Distributive Services
Drug Distribution Services include concurrent drug use review; preparation and distribution of sterile and non-sterile products; and investigational drug dispensing to inpatients and ambulatory patients.
Clinical Programs
Clinical Programs include participation in drug selection and experimental protocol design and implementation; monitoring patient response to drug therapy; patient education; provision of drug information; drug use evaluation; and patient counseling.=
Investigational Drug Management
Investigational Drug Management includes protocol support activities, investigational drug information development, and control and accountability of investigational agents.
FDA Observations and Clinical Center Responses
FDA Inspection Observations Form 483 (February / March 2019)
FDA Inspection Observations Form 483 (May / June 2015)