Facility and Engineering Controls Using USP 800 Guidelines

Like many layers of an onion, there are unanswered questions on the intricate details of USP 800-related engineering control parameters. In addition, the multitude and flexibility of theengineering controls can seem daunting to the independent pharmacy owner. Even more concerning, and certainly at the forefront of all of the independent pharmacy owners’ minds, is the cost associated with being compliant with USP 800. The costs associated with building a new facility or remodeling an existing space, are proving to be as equally subjective as the choice of engineering controls. The focus of this white paper is to discuss the details for consideration of a good working design of a USP 800 compliant compounding lab.