South Carolina Boards of Medical Examiners, Nursing and Pharmacy Issue Joint Advisory Opinion on Retail IV Therapy Businesses

By Meghan Riordan and Sara Sykes

The IV therapy business is booming across South Carolina—on every corner there seems to be a new IV/hydration/wellness storefront or mobile clinic advertising hangover cures and wellness improvement. But, not all IV therapy businesses are created equal, and South Carolina licensing boards have started paying attention.

Citing the “proliferation” of IV therapy businesses, the lack of industry guidance or laws, and the “potential harm” to South Carolinians, the Board of Medical Examiners, Board of Nursing, and Board of Pharmacy recently issued a Joint Advisory Opinion on “retail” IV therapy, which can be found here (https://llr.sc.gov/med/Policies/Joint-Position-Statement-Retail-IV-Therapy.pdf). There are several main takeaways that current and prospective IV therapy businesses should take into account:

First, the Advisory Opinion makes clear that operating an IV therapy business IS the practice of medicine. In South Carolina, only certain providers are authorized to prescribe intravenous medication, including IV “cocktails” that simply contain saline and/or vitamins (“Authorized Providers”). Authorized Providers are limited to:

• South Carolina licensed physicians;
• South Carolina licensed physician assistants (practicing under an approved scope of practice); and
• South Carolina licensed nurse practitioners, clinical nurse specialists, or certified nurse midwives (practicing under a collaboration agreement with a licensed physician).

Second, Licensed Practical Nurses (LPNs) and EMTs or paramedics may not participate in retail IV hydration and vitamin infusion therapy. However, registered nurses (RNs) may administer retail IV hydration and vitamin infusion therapy provided it has been validly prescribed by an Authorized Provider. Notably, an RN does not need an Authorized Provider to be physically onsite when retail IV hydration and vitamin infusion therapy is administered.

Third, in order for an Authorized Provider to validly prescribe retail IV hydration and vitamin infusion therapy, the following conditions must be met:

• The Authorized Provider must establish a practitioner-patient relationship through an evaluation. This evaluation may be done by telemedicine. However, Schedule II or Schedule III medications (narcotic or non-narcotic) may not be prescribed or administered solely via a telemedicine visit and require an in-person visit by an Authorized Provider.
• The Authorized Provider must create a medical record.
• The Authorized Provider must follow the standard of care for diagnosing and treating medical conditions.
• The Authorized Provider must arrange for any follow-up care that may be needed.

Fourth, the Advisory Opinion specifically highlights the need for any IV therapy business to obtain a Board of Pharmacy permit if it stores and/or administers any legend medications, including those administered at IV hydration clinics. Medications can only be stored at the permitted site. Storage in a home or vehicle is prohibited. However, no pharmacy permit is required if an entity is 100% owned by an Authorized Provider. Non-practitioners, including but not limited to RNs, EMTs, and LPNs, may not possess and/or store legend medications of any type without a suitable permit for the respective facility (e.g., non-drug dispensing outlet permit).

Finally, the Advisory Opinion expressly provides that failure to abide by these rules and regulations is the unauthorized practice of medicine and a violation of South Carolina law. Violations could result in disciplinary actions and sanctions, such as a restricted or revoked licenses, prison time, and/or monetary fines.

Now that the Board of Medical Examiners, Board of Nursing, and Board of Pharmacy have issued a clear opinion regarding IV therapy businesses, it is important for current and prospective business owners to examine their business structures to make sure their practices are in line with the applicable requirements.

Please contact Meghan Riordan or Sara Sykes with HSB’s Healthcare Practice Team should you have questions about this topic.

Meghan Riordan (https://www.hsblawfirm.com/Attorneys/Meghan-G-Riordan) is a shareholder in Haynsworth Sinkler Boyd’s Greenville office. Meghan’s practice focuses on advising hospitals, physicians and physicians’ groups, nursing and long term care facilities and other healthcare providers on a wide range of matters, including HIPAA, Medicare and Medicaid, and fraud and abuse. She also assists clients with general healthcare-related business and operational issues including drafting organizational documents, employment and service contracts, and provider policies.

Sara Sykes (https://www.hsblawfirm.com/Attorneys/Sara-A-Sykes) is a litigation associate in Haynsworth Sinkler Boyd’s Greenville office, and she assists our commercial, construction and healthcare clients. With respect to the healthcare side of her practice, Sara devotes time to helping practitioners in matters such as practice formation and FDA regulation.

Haynsworth Sinkler Boyd (https://www.hsblawfirm.com/) provides business, litigation and financial legal services to local, national and international clients. The firm has offices in Charleston, Columbia, Florence and Greenville, South Carolina and Raleigh, North Carolina.