The Centers for Medicare & Medicaid Services (CMS) reiterated that healthcare organizations will be cited for using single-dose/single-use vials on multiple patients except when the medications are repackaged into smaller doses by following the standards of the United States Pharmacopeia (USP).
The CMS memorandum [1] was issued to state survey agency directors on June 15.
“Under certain conditions, it is permissible to repackage single-dose vials or single use vials (collectively referred to in this memorandum as “SDVs”) into smaller doses, each intended for a single patient.” according to the memo. “These USP compounding standards include USP General Chapter 797, Pharmaceutical Compounding – Sterile Preparations (“USP <797>”).”
These standards currently require that:
- The facility doing the repackaging must use qualified, trained personnel to do so, under International Organization for Standardization (ISO) Class 5 air quality conditions within an ISO Class 7 buffer area. All entries into a SDV for purposes of repackaging under these conditions must be completed within 6 hours of the initial needle puncture.
- All repackaged doses prepared under these conditions must be assigned and labeled with a beyond use date (BUD), based on an appropriate determination of contamination risk level in accordance with USP <797>, by the licensed healthcare professional supervising the repackaging process
“Healthcare facilities that do not adhere to USP <797> standards but reuse SDVs for multiple patients must be cited for deficiencies under the applicable infection control standards for each type of provider/supplier,” according to the CMS.