CMS May Cite Facilities for Non-Compliance to SDV Standards

CMS recently issued a memorandum entitled Safe Use of Single Dose /Single Use Medications to Prevent Healthcare-associated Infections. In this June 15, 2012 letter, CMS reiterates its policy that providers and suppliers will be cited for an infection control deficiency if they reuse single-dose or single use vials (SDV) for  multiple patients.  Practitioners have asked CMS to review their policy as it may aggravate existing drug shortages by requiring wastage of SDV medication that exceeds the needed dosage for a single patient.  CMS states they are not changing their policy.  However, this memorandum does clarify CMS guidelines regarding the use of SDVs for multiple patients stating it is permissible to repackage SDVs under controlled conditions.  

It is important to note the distinction between reuse and repackaging:

  • Reuse is the inappropriate subdivision of the contents of a SDV for multiple patients that is not performed in accordance with USP <797>.   Facilities will be cited for this activity.
  • Repackaging is the appropriate repackaging of a previously unopened SDV, in accordance with USP <797>, into multiple smaller doses.  When done correctly, facilities will not be cited for using repackaged, single use doses.   

USP <797> standards currently require that the facility doing the repackaging must use qualified trained personnel  to do so under International Standardization for Organization (ISO) Class 5 air quality conditions within an ISO Class 7 buffer area.  This is typically a laminar airflow hood located inside of a clean room.  All repackaged doses prepared under these conditions must be  assigned a Beyond Use Date (BUD) and labeled correctly with this expiration date, the name and concentration of the product as well as storage conditions for safe use. 

The letter also points out examples what is not permissible repackaging:

  • Preparation on a patient/resident care unit of multiple doses for multiple patients.
  • A syringe with a single dose from an SDV that will be administered more than one hour after preparation.
  • Using an SDV in the same manner as a multi-dose vial.
  • An anesthetist using a SDV to administer anesthesia, moderate sedation, or other medication to more than one patient.  

A healthcare facility may use medication doses that have been repackaged from SDVs by an off-site vendor such as a high-risk sterile compounding pharmacy.  In such cases CMS surveyors must ask for evidence that the healthcare facility has obtained documentation from the compounding pharmacy that the pharmacy adhered to USP <797> guidelines. 

It is imperative that you perform extensive due diligence when vetting compounding pharmacies.  Consider utilizing an independent third party pharmacy auditor or perform a site visit in person.  Quality sterile compounding pharmacies will have an open door policy allowing and even encouraging site visits.

Written by Newport Beach Compounding Center Staff

As one of the most experienced compounding pharmacies in Newport Beach, We provide a valuable service working together with physicians and patients to create medications tailored to specific requirements. We are specialists in the art and science of pharmacy compounding. Our Team of experts can meet all of your unique pharmaceutical needs.

No Comments Yet.

Leave a Reply

You must be logged in to post a comment.