USP is a nonprofit, nongovernmental standard-setting organization. In 2013, Congress passed legislature regulating the compounding of sterile medications, requiring a prescription for all sterile compounded medications and for all physicians to comply with USP 797 sterile compounding rules.

The United States Pharmacopeia (USP) is a nonprofit, nongovernmental standard-setting organization. The initial compounding guidelines came out in 2003 and requirements for USP < 797 >. 

USP came out with revisions in June of 2008 with reduced requirements including removing the need for a vent hood for compounding and short storage period. In November of 2013, Congress passed legislature regulating the compounding of sterile medications as a reaction to 64 deaths. The two enacted requirements were the need to write a prescription for all sterile compounded medications and for all physicians to comply with USP 797 sterile compounding rules.

An update of USP < 797 > was released on June 1, 2019 with an anticipated date effect date of December 1, 2019.