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CMS will cite on reuse of single dose vials except…

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:

“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.