SB 282

           Second Regular Session of the 124th General Assembly (2026)
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between statutes enacted by the 2025 Regular Session of the General Assembly.
    SENATE ENROLLED ACT No. 282
    AN ACT to amend the Indiana Code concerning health.
    Be it enacted by the General Assembly of the State of Indiana:
   SECTION 1. IC 16-18-2-41.2 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2026]: Sec. 41.2. "Bulk drug substance", for
purposes of IC 16-42-22.5, has the meaning set forth in
IC 16-42-22.5-1.
   SECTION 2. IC 16-18-2-66.8 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2026]: Sec. 66.8. "Compounding", for
purposes of IC 16-42-22.5, has the meaning set forth in
IC 16-42-22.5-2.
   SECTION 3. IC 16-42-22.5 IS ADDED TO THE INDIANA CODE
AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2026]:
   Chapter 22.5. Drugs: Restrictions on Bulk Drug Substances
   Sec. 0.5. This chapter does not apply to:
     (1) the compounding of; or
     (2) a compounded;
drug for animal use.
   Sec. 1. (a) As used in this chapter, "bulk drug substance" means
a substance that is intended:
     (1) for incorporation into a finished drug product; and
     (2) to furnish pharmacological activity or other direct effect;
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in the diagnosis, cure, mitigation, treatment, or prevention of
disease, or to affect the structure or any function of the body.
   (b) The term includes an amino acid.
   (c) The term does not include the following:
     (1) A vitamin, mineral, herb, essential oil, extract, or other
     non-pharmaceutical ingredient not described in subsection
     (a).
     (2) Intermediates used in the synthesis of a substance.
   Sec. 2. (a) As used in this chapter, "compounding" means the
combining, admixing, mixing, diluting, pooling, reconstituting, or
otherwise altering of a drug or bulk drug substance by:
     (1) a pharmacist licensed under IC 25-26;
     (2) a physician licensed under IC 25-22.5; or
     (3) an individual under the supervision of an individual
     described in subdivision (1) or (2);
to create a compounded drug.
   (b) The term does not include the following:
     (1) The mixing, reconstituting, or other acts performed in
     accordance with:
        (A) directions contained in the labeling that are:
           (i) approved by the federal Food and Drug
           Administration; and
           (ii) provided by the product's manufacturer; and
        (B) any other directions provided by a manufacturer that
        are consistent with the labeling.
     (2) The addition of flavoring.
   Sec. 3. (a) A person may not engage in compounding unless the
following requirements are met:
     (1) The bulk drug substance is not:
        (A) research grade, unless part of a study approved by an
        institutional review board; or
        (B) veterinary grade.
     (2) The bulk drug substance was manufactured by an
     establishment that is registered as a human drug
     establishment with the federal Food and Drug Administration
     under 21 U.S.C. 360.
     (3) The bulk drug substance is accompanied by a valid
     certificate of analysis that includes the following:
        (A) The identity and content of the bulk drug substance.
        (B) The country where the bulk drug substance was
        originally manufactured.
     (4) The bulk drug substance has had quality control testing
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     conducted.
     (5) The compounding complies with the federal Food, Drug,
     and Cosmetic Act.
     (6) The compounding complies with any applicable chapter of
     the United States Pharmacopeia (USP).
   (b) Upon request by the Indiana board of pharmacy, a
nonresident pharmacy (as defined in IC 25-26-17-2) that ships,
mails, delivers, or dispenses a compounded drug into Indiana that
is compounded using a bulk drug substance shall provide
documentation demonstrating compliance with this chapter and
IC 25-26-17-3 within a reasonable time, as determined by the
Indiana board of pharmacy based on the circumstances of the
request.
   (c) Any person engaging in the sale, transfer, or distribution of
compounding drugs shall maintain all records related to the
acquisition, examination, and testing of the bulk drug substance for
at least two (2) years after the expiration date of the last lot of
compounded drugs containing the bulk drug substance.
   Sec. 4. (a) A pharmacy that is subject to Section 503A of the
federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a) shall
comply with Section 503A of the federal Food, Drug, and Cosmetic
Act, and any regulation promulgated under Section 503A of the
federal Food, Drug, and Cosmetic Act.
   (b) A facility that is subject to Section 503B of the federal Food,
Drug, and Cosmetic Act (21 U.S.C. 353b) shall comply with Section
503B of the federal Food, Drug, and Cosmetic Act, and any
regulation promulgated under Section 503B of the federal Food,
Drug, and Cosmetic Act.
