FDAs Draft Guidances of Compounding and Repackaging of Radiopharmaceuticals

Recommendation

7/8 May 2024

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Regulatory Requirements and Practical Implementation

End of December, the FDA published two drafts of guidance documents for Radiopharmaceuticals:

• Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities and
• Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities.

Both guidelines are distributed for comment purposes only.

Currently, there are differences between the legal handling of

• radiopharmaceuticals that are compounded by entities not registered  with FDA as outsourcing facilities and
• radiopharmaceuticals that are repackaged on one side and
• compounding and repackaging of radiopharmaceuticals for human use by entities registered with FDA as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act.

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.