Nonsterile compounding-USP ch 795

1. Nonsterile compounding-USP ch 795 • USP <795> outlines the responsibilities of the compounder, • which can be summarized as being responsible for compounding • preparations of acceptable strength, quality, and purity with appropriate packaging • and labeling in compliance with requirements established by applicable laws and • agencies (eg, state boards of pharmacy). Specifically, the responsibilities of the • compounder include the following general principles: • Personnel are capable and qualified to perform their assigned duties. • Compounding ingredients of the appropriate identity, quality, and purity • are purchased from reliable sources. • All equipment used in compounding is clean, properly maintained, an • used appropriately. • Only authorized personnel are allowed in the immediate vicinity of the • drug compounding operations. • There is assurance that processes are always carried out as intended or • specified and are reproducible. • The compounding environment is suitable for its intended purpose and to • prevent errors. • Adequate procedures and records exist for investigating and correcting • failures or problems in compounding, in testing, or in the • preparation itself.

2. USP ch 795 • USP 795 carries the force of law. Its provisions can be, and are, enforced by U.S. Food and Drug Administration agents and state board of pharmacy officials. All states have adopted USP 795 as the baseline for safe and legal nonsterile compounding • It is the most common kind of drug compounding done by pharmacists and pharmacy technicians in community and hospital pharmacies. • Preventing contamination is important when doing nonsterile compounding, but compounders do not have to work in completely sterile environments like cleanrooms. • "the production of solutions, suspensions, ointments and creams, powders, suppositories, capsules and tablets."

3. USP ch 795 • extemporaneous compounding----making a drug dosage not made by manufacturer. • simple, moderate and complex categories. • Simple nonsterile compounding involves mixing medications according to established formulas, or "recipes," and creating liquid versions of drugs usually sold only as tablets or capsules. • Used in doses smaller than ones in commercially produced products. • 125 simple nonsterile compounds in USP. • It gives APIs and nonpharmaceutical ingredients to use, as well as how to measure and mix the ingredients, label the finished drug product and determine an expiration date

4. USP ch 795 • Moderate nonsterile compounding involves making dosages containing potentially harmful medications or preparations that require special handling. • Fentanyl troches, which are better known as lollipops, and ointments that can only be safely applied with gloves fall into this category. • Mostly from dentists, oncologists and dermatologists • Few pharmacies perform complex nonsterile compounding, which requires advanced training and special equipment to make products like extended-release capsules and transdermal patches. • Sterile compounding is ---Medication intended for injection, infusion or application to the eye must be compounded according the rules and standards for sterile compounding due to bacteria or fungi.