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).