Little Health Law Blog

Our healthcare law firm works with many providers who prescribe medications, including medications for use that is considered “off label” by the Food and Drug Administration (“FDA”).  One such off-label use is administering ketamine to patients for treatment-resistant depression. On August 13, 2025, our firm posted a blog titled “Three Considerations When Administering Ketamine to Patients.” We have recently encountered other issues related to ketamine, including whether other providers, such as nurses, can administer ketamine. Ketamine, and the recently FDA-approved Spravato®, which has esketamine as its active ingredient, has garnered popularity as a potential treatment for treatment-resistant depression, but it has come under scrutiny in recent years. This blog covers three considerations that providers should consider before administering ketamine or Spravato® to patients. If you need assistance setting up a practice to administer ketamine or Spravato® 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: Ketamine and Spravato® Are Controlled Substances That Are Subject to DEA Regulations

Ketamine and Spravato® are Schedule III controlled substances that are subject to controlled substance laws and regulations under the Drug Enforcement Administration (“DEA”). Providers who administer ketamine or Spravato® should have a DEA registration and may need a DEA registration for their facility if they are administering and storing Continue reading ›

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 Continue reading ›

Our healthcare and business law firm works with many providers who work with compounded medications.  Our firm previously posted Two Considerations When Prescribing Compounded Weight Loss Drugs on July 14, 2025, which gives an overview of several considerations that providers should consider before prescribing compounded weight loss drugs as part of their practice. We have recently encountered other issues related to compounded weight loss drugs, including prescribers offering compounded glucagon-like peptide-1 (“GLP-1”) drugs with ingredients such as retatrutide and cagrilintide, that have created separate legal risks regarding compounded weight loss drugs. If you are interested in prescribing compounded weight loss drugs as part of your practice or would like to discuss this blog post, you may contact our healthcare and business 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.

Background

Retatrutide is a GLP-1 peptide that has shown promise in clinical trials as a weight loss drug, but the Food and Drug Administration (“FDA”) has not approved retatrutide for any nonexperimental use in humans. Cagrilintide is different from a GLP-1 drug and has also shown promise as a weight loss drug along with semaglutide, the active ingredient in popular weight loss drugs like Ozempic® and Wegovy®, and Novo Nordisk, the maker of Ozempic®,  has a clinical trial to determine if cagrilintide can be an effective weight loss drug standing alone.

First Consideration: The FDA Prohibits Providers from Compounding Retatrutide and Cagrilintide

The FDA has recently issued guidance expressing the agency’s concerns about providers prescribing unapproved GLP-1 drugs for weight loss. In this guidance, the FDA explicitly stated that retatrutide and cagrilintide cannot be used in Continue reading ›

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 laser therapy as part of their practice. Laser therapy is being offered at med spas as cosmetic procedures and carries legal risks.

Our previous blog post discussed non-ablative, cosmetic lasers, while this blog post discusses ablative cosmetic lasers. If you need assistance setting up a practice to provide ablative laser 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: Providing Ablative Cosmetic Lasers Constitute the Practice of Medicine

Unlike non-ablative cosmetic lasers, which do not damage the skin’s epidermis layer, ablative cosmetic lasers, such as carbon dioxide and erbium lasers, typically involve damage to or removing the epidermis. As a result, providing ablative cosmetic lasers fall under general rules for practicing medicine. The Georgia Medical Board has more restrictions on ablative cosmetic lasers than on non-ablative cosmetic lasers, such that, for example, a senior laser practitioner entered into a Consent Order for operating without a license when the practitioner used CO2 ablative lasers because using CO2 ablative lasers “is the practice of medicine.”

Second Consideration: Practitioners Should Consider Their Scope-of-Practice Rules Before Providing Ablative Cosmetic Lasers

Because providing ablative cosmetic lasers falls under the practice of medicine, practitioners need to consider whether Continue reading ›

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 laser therapy as part of their practice. Laser therapy is being offered at med spas as cosmetic procedures and carries legal risks.

Laser therapy is generally divided into two categories: (1) Non-ablative, cosmetic lasers and (2) ablative cosmetic lasers. Non-ablative lasers penetrate skin layers below the epidermis layer to stimulate healing properties, like collagen production, without damaging the skin’s epidermis layer. By contrast, ablative lasers typically involve damage to or removing the epidermis, or “vaporizes tissue,” as the Georgia Composite Medical Board puts it.

In Georgia, for example, the Medical Board has Cosmetic Laser Rules that generally govern non-ablative lasers, while ablative cosmetic lasers fall under general rules for practicing medicine. This blog addresses non-ablative laser therapy. This blog covers two considerations that med spas should consider before offering non-ablative laser therapy. If you need assistance setting up a med spa to provide non-ablative laser 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: Certain Licensed Professionals May Require a Laser Practitioner License to Provide Non-Ablative Laser Therapy Continue reading ›

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 Continue reading ›

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 med spa clients often ask to consider whether they can offer stem cell or exosome therapies as part of their practice. Stem cell and exosome therapies are popular treatment items for med spas, but offering these therapies also carries legal risk and compliance issues. This blog covers two considerations that med spas should consider before offering stem cell and exosome treatments to patients for therapeutic purposes. If you need assistance setting up a med spa to offer stem cell and exosome treatments 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.

Background

Stem cells and exosomes are biological products that can be marketed and sold only if a business has a valid biologics license application (BLA) or, if in the development stage, such a product can be distributed for clinical use in humans if the sponsor has an Investigation New Drug (IND) designation. If a sponsor has an IND and wishes to work with another entity to investigate by conducting research, that researching entity Continue reading ›

We previously wrote about concierge medical practices in 2022 but wanted to write an updated post because our clients have had renewed interest in starting concierge medical practices. Concierge medical practices are a subscription-based model where patients pay a membership fee to receive a menu of healthcare services. Concierge medical practices can provide healthcare services under several business models, including providing only non-medical services that are self-pay or providing both non-medical services that are self-pay and medical services that are billed to insurance and Medicare.

Before starting a concierge practice, it is important to be aware of the legal pitfalls that can come with starting a concierge medical practice. This blog covers two considerations that providers should consider before starting a concierge medical practice. If you need assistance setting up a concierge medical practice 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: It Is Important to State Clearly the Type of Services Your Practice Provides Under Its Membership Fee to Avoid Double-Billing.

A concierge medical practice’s membership contract is a crucial document for the practice. The membership contract outlines the services your concierge medical practice will provide, the membership fees that the patient will pay, and what services are covered under Continue reading ›