Final answer:
The regulation mandating that each parental compounding facility must have a quality assurance program is known as USP Chapter 797. It sets standards for sterile compounding practices to ensure medication safety and effectiveness.
Step-by-step explanation:
The regulation that requires every parental compounding facility to have a quality assurance program is USP Chapter 797. This chapter provides guidelines on the process of compounding sterile preparations to ensure patient safety, including procedures for maintaining a sterile environment and proper testing to ensure the compounded medications meet required purity and potency standards. Facilities that perform compounding are expected to comply with these standards to prevent contamination and ensure that compounded medications are safe for patient use.
These guidelines are critical for protecting patient health, as they help to prevent microbial contamination, excessive bacterial endotoxins, variability in the intended strength of ingredients, unintended chemical and physical contaminants, and ingredients of inappropriate quality in compounded sterile preparations. Enforcement of these regulations helps ensure the effectiveness and safety of medications, while also providing truthful labeling as required by law.