[FONT=Arial Narrow]I am a clinical research coordinator in the university setting. I am looking for information regarding the dispensing of medications for patients who need to substitute for prohibited meds. In particular, legal issues concerning dispensing medications not supplied by a sponsor. (ie: substituting an ICS for ICS/LABA combo in an asthma trial.) Would this be similar to dispensing samples in a physicians office?
Do any of you experienced research coordinators know where i can locate this information. I work in PA, and I know some state regulations will apply. any direction would be appreciated.