Final answer:
The regulation mandating a quality assurance program for parental compounding facilities is USP 797, which helps ensure patient safety by setting guidelines for sterile compounding. The FDA's role in overseeing drug safety can protect patients but can also result in delayed drug availability and financial impacts on those in need of new medications.
Step-by-step explanation:
Quality Assurance Program Requirements for Compounding Facilities
The regulation that requires every parental compounding facility to have a quality assurance program is USP 797. USP 797 provides guidelines for the compounding of sterile preparations to ensure patient safety and high-quality standards are met in compounding pharmacies. It is part of the U.S. Pharmacopeia, a compendium of drug information that is widely used as a reference by healthcare professionals. The regulation addresses procedures and requirements for the environment, personnel, equipment, and compounding processes to minimize risks, including microbial contamination, excessive bacterial endotoxins, variability in the intended strength of ingredients, and unintended chemical and physical contaminants. Ensuring adherence to USP 797 helps protect patients and maintains the integrity of the compounded medications.
The Food and Drug Administration (FDA) plays a significant role in ensuring safety and efficacy by regulating medicines that pharmacies are allowed to sell. Although the regulatory process brings substantial benefits by protecting patients from unsafe drugs, it can also lead to more anonymous losers who suffer due to delayed access to new treatments and the financial burden associated with the lengthy and costly drug development and approval process.