contract manufacturing organization facility
Defined in 1 dictionary — U.S. Code
United States Code
21 U.S.C. § 379j-41 — for purposes of this subpart
The term "contract manufacturing organization facility" means a manufacturing facility of a finished dosage form of a drug approved pursuant to an abbreviated new drug application, where such manufacturing facility is not identified in an approved abbreviated new drug application held by the owner of such facility or an affiliate of such owner or facility.
21 U.S.C. § 379j-71 — in this subpart
The term "contract manufacturing organization facility" means an OTC monograph drug facility where neither the owner of such manufacturing facility nor any affiliate of such owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States.