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 ).
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