Insanitary Conditions


FDA has released final approved guidance addressing Insanitary Conditions at Compounding Facilities.  The guidance is available at this FDA link.

This guidance provides specific examples of insanitary conditions identified during FDA inspections of 503A and 503B facilities in section IIIA for both sterile and non-sterile compounding. Some examples in the guidance include:

  • Vermin (e.g., insects, rodents) or other animals (e.g., dogs) or evidence of their presence (e.g., urine, feces) in the production area or adjacent areas.
  • Visible microbial contamination (e.g., bacteria, mold) in the production area or adjacent areas
  • Using active ingredients, inactive ingredients, or processing aides, that have or may have higher levels of impurities compared to compendial or pharmaceutical grade equivalents (e.g., ingredients with potentially harmful impurities, ingredients labeled with “not for pharmaceutical use” or an equivalent statement)
  • Engaging in aseptic processing wearing nonsterile gown components
  • Failing to disinfect or change gloves frequently enough given the nature of the operations to prevent contamination. This includes, for example, gloves exiting and re-entering the ISO 5 area without changing or sanitizing them, touching a non-sterile object and returning to compounding without first changing or sanitizing gloves, cleaning up after a spill without changing gloves when returning to compounding, and not changing the sterile gloves when glove integrity may have been compromised.
  • Performing aseptic manipulations with exposed hair or skin (e.g., on hands, wrists, forehead, mouth, or legs)
  • Microbial contamination in the ISO 5 area
  • Lack of routine and rigorous certification of the ISO 5 area, including smoke studies performed under dynamic conditions.

In section IIIB the guidance provides examples for preventive and corrective action. And lastly in section IIIC the guidance discusses potential regulatory action for facilities which produced drugs under insanitary conditions.