October 7, 2026

Via Comment Portal

Erin Barrett

Director of Legislative and Regulatory Affairs

Perimeter Center

9960 Mayland Drive, Suite 300

Henrico, VA 23233

erin.barrett@dhp.virginia.gov

Re:        Regulatory Considerations for IV Hydration Clinics and Med Spas in Virginia

Dear Director Barrett:

The Collaborative for Evidence-Based Medicines (“CEBM”) is a national provider-led organization advancing evidence-backed medicines, safe compounding, and stronger oversight and accountability to protect patients.  CEBM brings together providers, patient advocates, academics, consumer groups, manufacturers, and other stakeholders to advance our patient safety mission.  The signatories to this letter are pharmacists, physicians, and regulatory professionals who sit on the CEBM Board. 

CEBM writes in strong support of the draft guidance document, Regulatory Considerations for IV Hydration Clinics and Med Spas in Virginia (the “Guidance”).  As the Virginia Boards of Medicine, Nursing, and Pharmacy (hereafter referred to as the “Boards”) acknowledge, IV hydration clinics and med spas offering IV fluids, vitamin and amino acid infusions, GLP-1 and other peptide products, and compounded drugs are expanding rapidly across the Commonwealth, often in consumer-focused settings where patients select treatments from a menu, complete a brief questionnaire, and receive therapy without ever meaningfully interacting with a prescriber (if at all).[1]  These practice models present real and avoidable risks of infection, contamination, and dosing errors.  The Guidance appropriately reminds these businesses that selecting, preparing, compounding, and administering prescription drugs is the practice of medicine, nursing, or pharmacy, and is subject to the same standards that apply in any other clinical setting.

The Guidance comes at a critical time.  We urge the Boards to consider the growing body of evidence documenting patient harm from compounded drugs[2] which motivates CEBM’s comments.  For example, a recent study from researchers at Binghamton University found that patients who took compounded GLP-1/GIP drugs reported adverse events that required hospitalization at a 2.5 times higher rate and were over 8.5 times more likely to have an adverse event that involved product quality issues as compared to those taking FDA-approved medicines.[3]  From our perspective as providers and patient advocates, these numbers represent real patients who sought treatment and instead received products that put their health at risk.

CEBM particularly supports the Guidance’s clarification of the following points:

• Patient-specific care.  Each patient must be evaluated by a licensed prescriber who issues a patient-specific order within a bona fide practitioner-patient relationship, and drugs may not be administered under protocols or standing orders.[4]

• Compounding standards.  Adding medications, vitamins, or minerals to IV fluids, or preparing customized formulations such as peptides, is compounding and constitutes the practice of pharmacy, and all such compounding must comply with USP standards as required by Virginia Code § 54.1-3410.2.  The Guidance’s reminder that compounded drugs are not FDA-approved, and that improper sterile technique can cause serious patient harm, is especially important.[5]

• Drug sourcing.  Drugs should be purchased only from licensed wholesale distributors, pharmacies, or outsourcing facilities, and products labeled “for research purposes only” may not be possessed by these businesses regardless of patient consent.  This is a critical safeguard against the unapproved and illegitimate products, including purported GLP-1 drugs, that have proliferated in this market.[6]

Further, we appreciate that the Guidance notes, “Any medication indicating ‘for research purposes only’ or other similar statement is unlawful to possess by IV hydration clinics and med spas and is both a violation of state and federal law regardless of patient ‘consent’”.[7]  The compounding of the investigational drug retatrutide has expanded dramatically over the past months, a trend that will likely repeat for future drugs after positive clinical data are announced.  The widespread compounding of unapproved drugs while they are still under clinical investigation puts patients at risk and threatens the foundation of drug development that depends on the creation of rigorous evidence to assess safety and effectiveness before new drugs reach patients.  Patients deserve treatments supported by rigorous evidence, not unauthorized products marketed before the development process is complete.

Beyond the guidance itself, we urge the Board to scrutinize potentially false or misleading marketing of compounded drugs by med spas, hydration clinics, and similar facilities. This can include the marketing of compounded drugs in ways that fail to disclose any meaningful risk information to prospective patients, and creates the impression that certain entities are licensed pharmacies when they are not. The mass marketing of compounded drugs induces demand for these products beyond the limited, gap-filling role compounding is intended to play in our health care system.

CEBM commends the Board for its leadership in protecting Virginia patients and urges the Boards to finalize the Guidance.  In addition, CEBM encourages the Boards to support legislation that would enhance the ability of the Boards to oversee med spas and IV hydration clinics. One example of such legislation is the National Association of Boards of Pharmacy (NABP) “Model Medical Spa Oversight Act,” which would require site licensure, specific inspection schedules, and adverse event reporting, all of which will enhance patient safety.[8] Additional legislation would further strengthen the Boards’ ability to take effective action to protect Virginians and ensure that patients receive high-quality care and medication regardless of the setting.

Thank you for your consideration.

Sincerely,

John Hertig, PharmD, MS, CPPS, FASHP, FFIP (Chair of CEBM)  Michael Stepanovic, PharmD, MS

Dr. Adonis Saremi, MD, MS, DABOM                Donney John, PharmD

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