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FOUNDATION OVERVIEW

Note: United States Pharmacopeia (USP) Chapters 795 and 797 have been recently revised. The revision implementation date was originally set for December 1st 2019; however, several appeals were submitted. At this point it is not certain when the newest version of both chapters will become official, as the official date for the chapter must be at least 6 months from the date of the decision to uphold the standards. During the appeals process of the USP Chapter 797 revisions, the Joint Commission will evaluate organizations based on the version they have adopted and are currently using.

General Sterile Compounding Regulations

Sterile and nonsterile compounding are key elements of the pharmacy profession. Compounding plays an important role in modern pharmacotherapy, as doses of medications can be prepared specifically for each individual patient. The Food and Drug Administration (FDA) divides compounded products into two categories. When medications are prepared for a specific patient according to orders from a licensed prescriber, the medication is considered to be a part of the 503A section1 of Federal Food, Drug and Cosmetic Act (FD&C Act). Section 503B was added to the FD&C Act by the Drug Quality and Security Act in 2013, and it defines a new category of compounders labeled as “outsourcing facilities1”. Products that are prepared under the section 503A of the FD&C Act are what most clinicians consider “traditional compounds.” Compounders prepare medications for specific patients as they receive the prescription, with some minor exceptions when a pharmacy may be compounding a product for physician’s in-office use, or in anticipation of a prescription. The majority of hospitals and mainstream retail compounding pharmacies fall into this category. Outsourcing facilities are subject to much more stringent Current Good Manufacturing Practices (CGMP) regulations and can compound and distribute preparations that are not patient-specific.

Sterile compounding is a skill that is unique to pharmacists, as it requires specialized equipment and environment, as well as additional training. The resulting preparations are sterile and can be used in parenteral or any other type of application that requires sterile preparations. The term sterile is not relative, as preparation either is or is not sterile. The finished product must not become contaminated by microorganisms or any other chemical or physical contaminants during the process of preparation, as patient harm may result from exposure to nonsterile preparation when used parenterally. Until the recent past there were few official documents providing guidance on best practices for sterile compounding, and many patients were harmed as an outcome of poor standards and practices, because none of those documents were enforceable by any agency. In 2004, USP published in its USP compendium Chapter 797, whose guidelines first became enforceable in 2008.3 USP is a not for profit, independent, scientific, nongovernmental organization composed of scientists and practitioners from different fields, who offer their expertise on a variety of advisory boards. They create, ...

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