On June 15, 2012, the Office of Clinical Standards and Quality/Survey & Certification Group at CMS issued a memorandum regarding the CMS regulatory and policy requirements for repackaging single-dose vials or single-use vials (SDVs) of drug products into smaller dose quantities.
Under the United States Pharmacopeia compounding standards, specifically USP General Chapter 797 (USP 797), healthcare providers may repackage drug products from SDVs into smaller doses so long as the individual, repackaged doses are intended for use with single patients, and very careful environmental and use controls are applied. USP 797 sets forth standards and conditions that providers must follow to re-package SDVs in a manner that controls potential contamination (both from the repackaging process itself, and due to common lack of antimicrobial preservatives). CMS reiterated its expectation “that medications labeled as SDVs must not be used directly for multiple patients, due to the risk of spreading infections. CMS’s “policy is to cite the reuse of a SDV for multiple patients as an infection control deficiency, since this practice of reuse is in conflict with nationally recognized standards.”
The policy clarification comes in response to an increase in the number and severity of drug shortages. Healthcare providers may seek to avoid wastage of SDV medication that exceeds the needed dose for a single patient.
The CMS memorandum acknowledges this current concern and describes the protocol for providers to follow:
[W]hen previously unopened SDVs are repackaged consistent with aseptic conditions under the requirements of USP <797>, and subsequently stored consistent with USP <797> and the manufacturer’s package insert, it is permissible for healthcare personnel to administer repackaged doses derived from SDVs to multiple patients, provided that each repackaged dose is used for a single patient with applicable storage and handling requirements.
(Emphasis in original.) The distinction, CMS explains, is between proper “repackaging” and inappropriate “reuse.”
The CMS Memorandum is available by clicking here.