Inventory Control And StorageInvestigational drugs are stored in both the Investigational Drug Service and the Department ofPharmacy to ensure appropriate access, security, stability, and compliance with Food and DrugAdministration (FDA) guidelines. Drug order, receipt, and return forms are maintained for allmedications used in clinical trials. The IDS will order and receive shipments of investigationaldrugs.Drug AccountabilityDrug accountability records are maintained for all study drugs received, stored, and dispensedby the IDS. Study drug supplies are inventoried on a regular basis for quality assurancepurposes. The IDS maintain records after study completion according to FDA requirements, oras specified per protocol.Packaging and LabelingThe IDS utilizes a fully computerized dispensing system to generate labels and track patientprofiles. The IDS repackages medication to accommodate special dispensing and blindingrequirements. Outpatient prescriptions are dispensed pursuant to a written prescription, legal in
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Pharmacology,Clinical trial,INVESTIGATIONAL DRUG SERVICES,URMC Investigational Drug Service