Our healthcare law firm works with many providers and healthcare practices to assist them in complying with federal, state, and local laws. In particular, our clients often ask whether they can offer IV therapy as part of their practice. IV therapy is being offered at med spas, and people are opening IV clinics, so it is important to consider the legal risks of offering IV therapy before opening a med spa or IV clinic. This blog covers two considerations that med spas and IV clinics should consider before offering IV therapy and particularly focuses on non-practitioners (e.g., nurse practitioners or physician assistants) wanting to open an IV clinic in South Carolina. If you need assistance setting up an IV clinic in South Carolina or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.
First Consideration: Non-Practitioners Need to Determine If They Will Add Medications and Vitamins into IV Bags as Part of Their IV Clinic
This first consideration is important because it determines whether the non-practitioner would be engaged in compounding. In South Carolina, it is not compounding to push medications and vitamins through an IV; however, putting medications and vitamins into an IV bag is compounding. If compounding occurs, then the IV clinic would need a Pharmacy Permit, which requires a pharmacist to be on staff at all times. By contrast, if the IV clinic will not be engaged in compounding, the clinic may need to obtain a Non-Dispensing Drug Outlet Permit (discussed below).
Second Consideration: If a Non-Practitioner Owns an IV Therapy Clinic and Stores Legacy Drugs and Devices, then the Clinic Will Need a Non-Dispensing Drug Outlet Permit and a Consultant Pharmacist
If the IV clinic is not 100% owned by a practitioner, and the clinic stores legacy drugs and devices but does not dispense or compound drugs, the clinic must obtain a Non-Dispensing Drug Outlet Permit. The permit also requires the clinic to hire a “Consultant Pharmacist,” and after the consultant pharmacist performs the necessary tasks for the clinic, the clinic will submit an application to the South Carolina Pharmacy Board.
If you want to open a mobile IV clinic, the permit requires that the drugs live overnight at the business address on the permit (i.e., not a residential address or car). Non-practitioners are also required to pick up the drugs each day and return them each night to the permitted business address.
If you need assistance setting up an IV clinic in South Carolina or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.
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