   (c) A manufacturer required to obtain approval under 21 U.S.C.
355 shall comply with federal new drug approval and current good
manufacturing practice requirements.
   Sec. 5. (a) The Indiana board of pharmacy shall have primary
authority to investigate the:
     (1) sourcing;
     (2) storage;
     (3) labeling;
     (4) handling; and
     (5) compounding;
of a prescription drug.
   (b) The Indiana board of pharmacy may investigate any alleged
violation of this chapter.
   Sec. 6. (a) The state department, in consultation with the
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Indiana board of pharmacy, the medical licensing board of
Indiana, the Indiana state board of nursing, and the office of the
attorney general shall develop and publish a report not later than
March 1 and September 1 of each year concerning the oversight of
drug compounding and the risks and benefits posed by the practice
of compounding.
   (b) The report must include the following:
      (1) The number and type of professional licenses issued, by
      license type, under which the license holder may engage in
      drug compounding.
      (2) The number of licensed facilities and practices that:
          (A) conduct drug compounding; or
          (B) handle, store, administer, dispense, distribute, or use
          compounded drugs in a retail or outpatient setting,
          including:
            (i) a 503A pharmacy (as described in 21 U.S.C. 353a);
            and
            (ii) a medical spa (as defined in IC 25-22.5-12.5);
      categorized by license type. This subdivision does not include
      a hospital or ambulatory outpatient surgical center licensed
      under IC 16-21.
      (3) A summary of any findings related to deficiencies or
      violations found by the regulating board for a facility
      described in subdivision (2).
      (4) The number of investigations conducted concerning drug
      compounding.
      (5) The number and type of disciplinary actions taken,
      including improper marketing, advertising, or promotion of
      compounding drugs or related services.
   (c) The report required by this section must be posted on the
websites of the state department and the Indiana board of
pharmacy. The state department shall submit the report to the
legislative council in an electronic format under IC 5-14-6.
   SECTION 4. IC 25-22.5-12.5 IS ADDED TO THE INDIANA
CODE AS A NEW CHAPTER TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2026]:
   Chapter 12.5. Medical Spas
   Sec. 1. (a) As used in this chapter, "medical spa" means a
facility or practice that:
      (1) offers or provides medical health care services;
      (2) engages in the preparation, administration, or dispensing
      of prescription drugs or otherwise uses prescription drugs for
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     intravenous, intramuscular, or subcutaneous delivery; and
     (3) holds itself out as a facility or practice focused on cosmetic
     or lifestyle treatments, including any of the following:
         (A) Weight loss.
         (B) Wellness.
         (C) Longevity.
         (D) Cosmetic or aesthetic health services and treatments,
         including the preparation, administration, or dispensing of
         prescription drugs for:
           (i) weight loss;
           (ii) botulinum toxin injections and dermal fillers;
           (iii) hair loss;
           (iv) hormone therapies; or
           (v) parenteral nutrient therapies.
         (E) The nonsurgical use of a laser or other energy device
         for cosmetic purposes, including use for rejuvenation,
         anti-aging, or hair removal.
   (b) The term does not apply to the following:
     (1) A physician's office.
     (2) A facility or practice that is otherwise licensed by the state.
   Sec. 2. As used in this chapter, "practitioner" means any of the
following:
     (1) A physician licensed under IC 25-22.5.
     (2) An advanced practice registered nurse who meets the
     requirements of IC 25-23-1-19.5.
     (3) A physician assistant licensed under IC 25-27.5 who is
     delegated prescriptive authority under IC 25-27.5-5-6.
   Sec. 3. (a) Beginning January 1, 2027, a medical spa is required
to be registered under this chapter in order to do business in
Indiana.
   (b) The board shall establish a registration procedure for
medical spas not later than October 1, 2026. An application for
registration for a medical spa must include the following:
     (1) The name of the medical spa, including the following:
         (A) Any name under which the medical spa does or will do
         business in Indiana.
         (B) The legal name of the medical spa.
     (2) The address of the medical spa.
     (3) The website address of the medical spa.
     (4) The medical health care services intended to be provided
     at the medical spa.
     (5) A statement concerning whether or not the medical spa
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     engages in or plans to engage in compounding (as defined in
     IC 16-42-22.5-2) drugs at the medical spa.
     (6) The name and license number of the medical spa's licensed
     responsible practitioner described in section 5 of this chapter
     and the name of the responsible practitioner's collaborating
     physician or supervising practitioner, if applicable.
