CMS Now Requires Compliance to Standards for Single-Dose Vials

CMS has issued a memorandum that states healthcare providers that do not comply with United States Pharmacopeia standards for single-dose vials are subject to federal citation, according to an AORN release.


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USP standards 797 require that healthcare providers comply with strict rules for repackage and re-entering single dose. The standards include a requirement that healthcare providers use qualified, trained personnel to repackage single dose vials under International Organization for Standardization Class 5 air quality conditions within an ISO Class 7 buffer area. For a full overview of USP 797, click here.

Healthcare providers that fail to comply with these standards may be cited for deficiencies under applicable federal infection control standards.

Related Articles on Single Dose Vials:

Rep. Cliff Sterns Requests More Information on Single Dose Vials Guideline

Letter to the Editor: Clarifying Multiple-Dose Vial Usage

CDC Releases Statement Reiterating Position on Single Dose, Single Use Vials

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