SB 130

                           Second Regular Session
                        Seventy-fifth General Assembly
                          STATE OF COLORADO
                                                                          INTRODUCED
LLS NO. 26-0751.02 Brita Darling x2241  SENATE BILL 26-130
                           SENATE SPONSORSHIP
 Kipp and Frizell,
                            HOUSE SPONSORSHIP
 Lieder,
Senate Committees  House Committees
Health & Human Services
                                    A BILL FOR AN ACT
101      CONCERNING THE OPERATION OF MEDICAL SPAS INVOLVING THE USE
102OF PRESCRIPTION DRUGS, AND, IN CONNECTION THEREWITH,
103ESTABLISHING THAT CERTAIN ACTIONS BY MEDICAL SPAS ARE
104UNFAIR       OR    DECEPTIVE  TRADE       PRACTICES  UNDER       THE
105"COLORADO CONSUMER PROTECTION ACT".
                                          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.
1 Be it enacted by the General Assembly of the State of Colorado:
2SECTION 1. Short title. The short title of this act is the "Medical
3 Spa Prescription Drug Consumer Protection Act".
4SECTION 2. Legislative declaration. (1) The general assembly
5 finds that:
6(a) Medical spas operating in Colorado increasingly provide
7 services involving the administration or use of prescription drugs,
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1 including injectable and sterile drug products, in facilities marketed
2 primarily for cosmetic, aesthetic, wellness, longevity, or lifestyle purposes
3 rather than as traditional health-care offices;
4(b) Consumers may reasonably assume that prescription drugs
5 administered in medical spa settings are subject to uniform safety
6 standards and truthful representations, when in fact oversight varies
7 depending on the business model and the credentials of individual
8 practitioners;
9(c) The improper acquisition, storage, handling, administration,
10 or marketing of prescription drugs in a medical spa setting presents a risk
11 of serious adverse events and patient harm, particularly when prescription
12 drugs are used without adequate clinical oversight or outside the scope of
13 a practitioner's license;
14(d) The state has a compelling interest in preventing deceptive,
15 misleading, or unsafe business practices involving prescription drugs,
16 regardless of the setting in which those drugs are administered; and
17(e) The "Colorado Consumer Protection Act", article 1 of title 6,
18 Colorado Revised Statutes, provides the attorney general and district
19 attorneys with established investigatory and enforcement authority to
20 address deceptive or unfair trade practices without the creation of a new
21 regulatory or licensing program.
22(2) Therefore, the general assembly declares that the purposes of
23 this act are to:
24(a) Establish clear, enforceable standards of conduct applicable to
25 medical spas that administer or use prescription drugs;
26(b) Prohibit deceptive or unfair practices relating to the sourcing,
27 handling, administration, and representation of prescription drugs in
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1 medical spa settings;
2(c) Authorize enforcement by the attorney general and district
3 attorneys under the "Colorado Consumer Protection Act";
4(d) Avoid the creation of a new state registration, licensing, or
5 inspection program or the imposition of mandatory administrative duties
6 on a state agency; and
7(e) Preserve the authority of existing professional regulatory
8 boards to regulate professionals within their respective scopes of practice.
9SECTION 3. In Colorado Revised Statutes, add 6-1-741 as
10 follows:
116-1-741. Medical spas - prohibited practices - enforcement -
12 rules - definitions.
13(1) Definitions. AS USED IN THIS SECTION, UNLESS THE CONTEXT
14 OTHERWISE REQUIRES:
15(a) "FOOD AND DRUG ADMINISTRATION" OR "FDA" MEANS THE
16 FOOD AND DRUG ADMINISTRATION IN THE UNITED STATES DEPARTMENT
17 OF HEALTH AND HUMAN SERVICES, OR ANY SUCCESSOR ENTITY.
18(b) "MEDICAL SPA" MEANS A FACILITY OR PRACTICE THAT:
19(I) OFFERS OR PROVIDES MEDICAL HEALTH-CARE SERVICES;
20(II) PREPARES, ADMINISTERS, DISPENSES, OR OTHERWISE USES
21 PRESCRIPTION     DRUGS     FOR   INTRAVENOUS,      INTRAMUSCULAR,        OR
22 SUBCUTANEOUS DELIVERY; AND
23(III) HOLDS ITSELF OUT TO THE PUBLIC AS PROVIDING COSMETIC,
24 AESTHETIC,    WELLNESS,     LONGEVITY,     OR   LIFESTYLE    TREATMENTS,
25 INCLUDING WEIGHT LOSS SERVICES, BOTULINUM TOXIN INJECTIONS,
26 DERMAL FILLERS, HORMONE THERAPIES, HAIR LOSS TREATMENTS, OR
27 PARENTERAL NUTRIENT THERAPIES.
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1(c) "PRESCRIPTION DRUG" HAS THE MEANING SET FORTH IN
