7 Things to Know About IV Hydration Therapy in South Carolina

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Intravenous (IV) hydration therapy is becoming more and more popular in the United States, and South Carolina is no exception. For those unfamiliar with the business model, IV hydration therapy services involve the offering of certain additives to basic IV saline – for example, amino acids, vitamins, minerals, and sometimes prescription drugs like Pepcid, Toradol, and Zofran – typically marketed to potential patients on a walk-in basis. Though gaining increased popularity, there are no specific rules or guidelines in South Carolina governing the retail IV therapy services. Similar to other states that have begun to take notice of this new trend in healthcare delivery ^[1], the South Carolina Boards of Medical Examiners, Pharmacy, and Nursing (the “Boards”) issued a Joint Advisory Opinion to provide some clarity as to the regulation of IV hydration therapy. 

Here are 7 key takeaways from the Joint Advisory Opinion:

1. IV hydration therapy services “unambiguously” constitute the practice of medicine. Consequently, the administration of IV hydration therapy by a person not authorized to diagnose, treat, correct, advise, or prescribe intravenous medication for any disease or other condition constitutes the unauthorized practice of medicine.

In South Carolina, the practice of medicine can only be performed by three categories of individuals: (1) a physician licensed to practice in South Carolina; (2) a physician assistant (PA) with prescriptive authority licensed to practice in South Carolina and practicing pursuant to approved scopes of practice guidelines and with a supervising physician; and (3) an advanced practice Registered Nurse (APRN) licensed to practice in South Carolina who has prescriptive authority and is practicing pursuant to a collaborative practice agreement with a licensed physician.

The Joint Advisory Opinion specifies that when a RN, or other individual who is not an authorized licensed practitioner described above, makes medication recommendations, administers the IV therapy services, assesses treatment and then discharges the patient, they are performing the unlicensed practice of medicine and are jeopardizing patient safety.

2. It’s not enough to have a licensed practitioner “on staff” or “available.” If a physician or another licensed practitioner does not actually evaluate the patient, this is insufficient to establish a valid practitioner-patient relationship, which is required before the administration of prescribed drugs under South Carolina law. Administration of prescribed drugs, like those often included in IV hydration therapy, without having created a physician-patient relationship subjects a practitioner to disciplinary actions. And, when such administration is performed by a RN, the RN is subject to disciplinary action by the South Carolina Board of Medical Examiners for practicing medicine without a license, and by the Board of Nursing for performing acts outside the RN’s scope of practice. 

3. Physician-patient relationships can be established via telemedicine. South Carolina Code § 40-47-37 allows for establishment of a relationship between practitioner and patient via telemedicine, unless an in-person physical exam is necessary for diagnosis, so long as the practitioner adheres to the same standard of care as more traditional in-person care. Note that Schedule II or Schedule III medications may not be prescribed or administered via a telemedicine visit and require an in-person visit with a licensed prescriber. A practitioner must employ technology “sufficient to accurately diagnose and treat the patient in conformity with the applicable standard of care,” according to the Joint Advisory Opinion. 

4. “Standing orders” are also not enough to get around the requirement that a patient be seen by a physician, PA, or APRN. The Joint Advisory Opinion emphasizes that a retail IV therapy business requires an individualized assessment, diagnosis, and treatment of patients by a licensed and qualified practitioner with prescriptive authority in South Carolina. A physician, PA, or APRN must personally evaluate, diagnose, and make treatment recommendations for the patient, and must further create a comprehensive medical record that complies with the applicable standard of care. 

5. Patients cannot “choose” or “select” their IV additives or direct their own care. The Joint Advisory Opinion very plainly states that patients are not licensed to practice medicine, and just like a patient cannot “direct his or her own appendectomy,” a patient cannot select their own IV medications for administration. It is the obligation of the physician, PA, or APRN to exercise independent medical judgment in determining what treatment will actually benefit the patient. It is also important to obtain the informed consent of the patient, which means providing each patient with the necessary medical information including (1) diagnosis, (2) nature and purpose of recommended interventions, (3) burdens, risks, and expected benefits of all options, including forgoing treatment, (4) document the informed consent conversation, or written consent, and (5) documentation of the patient’s decision in the medical record. 

6. Retail IV hydration clinics may implicate multiple areas of the Pharmacy Practice Act. The Joint Advisory Opinion explains that the compounding, dispensing, storage, and administration of what should be sterile products, and individuals providing IV hydration services, may be engaging in the practice of pharmacy as defined by South Carolina Code § 40-43-30. The Board of Pharmacy is “troubled” about the safety of this practice, for example the practice of “compounding” (which includes the combining of two or more drugs) and must result from a valid practitioner’s order in the course of professional practice, “and not from a patient-driven menu akin to a fast-food restaurant.” While it is not entirely clear who has authority to compound these drugs, it is clear that an RN cannot. 

7. The Board of Nursing is concerned with nurses practicing beyond their scope. The Board of Nursing states unequivocally that LPNs cannot participate in retail IV hydration therapy, as this “complex, learned skill” is outside the scope for LPNs. For RNs, the administration of intravenous fluids, nutrient therapies, vitamin infusions, and medications can only be done after obtaining a valid prescription issued by a qualified licensed physician, PA, or APRN. While a RN does not require the on-site presence of a physician, PA, or NP to administer prescribed/ordered IV hydration, the RN must have the requisite knowledge, skill, and competency needed to carry out the administration procedures and monitor the patient in a safe manner.

The foregoing takeaways summarize several of the primary concerns expressed by the Boards in the Joint Advisory Opinion, but certainly not all of them. It is important for anyone interested in the retail IV hydration business model or looking to engage in IV hydration therapy services with these businesses to read the entirety of the Joint Advisory Opinion and educate themselves on the myriad of implicated rules and regulations. The complete opinion is available here: https://llr.sc.gov/med/Policies/Joint-Position-Statement-Retail-IV-Therapy.pdf.

_{[1] For example, the Alabama Board of Medical Examiners issued guidance addressing retail IV therapy in July 2022 (available at https://www.albme.gov/uploads/pdfs/IVTherapy.Declaratory_Ruling_.pdf), as did the North Carolina North Carolina Board of Nursing in September 2022 (available at https://www.ncbon.com/myfiles/downloads/board%20information/laws-rules/position-statements/ps-iv-hydration-clinics.pdf), and the Mississippi State Board of Medical Licensure in September 2023 (available at https://www.msbml.ms.gov/sites/default/files/news/IV%20Hydration%20Therapy%20Guidance%2009-05-23.pdf). Notably, South Carolina’s guidance was a collaborative effort and joint position adopted by three state licensing boards charged with regulatory oversight of a wide array of healthcare providers.}