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Repackaging requirements for single-use medications

June 25, 2012

Hospitals and other health care facilities may in certain cases use medications that have been repackaged into smaller doses from unopened singledose/ single-use vials, the Centers for Medicare & Medicaid Services (CMS) clarified in a recent memorandum sent to state survey agencies. To comply with CMS requirements and avoid a citation from surveyors, facilities must appropriately repackage the medications in accordance with United States Pharmacopeia (USP) General Chapter 797 standards for sterile compounding; store the repackaged doses consistent with USP 797 standards and the manufacturer’s package insert; and use each repackaged dose only for a single patient.

For more, go to the “Medicare” section ofwww.cms.gov and click on “Provider Enrollment & Certification.”