Medical Spas Deceptive Trade Practices

Second Regular Session Seventy-fifth General Assembly STATE OF COLORADO INTRODUCED SENATE BILL 26-130 LLS NO. 26-0751.02 Brita Darling x2241 SENATE SPONSORSHIP Kipp and Frizell, HOUSE SPONSORSHIP Lieder, Senate Committees House Committees Health & Human Services A BILL FOR AN ACT CONCERNING THE OPERATION OF MEDICAL SPAS INVOLVING THE USE OF PRESCRIPTION DRUGS, AND, IN CONNECTION THEREWITH, ESTABLISHING THAT CERTAIN ACTIONS BY MEDICAL SPAS ARE UNFAIR "COLORADO CONSUMER PROTECTION ACT".

OR DECEPTIVE TRADE PRACTICES UNDER THE Bill Summary (Note: This summary applies to this bill as introduced and does not reflect any amendments that may be subsequently adopted. If this bill passes third reading in the house of introduction, a bill summary that applies to the reengrossed version of this bill will be available at http://leg.colorado.gov.) The bill makes it an unfair or deceptive trade practice under the "Colorado Consumer Protection Act" for a facility or medical practice Shading denotes HOUSE amendment. Double underlining denotes SENATE amendment.

Capital letters or bold & italic numbers indicate new material to be added to existing law. Dashes through the words or numbers indicate deletions from existing law.

providing cosmetic, aesthetic, wellness, longevity, or lifestyle treatments involving the administration or use of prescription drugs, including injectable and sterile drug products (medical spa), to: ! Acquire or receive a prescription drug from a person not legally authorized to distribute or transfer the prescription drug; ! Fail to store, handle, prepare, or administer a prescription drug in accordance with manufacturer requirements, applicable federal and state law, or generally accepted standards of medical practice; ! Permit an individual to prescribe or administer prescription drugs outside the scope of the individual's state-issued credential; ! Fail to maintain reasonable safeguards to prevent contamination, diversion, theft, or misuse of prescription drugs; ! Represent that a prescription drug is safe or effective in a manner inconsistent with federal law or federal food and drug administration-approved labeling; has sponsorship, approval, characteristics, ingredients, uses, or benefits that it does not have; or is approved by the federal food and drug administration when it is not; ! Fail to designate a licensed health-care provider with prescriptive authority to provide clinical oversight of prescription drugs used at the medical spa; or ! Fail to create, maintain, or produce to the attorney general or a district attorney records of serious adverse events involving patients. The attorney general or a district attorney may enforce a violation of a prohibited action specified in the bill. The attorney general may adopt rules to implement the bill.

Be it enacted by the General Assembly of the State of Colorado: SECTION 1. Short title. The short title of this act is the "Medical Spa Prescription Drug Consumer Protection Act". SECTION 2. Legislative declaration. (1) The general assembly finds that:

(a) Medical spas operating in Colorado increasingly provide services involving the administration or use of prescription drugs, including injectable and sterile drug products, in facilities marketed primarily for cosmetic, aesthetic, wellness, longevity, or lifestyle purposes rather than as traditional health-care offices;

(b) Consumers may reasonably assume that prescription drugs administered in medical spa settings are subject to uniform safety standards and truthful representations, when in fact oversight varies depending on the business model and the credentials of individual practitioners;

(c) The improper acquisition, storage, handling, administration, or marketing of prescription drugs in a medical spa setting presents a risk of serious adverse events and patient harm, particularly when prescription drugs are used without adequate clinical oversight or outside the scope of a practitioner's license;

(d) The state has a compelling interest in preventing deceptive, misleading, or unsafe business practices involving prescription drugs, regardless of the setting in which those drugs are administered; and

(e) The "Colorado Consumer Protection Act", article 1 of title 6, Colorado Revised Statutes, provides the attorney general and district attorneys with established investigatory and enforcement authority to address deceptive or unfair trade practices without the creation of a new regulatory or licensing program.

(2) Therefore, the general assembly declares that the purposes of this act are to: (a) Establish clear, enforceable standards of conduct applicable to medical spas that administer or use prescription drugs;

(b) Prohibit deceptive or unfair practices relating to the sourcing, handling, administration, and representation of prescription drugs in medical spa settings; (c) Authorize enforcement by the attorney general and district attorneys under the "Colorado Consumer Protection Act";

(d) Avoid the creation of a new state registration, licensing, or inspection program or the imposition of mandatory administrative duties on a state agency; and

(e) Preserve the authority of existing professional regulatory boards to regulate professionals within their respective scopes of practice.

SECTION 3. In Colorado Revised Statutes, add 6-1-741 as follows: 6-1-741. Medical spas - prohibited practices - enforcement rules - definitions. (1) Definitions. AS USED IN THIS SECTION, UNLESS THE CONTEXT OTHERWISE REQUIRES:

(a) "FOOD AND DRUG ADMINISTRATION" OR "FDA" MEANS THE FOOD AND DRUG ADMINISTRATION IN THE UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, OR ANY SUCCESSOR ENTITY.

