Ms. Alexandra Blasi, J.D., M.B.A.
Kansas State Board of Pharmacy
800 S.W. Jackson
Topeka, Kan. 66612-124
Subject: Letter Regarding the Proposed Rules on Sterile and Non-sterile Compounding (KAR 68-13-2, 68-13-3, 68-13-4)
Dear Ms. Blasi:
On behalf of the Kansas members of ASHP (American Society of Health-System Pharmacists), I am writing to express our concerns over the proposed rules on sterile and non-sterile compounding (KAR 68-13-2, 68-13-3, 68-13-4) and to request that the state allow the federal oversight process to be finalized prior to promulgating rules at the state level. ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings. The organization’s 45,000 members include pharmacists, student pharmacists, and pharmacy technicians. For more than 75 years, ASHP has been at the forefront of efforts to improve medication use and enhance patient safety.
ASHP is concerned that the proposed rules are premature and could conflict with U.S. Food & Drug Administration (FDA) and U.S. Pharmacopeia (USP) requirements. Both FDA and USP are in the process of finalizing or updating their respective compounding requirements. As such, ASHP respectfully asks the State of Kansas to consider delaying its rulemaking until these requirements are settled at the federal level. Not doing so may result in state regulations that conflict with FDA requirements or USP standards.
The FDA has yet to finalize any guidance governing compounding and related activities — including repackaging in hospitals and health systems — and is still working to finalize several other guidances related to Section 503A of the Food, Drug, and Cosmetic Act dealing with pharmacy compounding. Further, the USP chapters governing compounding and hazardous drugs (USP Chapters <797> and <800>) do not take effect until December 1, 2019. Although Chapter <800> is final, Chapter <797> is still undergoing revisions based on stakeholder comment. Both the USP chapters and the FDA guidances will likely have a major impact on sterile and non-sterile compounding practices. We strongly encourage Kansas to refrain from overhauling its own compounding framework until the federal standards are in place.
We appreciate the opportunity to offer our feedback on the proposed rules. If you have any questions regarding this letter, or if we can be of any assistance, please contact Nicholas Gentile, Director of State Grassroots Advocacy and Political Action, at [email protected] or 301-664-8687.
Joseph M. Hill III
Director, Government Relations Division