42 C.F.R. § 414.802 Definitions.
Title 42 - Public Health
As used in this subpart, unless the context indicates otherwise— Drug means both drugs and biologicals. Manufacturer means any entity that is engaged in the following (This term does not include a wholesale distributor of drugs or a retail pharmacy licensed under State law): (1) Production, preparation, propagation, compounding, conversion or processing of prescription 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. (2) The packaging, repackaging, labeling, relabeling, or distribution of prescription drug products. Unit means the product represented by the 11-digit National Drug Code. During the first 3 years of the CAP (as defined in §414.902), the method of counting units excludes units of CAP drugs (as defined in §414.902) sold to an approved CAP vendor (as defined in §414.902) for use under the CAP (as defined in §414.902). [70 FR 69 FR 17938, Apr. 6, 2004, as amended at 70 FR 70481, Nov. 21, 2005; 71 FR 48143, Aug. 18, 2006]
Title 42: Public Health
PART 414—PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES
Subpart J—Submission of Manufacturer's Average Sales Price Data
§ 414.802 Definitions.
