Updates to USP General Chapter <797> become fully enforceable November 1, 2023. This means facilities have roughly 6 months to finalize and validate workflows and processes associated with the new standard. 

Since approving the final version of USP <797>, USP has provided, and regularly updated, a frequently asked questions section to provide transitional support and information. 

SIGNIFICANT CHANGES 

Hazardous Drug Preparation – November 1, 2023, also represents the enforceability date of USP General Chapter <800>, which provides standards for preparation, storage, and administration of hazardous drugs. 

Standard Operating Procedures (SOPs) – Facilities are required to develop, maintain, and follow additional SOPs under new USP <797> standards. A major focus of the updated SOP requirement is to minimize sterile compounded preparation contamination and mix up. The additional SOPs required also focus on training, competency, and assigned duties for staff involved in sterile compounding. Read more >