IV Providers Need to Plug Into Compliance

One of the fastest growing industries in health care is IV hydration. The low cost of entering the space, together with a skill set that can be attained rapidly and inexpensively are two of the reasons. But providers have to be very careful not to confuse the ease of entering the space with the regulatory risks. They are two very different things! One is easy; the other isn’t.

The biggest warning sign of “risk ignorance” is how IV hydration providers describe what they do. Here are the three biggest “tells”:

1. “It’s just vitamins."

2. “It’s super low risk, and the FDA doesn’t really focus on this."

3. “IV infusion will absolutely cure/fix _________________.”

Many IV hydration providers are businesspeople with no clinical qualifications. They may assume that no state or federal professional licensing body will focus on what they do with their business. But that’s simply not true. The state licensing authorities of every professional working in their business are focused on the behavior of that professional. And (described below) several state and federal authorities have already shown very active interest in the IV hydration industry. For these reasons, there is no basis for the assumption that no license equals no risk.

Physicians and medical practices who have added IV hydration therapy to their practices might also be surprised about the level of state and federal scrutiny. Thinking that the space is somehow more relaxed than what they do every day is a mistake. And while drugs can be compounded by licensed physicians, doing it in office is restricted to a patient who presents with an immediate need for the product or because “it would not be safe for the patient to take the drug home for self-administration, and it would be more convenient for the physician to have the drug in his or her office to administer immediately upon diagnosis, rather than asking the physician to order the drug and have the patient return to the health care practitioner for administration.”

The truth is that IV hydration is full of legal risks. And the key reason is that it involves dependence on compounded pharmaceutical items. IV hydration providers need to take note of things like:

1. The FDA’s job is principally to protect the public by ensuring that products we use are clean and effective.

2. Products used by the IV hydration industry are produced by compounding pharmacies, which are regulated to the minute detail of how they do things (e.g., the clothing worn by pharmacy staff, air filtration).

3. Compounded products are not considered to be FDA approved and are inherently suspect by regulatory authorities of being insterile and/or ineffective.

4. The FDA is completely aware of the IV hydration industry.

5. The FDA works hand-in-hand with the state boards of pharmacy and other agencies to investigate and shut down dangerous situations.

6. There have been reported cases of people almost dying from infusion of vitamins, which have resulted in the FDA and other state and federal authorities swooping in to protect the public. Those efforts have caught physicians, compounding pharmacies and IV hydration providers in the regulatory net.

7. The Federal Trade Commission (FTC) actively suppresses all claims of outcomes from using compounded products (including IV hydration).

To get an “inside view” of how the FDA view the IV hydration (and HRT and med spa) industry, read the October 25, 2021 FDA Memo¹ on the topic, which:

• Reminds us of the application of very specific regulatory requirements applicable to pharmacies.
• Reminds that the 503A FDC exemption applicable to physicians compounding in office is limited to situations involving a valid patient-specific prescription. 
• Discussed specific cases of medical offices compounding in insanitary conditions, including those involving the infusion of IV vitamins.

State medical boards also see the risk. In 2020, the Federation of State Medical Boards (2020 “White Paper on Compounding Medications by Physicians”)² addressed physician compounding and stated it should only be done:

1. When triggered by a specific patient need.

2. Only for one’s own patients.

3. Not in large quantities or for retail sale.

4. Ensuring the ingredients are necessary for treating a patient’s medical condition (documented in the patient medical record).

5. When the fees are not “unreasonable” or “excessive” fees.

6. Guided by what’s in the patient’s best interest.

In response to the regulatory environment facing the IV hydration industry, providers would be best served to:

1. Appreciate that IV hydration is viewed by state and federal regulators like any other medical procedure.

2. Make sure they’re fully educated about the laws applicable to them.

3. Only use compound pharmacies that have been fully vetted and with well-documented historical and ongoing regulatory compliance. There is no liability protection for an IV hydration provider simply pointing the finger at their pharmacy supplier.

4. Understand that submitting claims for reimbursement by any insurer will materially increase regulatory risks.

5. Accept that making any promises about the outcomes of using IV hydration is an invitation to meet people with three letter agencies emblazed on their wind breakers.

6. Work with competitors and regulators to agree on workable and science-based definitions of what “quality” actually means for the industry.

1. FDA highlights concerns with compounding of drug products by medical offices and clinics under insanitary conditions 10.25.2021 | FDA https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-compounding-drug-products-medical-offices-and-clinics-under-insanitary

2. White Paper on Compounding of Medications by Physicians 5.27.2020 | Federation of State Medical Boards https://www.fsmb.org/siteassets/advocacy/publications/white-paper-on-physician-compounding-2020-for-posting.pdf