsequently issue the purchase requisition and mail it and the corresponding required documents to Henry Schein.
  • Orders for controlled substances shall be limited to only those drugs specified on the principal investigator’s currently active DEA registration.
  • Orders for controlled substances shall be limited to the quantity necessary for 1-2 months of laboratory research use.
  1. Prescription drugs (excluding controlled substances) and devices: Orders of prescription drugs, excluding controlled substances, or prescription devices for laboratory research may be placed through the external supplier of choice.
  2. If the preferred external supplier of the prescription drugs or devices is not currently established in the University’s PantherExpress supplier database, submit a completed Supplier Verification Form to University Purchasing Services. With approval of University Purchasing Services, the external supplier will be subsequently added to the PantherExpress supplier database.
  3. If the order total is $5000 or less, place the order through PantherExpress directly to the external supplier. FAX or e-mail, to the external supplier, a copy of the principal investigator’s Certification of Exemption memorandum2 or the principal investigator’s currently active Practitioner License. Specify the corresponding PantherExpress requisition number on this document so as to permit its linkage with the prescription drug/device order.
  4. If the order total is over $5000, submit an electronic requisition through the University’s PantherExpress system. FAX (412-624-9339) or deliver (3309 Cathedral of Learning), to University Purchasing Services, a copy of the principal investigator’s Certification of Exemption memorandum2 or the principal investigator’s currently active Practitioner License. Specify the corresponding PantherExpress requisition number on this document so as to permit its linkage with the prescription drug/device order. 

Certification of Exemption memorandum must be signed by the principal investigator’s dean or department chair.

1 In accordance with the decision of UPMC administration, subsequent to the issuance of these Policies and Procedures, the UPMC Departments of Pharmacy may no longer be used as a supplier of controlled substances and prescription drugs for laboratory research use.2 A Registration Exemption issued by the Pennsylvania Department of Health can be submitted instead of the Certification of Exemption memorandum. Memorandum Document
http://cfo.pitt.edu/pexpress/documents/reqchecklist.pdf 

State and Federal Registration Requirements

  1. 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.
  2. 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.
  3. 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.