[Drug Compounding Draft Guidances]: Compounding and repackaging of radiopharmaceuticals

Today FDA issued two draft guidances on compounding and repackaging of radiopharmaceuticals:

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

The comment period on the draft guidances closes in 60 days. Information on how to comment on the guidances is available in the Federal Register:

• Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities; Draft Guidance for Industry; Availability
• Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies; Draft Guidance for Industry; Availability

FDA’s website has additional information on compounding.