FDA Releases New Policy Documents Related to Compounding

The FDA has released three new policy documents, in addition to the 2018 Compounding Policy Priorities Plan released earlier this year, related to compounding.  The FDA notes that implementing federal law on compounding is a high priority for the agency.

  1. Revised Draft Guidance: Insanitary Conditions at Compounding Facilities
  2. Final Guidance: Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities
  3. Final Guidance: Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities

More Information

Leave a Reply