When it comes to quality assurance, what is the most important aspect of PPE related to compounding?

The Food and Drug Administration (FDA) is responsible for maintaining the FDA Error Reporting System (FAERS; formerly known as AERS).

The American Society of Health System Pharmacists (ASHP) established three different risk levels for pharmacy-prepared sterile products. Level I products are to be stored at room temperatures and administered completely within 28 hours after being prepared; unpreserved products that are prepared for more than one patient that contain preservatives; and products prepared by closed system aseptic transfer of nonpyrogenic, sterile finished products (in sterile containers) from licensed manufacturers. Level II products are administered more than 28 hours after preparation and stored at room temperature; products that are batch prepared with no preservatives for more than one patient; and products compounded by various manipulations of sterile ingredients using close-system aseptic transfer from licensed manufacturers. Level III products are compounded from nonsterile components, containers, or equipment before they are terminally sterilized and products prepared with sterile or nonsterile products pre- pared from sterile or nonsterile ingredients using open-system transfer before they are terminally sterilized.

All of the instruments used in the pharmacy are required to be very accurate to ensure the purest quality and the best possible product. To maintain the accuracy of the instruments, regular cleaning and maintenance is needed. This often includes calibration where a standard is used to make minor modifications to the measurements the device makes so that it meets the highest possible standards of accuracy. An example of this would be a scale used to measure ingredients for a compound or the volume dispensed in an automatic TPN compounding machine.

Gloves should be changed hourly or after they become contaminated.

USP ,795. requires that pharmacy weights be calibrated every year.

The United States Pharmacopeia (USP) establishes the standards for the identity, strength, quality, and purity of medications. The FDA ensures that medications are pure, safe, and effective; the ISMP focuses on medication safety and methods to reduce medication errors from occur- ring; and the TJC is concerned about patient safety in hospitals, long-term care facilities, and nursing homes.

USP,797. requires that used syringes must be placed in a sharps container.