HSB 591 (LSB 5340YC (7) 91)

HOUSE FILE _____ 

BY  (PROPOSED COMMITTEE ON HEALTH AND HUMAN SERVICES BILL BY CHAIRPERSON HARRIS)

A BILL FOR

An Act establishing the medical spa oversight Act, and making penalties applicable.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:

    Section 1.  NEW SECTION.  135S.1  Title.
   This chapter shall be known and may be cited as the “Medical Spa Oversight Act”.
    Sec. 2.  NEW SECTION.  135S.2  Definitions.
   1.  “Adverse event” means any untoward medical occurrence associated with the use of a prescription drug.
   2.  “Biological product” means the same as defined in 42 U.S.C. §262.
   3.  “Board” means the board of medicine.
   4.  “Bulk drug substance” means the same as defined in 21 C.F.R. §207.3.
   5.  “Medical spa” means a business licensed under this chapter to provide wellness services.
   6.  “Prescription device” means the same as defined in 21 C.F.R. §801.109.
   7.  “Prescription drug” means a drug, as classified by the United States food and drug administration, that is required by the United States food and drug administration to be prescribed prior to being dispensed or administered to a patient by a practitioner. “Prescription drug” includes but is not limited to all of the following:
   a.  A biological product, not including blood and blood components intended for transfusion or a biological product that is also a medical device.
   b.  A bulk drug substance.
   8.  “Responsible person” means an individual licensed under chapter 148 or 155A who has been designated under section 135S.5.
   9.  “Serious adverse event” means the same as defined in 21 C.F.R. §251.2.
   10.  “Suspected adverse reaction” means an adverse event for which there is a reasonable possibility that a prescription drug or a wellness service caused the adverse event.
   11.  “Wellness service” means a medical service for which a person is not required to have a license under chapter 148 or 155A to perform that is primarily used to enhance an individual’s health or physical appearance rather than address an underlying medical condition. “Wellness service” includes but is not limited to all of the following:
   a.  Botox injections.
   b.  Laser hair removal.
   c.  Skin pigmentation treatment.
   d.  Microneedling.
   e.  Intravenous nutrient therapy.
   f.  Intramuscular injections of vitamins, minerals, or other nutrients.
    Sec. 3.  NEW SECTION.  135S.3  Licensing.
   1.  A business shall not operate as a medical spa, provide wellness services, or handle, store, administer, dispense, or distribute prescription drugs unless licensed by the board under this chapter.
   2.  The board shall maintain a public database on the board’s internet site of each medical spa licensed by the board. The database shall include all of the following:
   a.  The medical spa’s legal name and, if applicable, the name under which the spa is doing business.
   b.  The medical spa’s business address.
   c.  Each address at which the medical spa intends to provide prescription drugs or wellness services.
   d.  The medical spa’s license number as issued by the board.
   e.  The name and license number of the individual the medical spa has designated as a responsible person and each location of the medical spa for which the responsible person has been designated.
    Sec. 4.  NEW SECTION.  135S.4  Prescription drugs and prescription devices.
   1.  A medical spa shall be considered a dispenser as that term is defined in section 581 of the federal Drug Supply Chain Security Act, and shall comply with all the requirements of a dispenser in section 582 of the federal Drug Supply Chain Security Act.
   2.  A medical spa shall store prescription drugs and prescription devices in areas that are dry, well-lit, well-ventilated, and maintained in a clean and orderly condition. Prescription drugs and prescription devices requiring specific storage conditions, such as cold chain storage products, must be stored in accordance with instructions provided by the manufacturer of the prescription drug or prescription device.
   3.  Prescription drugs and prescription devices must be maintained under appropriate supervision and controlled distribution at all times.
   4.  A medical spa and the medical spa’s responsible person shall ensure the medical spa has sufficient security controls and procedures to deter and detect the theft and diversion of prescription drugs.
    Sec. 5.  NEW SECTION.  135S.5  Responsible person.
   1.  A medical spa shall designate a responsible person for each of the medical spa’s locations and the same individual shall not be designated for more than one medical spa location without prior board approval.
   2.  A responsible person shall ensure each medical spa location for which the responsible person is designated complies with this chapter and all rules adopted by the board under this chapter.
    Sec. 6.  NEW SECTION.  135S.6  Inspections and audits.
   1.  A person’s submission of an application for a license under this chapter shall constitute permission for the board or the board’s authorized agent to enter and inspect the person’s proposed medical spa facilities and to audit the person’s proposed wellness services.
   2.  An inspection and audit under this section shall occur prior to a person’s initial licensure under this chapter and may occur periodically after the person’s initial licensure as determined by the board.
    Sec. 7.  NEW SECTION.  135S.7  Serious adverse event reporting.
   A medical spa shall provide written notice to the board within five business days from the date a serious adverse event occurs at the medical spa. The notice shall include all of the following:

   1.  The date the serious adverse event occurred.
   2.  A summary of the serious adverse event.
   3.  The address of the medical spa location at which the serious adverse event occurred.
   4.  The number of individuals directly affected by the serious adverse event.
    Sec. 8.  NEW SECTION.  135S.8  Deceptive and unfair trade practices.
   A medical spa commits an unfair practice as that term is defined in section 714.16 when the medical spa does any of the following:

