Medical Spa Laws and Regulations
Medical spas, aka med spas, aka medispas, offer a variety of cosmetic services and are more popular then ever. Minnesota does not have any laws that specifically address medical spas, but that does not mean that the procedures and treatments are unregulated. There are laws and regulations that govern the individual procedures and the professionals who administer them. Additionally, these laws must be followed to operate as a medical spa and to provide quality care to clients. Holt Law offers a variety of services to assist in the process of opening a medical spa, or healthcare clinic, and to remain in compliance once open. Click Here to view the details of services and flat fee packages.
Who can prescribe medications in Minnesota?
Practitioners who can prescribe include:
- Doctors of medicine (MDs),
- Licensed doctors of osteopathic medicine duly licensed to practice medicine (DOs),
- Licensed doctors of dentistry,
- Licensed doctors of optometry,
- Licensed podiatrists,
- Licensed veterinarians,
- Licensed advanced practice registered nurses (APRNs), and
- Licensed physician assistants (PAs).
(Minn. Stat. §151.01, Subd. 23; Minn. Stat. §151.37, Subd. 2)
What is considered a drug?
A drug is:
- all medicinal substances and preparations recognized by the United States Pharmacopoeia and National Formulary, or any revision thereof;
- biological products, other than blood or blood components;
- all substances and preparations intended for external and internal use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals;
- all substances and preparations, other than food, intended to affect the structure or any function of the bodies of humans or other animals;
- any compound, substance, or derivative that is not approved for human consumption by the United States Food and Drug Administration or specifically permitted for human consumption under Minnesota law, and, when introduced into the body, induces an effect similar to that of a Schedule I or Schedule II controlled substance, regardless of whether the substance is marketed for the purpose of human consumption. (Schedule I drugs have no known medical value and a great potential for abuse. Some Schedule II drugs may have some medical value but they still possess a great potential for abuse.)
(Minn. Stat. §151.01, Subd. 5)
What is Botox?
Botulinum toxin, or botulinum neurotoxin is a protein that prevents neurotransmitters from releasing acetylcholine at the neurotransmitter level. Acetylcholine triggers motor neurons and impacts voluntary movements. When botulinum neurotoxins are injected into the muscles under facial wrinkles and fine lines, it causes the muscles to paralyze, weaken, or relax. The result of the relaxation of the muscle is that the skin smooths out over the muscle and lessens the appearance of wrinkles and fine lines. Botox is a brand name of a botulinum toxin and there are several other brand name products that can be used for the same effects.
What are fillers?
Dermal fillers are also injected under the skin, but are generally used to create a fuller appearance or to smooth out deeper wrinkles. The filler is a gel-like substance and the ingredients in filler products are broken down over time and absorbed, because most of them are made from substances that are already present in our bodies. One filler is made from a synthetic material, Poly-L-lactic acid, but it is biocompatible and biodegradable and is sold under the brand name, Sculptra. Poly-L-lactic acid stimulates collagen production and eventually is broken down into water and carbon dioxide. Since fillers are broken down and absorbed by our bodies, they need to be readministered to maintain the same effect and appearance.
Bellafill, formally Artefill, is a polymethyl-methacrylate (PMMA) filler in 80% bovine collagen and is the only semi-permanent filler on the market. PMMA cannot be broken down by the body because the PMMA substance is a form of acrylic. Bellafill is FDA approved and is considered safe as PMMA has a long history of being used in surgical implants. One of the drawbacks of Bellafill is that the process can take several injection sessions to achieve the desired volume. Additionally, the injector must be highly skilled and experienced in administering this type of filler as it requires a different technique than other dermal fillers.
What is Kybella?
Kybella injections are used to decrease the appearance of under chin fat or a double chin. The medication is made with synthetic deoxycholic acid, a bile acid that is naturally in our bodies. The deoxycholic acid breaks down and absorbs fat so when injected under the chin, the acid dissolves the cell membrane and kills the fat cells, which are then metabolized and excreted from the body over the course of several weeks following the treatment.
How do Prescriptions work at a Medical Spa?
The products that are considered drugs at a medical spa include:
- Any of the botulinum neurotoxin products, Botox, Dysport, Xeomin, Jeauveau, etc.; and
- Kybella.
These drugs need to be prescribed in the same manner as other prescription drugs, by a licensed practitioner who has the ability to prescribe. These prescription drugs can be either prescribed for a specific patient, such as the case when it is used to treat a medical condition, or through a “prescription by protocol,” otherwise known as a standing order prescription.
