H.F. _____ Section 1. NEW SECTION . 135S.1 Title. 1 This chapter shall be known and may be cited as the “Medical 2 Spa Oversight Act” . 3 Sec. 2. NEW SECTION . 135S.2 Definitions. 4 1. “Adverse event” means any untoward medical occurrence 5 associated with the use of a prescription drug. 6 2. “Biological product” means the same as defined in 42 7 U.S.C. §262. 8 3. “Board” means the board of medicine. 9 4. “Bulk drug substance” means the same as defined in 21 10 C.F.R. §207.3. 11 5. “Medical spa” means a business licensed under this 12 chapter to provide wellness services. 13 6. “Prescription device” means the same as defined in 21 14 C.F.R. §801.109. 15 7. “Prescription drug” means a drug, as classified by the 16 United States food and drug administration, that is required by 17 the United States food and drug administration to be prescribed 18 prior to being dispensed or administered to a patient by a 19 practitioner. “Prescription drug” includes but is not limited 20 to all of the following: 21 a. A biological product, not including blood and blood 22 components intended for transfusion or a biological product 23 that is also a medical device. 24 b. A bulk drug substance. 25 8. “Responsible person” means an individual licensed under 26 chapter 148 or 155A who has been designated under section 27 135S.5. 28 9. “Serious adverse event” means the same as defined in 21 29 C.F.R. §251.2. 30 10. “Suspected adverse reaction” means an adverse event for 31 which there is a reasonable possibility that a prescription 32 drug or a wellness service caused the adverse event. 33 11. “Wellness service” means a medical service for which 34 a person is not required to have a license under chapter 35 -1- LSB 5340YC (7) 91 dg/ko 1/ 8

H.F. _____ 148 or 155A to perform that is primarily used to enhance an 1 individual’s health or physical appearance rather than address 2 an underlying medical condition. “Wellness service” includes 3 but is not limited to all of the following: 4 a. Botox injections. 5 b. Laser hair removal. 6 c. Skin pigmentation treatment. 7 d. Microneedling. 8 e. Intravenous nutrient therapy. 9 f. Intramuscular injections of vitamins, minerals, or other 10 nutrients. 11 Sec. 3. NEW SECTION . 135S.3 Licensing. 12 1. A business shall not operate as a medical spa, provide 13 wellness services, or handle, store, administer, dispense, or 14 distribute prescription drugs unless licensed by the board 15 under this chapter. 16 2. The board shall maintain a public database on the board’s 17 internet site of each medical spa licensed by the board. The 18 database shall include all of the following: 19 a. The medical spa’s legal name and, if applicable, the name 20 under which the spa is doing business. 21 b. The medical spa’s business address. 22 c. Each address at which the medical spa intends to provide 23 prescription drugs or wellness services. 24 d. The medical spa’s license number as issued by the board. 25 e. The name and license number of the individual the medical 26 spa has designated as a responsible person and each location 27 of the medical spa for which the responsible person has been 28 designated. 29 Sec. 4. NEW SECTION . 135S.4 Prescription drugs and 30 prescription devices. 31 1. A medical spa shall be considered a dispenser as that 32 term is defined in section 581 of the federal Drug Supply Chain 33 Security Act, and shall comply with all the requirements of 34 a dispenser in section 582 of the federal Drug Supply Chain 35 -2- LSB 5340YC (7) 91 dg/ko 2/ 8

H.F. _____ Security Act. 1 2. A medical spa shall store prescription drugs and 2 prescription devices in areas that are dry, well-lit, 3 well-ventilated, and maintained in a clean and orderly 4 condition. Prescription drugs and prescription devices 5 requiring specific storage conditions, such as cold 6 chain storage products, must be stored in accordance with 7 instructions provided by the manufacturer of the prescription 8 drug or prescription device. 9 3. Prescription drugs and prescription devices must 10 be maintained under appropriate supervision and controlled 11 distribution at all times. 12 4. A medical spa and the medical spa’s responsible person 13 shall ensure the medical spa has sufficient security controls 14 and procedures to deter and detect the theft and diversion of 15 prescription drugs. 16 Sec. 5. NEW SECTION . 135S.5 Responsible person. 17 1. A medical spa shall designate a responsible person for 18 each of the medical spa’s locations and the same individual 19 shall not be designated for more than one medical spa location 20 without prior board approval. 21 2. A responsible person shall ensure each medical spa 22 location for which the responsible person is designated 23 complies with this chapter and all rules adopted by the board 24 under this chapter. 25 Sec. 6. NEW SECTION . 135S.6 Inspections and audits. 26 1. A person’s submission of an application for a license 27 under this chapter shall constitute permission for the board or 28 the board’s authorized agent to enter and inspect the person’s 29 proposed medical spa facilities and to audit the person’s 30 proposed wellness services. 31 2. An inspection and audit under this section shall occur 32 prior to a person’s initial licensure under this chapter and 33 may occur periodically after the person’s initial licensure as 34 determined by the board. 35 -3- LSB 5340YC (7) 91 dg/ko 3/ 8

H.F. _____ Sec. 7. NEW SECTION . 135S.7 Serious adverse event 1 reporting. 2 A medical spa shall provide written notice to the board 3 within five business days from the date a serious adverse event 4 occurs at the medical spa. The notice shall include all of the 5 following: 6 1. The date the serious adverse event occurred. 7 2. A summary of the serious adverse event. 8 3. The address of the medical spa location at which the 9 serious adverse event occurred. 10 4. The number of individuals directly affected by the 11 serious adverse event. 12 Sec. 8. NEW SECTION . 135S.8 Deceptive and unfair trade 13 practices. 14 A medical spa commits an unfair practice as that term is 15 defined in section 714.16 when the medical spa does any of the 16 following: 17 1. Represents that a prescription drug is of a particular 18 standard, quality, or grade if the prescription drug is not of 19 that standard, quality, or grade. 20 2. Represents that a prescription drug or a wellness service 21 has sponsorship, approval, characteristics, ingredients, uses, 22 or benefits that the prescription drug or wellness service does 23 not have. 24 3. Represents that a drug or wellness service is approved by 25 the United States food and drug administration if the United 26 States food and drug administration has not approved the drug 27 or wellness service. 28 Sec. 9. NEW SECTION . 135S.9 Violations —— discipline. 29 1. a. The board may maintain an action in the name of the 30 state for an injunction to restrain or prevent a violation of 31 this chapter or rules adopted by the board under this chapter. 32 b. Upon the board’s request, the attorney general shall 33 commence proceedings to enforce this chapter and, at the 34 request of the attorney general, a county attorney with 35 -4- LSB 5340YC (7) 91 dg/ko 4/ 8

H.F. _____ jurisdiction shall appear and prosecute the action. 1 2. The board may impose an administrative penalty of up to 2 five hundred dollars per violation on a person who does any of 3 the following: 4 a. Engages in a practice regulated by this chapter without 5 a current license. 6 b. Employs an individual without a current license to act 7 as a responsible person. 8 c. Fails any component of a routine inspection or audit 9 conducted by the board. 10 3. The assessment and payment of a penalty imposed pursuant 11 to subsection 2 shall not be considered a disciplinary action 12 and shall be confidential. 13 4. The board shall maintain a public record of disciplinary 14 actions involving violations of this chapter. 15 5. Penalties collected under this section shall be 16 deposited by the board into the general fund of the state. 17 Sec. 10. NEW SECTION . 135S.10 Rulemaking authority. 18 The board shall adopt rules pursuant to chapter 17A to 19 implement and administer this chapter. 20 Sec. 11. Section 714.16, subsection 2, Code 2026, is amended 21 by adding the following new paragraph: 22 NEW PARAGRAPH . t. It is an unlawful practice for a person 23 to violate section 135S.8. 24 EXPLANATION 25 The inclusion of this explanation does not constitute agreement with 26 the explanation’s substance by the members of the general assembly. 27 This bill establishes the medical spa oversight Act. 28 The bill defines “medical spa” (spa) as a business licensed 29 to provide wellness services. 30 The bill defines “responsible person” as a person licensed 31 to perform medicine and surgery, osteopathic medicine and 32 surgery, or pharmacy, and who has been designated by a medical 33 spa. 34 The bill defines “wellness service” (service) as a medical 35 -5- LSB 5340YC (7) 91 dg/ko 5/ 8

