FDA to Defer Enforcing Violations Related to the Compounding of Radioactive Drugs

The FDA has laid out a list of situations in which the agency would not enforce certain violations related to the compounding and repackaging of radiopharmaceuticals.

In two draft guidances — aimed at registered outsourcing facilities, as well as state-licensed nuclear pharmacies and federal facilities — the agency said it would not focus enforcement on the compounding of radiopharmaceuticals produced with minor deviations, such as increasing the amount of a radioactive material included in an FDA-approved kit, so it remains effective when used later.

For outsourcing facilities, the agency said it does not intend to take action on the compounding of radiopharmaceuticals that are essentially copies of an FDA-approved drug, as long as the facility does not use bulk drug substances, and follows all other related statutory requirements.