Research Protections Policies
RP13 Use of Controlled Substances in Research
Subject Matter Expert:
Policy Steward:Associate Vice President for Research, Director of the Office for Research Protections>
To ensure that all Uses of Controlled Substances in Research are performed in compliance with Applicable Law. Compliance with the Policy is intended to prevent theft, diversion, or abuse of Controlled Substances and to avoid violation of law and regulations.
This Policy applies to all University Personnel who make Use of Controlled Substances in Research at The Pennsylvania State University (“University”). This includes Controlled Substances associated with research involving animal or human subjects, as well as in vitro or analytical research with a Controlled Substance. This Policy does not apply to Controlled Substances administered or dispensed to a patient by a licensed practitioner in the course of professional medical or veterinary practice. University Personnel within the College of Medicine must also follow its Policy 20.7 – Acquisition, Storage and Use of Controlled Substances in Research, which may contain additional procedures and restrictions not contained in this Policy. University Personnel within the College of Medicine conducting human subjects research using Controlled Substances at a Penn State Health site must also follow all applicable hospital and hospital pharmacy policies in the conduct of such activities.
Applicable Law means the laws and regulations governing the Use in Research of Controlled Substances, including the Controlled Substances Act (21 U.S.C. Chapter 13 § 801 et. seq.); DEA regulations 21 C.F.R. § 1300 et. seq.; the Pennsylvania Controlled Substance, Drug, Device, and Cosmetic Act (35 P.S. §§ 780-101 to 780-144), and; 28 Pa. Code §25.1 et. seq.
Authorized Agent means University Personnel who have been authorized by and are under supervisory control of the Registrant to procure, access, use, store, and/or dispose of Controlled Substances on behalf of the Registrant for Uses in Research for which the Registrant’s DEA registration is issued.
Authorized Laboratory Personnel means University Personnel who have been authorized by and are under supervisory control of the Registrant to conduct research experiments using Controlled Substances that are within the scope of research for which the Registrant’s DEA registration is issued.
Controlled Substances means a drug or other substance, or immediate precursor, included in schedules I, II, III, IV or V, under Applicable Law.
DEA means the United States Drug Enforcement Administration.
Non-retrievable means a physical or chemical condition or state in which a Controlled Substance is irreversibly rendered unavailable and unusable for all practical purposes.
Registrant means an individual who holds a DEA registration that permits the individual to make Use of Controlled Substances in Research for which the Registrant’s DEA registration is issued.
University Personnel means any faculty, investigator, employee, staff, student, and/or any researcher, whether paid or unpaid, and including temporary or “visiting” researcher scientist appointments conducting research at the University.
Use(s) in Research, or Use(s) of Controlled Substances in Research means the use of Controlled Substances in research and instructional activities, including all incidentally related activities under a valid registration for research, such as acquisition, manufacture, importation, possession, handling, storage, and disposal.
All University Uses of Controlled Substances in Research must comply with Applicable Law. It is the responsibility of University Personnel making Use of Controlled Substances in Research to familiarize themselves with and comply with Applicable Law and this Policy. This includes the responsibilities outlined below.
University Personnel at the College of Medicine should report to the Safety Department and Director of the Animal Resource Program, and coordinate with those departments reporting to the DEA, with consultation from ORP and the Office of General Counsel as appropriate.
- DEA Registration Required. All Uses of Controlled Substances in Research must be authorized under and within the scope of an individual Registrant’s DEA registration. The University does not have a “blanket” license for Use of Controlled Substances in Research; thus, except in instances where one is acting as an Authorized Agent or Authorized Laboratory Personnel under a Registrant, it is the responsibility of the individual University Personnel to obtain the appropriate DEA registration (i.e., become a Registrant) in order to make Use of Controlled Substances in Research. In order to ensure proper registration has been obtained prior to engaging in activities with Controlled Substances, the University requires that a copy of the required registration be submitted to the Office for Research Protections (ORP) upon receipt. DEA registrations are also facility-specific. Therefore, Registrants must amend or file for new registrations as appropriate in the event that Controlled Substances are intended to be used or stored at a location not specified in the original DEA registration. Such amendments and new filings must also be provided to ORP.
- Authorized Agent and Authorized Laboratory Personnel Requirements. A Registrant may engage individuals to act as Authorized Agents or Authorized Laboratory Personnel under the Registrant’s DEA registration. It is the responsibility of the Registrant to supervise Authorized Agents, and ensure that Authorized Laboratory Personnel are appropriately supervised, either directly by the Registrant or by the Registrant’s Authorized Agent(s). Any University Personnel who will Use Controlled Substances in Research shall comply with the University Policy HR99 – Background Check Process for “Sensitive/Critical Positions” as defined under that policy. University Personnel at the College of Medicine shall follow its policies and procedures with regard to background check requirements. Authorized Agents and Authorized Laboratory Personnel are responsible for understanding how to Use Controlled Substances in Research in accordance with Applicable Law and this Policy. Registrants must keep an updated list of Authorized Agents and Authorized Laboratory Personnel as part of their Controlled Substances records. A Registrant may not designate an individual to be an Authorized Agent or Authorized Laboratory Personnel for research not under the Registrant’s direct supervision and control or not authorized under the Registrant’s DEA registration.
- Authorized Agents. In addition to conducting experiments with Controlled Substances, Authorized Agents may be appointed by the Registrant to manage other activities related to Controlled Substances under the Registrant’s DEA registration, such as procurement, recordkeeping, disposal, and supervision of Authorized Laboratory Personnel. Authorized Agents may have access to the safe or locked cabinet where Controlled Substances are stored. The number of Authorized Agents under a Registrant should be limited to that which the Registrant has capacity to appropriately supervise and minimize the risk of diversion.
