IC 16-42-22.5-2: "Compounding"
Where this section sits in the code
- TITLE 16. HEALTH
- ARTICLE 42. REGULATION OF FOOD, DRUGS, AND COSMETICS
- Chapter 22.5. Drugs: Restrictions on Bulk Drug Substances
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.
Collected 2026-09-11T20:02:18Z. Source file · JSON