Final answer:
The primary objective of USP 797 is to ensure medication safety and quality in healthcare settings, which has a substantial impact on patient care by providing standards for the sterile compounding of medications. The FDA also ensures drug safety, but strict regulations can delay the availability of new treatments, affecting patients who urgently need them.
Step-by-step explanation:
The primary objective of the U.S. Pharmacopeia (USP) 797 is ensuring medication safety and quality in healthcare settings by providing standards for the sterile compounding of medications. USP 797 sets forth procedures to prevent microbial contamination and other variances in compounded sterile preparations (CSPs), which are medications prepared in a sterile environment to ensure they are free from infectious agents. This has a significant impact on patient care, especially in hospitals and clinics where medications are compounded.
The Food and Drug Administration (FDA) plays a separate but complementary role to USP by regulating the medicines that pharmacies can sell, ensuring their safety and efficacy. This process often involves extensive testing before a drug can enter the market, promoting health and protecting patients from potentially harmful medications. However, due to strict medical regulations, the development and availability of new drugs can be delayed, representing a downside for patients with urgent needs for innovative treatments.