Manufacturer means any entity that holds the NDC for a covered outpatient drug or biological product and meets the following criteria:
(1) Is engaged in the production, preparation, propagation, compounding, conversion, or processing of covered outpatient drug products, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis; or
(2) Is engaged in the packaging, repackaging, labeling, relabeling, or distribution of covered outpatient drug products and is not a wholesale distributor of drugs or a retail pharmacy licensed under State law.
(3) For authorized generic products, the term “manufacturer” will also include the original holder of the NDA.
(4) For drugs subject to private labeling arrangements, the term “manufacturer” will also include the entity under whose own label or trade name the product will be distributed.
42 CFR § 447.502
For the purpose of this subpart, the following definitions apply: