Advocating for IV Compounding Policy Change
Sterile compounding has long been recognized as a high-risk area of health system pharmacy. Traditional manual IV compounding techniques can be prone to human error, leading to incorrect ingredients and volumes, contamination, and mislabeling. And while advancements in IV compounding automation are delivering proven clinical and operational outcomes, barriers to adoption continue.
In the 2025 State of Pharmacy Compounding (SOPC) survey conducted by Pharmacy Purchasing & Products, 91% of respondents indicated plans to increase or maintain their in-house sterile compounding volumes over the next three years.1 With persisting labor and supply challenges, IV automation will be essential to safely supporting these growing volumes.
How can we help to drive awareness and acceptance of this important pharmacy technology?
During Omnicell’s recent IV TRUST Summit (Transforming IV Robotics for Unifying Safety and Technology), Tim Perrin, Senior Policy Advisor, at Polsinelli PC, shared progress on advocacy initiatives that are bolstering the sterile compounding community to help drive IV compounding policy change.
Working closely with industry advocates, the hope is to amend federal policies to incentivize adoption of state-of-the-art automated IV drug compounding technology in two key ways:
- Calling on the FDA to update its policies that govern health system drug compounding for patients
- Advocating for legislation that would leverage the Medicare program to promote the use of transformative technologies to treat patients
The Drug Quality & Security Act (DQSA) was enacted 12 years ago yet still has not been fully implemented. Over the years, the FDA has released guidance documents, many bearing labels like draft, interim, revised, nonbinding recommendations, and even ones marked “final,” which are not truly final policy. This has led to regulatory ambiguity – at both the federal and state level – that complicates strategic planning and decision making. Urging federal policymakers to provide clear regulations will empower hospitals to treat their patients with the highest quality care.
In parallel, efforts are underway to educate members of the U.S. House of Representatives and the U.S. Senate to drive Congressional oversight of FDA guidance, as well as enact legislation that will help to incentivize adoption of sterile compounding technology. The Safer Compounding in Hospitals Act was first introduced by a bipartisan duo of House Members in 2020 and is expected to be reintroduced in the House during this session of Congress, while outreach continues to secure Senate champions. This important legislation and advocacy work has been endorsed by ASHP and the THRIV Coalition, and continues to gain support across the industry, including recently from the Emily Jerry Foundation.
A critical component of this advocacy strategy is the support of health systems weighing in with their elected representatives in Congress. Joined together, these stories and voices, as constituents, make a compelling case for policy change.
Watch the IV TRUST Summit replay to hear more about driving IV compounding policy change and the latest updates on the Safer Compounding in Hospitals Act from Tim Perrin, Senior Policy Advisor, at Polsinelli PC.
1Survey Respondents. State of Pharmacy Compounding. Pharm Purch Prod. 2025;4:S6.
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