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REFERENCE TITLE: medical spas; licensure; regulation |
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State of Arizona House of Representatives Fifty-seventh Legislature Second Regular Session 2026
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HB 4047 |
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Introduced by Representative Peņa
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AN ACT
Amending title 32, chapter 18, Arizona Revised Statutes, by adding article 4.1; relating to the Arizona state board of pharmacy.
(TEXT OF BILL BEGINS ON NEXT PAGE)
Be it enacted by the Legislature of the State of Arizona:
Section 1. Title 32, chapter 18, Arizona Revised Statutes, is amended by adding article 4.1, to read:
ARTICLE 4.1. MEDICAL SPAS
32-1998. Definitions
In this article, unless the context otherwise requires:
1. "Adverse event" means any untoward medical occurrence associated with the use of a prescription medication, whether or not considered prescription medication-related.
2. "Medical Spa":
(a) Means any facility or practice that offers medical or cosmetic health care services and that is required to be licensed pursuant to this article.
(b) Does not include a facility or practice that is otherwise licensed by this state.
3. "Person" means an individual, corporation, government or governmental subdivision or agency, statutory trust, business trust, estate, trust, partnership or unincorporated association or any of the foregoing having a joint or common interest, or any other legal or commercial entity.
4. "Prescription medication":
(a) Has the same meaning prescribed in section 32-1901.
(b) Includes any drug, including any biological product, except for blood and blood components intended for transfusion or biological products that are also medical devices, that is required by federal law or regulation to be dispensed only pursuant to a prescription order, including finished dosage forms and bulk drug substances that are subject to section 503(b) of the federal food, drug, and cosmetic act (21 United States Code section 355b).
5. "Responsible person" means a licensed health care provider who has supervising authority at a medical spa.
6. "Serious adverse event":
(a) Means an adverse event or suspected adverse reaction that results in any of the following outcomes:
(i) Death.
(ii) A life-threatening adverse event.
(iii) Inpatient hospitalization or prolongation of existing hospitalization.
(iv) A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.
(v) A congenital anomaly or birth defect.
(b) Includes an adverse event that, based on appropriate medical judgment, may jeopardize the patient's health and may require medical or surgical intervention to prevent one of the outcomes prescribed in subdivision (a) of this paragraph.
7. "Suspected adverse reaction" means any adverse event for which there is a reasonable possibility that a prescription medication caused the adverse event.
32-1998.01. Licensing requirements; public database; inspection authority
A. Each medical spa location that prepares, handles, stores, administers, dispenses, distributes or otherwise uses any prescription medication at its facility or in connection with providing services shall obtain and maintain a license from the board. Failure to obtain a license or comply with any requirements prescribed in this article may result in disciplinary action, including civil penalties or suspension or revocation of the medical spa license.
B. The board shall maintain a public database of each medical spa that is licensed pursuant to this section. The database shall include, at a minimum, the name, address and license number of the medical spa and the name and license number of the responsible person.
C. Submission by a medical spa of an application for a license constitutes permission for the board or its authorized agent to enter and inspect the medical spa facility at the time of initial licensure and at subsequent times as determined by the board. Refusal of the medical spa to allow the board or its authorized agent to conduct an inspection is a violation of this article.
32-1998.02. Prescription medications; acquisition; storage; security
A. A medical spa is a dispenser as defined in 21 United States Code section 360eee and this chapter and shall comply with the requirements of 21 United state code section 360eee-1 and this chapter with respect to the medical spa's role as a dispenser.
B. A medical spa may not acquire or receive any prescription medication from any person that does not have the license, registration, permit or other authorization required to distribute or otherwise transfer the prescription medication.
C. A medical spa shall store all prescription medications in an area that is dry, well-lit, well-ventilated and maintained in a clean and orderly condition. The storage of controlled substances and prescription medications that require specific storage requirements, such as cold chain storage products, shall be stored in accordance with those requirements.
D. Prescription medications that are not controlled substances and hypodermic needles and syringes shall be maintained under appropriate supervision and control at all times. The medical spa shall have security controls and procedures to deter and detect the theft and diversion of prescription medications. The security and control of prescription medications is the responsibility of both the responsible person and the medical spa.
32-1998.03. Responsible persons
Each licensed medical spa shall have a designated responsible person. The board may allow a responsible person to be the responsible person at more than one medical spa location. The responsible person shall be physically present at the medical spa location for a sufficient amount of time to perform the responsibilities of the position. The responsible person shall ensure that the medical spa complies with the requirements of this article.
32-1998.04. Serious adverse events; reporting
A medical spa shall notify the board within five business days after the occurrence of a serious adverse event. The notice shall include the date and location of the serious adverse event, a summary of the details and nature of the serious adverse event and a copy of the medical records of the patient who was affected.
32-1998.05. Deceptive and unfair trade practices
A medical spa engages in deceptive trade practices, in violation of title 44, chapter 10, article 7, when, in the course of business, the medical spa does any of the following:
1. Represents that a prescription medication is of a particular standard, quality or grade, if it is another.
2. Represents that a prescription medication has sponsorship, approval, characteristics, ingredients, uses, benefits or quantities that it does not have.
3. Represents that a prescription medication purports to be, work like, resemble or function similarly to another drug approved by the United States food and drug administration.
4. Represents that a prescription medication is approved by the United States food and drug administration if this is not true.
32-1998.06. Investigations; discipline; enforcement of article; rules
A. The board shall enforce this article, including enforcing actions taken if a license is required under this article but a person has failed to obtain a license. If the board has or receives information that any provision of this article has been violated, the board shall investigate and take such action as the board considers appropriate and is authorized under this chapter.
B. The board shall maintain a public record of disciplinary actions involving licensed medical spas, subject to state confidentiality laws.
C. The board shall adopt any rules necessary to implement this article that are not inconsistent with the requirements of this article. The board shall use the authority prescribed in this chapter to enforce the requirements of this article and the rules adopted pursuant to this article.