Pharmacy providers are increasingly moving into the infusion space – either standing up ambulatory infusion suites (“AIS”) or proving home infusion delivery models – despite unclear licensure requirements. While this space heats up given the significant market growth potential, providers need to monitor regulation developments as different states have begun issuing related guidance. And, as providers seek investment from private equity backers to facilitate their entry into the arena, a comprehensive review of federal and state laws, regulations, and guidance should remain a central focus of the due diligence process.
Providers must monitor varying provider guidance
A recent regulatory trend involves state regulatory bodies issuing guidance related to medical spas (“med spas”), intravenous (“IV”) hydration, and IV therapy clinics. Infusion pharmacy and home infusion providers cannot afford to overlook this guidance, as a lot of these documents include broad language that picks up some of the more traditional health care models such as infusion.
For example, the AIS model involves a specialty pharmacy compounding and delivering infusion drugs – prescribed by the patient’s practitioner – to be administered by a registered nurse for chronic medical conditions. The registered nurse will then properly secure the drugs to ensure their safety and integrity until the patient arrives at the AIS, with delivery and administration typically occurring the same day with no overnight storage.
Although this AIS model is typically not addressed in the various guidance documents that regulating agencies have been issuing, infusion providers need to be cognizant of their existence — in addition to trends in areas of concern and enforcement — in order to ensure alignment with any guidance that may pertain to their business model.
As we continue to monitor state developments, we have seen a handful of states issue guidance documents that illustrate how regulators are viewing the IV hydration and IV therapy businesses, which infusion providers should consider as part of their overall compliance monitoring efforts.
Evolving state guidance at a glance
Rhode Island
- A July 2024 guidance document issued by the Rhode Island Department of Health (“RIDOH”) focuses on the proliferation of med spas and IV therapy businesses, which broadly encompasses those entities that provide patients with IV fluids with or without medications, vitamins, minerals and/or amino acids. This may include the delivery and administration of prescription drugs as in the infusion therapy model.
- The RIDOH references that these services are often treated as spa treatments rather than medical procedures, though they intersect the specialties of medicine, nursing, and pharmacy.
- The guidance also makes clear that, depending upon the underlying ownership structure, the scope of services offered, and the professional licensure (if any) held by the owners of the business, these IV therapy providers, and by extension infusion therapy providers, may require licensure with the RIDOH, including as organized ambulatory care facilities (“OACFs”).
- Licensure as an OACF requires prior review by the Rhode Island Health Services Council, a thirty-day public comment period, and approval by the licensing agency.
Kentucky
- Similarly, the Kentucky Boards of Medical Licensure, Nursing and Pharmacy issued a joint statement, which is directed at the retail IV therapy business model and not, specifically, infusion.
- Unlike Rhode Island, however, the Kentucky guidance does not identify a specific facility licensure requirement for IV therapy business locations. Instead, the resource discusses what is within the scope of practice of individual licensed health care professionals that may provide services on behalf of such businesses and that the practice of creating IV therapies may in fact constitute compounding and the practice of pharmacy.
- The infusion industry can be distinguished from the model outlined in the Kentucky guidance which addresses practitioners compounding in the IV therapy clinics. Unlike compounding on-site, the infusion industry utilizes pharmacists in a licensed pharmacy setting to compound the drugs for further administration in the AIS.
Ohio
- In May 2025, the Ohio Boards of Medicine, Pharmacy and Nursing issued a joint regulatory statement pertaining to retail IV therapy clinics.
- As with the other states, this guidance makes similar statements that operating a retail IV therapy clinic may involve the practice of medicine, nursing, and pharmacy, all of which require a license and adherence to a scope of practice under state law.
- Similar to Kentucky, much of the Ohio guidance addresses what constitutes compounding. However, Ohio also includes a reference in the guidance that is particularly relevant to the AIS model. Storing compounded drugs on-site for any period of time (e.g., the day of an infusion appointment) will require licensure with the Ohio Board of Pharmacy as a terminal distributor of dangerous drugs.
- Also in line with other states, Ohio’s guidance makes clear that standing orders are not permitted for the recommendation, compounding, and administration of IV medications under state law.
Wisconsin
- On October 22, 2025, various professional boards within the Wisconsin Department of Safety and Professional Services released a joint advisory opinion regarding IV hydration therapy businesses, making Wisconsin the most recent state to issue guidance touching on the infusion industry.
- While Wisconsin’s guidance does not reference any required facility licensure, it does note that “IV hydration therapy fluids and additives are prescription drugs requiring purchase and storage by a qualified practitioner which may include a physician, PA [physician assistant], or APNP [advanced practice nurse prescriber].”
- Wisconsin does, however, acknowledge that a registered nurse with appropriate training and experience may administer the treatment.
Conclusion and takeaways
State-by-state infusion compliance varies significantly, blurring the lines as to what licensure is required, who can operate an IV therapy clinic, and who can administer IV therapy at all. This uncertainty is particularly relevant and concerning for those entities looking to enter the infusion industry by opening a new business or acquiring an existing business. When considering purchasing and assuming the operation of an infusion business, it is essential that the buyer understand: (1) the jurisdictions in which the business is located; (2) the full scope of services provided by the business and individuals; (3) the identity of the business’s owners; and (4) any professional licenses held by such owners. Obtaining this knowledge during the due diligence phase will allow the buyer to effectively determine what, if any, licenses the business itself is required to maintain.
Completing and submitting initial license or change of ownership applications can have significant impacts on the structure of a transaction and the timelines associated with closing. Moreover, to the extent a buyer determines that a target business failed to maintain licensure that it otherwise should have held prior to engaging in the transaction, the buyer should consider including mechanisms to protect itself from any resulting regulatory enforcement action or sanction. This may include: (i) requiring the seller to provide certain representations and warranties in the purchase agreement; (ii) obligating the seller to indemnify buyer from any such enforcement action or regulatory penalties; or (iii) obtaining representation and warranty insurance to protect buyer from any financial losses due to breaches of representations and warranties made in a transaction.
Photo: sdecoret, Getty Images
Jaya White is a Chicago-based Health & Life Sciences partner at Quarles & Brady who represents a wide range of health care providers in regulatory and transactional matters. She also has ample experience advising pharmacy, physician, wholesale distribution and infusion providers in a broad array of issues.
Kiel Zillmer is a Milwaukee-based Health & Life Sciences partner at Quarles & Brady. He provides counsel to hospitals and health care providers to achieve their business objectives while minimizing unnecessary risk, including advising on regulatory compliance and transactional matters.
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