(b) "MEDICAL SPA" MEANS A FACILITY OR PRACTICE THAT:

(I) OFFERS OR PROVIDES MEDICAL HEALTH-CARE SERVICES;

(II) PREPARES, ADMINISTERS, DISPENSES, OR OTHERWISE USES PRESCRIPTION SUBCUTANEOUS DELIVERY; AND DRUGS FOR INTRAVENOUS, INTRAMUSCULAR, OR

(III) HOLDS ITSELF OUT TO THE PUBLIC AS PROVIDING COSMETIC, AESTHETIC, WELLNESS, LONGEVITY, INCLUDING WEIGHT LOSS SERVICES, BOTULINUM TOXIN INJECTIONS, DERMAL FILLERS, HORMONE THERAPIES, HAIR LOSS TREATMENTS, OR PARENTERAL NUTRIENT THERAPIES.

OR LIFESTYLE TREATMENTS,

(c) "PRESCRIPTION DRUG" HAS THE MEANING SET FORTH IN SECTION 12-280-103.

(d) "SERIOUS ADVERSE EVENT" MEANS AN ADVERSE EVENT RESULTING IN DEATH, A LIFE-THREATENING CONDITION, INPATIENT HOSPITALIZATION, PERSISTENT OR SIGNIFICANT DISABILITY, OR MEDICAL INTERVENTION NECESSARY TO PREVENT SUCH OUTCOMES.

(2) Prohibited practices. A MEDICAL SPA ENGAGES IN AN UNFAIR OR DECEPTIVE TRADE PRACTICE UNDER THIS ARTICLE 1 WHEN, IN THE COURSE OF ITS BUSINESS, VOCATION, OR OCCUPATION, THE MEDICAL SPA:

(a) ACQUIRES OR RECEIVES A PRESCRIPTION DRUG FROM A PERSON NOT PRESCRIPTION DRUG;

LEGALLY AUTHORIZED TO DISTRIBUTE OR TRANSFER THE (b) PRESCRIPTION REQUIREMENTS, APPLICABLE FEDERAL AND STATE LAW, OR GENERALLY ACCEPTED STANDARDS OF MEDICAL PRACTICE;

(c) FAILS TO STORE, HANDLE, PREPARE, OR ADMINISTER A DRUG IN ACCORDANCE WITH MANUFACTURER PERMITS AN INDIVIDUAL TO PRESCRIBE OR ADMINISTER PRESCRIPTION DRUGS OUTSIDE THE SCOPE OF THE INDIVIDUAL'S STATE-ISSUED CREDENTIAL;

(d) FAILS TO MAINTAIN REASONABLE SAFEGUARDS TO PREVENT CONTAMINATION, DIVERSION, THEFT, OR MISUSE OF PRESCRIPTION DRUGS;

(e) REPRESENTS THAT A PRESCRIPTION DRUG:

(I) IS SAFE OR EFFECTIVE IN A MANNER INCONSISTENT WITH FEDERAL LAW OR FDA-APPROVED LABELING;

(II) HAS SPONSORSHIP, APPROVAL, CHARACTERISTICS, INGREDIENTS, USES, OR BENEFITS THAT IT DOES NOT HAVE; OR

(III) IS APPROVED BY THE FOOD AND DRUG ADMINISTRATION WHEN IT IS NOT;

(f) FAILS TO DESIGNATE A LICENSED HEALTH-CARE PROVIDER WITH PRESCRIPTIVE PRESCRIPTION DRUGS USED AT THE MEDICAL SPA; OR AUTHORITY TO PROVIDE CLINICAL OVERSIGHT OF

(g) FAILS TO CREATE, MAINTAIN, OR PRODUCE TO THE ATTORNEY GENERAL OR A DISTRICT ATTORNEY RECORDS OF SERIOUS ADVERSE EVENTS REQUIRED PURSUANT TO SUBSECTION (3) OF THIS SECTION.

(3) Records of serious adverse events.

(a) A MEDICAL SPA SHALL CREATE AND MAINTAIN INTERNAL RECORDS OF A PATIENT'S SERIOUS ADVERSE EVENTS INVOLVING PRESCRIPTION DRUGS ADMINISTERED AT THE MEDICAL SPA.

(b) RECORDS REQUIRED UNDER SUBSECTION (3)(a) OF THIS SECTION MUST BE PRODUCED UPON REQUEST OF THE ATTORNEY GENERAL OR THE DISTRICT ATTORNEY WITH JURISDICTION OVER THE MEDICAL SPA FOR PURPOSES OF ENFORCING THIS SECTION.

(c) RECORDS AND INFORMATION RELATING TO SERIOUS ADVERSE EVENTS ARE CONFIDENTIAL AND ARE NOT SUBJECT TO PUBLIC INSPECTION PURSUANT TO SECTION 24-72-204 (2).

(4) THE ATTORNEY GENERAL MAY ADOPT RULES TO IMPLEMENT THIS SECTION.

SECTION 4.

Act subject to petition - effective date - applicability. (1) This act takes effect at 12:01 a.m. on the day following the expiration of the ninety-day period after final adjournment of the general assembly (August 12, 2026, if adjournment sine die is on May 13, 2026); except that, if a referendum petition is filed pursuant to section 1

(3) of article V of the state constitution against this act or an item, section, or part of this act within such period, then the act, item, section, or part will not take effect unless approved by the people at the general election to be held in November 2026 and, in such case, will take effect on the date of the official declaration of the vote thereon by the governor.

(2) This act applies to actions taken on or after the applicable effective date of this act.