Prescription Drug Manufacturer

An entity that manufactures, prepares, derives, propagates, or produces a prescription drug, including: an entity that holds an application (NDA or ANDA) approved according to 21 U.S.C. 355 for a prescription drug product; a co-licensed partner of the entity described above that obtains the prescription drug product from the person or firm; or an affiliate of the entity that obtains the prescription drug product from the person or firm. Pharmacists are specifically exempted from this definition if they are acting in the course of their professional practice as defined in Chapter 90 and rules adopted pursuant to it.