IC 24-5-26.5-5: "Manufacturer"

Sec. 5. As used in this chapter, "manufacturer" means either of the following:

(1) A person that is engaged in a business to produce, create, make, or construct any product or component of a product, and that:

(A) designs, manufactures, or formulates; or

(B) engages another person to design, manufacture, or formulate;

a medical device or component or part of a medical device.

(2) A person that, by compounding, cultivating, harvesting, or mixing, or by another process produces or prepares legend drugs. The term includes a person that:

(A) prepares legend drugs in dosage forms by mixing, compounding, encapsulating, or entableting, or by another process; or

(B) packages or repackages legend drugs.

The term does not include a pharmacist or a practitioner (as defined in IC 16-42-19-5).