OTC monograph drug facility
Defined in 1 dictionary — U.S. Code
United States Code
21 U.S.C. § 379j-71 — in this subpart (2 versions over time)
The term “OTC monograph drug facility” means a foreign or domestic business or other entity that—
(i) is—
(I) under one management, either direct or indirect; and
(II) at one geographic location or address engaged in manufacturing or processing the finished dosage form of an OTC monograph drug;
(ii) includes a finished dosage form manufacturer facility in a contractual relationship with the sponsor of one or more OTC monograph drugs to manufacture or process such drugs; and
(iii) does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: production of clinical research supplies, testing, or placement of outer packaging on packages containing multiple products, for such purposes as creating multipacks, when each monograph drug product contained within the overpackaging is already in a final packaged form prior to placement in the outer overpackaging.