The United States Pharmacopeia (USP™) is the only independent, non-profit, and non-governmental organization responsible for establishing an inventory of drug and supplement standards. Their main function is to maintain a global catalog of over 4,500 monographs for prescription and over-the-counter (OTC) drugs, dietary supplements, and medical devices. 

The USP 800 guidelines developed by the United States Pharmacopeia were created to protect the working environment of pharmacists and technicians when dealing with compounding Hazardous Drugs. This was first published in 9/29/2019, becoming official on 7/1/2018. USP 800 guidelines and standards can vary by State. USP 800 is specific for compounding Hazardous Drugs, while the USP 797 is specialized for Non-Hazardous Drugs. 

USP 800 also enables the ability to work in a negative pressure environment. All medical equipment comes standard to meet USP 800 cleanroom requirements compliance, excluding floor color. Often times, these units are referred to as a compounding pharmacy or “Clean Room.” This is a room designed to be free from dust and other harmful contaminants using a combination of High Efficiency Particulate Air (HEPA) filtration air supply in the room. They require a certain amount of pressurization (comparable to an airplane) and specific number of Air Exchanges per Hour (ACH) to turn air at a constant rate. The cleanrooms are classified into ISO1-ISO9 with the larger the ISO# having more particles in the air. They have been designed as a place for the pharmacist to mix together the exact dosage of ingredients when creating personalized medications.