Request to Waive Direct Pharmacy IND Dispensing
Per current UCSF Medical Center Policy, unless a waiver is granted to an investigator by the UCSF Investigational Drug Pharmacist, the Department of Pharmaceutical Services will assume responsibility for the direct management (storage, accountability, preparation, dispensing and security) of all investigational drugs in use at the Medical Center, in compliance with Federal, State and all other regulatory and accreditation standards. Investigators given permission to manage the storage and dispensing of investigational drugs in their own trials will be subject to oversight and periodic inspections by Department of Pharmaceutical Services personnel. Once a waiver is granted, investigators will be evaluated based on the following criteria (see checklist). All studies that have been granted a waiver, will be audited by IDS per UCSF regulations on an up to quarterly basis. This audit will be remote and require submission by the PI for the items that are included in the original check-list. There will be an IDS pharmacy fee charged in the amount of $200/hr/audit ($200/hr up to a max of 2 hours) for pharmacy to review materials for compliance. An active Chart of Account (COA) will be required at the time of audit documentation submission. If you do not agree to this process implemented 4/14/2023, a waiver will not be granted. Please note, a waiver is no longer required for cell only or radiopharmaceuticals studies, nor studies that are executed at non-GACH licensed spaces per the UC Collaborative.
On this form, please document those reasons for which a waiver should be considered and document how your research practice will meet Medical Center standards for storage, security, accountability and dispensation of the IND product. You will be contacted within 10 business days after form submission.
Fill out ONE form for each protocol.