USP <825> Immediate-Use Sterile-Radiopharmaceutical Preparation Requirements
| Parameter | Requirement |
| Area (hot lab) | Ambient (unfiltered) room air with no engineering controls (hood) |
| Area restrictions | Separate from nonsterile compounding and patient care activities during preparation; limited traffic during preparation |
| Preparation (FDA-approved kit) | Sterile, conventionally manufactured radiopharmaceutical kits |
| Preparation restrictions | Single dose for single patient administered within 1 h of start of preparation; remaining material discarded |
| Personnel | Training on blood-borne pathogen and aseptic handling techniques |
| Personnel restrictions | Adherence to hand hygiene, garbing, and gloving procedures, as in section 4.4 (4) |
| Activities | Unit-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 restrictions | Radiolabeling of leukocytes or platelets and splitting of single-unit dose for more than 1 patient are not allowed |