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Indiana · Snapshot 2026

IC 16-42-22.5-2: "Compounding"

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Where this section sits in the code
  1. TITLE 16. HEALTH
  2. ARTICLE 42. REGULATION OF FOOD, DRUGS, AND COSMETICS
  3. 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

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