1. (a) A person may not engage in compounding unless the following requirements are met:

   1. (1) The bulk drug substance is not:

      1. (A) research grade, unless part of a study approved by an institutional review board; or
      2. (B) veterinary grade.
   2. (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. (3) The bulk drug substance is accompanied by a valid certificate of analysis that includes the following:

      1. (A) The identity and content of the bulk drug substance.
      2. (B) The country where the bulk drug substance was originally manufactured.
   4. (4) The bulk drug substance has had quality control testing conducted.
   5. (5) The compounding complies with the federal Food, Drug, and Cosmetic Act.
   6. (6) The compounding complies with any applicable chapter of the United States Pharmacopeia (USP).
2. (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.
3. (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.