Little Health Law Blog

Our healthcare and business law firm represents healthcare practitioners, including physicians, advance practice registered nurses, and physician assistants, with licensing and credentialing matters.  One occurrence we see often is a practitioner who signed DEA Form 104 to “voluntarily” surrendered their DEA registration and is now dealing with unexpected consequences of that decision.  Often, the surrender is obtained by a DEA agent during a time of severe duress of the provider-registrant.  We strongly recommend discussing with healthcare counsel before surrendering a license or registration.  Because of the amount of credentialing and licenses medical providers have, surrendering any sort of license or registration typically creates a snowball effect into numerous areas of the provider’s practice.  This post discusses specific credentialing impacts that may apply to a provider after the surrender of a DEA registration.  If you would like to discuss your options before voluntarily surrendering a license or registration or ideas to mitigate negative effects after voluntarily surrendering a license or registration, 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.

Following the surrender of a DEA license, the registrant should immediately do two things: Continue reading ›

Our healthcare and business law firm works with many providers who work with compounded medications.  As glucagon-like peptide-1 receptor agonists (“GLP-1s”) continue to be prescribed by providers, including FDA-approved commercial versions and compounded versions, we routinely are asked for guidance by providers around prescribing compounded drugs.  This blog identifies three categories of topics that are relevant to prescribing compounded GLP-1s. If you would like to discuss ways to protect your practice in prescribing GLP-1s 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.

1. FDA Requirements:

In sum, unless a drug is on the shortage list, compounding a drug is appropriate only for when a patient requires a modification to the commercial (FDA-approved) drug (such as, due to an allergy or need for some additional/replacement ingredient).  The FDA has a lot of concerns with GLP-1 drugs and has created a “green list” of importers based on its evaluation of sites, so a practice should work with compounding pharmacy that only import active pharmaceutical ingredients from importers on the green list.

There are many weight loss drugs that are currently in the FDA-approval process.  However, the drugs are 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. Our prior blog post discussed several considerations that med spas and IV clinics should consider before offering IV therapy in South Carolina as non-practitioners (e.g., nurse practitioners or physician assistants). This blog post discusses two considerations that practitioners (e.g., physicians) should consider before opening 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: Practitioners May Not Need a Non-Dispensing Drug Outlet Permit if the Medical Practice Does Not Compound, and the Practitioner Owns the Practice 100%

As discussed in the prior blog post, whether a practitioner or non-practitioner engages in compounding is an important consideration. In South Carolina, it is not compounding to push medications and vitamins through an IV; however, putting Continue reading ›

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 ›