Mixing Medicine and Risk: Ohio’s Joint Regulatory Statement Targets Retail IV Therapy Clinics

On May 15, 2025, the State Medical Board of Ohio, the Ohio Board of Pharmacy and the Ohio Board of Nursing (collectively, the “Boards”) jointly issued a significant regulatory statement (the “Statement”) clarifying the legal boundaries and compliance expectations for retail IV therapy clinics operating in the state.[i] The Statement responds to the rapid increase of wellness-based IV therapy businesses, and serves as a firm warning to these clinics that retail IV therapy involves the licensed practice of medicine, nursing and pharmacy, and that improper delegation, staffing, protocol-utilization or compounding activities can lead to serious enforcement consequences, including license revocation and criminal sanctions.

This alert provides an overview of the Statement’s key points, practical compliance takeaways for providers and owners and specific regulatory risks that operators should be evaluating considering the Boards’ position.

I. Overview and scope of the regulatory statement

Retail IV therapy clinics offer intravenous administration of fluids, vitamins, amino acids and prescription medications in outpatient, non-emergency settings. Common offerings include “cocktails”[ii] such as amino acids, vitamin C and Vitamin B complex, Myers’ Cocktail, Toradol, famotidine and ondansetron.  The Ohio Board of Pharmacy estimates there are over 200 retail IV therapy clinics currently operating in Ohio.[iii]

The Boards expressed deep concern that many businesses have providers operating outside Ohio’s defined scopes of practice, maintaining clinics without proper licensure, and often functioning without physician, physician assistant (PA) or advanced practice registered nurse (APRN) involvement in the critical steps of diagnosis, compounding and prescribing. The Statement emphasizes that:

• Diagnoses, treatment and prescribing of IV medication may be performed only by physicians, PAs or APRNs with prescriptive authority.
• The preparation or mixing of IV cocktails qualifies as “compounding” under Ohio law and requires a Terminal Distributor of Dangerous Drugs (TDDD) license.[iv]
• Protocol-driven care, whereby nurses or paramedics administer IV cocktails without a direct patient evaluation by a prescriber, is prohibited.
• Unlicensed individuals may not administer IV drugs under any circumstance.

II. Key legal and compliance takeaways

A.  Evaluation, diagnoses and prescribing must be conducted by licensed prescribers

The Statement reiterates that Ohio law reserves the diagnosis and treatment of medical conditions and the prescribing of medications, including IV fluids with additives, to individuals licensed under Ohio Revised Code Chapters 4731 (Physicians), 4730 (PAs) and 4723 (APRNs). It is not within the scope of practice for RNs, LPNs or paramedics to assess symptoms and recommend treatment protocols. Use of standing orders or protocols to bypass a direct prescriber-patient encounter is prohibited under Ohio Administrative Code Rule 4729-3-12. The Boards stress the role of personal evaluation by a physician, PA or APRN, and proper documentation, ordering and drug administration to comply with Ohio law.

B.  Compounded IV therapy is heavily regulated and requires TDDD licensure

The preparation of IV cocktails with more than saline—even when composed of common vitamins —meets the statutory definition of “compounding” and must be conducted in compliance with Ohio’s prescriber compounding rules. Clinics must obtain a TDDD license with the Ohio Board of Pharmacy, comply with sterile compounding standards and designate a responsible person physically present for oversight.

C.  Use of protocols or standing order is extremely limited

The Boards make clear that protocols - sometimes referred to as standing orders - cannot be used to automate or delegate IV therapy decisions in non-emergency, elective settings like retail IV clinics. The only exceptions relate to narrow emergency or public health situations (e.g., vaccine administration, anaphylaxis, vitamin K in newborns), none of which apply to elective wellness infusions.

D.  Delegation to unlicensed or improperly licensed individuals is prohibited

The Statement underscores that IV drug administration cannot be delegated to unlicensed personnel under any circumstance. Additionally, LPNs are not permitted to initiate infusions of IV therapies containing vitamins or electrolytes at retail clinics. RNs may only prepare and administer therapy pursuant to a valid prescription and must operate within defined supervision parameters.

III. Special Topics

A.  Use of telehealth in IV therapy prescribing

While the Boards acknowledge that prescriber-patient relationships may be established via telehealth, the standard of care remains identical to in-person patient encounters. Telehealth providers must verify the patient’s Ohio location, obtain informed consent, perform an evaluation appropriate for the patient and presenting condition, establish or confirm a diagnosis and treatment plan, including necessity of any prescription medication utilized, and complete medical record documentation reflecting the encounter among other requirements noted by the Boards. Where the clinical situation is not appropriate for remote assessment, in-person care or referral is required.

B.  Professional judgment limitations

Though physicians, APRNs and PAs may serve in leadership or medical director roles within retail IV therapy clinics, the business cannot control the clinical judgment of healthcare professionals or interfere with pharmacy compliance obligations., The Responsible Person designee on a TDDD license must also have a sufficient physical presence and meaningful involvement in oversight of the clinic.

IV. Enforcement risks and disciplinary exposure

The Boards signal a clear intent to increase enforcement activity against clinics and licensed professionals failing to comply with the guidance. Violations may result in:

• Personal license sanctions, including probation, suspension or revocation;
• Criminal penalties, particularly for unlicensed drug distribution or compounding; and
• Administrative penalties, including fines, suspension or revocation of the clinic’s TDDD license or denial of pending applications.

Given the heightened scrutiny, legal exposure exists not only for frontline staff but also for medical directors, responsible persons, investors and referring professionals for noncompliant operators.

V. Next steps

Businesses engaged in IV therapy must treat the process as a fully regulated medical and pharmacy service subject to strict licensing, scope-of-practice and compounding controls.

In light of the Statement, owners, operators and licensed healthcare professionals involved in retail IV therapy are encouraged to consider the following compliance measures:

• Conduct end-to-end review of IV therapy workflows;
• Audit prescriber involvement, documentation and telehealth protocols;
• Validate TDDD licensure and compounding compliance;
• Review staff licensure, scope of practice and delegation models;
• Review and update agreements for prescribers, including physician extenders;
• Establish internal policies to ensure compliance with the Boards’ standards.

If your organization operates or partners with a retail IV therapy clinic in Ohio, we recommend a comprehensive compliance review of your practices and procedures. For additional guidance regarding the Statement or compliance issues with the Boards, please contact your Dinsmore health care attorney.