Ind. Code § 16-42-22.5-0.5 Applicability
Sec. 0.5. This chapter does not apply to:
(1) the compounding of; or
(2) a compounded;
drug for animal use.
As added by P.L.136-2026, SEC.3.
Ind. Code ch. 16-42-22.5
Ind. Code ch. 16-42-22.5
in effectInd. Code § 16-42-22.5-1 "Bulk drug substance"
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;
in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
(b) 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.
As added by P.L.136-2026, SEC.3. Amended by P.L.160-2026, SEC.15.
Ind. Code § 16-42-22.5-2 "Compounding"
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.
As added by P.L.136-2026, SEC.3.
Ind. Code § 16-42-22.5-3 Requirements to engage in compounding; nonresident pharmacies; maintenance of records
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 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.
As added by P.L.136-2026, SEC.3.
Ind. Code § 16-42-22.5-4 Compliance with federal laws
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.
As added by P.L.136-2026, SEC.3.
Ind. Code § 16-42-22.5-5 Indiana board of pharmacy with primary authority to investigate
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.
As added by P.L.136-2026, SEC.3.
Ind. Code § 16-42-22.5-6 Report; requirements; posted on websites; submission to legislative council
Sec. 6. (a) The state department, in consultation with the 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.
As added by P.L.136-2026, SEC.3.
Source: Open US Law by Vaquill AI (CC BY 4.0)URL: https://iga.in.gov/laws/2026/ic/titles/16Fetched: 10/17/2026