### Question
Can you define what contract manufacturing organization facility means?


### Answer
**Contract manufacturing organization facility** is defined as the following in *21 U.S.C. § 379j*:

> 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

#### Citation:
  - *21 U.S.C. § 379j*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER VII-GENERAL AUTHORITY > Part C-Fees > subpart 10-fees relating to over-the-counter drugs**

