3/4 November 2021
End of December, the FDA published two drafts of guidance documents for Radiopharmaceuticals:
Both guidelines are distributed for comment purposes only.
Currently, there are differences between the legal handling of
Relating to the fact that radioactive drugs generally have very short half-lives they must reach the patient for administration shortly after they were produced. Hospitals and imaging centers hence often place orders with a nuclear pharmacy for delivery of radiopharmaceutical unit-doses for procedures scheduled for the following day or in anticipation of unscheduled nuclear medicine procedures that might take place during the evening or weekend when the nuclear pharmacy is closed.
In addition to the short half-lives, general public, patients and radiation workers must be protected from unnecessary exposure to radiation. Therefore, legal restriction determines who is permitted to obtain, transport, manipulate and use radioactive drugs. The two guidances set forth the FDA's policy regarding the compounding and repackaging of radiopharmaceuticals for human use. When adopted, the first one will supersede the Guidance for Industry on Nuclear Pharmacy Guideline "Criteria for Determining When to Register as a Drug Establishment from 1984".
Please also see the two Guidelines Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities and Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities.