Outsourcing/Nonresident Outsourcing Facility License
Effective January 1, 2017, an entity must have a license issued by the board prior to conducting business within or into California as an outsourcing facility. The licenses are renewed annually and are not transferrable. The outsourcing facility must comply with all laws and regulations regarding drug recalls.
An outsourcing facility must meet the following criteria:
- The facility that is located in California and engaged in compounding of sterile and nonsterile drugs AND
- Is registered with the federal Food and Drug Administration (FDA) under Section 503B of the federal Food Drug and Cosmetic Act
A nonresident outsourcing facility must meet the following criteria:
- The facility that is located within the US, but outside of California, and is engaged in compounding of sterile and nonsterile drugs; AND
- The facility is registered with the federal Food and Drug Administration (FDA) under Section 503B of the federal Food Drug and Cosmetic Act; AND
- The facility is doing business into California.
Note: A facility licensed with the board as a sterile compounding pharmacy may not be concurrently licensed with the board as an outsourcing facility at the same location.
Application