Adherence to 797 will reduce the potential for contamination caused by unclean environment, pharmacist error, lack of quality control, incorrect beyond-use dating and other factors.The standard applies to anyone who prepares CSPs and all places where they are prepared.It is the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP).
These standards are enforced by regulatory bodies including the U. Food and Drug Administration, individual state boards of pharmacy and accreditation organizations (see Legal Considerations for more information).
A summary of the six essential compounding General Chapters are provided below.
Products manufactured as an aseptic parenteral have the greatest risk of contamination and must be manufactured in an area tolerating only the lowest level of risk.
Therefore, the greatest level of control over manufacturing must be proven.
CSPs include drugs, nutrients, biologics, diagnostics and radiopharmaceuticals.