What is the purpose of USP Chapter 797?
The purpose of USP Chapter <797> Pharmaceutical Compounding is to provide standards for the protection and safety of patients and healthcare workers involved in sterile compounding preparations such as pharmacists, nurses, physicians and pharmacy technicians by reducing the potential for microbial contamination caused …
What is the current USP 797 version?
The currently official <797>, last revised in 2008, remains official. On June 1, 2019, USP published revisions to General Chapter <795> for nonsterile compounding and General Chapter <797> for sterile compounding, as well as a new General Chapter <825> for radiopharmaceuticals.
Is USP 797 finalized?
On March 12, 2020, USP published that the 2019 revision of USP 797 was remanded as a result of a final appeal hearing. Therefore, the 2019 revision of USP 797 is no longer enforceable. Based on the current USP 797 (2008 version), only low-risk-non-hazardous compounded sterile products may be prepared in the SCA.
When was USP 797 last updated?
2008
Important Updates *IMPORTANT NOTE: The currently official version of General Chapter <797> (last revised in 2008) remains official.
Is TPN high risk?
Patients receiving total parenteral nutrition (TPN) are at high risk for bloodstream infections (BSI). The notion that intravenous calories and glucose lead to hyperglycemia, which in turn contributes to BSI risk, is widely held but is unproven.
When did USP 797 go into effect?
2008: USP 797 is Launched.
What does Chapter 797 of the USP say?
USP Chapter 797 – Suggested Standard Operating Procedures. “The compounding facility shall have written, properly approved SOPs designed to ensure the quality of the environment in which a CSP is prepared.” Compounding Personnel
What are the USP 797 standards for sterile products?
USP 797 Guidelines – Minimum Requirements for Validation The purpose of USP 797 is to provide standards that set the minimum threshold required for your operations to be considered safe for the preparations of compounded sterile products. Further, these standards also ensure that the compounded sterile products are of high-quality.
What is the general chapter of the USP?
Developing USP General Chapter <797>. USP is a not-for-profit, science-driven organization that has an established process for convening independent experts in the development and maintenance of healthcare quality standards.