Infusion industry boom sets off wake-up call from state regulators

Pharmacy providers are increasingly moving into the infusion business – either in standing ambulatory infusion suites (“AIS”) or testing home infusion delivery models – despite unclear licensing requirements. As this space heats up given the market’s significant growth potential, vendors need to monitor regulatory developments as different states have started issuing guidelines on the matter. And, as providers seek investment from private equity backers to ease their entry into the arena, a comprehensive review of federal and state laws, regulations and guidelines should remain central to the due diligence process.

Providers must follow the various provider guidelines

A recent regulatory trend involves state regulators issuing guidelines relating to medical spas (“medical spas”), intravenous (“IV”) hydration, and IV therapy clinics. Infusion pharmacies and home infusion providers cannot afford to neglect this guidance, as many of these documents contain broad language that repeats some of the more traditional healthcare models such as infusion.

For example, the AIS model involves a specialty pharmacy that prepares and dispenses infusion medications – prescribed by the patient’s practitioner – to be administered by a registered nurse for chronic health conditions. The registered nurse will then properly secure the medications 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 not typically addressed in the various guidance documents published by regulatory bodies, infusion providers should be aware of its existence – in addition to trends in areas of concern and application – to ensure alignment with any guidance that may concern their business model.

As we continue to monitor state developments, we have seen a handful of states issue guidance documents illustrating how regulators view IV hydration and IV therapy activities, which infusion providers should consider as part of their overall compliance monitoring efforts.

The evolution of state orientations at a glance

Rhode Island

• A July 2024 guidance document published by the Rhode Island Department of Health (“RIDOH”) focuses on the proliferation of medical spas and IV therapy businesses, which broadly encompasses entities that provide patients with IV fluids with or without drugs, vitamins, minerals and/or amino acids. This may include dispensing and administration of prescription medications as in the infusion therapy model.
• RIDOH refers to the fact that these services are often treated as spa treatments rather than medical procedures, although they overlap with the specialties of medicine, nursing and pharmacy.
• The guidance also makes clear that, depending on the underlying ownership structure, scope of services offered, and professional licensure (if any) held by the business owners, these IV therapy providers, and by extension infusion therapy providers, may require licensure with RIDOH, including as Organized Ambulatory Care Facilities (“OCFs”).
• Obtaining licensure as an OACF requires prior review by the Rhode Island Health Services Council, a thirty-day public comment period, and approval from the licensing agency.

Kentucky

• Similarly, the Kentucky Boards of Medical Licensing, Nursing, and Pharmacy issued a joint statement that addresses the IV therapy retail business model and not specifically infusion.
• However, unlike Rhode Island, Kentucky’s guidelines do not identify a specific establishment licensure requirement for commercial IV therapy sites. Instead, the resource discusses what falls within the scope of practice of licensed healthcare professionals who 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 Kentucky’s guidelines that are directed to practitioners who prepare preparations in IV therapy clinics. Unlike on-site preparation, the infusion industry uses pharmacists at a licensed pharmaceutical facility to prepare medications for subsequent administration in the AIS.

Ohio

• In May 2025, the Ohio Boards of Medicine, Pharmacy, and Nursing issued a joint regulatory statement regarding retail IV therapy clinics..
• As with other states, these guidelines contain similar statements that operating a retail IV therapy clinic may involve the practice of medicine, nursing, and pharmacy, all of which require licensing and compliance with a scope of practice under state law.
• Like Kentucky, much of Ohio’s guidelines address what constitutes composition. However, Ohio also includes a reference in the guidelines that is particularly relevant to the AIS model. Storing compounded medications on-site for any period of time (e.g., on the day of an infusion appointment) will require licensing with the Ohio Board of Pharmacy as a Terminal Dispenser of Hazardous Drugs.
• Consistent with those in other states, Ohio’s guidelines make clear that standing orders are not permitted for the recommendation, preparation, and administration of IV medications under state law.

Wisconsin

• On October 22, 2025, various professional boards of the Wisconsin Department of Safety and Professional Services issued a joint advisory opinion regarding IV hydration therapy businesses, making Wisconsin the most recent state to issue guidance regarding the infusion industry.
• Although Wisconsin’s guidelines do not reference any required establishment license, they note that “IV hydration therapy fluids and additives are prescription drugs that must be purchased and stored by a qualified practitioner who may include a physician, PA, or physician. [physician assistant]or APNP [advanced practice nurse prescriber].”
• Wisconsin, however, recognizes that a registered nurse with the appropriate training and experience can administer the treatment.

Conclusion and takeaways

Compliance with infusions varies widely from state to state, blurring the lines about what licensure is required, who can operate an IV therapy clinic, and who can administer IV therapy. This uncertainty is particularly relevant and concerning for entities seeking 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) all services provided by businesses and individuals; (3) the identity of the business 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 which licenses, if any, the business itself should 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. Additionally, to the extent a buyer determines that a target company has failed to maintain the license it otherwise should have held prior to engaging in the transaction, the buyer should consider including mechanisms to protect itself from any resulting regulatory actions or sanctions. This may include: (i) requiring the seller to provide certain representations and warranties in the purchase agreement; (ii) require Seller to indemnify Buyer from any enforcement action or regulatory penalty; or (iii) obtain representation and warranty insurance to protect Buyer from any financial loss due to breaches of representations and warranties made in a transaction.

Photo: sdécoret, Getty Images

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