USP <825> - Radiopharmaceuticals - Preparation, Compounding, Dispensing and Repackaging

What it says

Radiopharmaceuticals must be prepared, compounded, dispensed and repackaged under standards that address both conventional pharmaceutical quality attributes and the additional radiation safety, short half-life and specialized handling considerations unique to radioactive drug products.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Radiopharmaceuticals carry a time pressure that most other dosage forms do not, short radioactive half-lives mean quality and release decisions often have to happen on a compressed timeline that still cannot compromise on safety.
• This chapter layers radiation-specific controls, shielding, radioactive waste handling, personnel dosimetry, on top of the sterility and quality expectations that would apply to any comparable sterile or non-sterile compounded product.
• Because many radiopharmaceuticals are compounded at or near the point of patient use rather than centrally manufactured, this chapter's standards are particularly important for facilities that may not otherwise operate like a conventional drug manufacturing site.

What inspectors look for

• Whether radiopharmaceutical preparation facilities meet both conventional sterility or quality expectations and the radiation-specific handling requirements this chapter describes.
• Whether the compressed release timeline associated with short half-life products still includes the required quality release checks before patient administration.
• Whether personnel involved in radiopharmaceutical preparation have documented training covering both aseptic technique and radiation safety.

Related regulations