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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 the medications can be prepared specifically for a 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 503A section1 of the Food, Drug, and Cosmetic (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 facilities”.1 Products that are prepared under the section 503A of the FD&C Act are what most clinicians consider as “traditional compounds”. Compounders prepare medications for specific patients as they receive the prescription, with some minor exceptions when a pharmacy maybe compounding a product for physician in-office use, or in anticipation of a prescription. The majority of hospitals and the mainstream of retail compounding pharmacies fall into this category. Outsourcing facilities are subject to much more stringent current Good Manufacturing Practice (cGMP) regulations and can compound and distribute preparations that are not patient specific.

Sterile compounding is a skill that is very 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, but many patients were harmed as an outcome of poor standards and practices, because none of those documents were enforceable by any agency. In 2004, United States Pharmacopeia (USP) published in its USP compendium Chapter 797, which became the first enforceable guideline 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, validate, research, and publish guidelines, standard analytical methods, procedures for quality testing, and monographs for drugs, dietary supplements, and natural herbal products which are published and updated quarterly. Chapters 1 to 999 of the USP compendium are enforceable by FDA. In their pharmacy practice acts, many states have included USP 797 in its entirety or with some modifications as standards of sterile compounding.

USP Chapter 797

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