   (c) The board may fine a person that operates an unregistered
medical spa in an amount not to exceed five thousand dollars
($5,000) and require that the person obtain registration under this
chapter in order to do business in Indiana.
   Sec. 4. (a) The board shall establish and maintain a public data
base that contains the information specified in section 3(b) of this
chapter for each registered medical spa.
   (b) The board shall redact any personally identifying health
information as confidential before including any information on
the data base.
   Sec. 5. (a) A medical spa registered under this chapter must
designate a responsible practitioner who meets the following:
     (1) Has prescriptive authority.
     (2) Has education and training in the health care services and
     treatments being performed and medications being dispensed
     or administered in the medical spa.
   (b) A responsible practitioner shall be physically present at the
medical spa location for a sufficient amount of time to comply with
the responsibility of ensuring that the medical spa complies with
the requirements of this chapter.
   (c) A responsible practitioner shall ensure that each individual
working at the medical spa meets the following:
     (1) Is licensed to perform the health care services and
     treatments the individual is to perform and that the health
     care services and treatments are within the individual's scope
     of practice.
     (2) Has received appropriate training in the performance of
     the health care services and treatments being provided by the
     individual.
   Sec. 6. (a) As used in this section, "serious adverse event" means
any negative medical occurrence associated with the use of a
prescription medication or treatment provided that results in,
based on a reasonable medical judgment, jeopardy to an
individual's health resulting in medical or surgical intervention or
any of the following outcomes:
     (1) Death.
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     (2) A life threatening medical occurrence.
     (3) Inpatient hospitalization or prolonging of an existing
     hospitalization.
   (b) A medical spa shall notify the board in the manner
prescribed by the board not later than fifteen (15) days after the
occurrence of a patient's serious adverse event. The notice must
include, to the extent that the information may be obtained or
reasonably available from the source, the following:
     (1) The name of the patient, the prescription medication
     treatment involved, and the date of the serious adverse event.
     (2) The nature and location of the serious adverse event.
     (3) The medical records for the patient concerning the serious
     adverse event.
   Sec. 7. The board may investigate a responsible practitioner
concerning any claim of a violation of this chapter and forward
any substantiated claim to the governing board of the responsible
practitioner.
   Sec. 8. An individual licensed or certified under this title who
violates this chapter is subject to discipline under IC 25-1-9.
   Sec. 9. A medical spa may not provide health care services and
cosmetic and lifestyle treatments to a consumer at a location other
than the medical spa office unless the health care service or
treatment is being performed in another location for educational
or training purposes of individuals who intend to provide these
services or treatment.
   Sec. 10. (a) A medical spa shall comply with the advertising
requirements set forth in IC 25-1-10.3.
   (b) The board may suspend a registration under this chapter for
a violation of IC 25-1-10.3.
   Sec. 11. (a) The board shall consult with the appropriate
professional board that has oversight of a profession concerning
any issues concerning the practice of the profession as it relates to
providing services in a medical spa.
   (b) Nothing in this chapter precludes a governing board of a
practitioner to take any action against a practitioner for a violation
of the practitioner's license or certification.
   SECTION 5. IC 25-26-13-4, AS AMENDED BY P.L.93-2024,
SECTION 186, IS AMENDED TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2026]: Sec. 4. (a) The board may:
     (1) adopt rules under IC 4-22-2 for implementing and enforcing
     this chapter;
     (2) establish requirements and tests to determine the moral,
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    physical, intellectual, educational, scientific, technical, and
    professional qualifications for applicants for pharmacists'
    licenses;
    (3) refuse to issue, deny, suspend, or revoke a license or permit or
    place on probation or fine any licensee or permittee under this
    chapter;
    (4) regulate the sale of drugs and devices in the state of Indiana;
    (5) impound, embargo, confiscate, or otherwise prevent from
    disposition any drugs, medicines, chemicals, poisons, or devices
    which by inspection are deemed unfit for use or would be
    dangerous to the health and welfare of the citizens of the state of
    Indiana; the board shall follow those embargo procedures found
    in IC 16-42-1-18 through IC 16-42-1-31, and persons may not
    refuse to permit or otherwise prevent members of the board or
    their representatives from entering such places and making such
    inspections;
    (6) prescribe minimum standards with respect to physical
    characteristics of pharmacies, as may be necessary to the
    maintenance of professional surroundings and to the protection of
    the safety and welfare of the public;
    (7) subject to IC 25-1-7, investigate complaints, subpoena
    witnesses, schedule and conduct hearings on behalf of the public
    interest on any matter under the jurisdiction of the board;
    (8) prescribe the time, place, method, manner, scope, and subjects
    of licensing examinations which shall be given at least twice
    annually; and
    (9) perform such other duties and functions and exercise such
    other powers as may be necessary to implement and enforce this
    chapter; and
    (10) oversee and investigate IC 16-42-22.5.
