CMS allows repackaging of single-dose vials “under certain circumstances”

Each Friday I receive a newsletter from CompoundingToday.com. The newsletter features an editorial from Dr. Loyd V. Allen, Jr, Editor-in-Chief of the International Journal of Pharmaceutical Compounding.

A couple of weeks ago the editorial focused on the Centers for Medicare and Medicaid Services (CMS) newly clarified position on the use of sing-dose vials in medication distribution. It’s a rather important piece of information that I haven’t seen elsewhere. You’d think hospitals would be jumping all over this as it not only saves waste, i.e. cost, but can help with the drug shortage issue as well. It’s hard to say why I haven’t heard more about it, but I haven’t. Go figure.

Anyway, Dr. Allen’s editorial is reproduced in its entirety below. The CMS document can be found here (PDF).

Editorial: CMS Clarifies Position on Single-Dose Vials

On June 15, the Centers for Medicare and Medicaid Services (CMS) issued a new memorandum on the Safe Use of Single-Dose/Single-Use Medications to Prevent Healthcare-associated Infections. Referring to shortages of critical pharmaceuticals, the CMS has told surveyors not to cite facilities for noncompliance if they reuse single-dose vials under certain circumstances. It states the following:

“Under certain conditions, it is permissible to repackage single-dose vials or single-use vials (SDVs) into smaller doses, each intended for a single patient: The USP has established standards for compounding which, to the extent such practices are also subject to regulation by the FDA, may also be recognized and enforced under “501” and “502” of the FDCA. These USP compounding standards include USP General Chapter 797, Pharmaceutical Compounding – Sterile Preparations. Under USP , healthcare facilities may repackage SDVs into smaller doses, each intended for use with one patient.”

The memorandum goes on to say:
“Administering drugs from one SDV to multiple patients without adhering to USP standards is not acceptable under CMS infection control regulations.”

The Memorandum Summary concludes with:
“Deficiency Citation Policy: Healthcare facilities that do not adhere to USP 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 must not be cited solely on the basis of this practice.”