USP <825> Immediate-Use Sterile-Radiopharmaceutical Preparation Requirements

Area (hot lab)Ambient (unfiltered) room air with no engineering controls (hood)
Area restrictionsSeparate from nonsterile compounding and patient care activities during preparation; limited traffic during preparation
Preparation (FDA-approved kit)Sterile, conventionally manufactured radiopharmaceutical kits
Preparation restrictionsSingle dose for single patient administered within 1 h of start of preparation; remaining material discarded
PersonnelTraining on blood-borne pathogen and aseptic handling techniques
Personnel restrictionsAdherence to hand hygiene, garbing, and gloving procedures, as in section 4.4 (4)
ActivitiesUnit-dose manipulations allowed (needle changes, adjusting of radioactivity or volume); dispensing single dose from vial; dose pooling for single patient dose; addition of nonradioactive, sterile, commercially manufactured pharmaceutical to unit dose
Activity restrictionsRadiolabeling of leukocytes or platelets and splitting of single-unit dose for more than 1 patient are not allowed