USP Delays Effective Dates of New and Revised Compounding Standards
Tuesday, September 24, 2019 2:29 PM
Yesterday, the United States Pharmacopeia (USP) notified stakeholders that it is postponing the official effective dates of several new and revised standards pertaining to pharmaceutical handling until further notice while it reviews appeals to the standards. Those standards include general chapters <795> (Pharmaceutical Compounding – Nonsterile Preparations), <797> (Pharmaceutical Compounding – Sterile Preparations), and <825> (Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging). In addition, due to the pending appeals, USP new general chapter <800> (Hazardous Drugs Handling in Healthcare Settings) will remain official, but only informational and will not be applicable until the appeals process is complete.
KHA submitted a letter to the Kentucky Board of Pharmacy urging the Board to delay adoption of these new rules so that Kentucky hospitals have sufficient time to comply. Compliance with these rules will be costly for hospitals and will require significant changes in small and large hospitals alike.
For further information, contact Nancy Galvagni at KHA (email@example.com).