Guidance Focuses on Sanitary Conditions at Compounding Facilities

The FDA is spelling out its expectations for sanitary conditions during compounding to address repeated issues with adulteration concerns.

A draft guidance issued gives a laundry list of potential contaminants and practices considered unsanitary. Those range from the obvious, such as vermin or mold, to more subtle issues, like loose ceiling tiles in clean rooms or sterilization settings too low to kill potential pathogens.

The list is meant to give compounders fair warning about what inspectors will look for when determining whether a facility is sanitary, a common issue raised in warning letters. If products are developed under unsanitary conditions, the agency deems affected products to be adulterated.