As IV clinics boom, Ohio regulators warn of safety violations

Ohio medical regulators have a warning for the growing number of retail IV hydration clinics in the state: They’re practicing medicine and pharmacy, and if they don’t follow the rules, they could face severe penalties.

The State Medical Board and the Ohio boards of pharmacy and nursing on Thursday released a joint regulatory statement reminding the businesses that they have to adhere to high standards. 

“Retail IV therapy clinics have proliferated across Ohio, often offering the administration of preselected IV fluid ‘cocktails’ that include a mix of saline, vitamins, prescription drugs, and amino acids,” a press release accompanying the joint statement said. “While these services claim to treat conditions such as dehydration, migraines, and to enhance athletic recovery, the Boards emphasize that such IV therapy is a medical practice requiring licensed professionals and compliance with Ohio laws and regulations.”

There are 201 such clinics in Ohio, according to a spreadsheet from the pharmacy board. They administer intravenous infusions promising to cure hangovers and speed recovery from tough workouts. They also said their IVs deliver vitamins and other compounds that can help improve patients’ complexion, boost immune systems and relieve stress.

“Generally, a patient will walk into the business, review the menu of treatment options, complete a health screening questionnaire, and undergo a precursory evaluation (including pulse oximetry, heart rate, blood pressure, review of medications, and allergies) with an employee who is not a prescriber, usually a registered nurse or a paramedic,” the medical regulators’ joint statement said. “The employee will then recommend an IV cocktail, with or without additives, based on the ‘protocol’ established by a licensed prescriber…” 

The regulatory boards said they’re concerned that personnel in the clinics are doing things for which they’re not licensed.

“The operation of a retail IV therapy clinic involves the practice of medicine, nursing, and pharmacy,” the statement said. “The practice of these professions requires a license and adherence to a scope of practice established by Ohio law.  A license to practice these professions is specific to the licensee and does not generally permit the delegation of their scope of practice to any other unlicensed person except under specific laws and rules.”

The statement cites several specific concerns. One has to do with the cocktails the clinics are running into customers’ veins.

“Compounding may only be performed by a licensed pharmacist or licensed health professional authorized to prescribe drugs,” the statement said. “The preparation of IV cocktails as previously described is considered compounding under Ohio law and the clinic is required to obtain a license as a terminal distributor of dangerous drugs… from the Ohio Board of Pharmacy.”

Similarly, the statement said, “The services provided by retail IV therapy clinics constitute the practice of medicine or osteopathic medicine” and must abide by all the licensure requirements and other regulations pertaining to those fields. Violations can result in fines, license suspensions or revocations, and even criminal charges.

In a related matter, the board of pharmacy last week suspended the distribution licenses of two more wellness clinics and those of two out-of-state suppliers.

It suspended the license of Jenerous Hydration in Dover in part on allegations that it was selling retatrutide, a weight-loss drug that hasn’t been approved by the U.S. Food and Drug Administration. It also suspended the license of Brooksville Pharmaceuticals, the Florida-based company that allegedly supplied the compounded drug.

In addition, the pharmacy board suspended the license of Harmony Aesthetics, a spa in Mason, partly on allegations that it had mislabeled a drug meant to ease frown lines. The person in charge there first told inspectors she got the drug from its U.S. distributor, then she admitted she had gotten it at a deep discount through a Facebook group, the report said.

It also suspended the license of CRE8 Pharmacy Group of Coral Springs, Fla., on allegations that it sold compounded drugs to Ohio clinics that contained unapproved components.

The pharmacy board already this year has suspended the licenses of more than a half-dozen spas, largely over their practices regarding high-demand GLP-1 weight-loss drugs. As retail hydration clinics boom, suspensions related to their practices seem likely.