FDA Releases Guidance on Radiopharmaceutical Compounding at Outsourcing Facilities

The FDA issued final guidance Tuesday for outsourcing facilities on compounding and repackaging radiopharmaceuticals, along with draft guidance on insanitary conditions at compounding facilities.

Outsourcing facilities that compound radiopharmaceuticals must not compound products using a bulk drug substance unless the substance is included on the agency’s 503B bulks list or the drug compounded from the bulk drug substance appears on the FDA’s drug shortages list, the FDA said.

The agency said it will not take action against facilities that compound a radiopharmaceutical that is essentially a copy of an approved drug with “minor deviations.” Those so-called minor deviations may address conditions not normally considered in FDA-approved labeling, such as a drug’s geographical distance from a patient or the rate of radioactive decay.