Blog
Survey on USP 800 Readiness Are our state compounding pharmacies ready?
- By: admin
- On: 04/26/2023 15:55:25
- In: KPhA Updates
Earlier this month, the KY Board of Pharmacy (KYBOP) sent an email addressing USP revisions to 795 and 797, expected to be implemented by November 1, 2023. The KYBOP has revised Kentucky's current compounding regulation 201 KAR 2:076 to include adoption of the revised 795 and 797, as well as other changes for clarification and standardization purposed, to be reviewed by the Board at the next Board meeting, May 24, 2023.
A decision to adopt USP revisions to 795 and 797 by the KYBOP would also come with the adoption of USP 800, the standards for handling hazardous drugs. USP 800 standards for sterile and nonsterile compounding ultimately protect pharmacy staff handling hazardous materials. However, USP 800 adoption may have a hefty price tag for pharmacies that compound hazardous drugs, as many would need to update their compounding equipment to meet USP 800 compliance.
KPhA would appreciate your participation in a brief survey to assess pharmacies who are compounding, those compounding hazardous materials, their readiness for USP 800 adoption, and approximately how long you would anticipate it would take to get your pharmacy's compounding lab compliant to USP 800 standards. Survey responses are completely anonymous.
Public comments on the draft regulation are open until the end of the day on May 10, 2023. If this version or an amended version is approved, there will be an additional period for public comment and a public hearing. If you strongly feel one way or the other on this draft regulation, please let us know in the survey comments so that we can best serve our membership.