Safe Use of Single Dose/Single Use Medications to Prevent Healthcare-associated Infections
Guidance for certain conditions,under which 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).
Issued by: Centers for Medicare & Medicaid Services (CMS)
Issue Date: June 15, 2012
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