Important Compliance Tip: Management of Investigational Medications

UCI Health policy requires that investigational medications are under the control of Investigational Drug Services (IDS) Pharmacy.

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An Important Compliance Tip from Compliance + Pharmacy:

Management of Investigational Medications

Vials of medicine/drugsIn order to promote a commitment to compliance with FDA regulations and Good Clinical Practice (GCP) guidelines, UCI Health policy requires that investigational medications are under the control of Investigational Drug Services (IDS) Pharmacy.

This includes the storage, control, and distribution of investigational products (IP). UCI Health personnel who prepare, store, administer, and dispose of IP must comply with all federal, state, and institutional policies, and adhere to the procedures indicated in the UCI Health Management of Investigational Medications policy.

IDS Pharmacy oversight waivers may be granted to off-site locations (not located at the Orange Campus). Investigators who wish to request a waiver of the UCI Health requirement to utilize IDS Pharmacy services for studies involving the use of investigational products must follow the IDS Guideline for Consultation and Waiver process.

Please contact the Compliance & Privacy Office at hacompliance@hs.uci.edu with any questions or concerns.

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Copyright © 2022 UCI Office of Research, All rights reserved.
You signed up to receive email on the UCI IRB-HRP listserv (or-irb-hrp@department-lists.uci.edu).

Our mailing address is:

UCI Office of Research

160 Aldrich Hall

Irvine, CA92697-0001

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