OTC monograph drug facility

(10) (A) 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. (B) For purposes of subparagraph (A)(i)(II), separate buildings or locations within close proximity are considered to be at one geographic location or address if the activities conducted in such buildings or locations are— (i) closely related to the same business enterprise; (ii) under the supervision of the same local management; and (iii) under a single FDA establishment identifier and capable of being inspected by the Food and Drug Administration during a single inspection. (C) If a business or other entity would meet criteria specified in subparagraph (A), but for being under multiple management, the business or other entity is deemed to constitute multiple facilities, one per management entity, for purposes of this paragraph.


21 USC § 379j-71(10)

Scoping language

for purposes of this paragraph
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