  (b) The board shall adopt rules under IC 4-22-2 for the following:
    (1) Establishing standards for the competent practice of
    pharmacy.
    (2) Establishing the standards for a pharmacist to counsel
    individuals regarding the proper use of drugs.
    (3) Establishing standards and procedures before January 1, 2006,
    to ensure that a pharmacist:
        (A) has entered into a contract that accepts the return of
        expired drugs with; or
        (B) is subject to a policy that accepts the return of expired
        drugs of;
    a wholesaler, manufacturer, or agent of a wholesaler or
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       manufacturer concerning the return by the pharmacist to the
       wholesaler, the manufacturer, or the agent of expired legend drugs
       or controlled drugs. In determining the standards and procedures,
       the board may not interfere with negotiated terms related to cost,
       expenses, or reimbursement charges contained in contracts
       between parties, but may consider what is a reasonable quantity
       of a drug to be purchased by a pharmacy. The standards and
       procedures do not apply to vaccines that prevent influenza,
       medicine used for the treatment of malignant hyperthermia, and
       other drugs determined by the board to not be subject to a return
       policy. An agent of a wholesaler or manufacturer must be
       appointed in writing and have policies, personnel, and facilities
       to handle properly returns of expired legend drugs and controlled
       substances.
    (c) The board may grant or deny a temporary variance to a rule it
has adopted if:
       (1) the board has adopted rules which set forth the procedures and
       standards governing the grant or denial of a temporary variance;
       and
       (2) the board sets forth in writing the reasons for a grant or denial
       of a temporary variance.
    (d) The board shall adopt rules and procedures, in consultation with
the medical licensing board, concerning the electronic transmission of
prescriptions. The rules adopted under this subsection must address the
following:
       (1) Privacy protection for the practitioner and the practitioner's
       patient.
       (2) Security of the electronic transmission.
       (3) A process for approving electronic data intermediaries for the
       electronic transmission of prescriptions.
       (4) Use of a practitioner's United States Drug Enforcement
       Agency registration number.
       (5) Protection of the practitioner from identity theft or fraudulent
       use of the practitioner's prescribing authority.
    (e) The governor may direct the board to develop:
       (1) a prescription drug program that includes the establishment of
       criteria to eliminate or significantly reduce prescription fraud; and
       (2) a standard format for an official tamper resistant prescription
       drug form for prescriptions (as defined in IC 16-42-19-7(1)).
The board may adopt rules under IC 4-22-2 necessary to implement
this subsection.
    (f) The standard format for a prescription drug form described in
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subsection (e)(2) must include the following:
      (1) A counterfeit protection bar code with human readable
      representation of the data in the bar code.
      (2) A thermochromic mark on the front and the back of the
      prescription that:
          (A) is at least one-fourth (1/4) of one (1) inch in height and
          width; and
          (B) changes from blue to clear when exposed to heat.
   (g) The board may contract with a supplier to implement and
manage the prescription drug program described in subsection (e). The
supplier must:
      (1) have been audited by a third party auditor using the SAS 70
      audit or an equivalent audit for at least the three (3) previous
      years; and
      (2) be audited by a third party auditor using the SAS 70 audit or
      an equivalent audit throughout the duration of the contract;
in order to be considered to implement and manage the program.
   (h) The board shall adopt rules under IC 4-22-2 concerning:
      (1) professional determinations made under IC 35-48-4-14.7(d);
      and
      (2) the determination of a relationship on record with the
      pharmacy under IC 35-48-4-14.7.
   (i) The board may:
      (1) review professional determinations made by a pharmacist; and
      (2) take appropriate disciplinary action against a pharmacist who
      violates a rule adopted under subsection (h) concerning a
      professional determination made;
under IC 35-48-4-14.7 concerning the sale of ephedrine and
pseudoephedrine.
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President of the Senate
President Pro Tempore
Speaker of the House of Representatives
Governor of the State of Indiana
Date:  Time:
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