   1.  Represents that a prescription drug is of a particular standard, quality, or grade if the prescription drug is not of that standard, quality, or grade.
   2.  Represents that a prescription drug or a wellness service has sponsorship, approval, characteristics, ingredients, uses, or benefits that the prescription drug or wellness service does not have.
   3.  Represents that a drug or wellness service is approved by the United States food and drug administration if the United States food and drug administration has not approved the drug or wellness service.
    Sec. 9.  NEW SECTION.  135S.9  Violations —— discipline.
   1.  a.  The board may maintain an action in the name of the state for an injunction to restrain or prevent a violation of this chapter or rules adopted by the board under this chapter.
   b.  Upon the board’s request, the attorney general shall commence proceedings to enforce this chapter and, at the request of the attorney general, a county attorney with jurisdiction shall appear and prosecute the action.
   2.  The board may impose an administrative penalty of up to five hundred dollars per violation on a person who does any of the following:
   a.  Engages in a practice regulated by this chapter without a current license.
   b.  Employs an individual without a current license to act as a responsible person.
   c.  Fails any component of a routine inspection or audit conducted by the board.
   3.  The assessment and payment of a penalty imposed pursuant to subsection 2 shall not be considered a disciplinary action and shall be confidential.
   4.  The board shall maintain a public record of disciplinary actions involving violations of this chapter.
   5.  Penalties collected under this section shall be deposited by the board into the general fund of the state.
    Sec. 10.  NEW SECTION.  135S.10  Rulemaking authority.
   The board shall adopt rules pursuant to chapter 17A to implement and administer this chapter.
    Sec. 11.  Section 714.16, subsection 2, Code 2026, is amended by adding the following new paragraph:
   NEW PARAGRAPH.  t.  It is an unlawful practice for a person to violate section 135S.8.
EXPLANATION
The inclusion of this explanation does not constitute agreement with
the explanation’s substance by the members of the general assembly.
   This bill establishes the medical spa oversight Act.
   The bill defines “medical spa” (spa) as a business licensed to provide wellness services.
   The bill defines “responsible person” as a person licensed to perform medicine and surgery, osteopathic medicine and surgery, or pharmacy, and who has been designated by a medical spa.
   The bill defines “wellness service” (service) as a medical service for which a person is not required to have a license for medicine and surgery, osteopathic medicine and surgery, or pharmacy to perform, and that is primarily used to enhance an individual’s health or physical appearance rather than address an underlying medical condition. The bill lists several examples of services.
   The bill also defines “adverse event”, “biological product”, “bulk drug substance”, “prescription device” (device), “prescription drug” (drug), and “serious adverse event”.
   The bill prohibits a business from handling, storing, administering, dispensing, or distributing drugs unless the business is licensed by the board of medicine (board) as a spa. The bill also prohibits a business from providing services unless licensed by the board.
   The bill requires the board to maintain a public database on the board’s internet site of each spa and details the minimum information the database must include.
   Under the bill, a spa is a dispenser as defined in section 581 of the federal Drug Supply Chain Security Act and is required to comply with all requirements of a dispenser in that Act.
   The bill requires a spa to store drugs and devices in areas that are dry, well-lit, well-ventilated, and maintained in a clean and orderly condition. Drugs and devices requiring specific storage conditions, such as cold chain storage, must be stored according to instructions provided by the manufacturer of the drug or device. Drugs and devices must be maintained under appropriate supervision with controlled distribution. The bill requires a spa and the spa’s responsible person to ensure the spa has sufficient security controls and procedures to deter and detect the theft and diversion of drugs.
   The bill requires a spa to designate a responsible person for each of the spa’s locations, and prohibits a responsible person from being designated for more than one spa location without prior board approval. The responsible person must ensure each spa location for which the responsible person is designated complies with the bill.
   Under the bill, a person’s submission of an application for a spa license constitutes permission for the board or the board’s authorized agent to enter and inspect the person’s proposed spa facilities and audit the person’s proposed services. The bill requires an inspection and audit to occur prior to a person’s initial spa licensure and allows the board to conduct inspections and audits after the person’s initial licensure.
   The bill requires a spa to provide written notice to the board within five business days from the date a serious adverse event occurs at the spa. The bill details the information the notice must include.
   The bill makes it an unfair practice under Code section 714.16 (consumer fraud) when a spa represents that a drug is of a particular standard, quality, or grade if the drug is not of that standard, quality, or grade; represents that a drug or a service has sponsorship, approval, characteristics, ingredients, uses, benefits, or quantities that it does not have; or represents that a drug or service is approved by the United States food and drug administration (FDA) when the FDA has not approved the drug or service.
   The bill allows the board to maintain an action in the name of the state for an injunction to restrain or prevent a violation of the bill or rules adopted pursuant to the bill. Upon the board’s request, the bill requires the attorney general to commence proceedings to enforce the bill and, at the request of the attorney general, a county attorney with jurisdiction must appear and prosecute the action.
   The bill allows the board to impose an administrative penalty of up to $500 per violation on a person as detailed in the bill. The assessment and payment of an administrative penalty shall not be considered a disciplinary action and shall be confidential. Penalties collected are to be deposited by the board into the general fund of the state.
   The bill requires the board to maintain a public record of disciplinary actions involving violations of the bill.
   The bill requires the board to adopt rules to implement and administer the bill.
   The bill makes a conforming change to Code section 714.16.