2 SECTION 12-280-103.
3(d)    "SERIOUS ADVERSE EVENT" MEANS AN ADVERSE EVENT
4 RESULTING IN DEATH, A LIFE-THREATENING CONDITION, INPATIENT
5 HOSPITALIZATION, PERSISTENT OR SIGNIFICANT DISABILITY, OR MEDICAL
6 INTERVENTION NECESSARY TO PREVENT SUCH OUTCOMES.
7(2) Prohibited practices. A MEDICAL SPA ENGAGES IN AN UNFAIR
8 OR DECEPTIVE TRADE PRACTICE UNDER THIS ARTICLE 1 WHEN, IN THE
9 COURSE OF ITS BUSINESS, VOCATION, OR OCCUPATION, THE MEDICAL SPA:
10(a) ACQUIRES OR RECEIVES A PRESCRIPTION DRUG FROM A PERSON
11 NOT   LEGALLY    AUTHORIZED   TO     DISTRIBUTE    OR   TRANSFER   THE
12 PRESCRIPTION DRUG;
13(b)    FAILS TO STORE, HANDLE, PREPARE, OR ADMINISTER A
14 PRESCRIPTION     DRUG   IN   ACCORDANCE      WITH       MANUFACTURER
15 REQUIREMENTS, APPLICABLE FEDERAL AND STATE LAW, OR GENERALLY
16 ACCEPTED STANDARDS OF MEDICAL PRACTICE;
17(c)    PERMITS AN INDIVIDUAL TO PRESCRIBE OR ADMINISTER
18 PRESCRIPTION DRUGS OUTSIDE THE SCOPE OF THE INDIVIDUAL'S
19 STATE-ISSUED CREDENTIAL;
20(d) FAILS TO MAINTAIN REASONABLE SAFEGUARDS TO PREVENT
21 CONTAMINATION, DIVERSION, THEFT, OR MISUSE OF PRESCRIPTION DRUGS;
22(e) REPRESENTS THAT A PRESCRIPTION DRUG:
23(I) IS SAFE OR EFFECTIVE IN A MANNER INCONSISTENT WITH
24 FEDERAL LAW OR FDA-APPROVED LABELING;
25(II)      HAS   SPONSORSHIP,     APPROVAL,    CHARACTERISTICS,
26 INGREDIENTS, USES, OR BENEFITS THAT IT DOES NOT HAVE; OR
27(III) IS APPROVED BY THE FOOD AND DRUG ADMINISTRATION WHEN
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1 IT IS NOT;
2(f) FAILS TO DESIGNATE A LICENSED HEALTH-CARE PROVIDER WITH
3 PRESCRIPTIVE     AUTHORITY TO PROVIDE  CLINICAL OVERSIGHT  OF
4 PRESCRIPTION DRUGS USED AT THE MEDICAL SPA; OR
5(g) FAILS TO CREATE, MAINTAIN, OR PRODUCE TO THE ATTORNEY
6 GENERAL OR A DISTRICT ATTORNEY RECORDS OF SERIOUS ADVERSE
7 EVENTS REQUIRED PURSUANT TO SUBSECTION (3) OF THIS SECTION.
8(3) Records of serious adverse events.
9(a) A MEDICAL SPA SHALL CREATE AND MAINTAIN INTERNAL
10 RECORDS OF A PATIENT'S SERIOUS ADVERSE EVENTS INVOLVING
11 PRESCRIPTION DRUGS ADMINISTERED AT THE MEDICAL SPA.
12(b)    RECORDS REQUIRED UNDER SUBSECTION (3)(a) OF THIS
13 SECTION MUST BE PRODUCED UPON REQUEST OF THE ATTORNEY GENERAL
14 OR THE DISTRICT ATTORNEY WITH JURISDICTION OVER THE MEDICAL SPA
15 FOR PURPOSES OF ENFORCING THIS SECTION.
16(c) RECORDS AND INFORMATION RELATING TO SERIOUS ADVERSE
17 EVENTS ARE CONFIDENTIAL AND ARE NOT SUBJECT TO PUBLIC INSPECTION
18 PURSUANT TO SECTION 24-72-204 (2).
19(4) THE ATTORNEY GENERAL MAY ADOPT RULES TO IMPLEMENT
20 THIS SECTION.
21SECTION 4.  Act subject to petition - effective date -
22 applicability. (1) This act takes effect at 12:01 a.m. on the day following
23 the expiration of the ninety-day period after final adjournment of the
24 general assembly (August 12, 2026, if adjournment sine die is on May 13,
25 2026); except that, if a referendum petition is filed pursuant to section 1
26 (3) of article V of the state constitution against this act or an item, section,
27 or part of this act within such period, then the act, item, section, or part
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1 will not take effect unless approved by the people at the general election
2 to be held in November 2026 and, in such case, will take effect on the
3 date of the official declaration of the vote thereon by the governor.
4(2) This act applies to actions taken on or after the applicable
5 effective date of this act.
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