American IV Association Legal Network Tracking California IV Hydration Therapy Rebellion

Published on January 28th, 2023.

At the American IV Association, we have a very clear purpose - to help an industry achieve success and sustainability. It shapes everything we do and how we do it. This is imperative to helping IV hydration therapy providers successfully navigate the complex and ever evolving regulatory and business landscape of the industry. One of the organization's objectives requires the tracking of developing governmental enforcement, regulations, and emerging legal issues.

The State of California has imposed additional licenses, more stringent standards, and thorough inspections for compounding pharmacies, and it has become increasingly difficult for healthcare providers to obtain sterile medications from 503A and 503B compounding pharmacies for both legal and economic reasons. The additional and more stringent requirements imposed by California law have led to a lack of and need for IV-specific compounding pharmacies existing in California and outside of California that can ship into California.

Some compounding pharmacies only offer non-sterile products and some only dabble in certain areas. Therein lies one problem for IV hydration therapy providers in California. Only one sterile pharmacy that produces IV therapy treatments can sell such treatments to California healthcare providers. While some may think that should solve the problem, many providers may not know about this pharmacy or are on the hunt for less costly product. It's not surprising that California healthcare providers are rebelling. Some providers, on their own, and even at the direction of certain compounding pharmacies, have set up PO boxes in neighboring states, like Nevada, to ship medications to and then transport over state lines into California. Other providers are allocating patient-specific prescriptions across multiple patients.

"It should seem obvious that if you have to get "creative," either the system or program within which you are acting is flawed, or you probably shouldn't be doing what you're doing. In this case, it could be both. Where does all this regulation and creativity leave healthcare providers? Any healthcare provider purchasing, lending their license for purchasing and/or administering medication improperly sourced is, at the very least, at risk for loss of their license. In fact, to say "at risk" is an understatement. They may also very well be charged and convicted of a misdemeanor or felony, and subject to fines," says Amanda Howard, Attorney at Florida Healthcare Law Firm in Delray Beach, FL and legal contribution author for AIVA.

Howard goes on with a message that mirrors other trade experts who believe the time is now for the IV hydration therapy industry to self-regulate. "The day an improperly sourced IV hydration therapy treatment causes a severe reaction, or fatal threat to a Californian, the very people the Board seeks to protect, expect a reckoning. If, of course, it doesn't come before. Access will be even more restricted than it is now. The bad players AND good players will suffer the consequences."

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