Infusion Trade Increase Raises Pink Flag from State Regulators

Pharmacy suppliers are more and more shifting into the infusion area – both standing up ambulatory infusion suites (“AIS”) or proving residence infusion supply fashions – regardless of unclear licensure necessities. Whereas this area heats up given the numerous market progress potential, suppliers want to observe regulation developments as completely different states have begun issuing associated steering. And, as suppliers search funding from non-public fairness backers to facilitate their entry into the sector, a complete assessment of federal and state legal guidelines, laws, and steering ought to stay a central focus of the due diligence course of.

Suppliers should monitor various supplier steering 

A current regulatory pattern includes state regulatory our bodies issuing steering associated to medical spas (“med spas”), intravenous (“IV”) hydration, and IV remedy clinics. Infusion pharmacy and residential infusion suppliers can not afford to miss this steering, as a whole lot of these paperwork embody broad language that picks up among the extra conventional well being care fashions similar to infusion.

For instance, the AIS mannequin includes a specialty pharmacy compounding and delivering infusion medication – prescribed by the affected person’s practitioner – to be administered by a registered nurse for power medical situations. The registered nurse will then correctly safe the medication to make sure their security and integrity till the affected person arrives on the AIS, with supply and administration usually occurring the identical day with no in a single day storage.

Though this AIS mannequin is often not addressed within the numerous steering paperwork that regulating businesses have been issuing, infusion suppliers must be cognizant of their existence — along with tendencies in areas of concern and enforcement — with the intention to guarantee alignment with any steering which will pertain to their enterprise mannequin.

As we proceed to observe state developments, we’ve got seen a handful of states subject steering paperwork that illustrate how regulators are viewing the IV hydration and IV remedy companies, which infusion suppliers ought to contemplate as a part of their total compliance monitoring efforts.

Evolving state steering at a look 

Rhode Island

• A July 2024 steering doc issued by the Rhode Island Division of Well being (“RIDOH”) focuses on the proliferation of med spas and IV remedy companies, which broadly encompasses these entities that present sufferers with IV fluids with or with out drugs, nutritional vitamins, minerals and/or amino acids. This will embody the supply and administration of prescribed drugs as within the infusion remedy mannequin.
• The RIDOH references that these companies are sometimes handled as spa therapies moderately than medical procedures, although they intersect the specialties of drugs, nursing, and pharmacy.
• The steering additionally makes clear that, relying upon the underlying possession construction, the scope of companies provided, and the skilled licensure (if any) held by the homeowners of the enterprise, these IV remedy suppliers, and by extension infusion remedy suppliers, might require licensure with the RIDOH, together with as organized ambulatory care amenities (“OACFs”).
• Licensure as an OACF requires prior assessment by the Rhode Island Well being Providers Council, a thirty-day public remark interval, and approval by the licensing company.

Kentucky

• Equally, the Kentucky Boards of Medical Licensure, Nursing and Pharmacy issued a joint assertion, which is directed on the retail IV remedy enterprise mannequin and never, particularly, infusion.
• In contrast to Rhode Island, nevertheless, the Kentucky steering doesn’t determine a particular facility licensure requirement for IV remedy enterprise areas. As a substitute, the useful resource discusses what’s throughout the scope of follow of particular person licensed well being care professionals which will present companies on behalf of such companies and that the follow of making IV therapies might in reality represent compounding and the follow of pharmacy.
• The infusion trade may be distinguished from the mannequin outlined within the Kentucky steering which addresses practitioners compounding within the IV remedy clinics. In contrast to compounding on-site, the infusion trade makes use of pharmacists in a licensed pharmacy setting to compound the medication for additional administration within the AIS.

Ohio

• In Could 2025, the Ohio Boards of Medication, Pharmacy and Nursing issued a joint regulatory assertion pertaining to retail IV remedy clinics.
• As with the opposite states, this steering makes comparable statements that working a retail IV remedy clinic might contain the follow of drugs, nursing, and pharmacy, all of which require a license and adherence to a scope of follow beneath state legislation.
• Just like Kentucky, a lot of the Ohio steering addresses what constitutes compounding. Nevertheless, Ohio additionally features a reference within the steering that’s significantly related to the AIS mannequin. Storing compounded medication on-site for any time period (e.g., the day of an infusion appointment) would require licensure with the Ohio Board of Pharmacy as a terminal distributor of harmful medication.
• Additionally in step with different states, Ohio’s steering makes clear that standing orders are usually not permitted for the advice, compounding, and administration of IV drugs beneath state legislation.

Wisconsin

• On October 22, 2025, numerous skilled boards throughout the Wisconsin Division of Security and Skilled Providers launched a joint advisory opinion concerning IV hydration remedy companies, making Wisconsin the newest state to subject steering referring to the infusion trade.
• Whereas Wisconsin’s steering doesn’t reference any required facility licensure, it does notice that “IV hydration remedy fluids and components are prescribed drugs requiring buy and storage by a certified practitioner which can embody a doctor, PA [physician assistant], or APNP [advanced practice nurse prescriber].”
• Wisconsin does, nevertheless, acknowledge {that a} registered nurse with applicable coaching and expertise might administer the remedy.

Conclusion and takeaways

State-by-state infusion compliance varies considerably, blurring the traces as to what licensure is required, who can function an IV remedy clinic, and who can administer IV remedy in any respect. This uncertainty is especially related and regarding for these entities trying to enter the infusion trade by opening a brand new enterprise or buying an present enterprise. When contemplating buying and assuming the operation of an infusion enterprise, it’s important that the client perceive: (1) the jurisdictions wherein the enterprise is positioned; (2) the total scope of companies offered by the enterprise and people; (3) the id of the enterprise’s homeowners; and (4) any skilled licenses held by such homeowners. Acquiring this data in the course of the due diligence section will enable the client to successfully decide what, if any, licenses the enterprise itself is required to keep up.

Finishing and submitting preliminary license or change of possession functions can have vital impacts on the construction of a transaction and the timelines related to closing. Furthermore, to the extent a purchaser determines {that a} goal enterprise failed to keep up licensure that it in any other case ought to have held previous to participating within the transaction, the client ought to contemplate together with mechanisms to guard itself from any ensuing regulatory enforcement motion or sanction. This will embody: (i) requiring the vendor to supply sure representations and warranties within the buy settlement; (ii) obligating the vendor to indemnify purchaser from any such enforcement motion or regulatory penalties; or (iii) acquiring illustration and guarantee insurance coverage to guard purchaser from any monetary losses as a consequence of breaches of representations and warranties made in a transaction.

Picture: sdecoret, Getty Pictures

This put up seems via the MedCity Influencers program. Anybody can publish their perspective on enterprise and innovation in healthcare on MedCity Information via MedCity Influencers. Click on right here to learn the way.