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. If you need assistance setting up a med spa or IV clinic to offer IV therapy 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: Providers Need to Consider State Scope of Practice Laws Before Offering IV Therapy
Because IV therapy has grown in popularity recently, state medical and nursing boards have scrutinized the scope of practice of licensed providers to prescribe and administer IV fluids. In Georgia, for example, the Board of Nursing has issued a position statement stating that practices cannot issue standing orders for IV therapy. Instead, a physician, nurse practitioner (NP), or physician assistant (PA) must perform a good-faith exam of a patient and prescribe or order IV therapy based on the patient’s history and physical. In the same statement, the Board says registered nurses (RNs) cannot prescribe IV fluids but can administer IVs “if there is a valid order/prescription and a completed history and physical performed by the physician, NP, or PA[,]” and they “have the documented knowledge, skill, and competency necessary” to administer IV therapy.
Second Consideration: Providers Also Need to Consider Compounding Laws and Regulations If They Add Anything to Bags of IV Fluids
Providers may want to create their own mixtures or solutions as part of their IV therapy treatment. If providers do this, they will need to consider state compounding laws. In Georgia, the Georgia Board of Pharmacy has regulations governing compounding. “Compounding” is defined as the “preparation, mixing, assembling, packaging, or labeling of a drug or device as the result of a practitioner’s prescription drug order . . . based on the relationship between the practitioner [and] patient . . . in the course of professional practice . . . .” “Compounding,” however, does not include “mixing, reconstituting, or similar acts that are performed in accordance with the directions contained in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with that labeling.”
Practitioners such as physicians can compound, but RNs, NPs, or PAs cannot compound drugs. If providers plan to mix vitamins and nutrients in IV bags, this would be considered compounding. By contrast, if you purchase pre-compounded mixtures and add them directly to an IV bag according to the compounder’s directions, this would not be considered compounding.
If you need assistance setting up a med spa or IV clinic that offers IV therapy, have questions about whether your practice is compliant with the various laws and regulations surrounding IV therapy, 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.