Contract Human Over-the-Counter FDF Manufacturing Produced Under a Monograph

**Semantic type:** Activity

**Definition:** The manufacture of human over-the-counter monograph drug products in final dosage form (FDF) 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.

**Synonyms:** - Contract Manufacturing for human over-the-counter drug products produced under a monograph