New IV Rules in Maine
By Patrick O’Brien, JD, General Counsel, American Med Spa Association (AmSpa)
The Maine Boards of Medicine, Osteopathic Medicine, and Nursing have adopted a joint rule which covers medical spas and IV therapy practices.
These rules contain important clarifications and changes about in-office compounding and IV mixing standards, using standing orders, performing good faith exams, and delegation to unlicensed medical assistants.
The new rule, referred to as “Chapter 15,” became effective in July 2026. This article will review some of the provisions of this new rule.
Maine’s statement regarding IV therapy and medical spas/aesthetic services
Section 1 is an extended statement providing rationale and context for this rule. The Boards have noted a rise in the popularity of IV therapy and medical spa services. And this rule is meant to provide a minimum set of standards for the practice. This section notes that these are all medical procedures and must be performed following a patient evaluation by a physician, physician associate, or advanced practice registered nurse. Importantly unlicensed persons are prohibited from performing any IV procedures and course completion certificates do not count as a license.
Definitions, license required, practice standards and scope of practice
Section 2 and 3 provide definitions and practice standards in this area. IV therapy businesses, medical spas, and medical aesthetic businesses must use evidence-based national standards, when available, to ensure patient safety and positive outcomes. IV therapy may only be administered after appropriate examination and diagnosis by a licensed physician, physician associate (PA), or advanced practice registered nurse (APRN) within a valid patient-provider relationship. These providers must make determinations about the treatment the patients receive including supervising those delegated to administer the treatments. All providers including registered nurses (RN) and licensed practical nurses must hold active Maine licenses. Medical spas and IV therapy businesses are held to the same standard of care and professional ethics as other medical settings. This rule does not expand anyone’s scope of practice and each licensee is still required to follow applicable rules related to scope of practice, supervision, and delegation.
The patient-provider relationship is created when: (1) the person seeks assistance, (2) the licensee agrees to examine, diagnose, assess, consult, or treat, and (3) the person agrees to receive services. As with other medical practices the patient must have their history taken and receive a physical exam from a physician, PA, or APRN. This can be in person or through telemedicine if the technology can be used to make an informed diagnosis to the same standard as in-person care. A static internet questionnaire with a static set of answers is not sufficient to meet these requirements. RNs may perform their nursing assessment using telehealth under similar circumstances as well.
Following the patient assessment by a physician, PA , or APRN must obtain the patient’s informed consent prior to treatment and document it in the patient’s medical records. The medical records are subject to the same standards as other types of medical records and should contain appropriate information as required by the standard of care. This may include the patient history, results of the physical exam and nursing assessment, the diagnosis, recommended treatments, test results, treatments, and the need for follow up care. Where providers elect to delegate services to unlicensed health care personal (medical assistants or “MA”) the must ensure that the MAs have appropriate training to provide the service and that they are supervised either on-site or electronically. Importantly, MAs may not be used in performing the examination, assessment, diagnosis, prescription, or administration of medications, including IV therapy or aesthetic treatments. Finally, this section addresses the use of “standing orders” for the individualized assessment, diagnosis and treatment of patients. Under this rule the use of such orders is considered unprofessional conduct.
Practice standards for compounding medication and obtaining compounded preparations
Section 4 covers rules relating to compounded drugs including mixing IV bags. Compounding may only be performed by persons legally authorized to compounding and in compliance with both federal and state law. The administration of compounding medicines, including IV bags, can only result from a treatment order from a licensed prescriber and not as a result of a selection from a menu. Licensed physicians must perform compounding or IV mixing in-office. This section also clarifies that USP <797> sterile compounding rules applies to these types of compounding and that walk-in, mobile or concierge IV therapy services do not fall under the USP <797> “immediate use” exception.
Drug shortages
Section 5 addresses drug shortages. In this section prescribers must document in each patient/s file information to support the prescribing of a drug to a patient for elective or nonmedical use that is subject to a current FDA declared drug shortage.
A reminder for med spas
These new rules provide a number of clarifications and changes that may affect Maine aesthetic and IV businesses. Now is an excellent time to review your practices, SOPs, and policies and make sure that they are in compliance with this new Chapter 15. While many of these provisions may have already been part of your practice, it is still a good idea to review your practices from time to time and make sure that your supporting documentation is up to date and matches how your business is operating.
Practice compliance is an active undertaking. AmSpa gives you the tools, legal access and operational support you need to not just keep up with regulations but to run your med spa with confidence. Learn more about your benefits and schedule your annual consultation with our legal partners.