H.F. _____ service for which a person is not required to have a license 1 for medicine and surgery, osteopathic medicine and surgery, or 2 pharmacy to perform, and that is primarily used to enhance an 3 individual’s health or physical appearance rather than address 4 an underlying medical condition. The bill lists several 5 examples of services. 6 The bill also defines “adverse event”, “biological product”, 7 “bulk drug substance”, “prescription device” (device), 8 “prescription drug” (drug), and “serious adverse event”. 9 The bill prohibits a business from handling, storing, 10 administering, dispensing, or distributing drugs unless the 11 business is licensed by the board of medicine (board) as a spa. 12 The bill also prohibits a business from providing services 13 unless licensed by the board. 14 The bill requires the board to maintain a public database on 15 the board’s internet site of each spa and details the minimum 16 information the database must include. 17 Under the bill, a spa is a dispenser as defined in section 18 581 of the federal Drug Supply Chain Security Act and is 19 required to comply with all requirements of a dispenser in that 20 Act. 21 The bill requires a spa to store drugs and devices in areas 22 that are dry, well-lit, well-ventilated, and maintained in 23 a clean and orderly condition. Drugs and devices requiring 24 specific storage conditions, such as cold chain storage, 25 must be stored according to instructions provided by the 26 manufacturer of the drug or device. Drugs and devices must 27 be maintained under appropriate supervision with controlled 28 distribution. The bill requires a spa and the spa’s 29 responsible person to ensure the spa has sufficient security 30 controls and procedures to deter and detect the theft and 31 diversion of drugs. 32 The bill requires a spa to designate a responsible person for 33 each of the spa’s locations, and prohibits a responsible person 34 from being designated for more than one spa location without 35 -6- LSB 5340YC (7) 91 dg/ko 6/ 8

H.F. _____ prior board approval. The responsible person must ensure each 1 spa location for which the responsible person is designated 2 complies with the bill. 3 Under the bill, a person’s submission of an application for a 4 spa license constitutes permission for the board or the board’s 5 authorized agent to enter and inspect the person’s proposed 6 spa facilities and audit the person’s proposed services. The 7 bill requires an inspection and audit to occur prior to a 8 person’s initial spa licensure and allows the board to conduct 9 inspections and audits after the person’s initial licensure. 10 The bill requires a spa to provide written notice to the 11 board within five business days from the date a serious adverse 12 event occurs at the spa. The bill details the information the 13 notice must include. 14 The bill makes it an unfair practice under Code section 15 714.16 (consumer fraud) when a spa represents that a drug is 16 of a particular standard, quality, or grade if the drug is 17 not of that standard, quality, or grade; represents that a 18 drug or a service has sponsorship, approval, characteristics, 19 ingredients, uses, benefits, or quantities that it does not 20 have; or represents that a drug or service is approved by the 21 United States food and drug administration (FDA) when the FDA 22 has not approved the drug or service. 23 The bill allows the board to maintain an action in the 24 name of the state for an injunction to restrain or prevent a 25 violation of the bill or rules adopted pursuant to the bill. 26 Upon the board’s request, the bill requires the attorney 27 general to commence proceedings to enforce the bill and, at 28 the request of the attorney general, a county attorney with 29 jurisdiction must appear and prosecute the action. 30 The bill allows the board to impose an administrative 31 penalty of up to $500 per violation on a person as detailed 32 in the bill. The assessment and payment of an administrative 33 penalty shall not be considered a disciplinary action and shall 34 be confidential. Penalties collected are to be deposited by 35 -7- LSB 5340YC (7) 91 dg/ko 7/ 8