CDC and ASCA meet to discuss Injectable Drugs in Single-Dose and Multi-Dose Vials and Whether A Compounding Pharmacy Can Divide Vials via 797

ASCA representatives met with Centers for Disease Control and Prevention (CDC) staff this past week to discuss issues affecting the ASC industry, particularly those related to injectable drugs packaged in single-dose and multi-dose vials. Attending the meeting were ASCA CEO Bill Prentice, ASCA Director of Education and Clinical Affairs Gina Throneberry, MBA RN CNOR ONC CASC, ASCA Board Member David Shapiro, MD, and ASCA consultant Marian Lowe.

The CDC gave ASCA an overview of the process behind their various recommendations, including their position on single-dose/single-use vials. An outline of past and recent outbreaks of infectious diseases associated with unsafe injection practices was also discussed by the CDC.

The ASCA representatives voiced concerns received from members with regard to the lack of science behind these recommendations, and asked for clarity from the agency as to why a more nuanced process pertaining to single-use vials could not be developed that would protect patients while eliminating the drug waste that currently occurs. They also briefed the agency on the different injectable drugs that ASCA members were either in having difficulty obtaining or are hard to find in appropriate doses. Finally, they rebutted the CDC’s notion that ASCs could use a compounding pharmacy to divide single-use vials via the US Pharmacopoeia (USP) 797.

The CDC staff stated that they would work to develop a clearer explanation for their position on single-use vials and pledged to work with us and other federal agencies to address both the drug shortage and drug packaging issues that are impacting patient care in ASCs. We agreed to continue our discussions after ASCA meets with the US Food and Drug Administration (FDA) on these topics next month.I

For more information, contact Gina Throneberry at gthroneberry@ascassociation.org

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