- Authorized Laboratory Personnel. The activities that an Authorized Laboratory Personnel can conduct with respect to Controlled Substances are limited to participating in and performing experiments within the scope of research allowed under the Registrant’s DEA registration. Authorized Laboratory Personnel may not have access to the safe or locked cabinet where Controlled Substances are stored, and therefore must rely on the Registrant or Authorized Agent(s) to provide limited quantities of Controlled Substances for relevant experiments.
- Security. All University Personnel who Use Controlled Substances in Research must follow appropriate security safeguards. Applicable Law and instruction from the DEA will dictate the proper security, storage and disposal of the Controlled Substances. At a minimum, all Controlled Substances in use (i.e., not in storage) must be accompanied by the Registrant, Authorized Agent, or Authorized Laboratory Personnel at all times, and Controlled Substances not in use must be stored in a securely locked, substantially constructed cabinet, or other means approved by the DEA. Only the Registrant and Authorized Agent(s) may have keys or combination access to the safe or locked cabinet where Controlled Substances are stored.
- Records. All University Personnel who Use Controlled Substances in Research must maintain at all times accurate and complete records as required by Applicable Law. Records include, but are not be limited to, current list of Authorized Agents and Authorized Laboratory Personnel, records documenting ordering and purchasing of Controlled Substances, formulating/reconstituting, current inventory, biennial inventory, usage/administration, and disposal. Records must accurately track all quantities of Controlled Substances obtained under the relevant DEA registration, from initial acquisition/creation to final disposition (whether used or disposed), and kept current so that all quantities, including balances remaining in working stock, are accounted in the records at any given time. Records documenting use of Controlled Substances must document the date a particular aliquot is used, the individual who used it, and the balance remaining in the stock after the aliquot is used. Records related to Controlled Substances are to be kept separate from other records, and records related to Schedule I and II Controlled Substances must be kept separate from other Controlled Substance records.
- Non-Transfer. Controlled Substances may only be used for research within the scope of the DEA registration under which they are acquired. Unless allowed for under the Registrant’s DEA registration, or pursuant to applicable law, regulation, or instruction from the DEA, Registrants, Authorized Agents, and Authorized Laboratory Personnel must not distribute Controlled Substances to others for purposes outside the scope of the research conducted under the DEA registration under which the Controlled Substances were acquired. This prohibition is not intended to restrict administration or dispensing of Controlled Substances to patients in the course of licensed medical or veterinary practice, or to subjects as allowed under a DEA-registered research activity.
- Disposal. Controlled Substances should be disposed promptly following their expiration, or when they are no longer required for research. In all instances, all Controlled Substances should be disposed of prior to vacating or decommissioning of a laboratory or termination of the applicable DEA registration, whichever occurs earlier. Controlled Substances must be disposed of in a manner that renders them Non-retrievable. Registrants may transfer Controlled Substances to a licensed reverse distributor for disposal, and the reverse distributor will render the substances non-retrievable. Please contact Environmental Health & Safety (EHS) at University Park and all other campuses. University Personnel at the College of Medicine should contact the Safety Department, and are expected to follow policy applicable to disposal of Controlled Substances at the College of Medicine.
- Reporting Generally. University Personnel who use, store, manufacture or transfer Controlled Substances in research must report immediately (upon discovery) to the University Police and Public Safety and the ORP (and in the case of College of Medicine, should report to the Safety Department, Facility Safety and Security, and Director of the Animal Resource Program), any of the following events:
- All unresolved discrepancies in inventory relating to Controlled Substances;
- Possible loss or theft/diversion of Controlled Substances;
- Improper removal of controlled substances from University premises;
- Improper removal of controlled substances from University premises;
- Any signs that a Controlled Substance may have been interfered or tampered with (such as broken, empty or cracked containers, broken seals, or lack of efficacy);
- Signs that a co-worker may be impaired due to self-administration of Controlled Substances;
- Discovery of misplaced or unsecured Controlled Substances; and
- Any other situations where policies and procedures relating to Controlled Substances may not have been followed.
- Reporting theft or loss. University Personnel who use, store, manufacture or transfer controlled substances in research, must report any theft or loss of unknown origin to the following, in the order listed:
- University Police and Public Safety;
- The Field Division Office of the DEA:
- writing, within one business day of discovery of loss or theft; and
- complete and submit DEA Form 106;
- ORP and EHS.
In order to ensure University Personnel are in compliance with this Policy, the ORP and EHS may periodically inspect and monitor the records and storage of Controlled Substances used in research, such as during semi-annual inspections of the Institutional Animal Care and Use Committee (IACUC) and post-approval review of human subjects research. The relevant IACUC, and Research Quality Assurance (RQA) may also conduct and assist with monitoring and inspection efforts as appropriate at the College of Medicine, such as during semi-annual inspections.
Failure to comply with this Policy or federal or state law may result in a decision of non-compliance and may require that a report be made to the DEA. Non-compliance can lead to the prescription of remediation and/or sanctions, up to and including stopping the research involving Controlled Substances or holding related research funds, or the recommendation of sanctions related to the University Personnel’s employment at the University to the appropriate administrator for action. Suspected non-compliance shall be handled by the ORP as described in the applicable standard operating procedures.
Failure to comply with applicable laws and regulations governing Controlled Substances can subject University Personnel to personal civil and criminal liability.
For questions, additional detail, or to request changes to this Policy, please contact the Office of the Associate Vice President for Research, Director of the Office for Research Protections.
Most recent changes:
- 2/25/2020 - New policy.
Revision History (and effective dates)
- 2/25/2020 - New policy.
Date Approved:March 25, 2020>
Date Published:March 25, 2020>