A standing order prescription is ordered, by a licensed practitioner who can prescribe, for a patient class with a certain criterion and specifies the circumstances under which the prescription can be prescribed and administered. The prescription then does not necessarily have to be administered by the actual prescriber, but ultimately, the prescriber is liable for its administration to be done in a responsible and appropriate manner. Generally, clinics will create a clinic policy for Botox injections with protocols and then injectors follow the policy. Policies should include who is in the patient class, who is not in the patient class, how the medication must be administered, and conditions for which the medication should not be administered. (Minn. Stat. §148.235, Subd. 8)
Dermal Fillers are not a prescription, but they are regulated by the FDA and are considered to be in the same category as medical devices. (See fda.gov.) Currently there are no laws regulating who can purchase dermal fillers, but companies that sell name brand dermal fillers will not sell their products to anyone other than licensed medical professionals—MDs, DOs, PAs, NPs, and APRNs. (See allerganaesthetics.com.) Only “off brand” or black market fillers, many times from countries other than the U.S., will sell to unlicensed individuals.
Who can inject at a medispa?
MDs, DOs, physician assistants (PA), nurse practitioners (NP), advanced practice registered nurses (APRN) — they all can inject. Some clinics allow registered nurses to inject, and other clinics prefer to take a more conservative approach and only allow RNs to inject while under the very close supervision of an MD, DO, PA, NP, or APRN.
Supervision also differs from provider to provider. Some require that the supervisor meet with the client for a consult before any services are provided by the injector who then works under the supervisor for all decisions related to client care. Others may just oversee as a medical director and are able to be contacted if needed, as this is the least amount of supervision that is required.
What is IV Vitamin or Hydration Therapy?
IV vitamin and/or hydration therapy is a treatment to help rehydrate a person and to deliver vitamins, minerals supplements, and antioxidants intravenously. The options of what can be mixed in the saline solution IV bag are numerous, but generally include things like, vitamin A, vitamin C, B complex vitamins, amino acids, glutathione, taurine, magnesium, nicotinamide adenine dinucleotide, lipostat plus, zinc, iron, exosomes, or even stem cells.
Who can administer an IV?
In the state of Minnesota, an MD, DO, PA, NP, APRN, RN, or LPN can all establish an intravenous line and administer intravenous fluids. Some clinics interpret Minnesota law to include licensed paramedics, under a medical director, in the list of those who can administer an IV, but a more conservative reading of the law would disallow it. (Minn. Stat. §144E.28 and §144E.001) Prescriptions are not required for saline bags and there are many medical supply companies to order them from. It is always recommended to research the medical supply company before purchasing to ensure you will be receiving a quality product that has not expired.
What about the vitamins and supplements for the infusion therapy?
Vitamins, minerals, and supplements are not considered drugs and are in the category of food since their intention is to supplement our diets. Because of this, supplements are not FDA regulated unless there is a serious adverse event related to the product. (See fda.gov.)
The clinic’s medical director should be involved in the process of deciding the dosage for each individual client. Many factors need to be considered including, the solubility of the vitamin, the age and health of the client, the dosage, if vitamins or supplements counteract each other, and what the client’s desired outcome is. The mixing of supplements in IV saline bags should only be done under the most sterile of environments and by trained medical professionals. Dangers associated with compounding under uncleanly conditions include fungal infections, staph infections, and sepsis. For these reasons, some clinics prefer to order premixed supplement IV bags from a 503B compounding pharmacy.
Lasers
Lasers can be an effective form of treatment for many issues while being minimally invasive. The cosmetic uses for them include, to decrease fine lines and wrinkles, hair removal, tattoo removal, skin tightening, to remove skin tags and warts, to lighten areas of pigmentation, to decrease rosacea, to smooth acne scars, to treat active acne, and to decrease vascular lesions. Different types of lasers can be used to target different issues and achieve the desired effect.
Who can use lasers?
Under Minnesota law, the use of lasers is in the same category as surgery. This means that it is considered “practicing medicine” to administer treatment with a laser, regardless of how noninvasive the procedure may be. To use a laser as a part of a cosmetic treatment, the practitioner must be an MD, DO, PA, NP, or APRN, and the statute does not allow for delegation of the use of lasers with supervision of a medical director. (Minn. Stat. §147.081) The only exception to this, and it would require an individual analysis of different types of lasers, is for advanced practice estheticians (APE). Under Minnesota law, APEs are allowed to use mechanical or electrical tools, apparatuses, or appliances, that are used on the epidermal layer of the skin. (Minn. Stat. §155A.23)
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