Requesting Human Pharmaceutical Agents for Animal and in Vitro Laboratory Research from the UNC Health Pharmacy.

University Procedure

Title

University of North Carolina at Chapel Hill Procedure for Requesting Human Pharmaceutical Agents for Animal and in Vitro Laboratory Research from the UNC Health Pharmacy

Introduction

Purpose

The purpose of this procedure is to describe the process for requesting human pharmaceutical agents from UNC Health Shared Services Center (SSC) Pharmacy for use in animal and in-vitro laboratory research (“ResearchRx Request Process”) conducted and supported by the University of North Carolina at Chapel Hill ("University").

Scope

This Procedure applies to Principal Investigators (PI) or designees who will utilize the ResearchRx Request Process.

Procedure

I. Prepare for the request of Pharmaceutical agent

1. Confirm that the requested pharmaceutical agent is available on the UNC Health Medication Formulary. Generally, only pharmaceutical agents available on the Formulary will be approved and processed.
   1. Contact UNCPharmacyPurch@unchealth.unc.edu for options if the required pharmaceutical is not on the Formulary.
2. Review the Shared Services Center (SSC) Submission Guidelines to identify the required information for the Grant/Study Pharmaceutical Agent Ordering (Non-Human Studies Only) Form.   
3. Confirm that applicable EHS Laboratory requirements are met, including but not limited to:
   1. Verify that all personnel responsible for handling the pharmaceutical agent(s) are included in the personnel list of the Laboratory Safety Plan (LSP), as applicable. 
   2. Confirm that a completed copy of Appendix 9-B, Questionnaire for Personnel who have Access to Substances Regulated is on file for each staff member authorized by the DEA registered PI to use the controlled substance for research purposes. Schedule I substances may not be issued to anyone other than the registrant.
   3. Ensure that the Worker Registration Form for all laboratory personnel specifies all applicable training requirements.
   4. Verify in the LSP that laboratory personnel have completed all applicable EHS Safety Training.
      1. Use the Laboratory Training Compliance link to access a list of required EHS trainings.
   5. Verify that the pharmaceutical agent(s) is listed in the LSP as follows:
      1. List drug(s) in the Chemical Inventory.
      2. List controlled substances in the information section of Schedule B: Hazardous Chemicals & Equipment.
   6. If requesting a biologic, contact the BioSafety Team at biosafety@ehs.unc.edu with the name and intended use prior to submitting the pharmacy request.
4. As applicable, confirm that animal research requirements are met, including but not limited to:
   1. Verify that all personnel responsible for handling the pharmaceutical agent(s) are included in the personnel list of the IACUC Protocol, as applicable.  
   2. Verify that animal research laboratory personnel have completed the applicable the Animal Training.
   3. Verify that the pharmaceutical agent(s) is detailed on the IACUC Protocol.
5. Complete any outstanding requirements described in procedures I.c. and I.d., as applicable, prior to requesting the pharmaceutical agent.

II. Request the Pharmaceutical agent

1. Complete the SSC Pharmacy Grant/Study Pharmaceutical Agent Ordering (Non-Human Studies Only) Form. The PI may delegate the completion of the request to qualified study personnel.
   1. Provide contact information for the submitter and the PI
   2. Indicate the type of research by checking either in-vitro or animal research.
   3. Provide the applicable research numbers, as prompted.
      1. The number of the approved Laboratory Safety Plan
      2. For funded research, the number of the associated RAMSeS IPF.
      3. For animal research, The number of the approved ACAP
   4. In the “Reason for Request Synopsis” field, provide a synopsis of the reason for the request of the pharmaceutical agent in 150 words or less.
   5. The shipping address for the delivery location.
   6. For controlled substances, provide documentation of NC DHHS DCU and DEA registrations.
   7. In the accounting section, include the PeopleSoft/Chartfield accounting information.
   8. In the drug section, provide information about the drug (drug name, form, strength) using the UNC Health Medication Formulary descriptors.
2.  Upon request, provide additional information to the SSC Pharmacy or the Office of the Vice Chancellor for Research (OVCR) Compliance Team.
   1. The OVCR Compliance Team reviews and certifies that each ResearchRx Request meets the University research requirements.

III. Manage the dispensed Pharmaceutical agent

1. Ensure that the agent is stored in accordance with applicable University policy and regulatory requirement(s).
2. Ensure that the agent is used only in accordance with the research protocol.
3. Maintain accurate records of the from the time it is ordered until it is completely used or otherwise disposed of in accordance with University policy and regulations.
4. Facilitate any post approval monitoring and inspections of the laboratory and documentation, including, but not limited to, inspections by NC DCU, DEA, EHS, and Office of Animal Care & Use (OACU).
5. Refer to the EHS Laboratory Safety Manual for additional information about managing and handling controlled substances.
6. Pay medication invoices issued by the UNC Health Care Affiliate Accounting.

Definitions

• ACAP (Electronic Application to Use Live Vertebrate Animals): An online system for submission and administration of IACUC protocols, as well as a tool for ordering animals and making other requests.
• Controlled substances: Any drugs or chemical substances whose possession and use are regulated under the United States Controlled Substances Act, or the North Carolina Controlled Substances Act. The U.S. Department of Justice, Drug Enforcement Administration (DEA) administers the federal law, and the North Carolina Department of Health and Human Services (DHHS), Drug Control Unit administers the state law. Controlled substances have stimulant, depressant, or hallucinogenic effects on the higher functions of the central nervous system and tend to promote abuse or physiological/psychological dependence.
• Institutional Animal Care and Use Committee (IACUC) Protocol: Also known as the Animal Care Application (ACA), the application that describes animal research activities in detail and is reviewed and approved by the IACUC.
• Laboratory Safety Plan (LSP): A written plan required by the OSHA Laboratory Standard that sets forth procedures, equipment, personal protective equipment, and work practices capable of protecting employees from health hazards presented by the chemicals used in the laboratory. At UNC-Chapel Hill, the complete LSP consists of 1) The Laboratory Safety Manual, which covers general safety procedures for University laboratories, and 2) an LSP prepared by the PI to address hazards and precautions specific to a given laboratory.
• Unit: Any administrative organization that is part of the University of North Carolina at Chapel Hill

Related Requirements

External Regulations

• North Carolina Controlled Substances Act: Chapter 90 - Article 5
• OSHA FactSheet: OSHA Laboratory Standard

University Policies, Standards, and Procedures

• EHS: Laboratory Safety Plan
• EHS Laboratory Safety Manual
• EHS Laboratory Safety Manual - Chapter 09: Controlled Substances
• EHS Laboratory Safety Manual - Chapter 02: Laboratory Safety Plan
• Research Code of Conduct Policy
• Research Code of Conduct Standard

Contact Information

Primary Contact

Office: OVCR Compliance

Email: researchRx@unc.edu

Other Contacts

Office: SSC Pharmacy

Email: UNCPharmacyPurch@unchealth.unc.edu