CMS will cite on reuse of single dose vials except…

By: June 26th, 2012 Email This Post Print This Post

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 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.


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