The National Association of Boards of Pharmacy® (NABP®), the Federation of State Medical Boards (FSMB), and the National Council of State Boards of Nursing (NCSBN) joined United States Food and Drug Administration (FDA) and the US Federal Trade Commission (FTC) for an online webinar, titled Intravenous (IV) Hydration Clinics: Federal and State Perspectives, on July 26, 2023, to discuss risks associated with IV hydration services being offered to the public.
As IV hydration clinics grow in popularity, federal and state regulators have received complaints and reports of serious adverse events. Due to the serious safety risks, regulators convened the panel discussion for regulators on federal and state regulatory perspectives. More than 700 regulators participated, and included members and staff of state medical boards, nursing boards, and pharmacy boards.
IV hydration clinics allow consumers to select an IV infusion from a menu of various vitamins and supplements advertised for various uses and are purported to boost immunity, promote recovery, and remediate hangovers or fatigue. However, consumer caution is advised, as FDA has received reports of adverse events at medical offices, clinics, and other business models, such as IV hydration clinics, medical spas, and mobile IV infusion services.
FDA issued a compounding risk alert in October 2021 to caution health care providers about drug products being prepared under insanitary conditions at IV hydration clinics. The alert warns that businesses are compounding drugs that may not meet the conditions of the Federal Food, Drug, and Cosmetic Act or comply with state regulations.
As FSMB, NABP, and NCSBN have continued to see concerning activity in this area, the three organizations worked with FDA and FTC to develop this webinar as a means to inform regulators and practitioners on how to protect and educate patients. Following are the key points presented and discussed at the webinar:
- Regulators from the state boards of nursing, medicine, and pharmacy need to work together to ensure that businesses that offer IV hydration products are being inspected by the appropriate agency.
- Basic knowledge of FTC regulations as they relate to claims made by IV hydration product providers can be helpful for regulators and practitioners.
- Educating patients about these products, the claims being made, and the fact that such products need to be prescribed and administered by a licensed health care professional is important to the health and safety of patients.
The three organizations will continue to work with federal agencies and keep their members informed of what is happening in this space. Regulators and practitioners are encouraged to familiarize themselves with this issue so that they can do their part to protect patients. Slides and resources from the webinar can be viewed here.
NABP is the independent, international, and impartial 501(c)(3) nonprofit Association that assists its state member boards and jurisdictions for the purpose of protecting the public health. NABP was established in 1904 to assist the state boards of pharmacy in creating uniform education and licensure standards. Today, we help support patient and prescription drug safety through examinations that assess pharmacist competency, pharmacist licensure transfer and verification services, and various pharmacy accreditation and inspection programs. To learn more about NABP, visit https://nabp.pharmacy.
FSMB is a national non-profit organization representing the medical boards within the United States and its territories that license and discipline allopathic and osteopathic physicians and, in some jurisdictions, other healthcare professionals. FSMB serves as the voice for state medical boards, supporting them through education, assessment, research and advocacy while providing services and initiatives that promote patient safety, quality healthcare and regulatory best practices. FSMB serves the public through Docinfo.org, a free physician search tool which provides background information on the more than 1 million doctors in the United States. To learn more about FSMB, visit www.fsmb.org.
Empowering and supporting nursing regulators across the world in their mandate to protect the public, NCSBN is an independent, not-for-profit organization. As a global leader in regulatory excellence, NCSBN champions regulatory solutions to borderless health care delivery, agile regulatory systems and nurses practicing to the full scope of their education, experience and expertise. A world leader in test development and administration, NCSBN’s NCLEX® Exams are internationally recognized as the preeminent nursing examinations. NCSBN’s membership is comprised of the nursing regulatory bodies (NRBs) in the 50 states, the District of Columbia and four U.S. territories. There are three exam user members and 27 associate members that are either NRBs or empowered regulatory authorities from other countries or territories. For more information, please visit https://www.ncsbn.org.