What defines an outsourcing facility in compounding?

An outsourcing facility in compounding is specifically defined as a facility at one geographic location that is engaged in the compounding of sterile drugs. This designation is crucial because it highlights the facility's focus on maintaining the standards required for sterile compounding, which involves more stringent regulations and practices to ensure the safety and effectiveness of compounded sterile preparations.

The defining characteristic of an outsourcing facility is its adherence to guidelines established by the U.S. Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) standards—notably USP Chapter 797, which outlines the requirements for sterile compounding. By being located at a single geographic site, these facilities can better manage quality control processes, staff training, and compliance with regulatory standards specific to sterile preparations, unlike facilities that might engage in various types of compounding or operate in multiple locations without the same level of oversight.

The other choices involve aspects of compounding but do not align with the regulatory framework that identifies an outsourcing facility. For instance, a facility that only packages non-sterile drugs does not meet the criteria for an outsourcing facility since it focuses on a different category of compounding. Facilities that operate multiple locations or provide delivery services for compounded medications may also not meet the specific requirements for sterile comp