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Title
Safe Use of Single Dose/Single Use Medications to Prevent Healthcare-associated Infections
Memo #
12-35-ALL
Posting Date
2012-06-15
Fiscal Year
2012
Title
•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: The United States Pharmacopeia (USP) has established standards for compounding which, to the extent such practices are also subject to regulation by the Food and Drug Administration (FDA), may also be recognized and enforced under §§501 and 502 of the Federal Food, Drug and Cosmetics Act (FDCA). These USP compounding standards include USP General Chapter 797, Pharmaceutical Compounding - Sterile Preparations (“USP <797>”). Under USP <797>, healthcare facilities may repackage SDVs into smaller doses, each intended for use with one patient. Among other things, 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.
•Administering drugs from one SDV to multiple patients without adhering to USP <797> standards is not acceptable under CMS infection control regulations: Medications in SDVs typically lack antimicrobial preservatives. According to the Centers for Disease Control and Prevention (CDC), ongoing outbreaks provide evidence that medications from SDVs can become contaminated and serve as a source of infection when they are used inappropriately.
•Deficiency Citation Policy: 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. On the other hand, healthcare facilities that utilize appropriately stored medications, derived from repackaged SDVs and prepared in accordance with USP <797> must not be cited solely on the basis of this practice.
•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.
•Administering drugs from one SDV to multiple patients without adhering to USP <797> standards is not acceptable under CMS infection control regulations: Medications in SDVs typically lack antimicrobial preservatives. According to the Centers for Disease Control and Prevention (CDC), ongoing outbreaks provide evidence that medications from SDVs can become contaminated and serve as a source of infection when they are used inappropriately.
•Deficiency Citation Policy: 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. On the other hand, healthcare facilities that utilize appropriately stored medications, derived from repackaged SDVs and prepared in accordance with USP <797> must not be cited solely on the basis of this practice.