In 2024, the Wisconsin Department of Safety and Professional Services (DSPS) formed an interdisciplinary advisory committee (Committee) consisting of the Wisconsin Medical Examining Board, Pharmacy Examining Board, Board of Nursing, Physician Assistant Affiliated Credentialing Board, Cosmetology Examining Board and Controlled Substances Board to discuss issues of mutual concern.    

Thus far, the Committee has focused on IV Hydration therapy. During its first four meetings, the Committee reviewed the regulatory landscape in seven other states related to IV hydration as well as FDA guidance on sterile drug compounding. During its most recent meeting on June 25, 2025, the Committee approved a draft joint advisory opinion regarding IV hydration practices (Draft Opinion).[1] The Draft Opinion will now be sent to each of the participating Boards for approval or comments. The Committee expects to conduct a final review of the Draft Opinion during its next meeting on August 27, 2025.

The Draft Opinion is based upon existing Wisconsin laws and details the relevant laws and standard of care implicated by IV hydration therapy business in the retail setting. The Draft Opinion is intended to provide guidance regarding compliance applicable to IV Hydration businesses at three main stages: (1) assessment, (2) compounding, and (3) administration. In addition, the Draft Opinion confirms that IV hydration is the practice of medicine. The Draft Opinion highlights areas of concern and focus for regulators in Wisconsin. 

IV Hydration = Practice of Medicine 

The Draft Opinion confirms that the services offered by IV Hydration therapy businesses constitutes the practice of medicine under Wisconsin law. The Committee notes it is concerned that basic health screening and selection of IVs is being performed by unlicensed individuals or otherwise outside of the scope of practice. Specifically, the Committee believes in some instances a registered nurse (RN) may be the only licensed health care professional interacting with a patient receiving IV hydration services. The Draft Opinion makes clear that a registered nurse (RN) (or any individual not holding the proper credential) undertaking the diagnosis or prescription of medications is beyond a RN’s scope of practice and can result in disciplinary action against the RN’s license as well as the physician, physician assistant (PA), or advanced practice nurse prescriber (APNP) overseeing the practice. 

Assessment

A patient must be assessed prior to ordering any IV hydration therapy. In Wisconsin, the only licensed practitioners that may order treatment are physicians, PAs, and APNPs. Though the assessment may be performed via telehealth, the Committee’s recommendation is that initial patient assessments be performed in-person. 

Regardless of the setting, an assessment must include a history and physical exam. An assessment consisting merely of a simple questionnaire without an appropriate clinical assessment does not meet the standard of care and is considered unprofessional conduct. 

As part of the assessment, the practitioner may make a diagnosis and provide recommendations. Treatment recommendations must include a discussion with the patient of risks, benefits, and alternative options, and this discussion must occur directly between the practitioner and the patient.

The use of standing orders outside of an established practitioner-patient relationship for an individualized assessment, diagnosis, and treatment of patients may be considered unprofessional conduct and inconsistent with the standard of minimal competence.

As part of the assessment prior to ordering any IV hydration therapy, a comprehensive medical record must be created and informed consent shall be obtained from the patient.

Compounding

After the assessment, a cocktail containing the additives ordered may need to be prepared. This act of adding medications, vitamins, minerals and/or amino acids to IV bags is the practice of compounding and subject to federal and state law. Only licensed pharmacists or physicians may compound. 

The United States Pharmacopeia (USP) is the recognized publication that contains standardized requirements for compounding, including sterile compounding found in USP <797> and has been adopted at the federal and state level as the enforceable standard. The utilization of the “immediate use” provision of USP <797> does not circumvent USP sterile compounding requirements. The Draft Order describes certain conditions that must be met under the “immediate use” provision and notes that the provision should not be used as a workaround for the standards governing sterile product preparation. 

Administration

Upon receipt from a licensed practitioner, IVs may be administered by RNs or LPNs with appropriate training and experience. During the IV administration, an RN must perform a nursing assessment of the patient, including monitoring vital signs. The RN must document all nursing acts. The Draft Opinion also notes that the performance of a nursing assessment is outside of the scope of an LPN. 

Next Steps

Any practice or organization that provides IV hydration services should review the Draft Opinion with legal counsel to ensure your practices align with the Draft Opinion. Businesses that provide IV Hydration therapy should review their internal policies and procedures and patient documents to ensure compliance with the rules and standards emphasized in the Draft Opinion in advance of its formal adoption later this summer. 

For additional information or to schedule a compliance check-in, please contact Katelyn Pellitteri - Michael Best & Friedrich LLP, Adam Witkov - Michael Best & Friedrich LLP, or your contact within the Michael Best healthcare team.

*Special thanks to Thomas Brinkman (Marquette Law) for contributing to this article. 
 

[1]The Draft Opinion is located on pages 30-35 of the Interdisciplinary Advisory Committee Meeting Agenda: https://dsps.wi.gov/Documents/BoardCouncils/IAC/20250625IACOpenSession.pdf