What are Some Compliance Standards That IV Therapy Providers Have to Meet?
Intravenous (IV) therapy is one of the newest popular trends in medicine, particularly among the wealthy and celebrities. Common therapies are IV drips of vitamins, which purport to boost the immune system, and low-level painkillers that claim to cure a hangover. Enough people have sought them out that many spas offer IV services, and even specialized IV drip bars have opened in many major American cities.
But the legality of many of these establishments is unclear. IV therapy operates in a gray area between a wellness service and the practice of medicine, and state and federal laws have been slow to clear things up. Only just last year did one state, Alabama, issue a declaratory ruling that classified IV therapy as the practice of medicine that required the input of certified medical professionals. Even that ruling, though, does not touch the compliance standards that IV therapy may have to meet for the Federal Food, Drug, and Cosmetic Act (FD&C Act) with regards to compounding pharmacies.
What is the New Business of IV Therapy?
Medical professionals have long used IVs in the hospital setting to deliver fluids directly into a patient’s vein. Generally, this gives the patient direct access to any of the following substances, as prescribed by a doctor:
IV therapy takes this practice out of the hospital setting and lets patrons choose what substances they get injected into their bloodstream. A couple of the “cocktails” that IV bars offer are:
- 500 ml of a mixture of Vitamin C, Magnesium, B12, B-Complex, Manganese, Zinc,Copper, and Selenium, to boost the metabolism, relieve stress, and increase energy
- 100 ml of Vitamin C, B12, B-Complex, and Magnesium for muscle aches and stress relief
- 500 ml of Vitamin C, B12, B-Complex, Magnesium, Taurine, Glutamine, and Carnitine to boost libido energy
However, it is not uncommon for IV therapy “cocktails” to include prescription drugs like Pepcid, Toradol, or Zofran.
Compliance Issue Number 1: Is This the Practice of Medicine?
For business owners who operate an IV bar or a spa that provides IV therapy, or who are thinking of entering the field, a pressing legal issue is to determine whether the business would operate within the practice of medicine or not. If it does for your jurisdiction, it would trigger numerous laws that must be complied with.
For example, in July, 2022, the Alabama State Board of Medical Examiners issued a declaratory ruling that stated that IV therapy fell within the ambit of the “practice of medicine.” Under state law, this meant that people must have been diagnosed by a medical professional and prescribed IV therapy in order to be lawfully provided the service. The medical professionals who are certified to make such a diagnosis have to be either:
- Licensed physicians, or
- Physician assistants, certified registered nurse practitioners, or nurse-midwifes legally practicing with a physician.
Furthermore, these medical professionals have to take reasonable steps before prescribing IV therapy in order for it to be valid, as is normal for the medical field. Before making the prescription, they have to:
- Perform a good faith exam,
- Create a medical record, and
- Issue a prescription for IV therapy.
While registered nurses could not prescribe IV therapy, they were certified to administer the procedure.
Importantly, though, Alabama is still at the forefront in regulating this novel medical trend. Most other states have not issued compliance guidelines like Alabama’s Board of Medical Examiners has, leaving it up to IV therapy providers to decide what is best for their business and the safety of their customers.
Compliance Issue Number 2: Is This Pharmaceutical Compounding?
Another legal issue that IV therapy providers have to deal with is Section 503A the FD&C Act, which regulates compounding pharmacies. Compounding pharmacies are those that provide customized medications for the unique needs of patients, rather than regular, FDA-approved drugs.
Whether the customized ingredients in IV therapies and “cocktails” amount to a customized medication is unsettled. Whenever prescription drugs are added to the mixture, however, the odds that the result is a “customized medication” increase substantially. Should IV therapy be classified as drug compounding, the legal landscape for IV therapy providers becomes far more difficult as it would trigger numerous federal requirements, such as:
- Compliant manufacturing practices
- Labeling requirements
- Premarket approval for drug compounds
Broadly speaking, compounding pharmacies – including IV therapy providers, if they are so classified – are only exempt from those federal requirements related to the manufacture and sale of drugs if they:
- Do their drug compounding in a licensed facility and by a licensed pharmacist or physician
- Compound drugs pursuant to a valid prescription
- Use bulk drugs that comply with federal requirements
- Comply with other state and federal obligations
Healthcare Compliance and Defense Lawyers at Oberheiden P.C.
As each legal obligation gets imposed, the costs of doing business as an IV therapy provider – as well as the risks associated with offering the service – increase. Spas and IV bars would have to demand a valid prescription from patrons, rather than offering a pre-made cocktail for anyone who walked in. This could decrease revenue and diminish the excitement that the public feels for this new type of business.
Of course, these compliance obligations are done in the public’s interest: Everyone wants to ensure that IV therapy patrons are safe and not unknowingly putting themselves at risk for serious harm that they later regret.
The reality is, though, that the more legal obligations that get imposed on IV therapy providers, bars, and spas, the more complicated and costly it will be to enter and run the business profitably, and the less the public will enjoy it as the costs are passed on to customers.
The healthcare compliance and defense lawyers at Oberheiden P.C. are closely monitoring the developments in this small but very interesting niche of healthcare law. If you need legal guidance for your IV therapy company or are facing a legal threat for its business conduct, contact us online or call our national law office at (888) 680-1745.
Dr. Nick Oberheiden, founder of Oberheiden P.C., focuses his litigation practice on white-collar criminal defense, government investigations, SEC & FCPA enforcement, and commercial litigation.