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Regulators Tell Senate Panel they Oppose Repeal of Hospital "White‑Bagging" Ban, Citing Patient‑Safety Risks
Summary
At a May 7 Senate Health and Welfare hearing, the Office of Professional Regulation said it opposes a temporary repeal of Vermont's white‑bagging restrictions in draft H.266, warning that shipments of unprepared IV drugs outside hospital pharmacy oversight create patient‑safety and ethical concerns for pharmacists.
Lauren Hibbert, deputy of state at the Office of Professional Regulation, told the Vermont Senate Health and Welfare Committee on May 7 that her office opposes removing limits on “white‑bagging” in draft H.266 because of ongoing patient‑safety concerns.
“White bagging is the shipping of a drug that's intended for intravenous infusion,” Hibbert said. “Preparation of drugs for infusion require very clear and known drug supply chains and then appropriate clean room environments and aseptic ... by appropriately trained, health care providers, which are pharmacists.”
Hibbert said the practice as managed by pharmacy benefit managers (PBMs) can place hospital pharmacists at a disadvantage because drugs arrive without the hospital pharmacist’s expectation or oversight. “Because those drugs are coming to the hospital for preparation outside of the hospital pharmacist knowledge, the drugs aren't expected,” she said, and “they could sit on a hospital loading dock ... hours. It could be a day. It could be 2 days.”
Nut graf: The issue matters because hospital pharmacists are legally and ethically responsible for preparing and ensuring the quality of infused medications. The Office of Professional Regulation (OPR) told the committee that the alternative PBM‑driven shipping model changes the supply‑chain visibility pharmacists rely on and therefore can create safety and professional‑judgment conflicts.
The committee reviewed a draft of H.266 that would temporarily repeal the ban on white‑bagging while adding reporting and review requirements. The draft discussed in committee includes: reporting on participation in the 340B direct‑pricing program, provisions to repeal and later reinstate the white‑bagging ban, and a mandate for the Green Mountain Care Board to report on the repeal’s budgetary and solvency impacts for hospitals and insurers. The draft reads that restoration of the ban would take effect on Jan. 1, 2030, while the bill would require hospital 340B reporting by a January deadline set in the draft.
Hibbert said OPR supported the 2022 provisions that originally addressed white‑bagging and that the office continues to have concerns about patient safety under alternative shipping models. “Our office has been trying to ensure patient safety. I think that is our office's role to do that,” she said, adding that pharmacists may be placed “in a bind” by the model.
When a committee member asked whether Vermont had documented patient harm from white‑bagging, Hibbert replied, “That's not something that our office would track, most likely. And so I don't have the answer to that.”
The committee heard that stakeholders such as the Vermont Society of Health System Pharmacy have submitted a letter; Hibbert recommended the committee consult that organization. The committee did not take a vote on H.266 and planned further consideration at a later meeting.
Ending: Committee leadership said members would have time to review the drafts and return to the bills in a subsequent session; no votes were taken on H.266 during the May 7 hearing.
